Conforms to ANSI Z400.5-2004 Standard (United States, Canada).
Material Safety Data Sheet
Amplification Reagent
1. Product and company identification
Product name : Amplification Reagent
Used in : APTIMA CT Assay 301088, APTIMA CT Assay TIGRIS 250-test kit 301199, APTIMA CT
Assay TIGRIS 2x50-test kit 302224, APTIMA GC Assay 301091, APTIMA GC Assay
TIGRIS 250-test kit 301196, APTIMA GC Assay TIGRIS 2x50-test kit 302225, APTIMA
Combo 2 301032, APTIMA Combo 2 TIGRIS 250-test kit 301130, PROGENSA PCA3
Assay Kit CE 302355, PROGENSA PCA3 100-Reaction Kit 302354, PROGENSA PSA
100-Reaction Kit 302357, PCA3 ASR 302247, PSA ASR 302250.
Material uses : In vitro diagnostic.
Supplier/Manufacturer : Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121-4362
MSDS # : 0025
In case of emergency : CANUTEC (613) 996-6666
CHEMTREC, U.S. : (800) 424-9300 International: (703) 527-3887
2. Hazards identification
Physical state : Solid.
OSHA/HCS status : While this material is not considered hazardous by the OSHA Hazard Communication
Standard (29 CFR 1910.1200), this MSDS contains valuable information critical to the
safe handling and proper use of the product. This MSDS should be retained and
available for employees and other users of this product.
Emergency overview : NOT EXPECTED TO PRODUCE SIGNIFICANT ADVERSE HEALTH EFFECTS WHEN
THE RECOMMENDED INSTRUCTIONS FOR USE ARE FOLLOWED.
No known significant effects or critical hazards. Avoid prolonged contact with eyes, skin
and clothing.
Potential acute health effects
Inhalation : Exposure to decomposition products may cause a health hazard. Serious effects may
be delayed following exposure.
Ingestion : No known significant effects or critical hazards.
Skin : No known significant effects or critical hazards.
Eyes : No known significant effects or critical hazards.
Potential chronic health effects
Chronic effects : No known significant effects or critical hazards.
Carcinogenicity : No known significant effects or critical hazards.
Mutagenicity : No known significant effects or critical hazards.
Teratogenicity : No known significant effects or critical hazards.
Developmental effects : No known significant effects or critical hazards.
Fertility effects : No known significant effects or critical hazards.
Over-exposure signs/symptoms
Inhalation : No specific data.
Ingestion : No specific data.
Skin : No specific data.
Eyes : No specific data.
Medical conditions : None known.
aggravated by over-
exposure
See toxicological information (section 11)
: 01/15/2008 Page: 1/6
Date of issue
Amplification Reagent
3. Composition/information on ingredients
Name CAS number %
No hazardous ingredient
Due to differing non-hazardous components, the products listed in each part number in 鈥淯sed In鈥? section are not
interchangeable. See package insert for product use.
There are no ingredients present which, within the current knowledge of the supplier and in the concentrations
applicable, are classified as hazardous to health or the environment and hence require reporting in this section.
4. First aid measures
Eye contact : Check for and remove any contact lenses. In case of contact with eyes, rinse
immediately with plenty of water. Get medical attention if symptoms occur.
Skin contact : Wash with soap and water. Get medical attention if symptoms occur.
Inhalation : If inhaled, remove to fresh air. If not breathing, give artificial respiration. Get medical
attention if symptoms appear.
Ingestion : Do not induce vomiting. Never give anything by mouth to an unconscious person. Get
medical attention if symptoms appear.
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training.
Notes to physician : In case of inhalation of decomposition products in a fire, symptoms may be delayed.
The exposed person may need to be kept under medical surveillance for 48 hours.
5. Fire-fighting measures
Flammability of the product : Non-flammable.
Extinguishing media
Suitable : Use an extinguishing agent suitable for the surrounding fire.
Not suitable : None known.
Hazardous thermal : Decomposition products may include the following materials:
carbon dioxide
decomposition products
carbon monoxide
nitrogen oxides
sulfur oxides
Special protective : Fire-fighters should wear appropriate protective equipment and self-contained breathing
apparatus (SCBA) with a full face-piece operated in positive pressure mode.
equipment for fire-fighters
6. Accidental release measures
Personal precautions : No action shall be taken involving any personal risk or without suitable training.
Evacuate surrounding areas. Keep unnecessary and unprotected personnel from
entering. Do not touch or walk through spilled material. Provide adequate ventilation.
Wear appropriate respirator when ventilation is inadequate. Put on appropriate personal
protective equipment (see section 8).
Environmental precautions : Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains
and sewers. Inform the relevant authorities if the product has caused environmental
pollution (sewers, waterways, soil or air).
Methods for cleaning up
Small spill : Move containers from spill area. Vacuum or sweep up material and place in a
designated, labeled waste container. Dispose of via a licensed waste disposal
contractor.
: 01/15/2008 Page: 2/6
Date of issue
Amplification Reagent
6. Accidental release measures
Large spill : Move containers from spill area. Approach release from upwind. Prevent entry into
sewers, water courses, basements or confined areas. Vacuum or sweep up material
and place in a designated, labeled waste container. Dispose of via a licensed waste
disposal contractor. Note: see section 1 for emergency contact information and section
13 for waste disposal.
7. Handling and storage
Handling : Put on appropriate personal protective equipment (see section 8). Eating, drinking and
smoking should be prohibited in areas where this material is handled, stored and
processed. Workers should wash hands and face before eating, drinking and smoking.
Do not ingest. Avoid contact with eyes, skin and clothing. Keep in the original container
or an approved alternative made from a compatible material, kept tightly closed when not
in use. Empty containers retain product residue and can be hazardous. Do not reuse
container.
Storage : Store in accordance with local regulations. Store in original container protected from
direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials
(see section 10) and food and drink. Keep container tightly closed and sealed until ready
for use. Containers that have been opened must be carefully resealed and kept upright
to prevent leakage. Do not store in unlabeled containers. Use appropriate containment
to avoid environmental contamination.
8. Exposure controls/personal protection
Consult local authorities for acceptable exposure limits.
Recommended monitoring : If this product contains ingredients with exposure limits, personal, workplace atmosphere
or biological monitoring may be required to determine the effectiveness of the ventilation
procedures
or other control measures and/or the necessity to use respiratory protective equipment.
Engineering measures : No special ventilation requirements. Good general ventilation should be sufficient to
control worker exposure to airborne contaminants. If this product contains ingredients
with exposure limits, use process enclosures, local exhaust ventilation or other
engineering controls to keep worker exposure below any recommended or statutory
limits.
Hygiene measures : Wash hands, forearms and face thoroughly after handling chemical products, before
eating, smoking and using the lavatory and at the end of the working period. Appropriate
techniques should be used to remove potentially contaminated clothing. Wash
contaminated clothing before reusing. Ensure that eyewash stations and safety showers
are close to the workstation location.
Personal protection
Eyes : Safety glasses.
Skin : Lab coat.
Respiratory : A respirator is not needed under normal and intended conditions of product use.
Hands : Disposable vinyl gloves.
Personal protective :
equipment (Pictograms)
HMIS Code/Personal :A
protective equipment
Environmental exposure : Emissions from ventilation or work process equipment should be checked to ensure they
comply with the requirements of environmental protection legislation. In some cases,
controls
fume scrubbers, filters or engineering modifications to the process equipment will be
necessary to reduce emissions to acceptable levels.
: 01/15/2008 Page: 3/6
Date of issue
Amplification Reagent
9. Physical and chemical properties
Physical state : Solid.
Color : White to off-white.
pH : 7.7
10 . Stability and reactivity
Stability : The product is stable.
Hazardous polymerization : Under normal conditions of storage and use, hazardous polymerization will not occur.
Conditions to avoid : No specific data.
Materials to avoid : No specific data.
Hazardous decomposition : Under normal conditions of storage and use, hazardous decomposition products should
not be produced.
products
11 . Toxicological information
Acute toxicity
Inhalation : Exposure to decomposition products may cause a health hazard. Serious effects may
be delayed following exposure.
Ingestion : No known significant effects or critical hazards.
Skin : No known significant effects or critical hazards.
Eyes : No known significant effects or critical hazards.
12 . Ecological information
Environmental effects : No known significant effects or critical hazards.
Other adverse effects : No known significant effects or critical hazards.
13 . Disposal considerations
Waste disposal : The generation of waste should be avoided or minimized wherever possible. Empty
containers or liners may retain some product residues. This material and its container
must be disposed of in a safe way. Dispose of surplus and non-recyclable products via
a licensed waste disposal contractor. Disposal of this product, solutions and any by-
products should at all times comply with the requirements of environmental protection
and waste disposal legislation and any regional local authority requirements. Avoid
dispersal of spilled material and runoff and contact with soil, waterways, drains and
sewers.
Disposal should be in accordance with applicable regional, national and local laws and regulations.
Refer to Section 7: HANDLING AND STORAGE and Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
for additional handling information and protection of employees.
14 . Transport information
AERG : Not applicable.
Regulatory information
DOT/ TDG / IMDG/ IATA : Not regulated.
: 01/15/2008 Page: 4/6
Date of issue
Amplification Reagent
15 . Regulatory information
United States
HCS Classification : Not regulated.
U.S. Federal regulations : United States inventory (TSCA 8b): Not determined.
SARA 302/304/311/312 extremely hazardous substances: No products were found.
SARA 302/304 emergency planning and notification: No products were found.
SARA 302/304/311/312 hazardous chemicals: No products were found.
SARA 311/312 MSDS distribution - chemical inventory - hazard identification: No
products were found.
Clean Water Act (CWA) 307: No products were found.
Clean Water Act (CWA) 311: Sodium hydroxide
Clean Air Act (CAA) 112 accidental release prevention: No products were found.
Clean Air Act (CAA) 112 regulated flammable substances: No products were found.
Clean Air Act (CAA) 112 regulated toxic substances: No products were found.
State regulations : Connecticut Carcinogen Reporting: None of the components are listed.
Connecticut Hazardous Material Survey: None of the components are listed.
Florida substances: None of the components are listed.
Illinois Chemical Safety Act: None of the components are listed.
Illinois Toxic Substances Disclosure to Employee Act: None of the components are
listed.
Louisiana Reporting: None of the components are listed.
Louisiana Spill: None of the components are listed.
Massachusetts Spill: None of the components are listed.
Massachusetts Substances: None of the components are listed.
Michigan Critical Material: None of the components are listed.
Minnesota Hazardous Substances: None of the components are listed.
New Jersey Hazardous Substances: None of the components are listed.
New Jersey Spill: None of the components are listed.
New Jersey Toxic Catastrophe Prevention Act: None of the components are listed.
New York Acutely Hazardous Substances: None of the components are listed.
New York Toxic Chemical Release Reporting: None of the components are listed.
Pennsylvania RTK Hazardous Substances: None of the components are listed.
Rhode Island Hazardous Substances: None of the components are listed.
Canada
WHMIS (Canada) : Not controlled under WHMIS (Canada).
Canadian lists : CEPA Toxic substances: None of the components are listed.
Canadian ARET: None of the components are listed.
Canadian NPRI: None of the components are listed.
Alberta Designated Substances: None of the components are listed.
Ontario Designated Substances: None of the components are listed.
Quebec Designated Substances: None of the components are listed.
Canada inventory : Canada inventory: All components listed.
This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations
and the MSDS contains all the information required by the Controlled Products Regulations.
International regulations
International lists : This product, (and its ingredients) is (are) listed on national inventories, or is (are)
exempted from being listed, in Australia (AICS), in Europe (EINECS/ELINCS), in Korea
(TCCL), in Japan (METI), in the Philippines (RA6969).
: 01/15/2008 Page: 5/6
Date of issue
Amplification Reagent
16 . Other information
Label requirements : NOT EXPECTED TO PRODUCE SIGNIFICANT ADVERSE HEALTH EFFECTS WHEN
THE RECOMMENDED INSTRUCTIONS FOR USE ARE FOLLOWED.
Hazardous Material : HAZARD RATINGS
Information System (U.S.A.)
0
Health 4- Extreme
3- Serious
0
Fire hazard 2- Moderate
1- Slight
0
Physical Hazard 0- Minimal
See section 8 for more detailed
A
Personal protection information on personal protection.
The customer is responsible for determining the PPE code for this material.
National Fire Protection :
Association (U.S.A.)
Flammability
0
0 0
Health Instability
Special
References : ANSI Z400.5, MSDS Standard, 2004. - Manufacturer's Material Safety Data Sheet. -
29CFR Part1910.1200 OSHA MSDS Requirements. - 49CFR Table List of Hazardous
Materials, UN#, Proper Shipping Names, PG. - Canada Gazette Part II, Vol. 122, No. 2.
Registration SOR/88-64, 31 December 1987. Hazardous Products Act "Ingredient
Disclosure List" - Canadian Transport of Dangerous Goods, Regulations and Schedules,
Clear Language version 2005.
: 01/15/2008
Date of issue
Date of previous issue : 08/31/2007
Version : 1.2
Notice to reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above named
supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the
information contained herein. Final determination of suitability of any material is the sole responsibility of the
user. All materials may present unknown hazards and should be used with caution. Although certain hazards are
described herein, we cannot guarantee that these are the only hazards that exist.
: 01/15/2008 Page: 6/6
Date of issue
Conforms to ANSI Z400.5-2004 Standard (United States, Canada).
Material Safety Data Sheet
Amplification Reconstitution Solution
1. Product and company identification
Product name : Amplification Reconstitution Solution
Used in : APTIMA CT Assay 301088, APTIMA CT Assay TIGRIS 250-test kit 301199, APTIMA CT
Assay TIGRIS 2x50-test kit 302224, APTIMA GC Assay 301091, APTIMA GC Assay
TIGRIS 250-test kit 301196, APTIMA GC Assay TIGRIS 2x50-test kit 302225, APTIMA
Combo 2 301032, APTIMA Combo 2 TIGRIS 250-test kit 301130, PROGENSA PCA3
Assay Kit CE 302355, PROGENSA PCA3 100-Reaction Kit 302354, PROGENSA PSA
100-Reaction Kit 302357,PCA3 ASR 302500; PSA ASR 302501.
Material uses : In vitro diagnostic.
Supplier/Manufacturer : Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121-4362
MSDS # : 0026
In case of emergency : CANUTEC (613) 996-6666
CHEMTREC, U.S. : (800) 424-9300 International: (703) 527-3887
2. Hazards identification
Physical state : Liquid.
OSHA/HCS status : While this material is not considered hazardous by the OSHA Hazard Communication
Standard (29 CFR 1910.1200), this MSDS contains valuable information critical to the
safe handling and proper use of the product. This MSDS should be retained and
available for employees and other users of this product.
Emergency overview : NOT EXPECTED TO PRODUCE SIGNIFICANT ADVERSE HEALTH EFFECTS WHEN
THE RECOMMENDED INSTRUCTIONS FOR USE ARE FOLLOWED.
No known significant effects or critical hazards. Avoid prolonged contact with eyes, skin
and clothing.
Potential acute health effects
Inhalation : Slightly irritating to the respiratory system.
Ingestion : No known significant effects or critical hazards.
Skin : Slightly irritating to the skin.
Eyes : Slightly irritating to the eyes.
Potential chronic health effects
Chronic effects : No known significant effects or critical hazards.
Carcinogenicity : No known significant effects or critical hazards.
Mutagenicity : No known significant effects or critical hazards.
Teratogenicity : No known significant effects or critical hazards.
Developmental effects : No known significant effects or critical hazards.
Fertility effects : No known significant effects or critical hazards.
Over-exposure signs/symptoms
Inhalation : No specific data.
Ingestion : No specific data.
Skin : No specific data.
Eyes : No specific data.
Medical conditions : None known.
aggravated by over-
exposure
See toxicological information (section 11)
: 01/15/2008 Page: 1/6
Date of issue
Amplification Reconstitution Solution
3. Composition/information on ingredients
Name CAS number %
No hazardous ingredient
Due to differing non-hazardous components, the products listed in each part number in 鈥淯sed In鈥? section are not
interchangeable. See package insert for product use.
There are no ingredients present which, within the current knowledge of the supplier and in the concentrations
applicable, are classified as hazardous to health or the environment and hence require reporting in this section.
4. First aid measures
Eye contact : Check for and remove any contact lenses. In case of contact with eyes, rinse
immediately with plenty of water. Get medical attention if symptoms occur.
Skin contact : Wash with soap and water. Get medical attention if symptoms occur.
Inhalation : If inhaled, remove to fresh air. If not breathing, give artificial respiration. Get medical
attention if symptoms appear.
Ingestion : Do not induce vomiting. Never give anything by mouth to an unconscious person. Get
medical attention if symptoms appear.
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training.
Notes to physician : No specific treatment. Treat symptomatically. Contact poison treatment specialist
immediately if large quantities have been ingested or inhaled.
5. Fire-fighting measures
Flammability of the product : Non-flammable.
Extinguishing media
Suitable : Use an extinguishing agent suitable for the surrounding fire.
Not suitable : None known.
Hazardous thermal : Decomposition products may include the following materials:
halogenated compounds
decomposition products
metal oxide/oxides
Special protective : Fire-fighters should wear appropriate protective equipment and self-contained breathing
apparatus (SCBA) with a full face-piece operated in positive pressure mode.
equipment for fire-fighters
6. Accidental release measures
Personal precautions : No action shall be taken involving any personal risk or without suitable training.
Evacuate surrounding areas. Keep unnecessary and unprotected personnel from
entering. Do not touch or walk through spilled material. Avoid breathing vapor or mist.
Provide adequate ventilation. Wear appropriate respirator when ventilation is
inadequate. Put on appropriate personal protective equipment (see section 8).
Environmental precautions : Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains
and sewers. Inform the relevant authorities if the product has caused environmental
pollution (sewers, waterways, soil or air).
Methods for cleaning up
Small spill : Stop leak if without risk. Move containers from spill area. Dilute with water and mop up
if water-soluble or absorb with an inert dry material and place in an appropriate waste
disposal container. Dispose of via a licensed waste disposal contractor.
: 01/15/2008 Page: 2/6
Date of issue
Amplification Reconstitution Solution
6. Accidental release measures
Large spill : Stop leak if without risk. Move containers from spill area. Approach release from
upwind. Prevent entry into sewers, water courses, basements or confined areas. Wash
spillages into an effluent treatment plant or proceed as follows. Contain and collect
spillage with non-combustible, absorbent material e.g. sand, earth, vermiculite or
diatomaceous earth and place in container for disposal according to local regulations
(see section 13). Dispose of via a licensed waste disposal contractor. Contaminated
absorbent material may pose the same hazard as the spilled product. Note: see section
1 for emergency contact information and section 13 for waste disposal.
7. Handling and storage
Handling : Put on appropriate personal protective equipment (see section 8). Eating, drinking and
smoking should be prohibited in areas where this material is handled, stored and
processed. Workers should wash hands and face before eating, drinking and smoking.
Do not ingest. Avoid contact with eyes, skin and clothing. Avoid breathing vapor or mist.
Keep in the original container or an approved alternative made from a compatible
material, kept tightly closed when not in use. Empty containers retain product residue
and can be hazardous. Do not reuse container.
Storage : Store in accordance with local regulations. Store in original container protected from
direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials
(see section 10) and food and drink. Keep container tightly closed and sealed until ready
for use. Containers that have been opened must be carefully resealed and kept upright
to prevent leakage. Do not store in unlabeled containers. Use appropriate containment
to avoid environmental contamination.
8. Exposure controls/personal protection
Consult local authorities for acceptable exposure limits.
Recommended monitoring : If this product contains ingredients with exposure limits, personal, workplace atmosphere
or biological monitoring may be required to determine the effectiveness of the ventilation
procedures
or other control measures and/or the necessity to use respiratory protective equipment.
Engineering measures : No special ventilation requirements. Good general ventilation should be sufficient to
control worker exposure to airborne contaminants. If this product contains ingredients
with exposure limits, use process enclosures, local exhaust ventilation or other
engineering controls to keep worker exposure below any recommended or statutory
limits.
Hygiene measures : Wash hands, forearms and face thoroughly after handling chemical products, before
eating, smoking and using the lavatory and at the end of the working period. Appropriate
techniques should be used to remove potentially contaminated clothing. Wash
contaminated clothing before reusing. Ensure that eyewash stations and safety showers
are close to the workstation location.
Personal protection
Eyes : Safety glasses.
Skin : Lab coat.
Respiratory : A respirator is not needed under normal and intended conditions of product use.
Hands : Disposable vinyl gloves.
Personal protective :
equipment (Pictograms)
HMIS Code/Personal :A
protective equipment
: 01/15/2008 Page: 3/6
Date of issue
Amplification Reconstitution Solution
8. Exposure controls/personal protection
Environmental exposure : Emissions from ventilation or work process equipment should be checked to ensure they
comply with the requirements of environmental protection legislation. In some cases,
controls
fume scrubbers, filters or engineering modifications to the process equipment will be
necessary to reduce emissions to acceptable levels.
9. Physical and chemical properties
Physical state : Liquid.
Color : Yellow.
Relative density : ~ 1.
Solubility : Miscible in water.
10 . Stability and reactivity
Stability : The product is stable.
Hazardous polymerization : Under normal conditions of storage and use, hazardous polymerization will not occur.
Conditions to avoid : No specific data.
Materials to avoid : No specific data.
Hazardous decomposition : Under normal conditions of storage and use, hazardous decomposition products should
not be produced.
products
11 . Toxicological information
Acute toxicity
Inhalation Slightly irritating to the respiratory system.
:
Ingestion : No known significant effects or critical hazards.
Skin : Slightly irritating to the skin.
Eyes : Slightly irritating to the eyes.
12 . Ecological information
Environmental effects : No known significant effects or critical hazards.
Aquatic ecotoxicity
Product/ingredient name Test Species Exposure Result
magnesium chloride Mortality Fish 96 hours Acute LC50 2120 mg/L
Other adverse effects : No known significant effects or critical hazards.
13 . Disposal considerations
Waste disposal : The generation of waste should be avoided or minimized wherever possible. Empty
containers or liners may retain some product residues. This material and its container
must be disposed of in a safe way. Dispose of surplus and non-recyclable products via
a licensed waste disposal contractor. Disposal of this product, solutions and any by-
products should at all times comply with the requirements of environmental protection
and waste disposal legislation and any regional local authority requirements. Avoid
dispersal of spilled material and runoff and contact with soil, waterways, drains and
sewers.
Disposal should be in accordance with applicable regional, national and local laws and regulations.
Refer to Section 7: HANDLING AND STORAGE and Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
for additional handling information and protection of employees.
: 01/15/2008 Page: 4/6
Date of issue
Amplification Reconstitution Solution
14 . Transport information
AERG : Not applicable.
Regulatory information
DOT/ TDG / IMDG/ IATA : Not regulated.
15 . Regulatory information
United States
HCS Classification : Not regulated.
U.S. Federal regulations : United States inventory (TSCA 8b): All components are listed or exempted.
SARA 302/304/311/312 extremely hazardous substances: No products were found.
SARA 302/304 emergency planning and notification: No products were found.
SARA 302/304/311/312 hazardous chemicals: No products were found.
SARA 311/312 MSDS distribution - chemical inventory - hazard identification: No
products were found.
Clean Water Act (CWA) 307: No products were found.
Clean Water Act (CWA) 311: No products were found.
Clean Air Act (CAA) 112 accidental release prevention: No products were found.
Clean Air Act (CAA) 112 regulated flammable substances: No products were found.
Clean Air Act (CAA) 112 regulated toxic substances: No products were found.
State regulations : Connecticut Carcinogen Reporting: None of the components are listed.
Connecticut Hazardous Material Survey: None of the components are listed.
Florida substances: None of the components are listed.
Illinois Chemical Safety Act: None of the components are listed.
Illinois Toxic Substances Disclosure to Employee Act: None of the components are
listed.
Louisiana Reporting: None of the components are listed.
Louisiana Spill: None of the components are listed.
Massachusetts Spill: None of the components are listed.
Massachusetts Substances: None of the components are listed.
Michigan Critical Material: None of the components are listed.
Minnesota Hazardous Substances: None of the components are listed.
New Jersey Hazardous Substances: None of the components are listed.
New Jersey Spill: None of the components are listed.
New Jersey Toxic Catastrophe Prevention Act: None of the components are listed.
New York Acutely Hazardous Substances: None of the components are listed.
New York Toxic Chemical Release Reporting: None of the components are listed.
Pennsylvania RTK Hazardous Substances: None of the components are listed.
Rhode Island Hazardous Substances: None of the components are listed.
Canada
WHMIS (Canada) : Not controlled under WHMIS (Canada).
Canadian lists : CEPA Toxic substances: None of the components are listed.
Canadian ARET: None of the components are listed.
Canadian NPRI: None of the components are listed.
Alberta Designated Substances: None of the components are listed.
Ontario Designated Substances: None of the components are listed.
Quebec Designated Substances: None of the components are listed.
Canada inventory : Canada inventory: All components listed.
This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations
and the MSDS contains all the information required by the Controlled Products Regulations.
International regulations
: 01/15/2008 Page: 5/6
Date of issue
Amplification Reconstitution Solution
15 . Regulatory information
International lists : This product, (and its ingredients) is (are) listed on national inventories, or is (are)
exempted from being listed, in Australia (AICS), in Europe (EINECS/ELINCS), in Korea
(TCCL), in Japan (METI), in the Philippines (RA6969).
16 . Other information
Label requirements : NOT EXPECTED TO PRODUCE SIGNIFICANT ADVERSE HEALTH EFFECTS WHEN
THE RECOMMENDED INSTRUCTIONS FOR USE ARE FOLLOWED.
Hazardous Material : HAZARD RATINGS
Information System (U.S.A.)
0
Health 4- Extreme
3- Serious
0
Fire hazard 2- Moderate
1- Slight
0
Physical Hazard 0- Minimal
See section 8 for more detailed
A
Personal protection information on personal protection.
The customer is responsible for determining the PPE code for this material.
National Fire Protection :
Association (U.S.A.)
Flammability
0
0 0
Health Instability
Special
References : ANSI Z400.5, MSDS Standard, 2004. - Manufacturer's Material Safety Data Sheet. -
29CFR Part1910.1200 OSHA MSDS Requirements. - 49CFR Table List of Hazardous
Materials, UN#, Proper Shipping Names, PG. - Canada Gazette Part II, Vol. 122, No. 2.
Registration SOR/88-64, 31 December 1987. Hazardous Products Act "Ingredient
Disclosure List" - Canadian Transport of Dangerous Goods, Regulations and Schedules,
Clear Language version 2005.
: 01/15/2008
Date of issue
Date of previous issue : 08/15/2007
Version : 1.1
Notice to reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above named
supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the
information contained herein. Final determination of suitability of any material is the sole responsibility of the
user. All materials may present unknown hazards and should be used with caution. Although certain hazards are
described herein, we cannot guarantee that these are the only hazards that exist.
: 01/15/2008 Page: 6/6
Date of issue
Conforms to ANSI Z400.5-2004 Standard (United States, Canada).
Material Safety Data Sheet
Probe Reagent
1. Product and company identification
Product name : Probe Reagent
Used in : APTIMA CT Assay 301088, APTIMA CT Assay TIGRIS 250-test kit 301199, APTIMA CT
Assay TIGRIS 2x50-test kit 302224, APTIMA GC Assay 301091, APTIMA GC Assay
TIGRIS 250-test kit 301196, APTIMA GC Assay TIGRIS 2x50-test kit 302225, APTIMA
Combo 2 301032, APTIMA Combo 2 TIGRIS 250-test kit 301130, PROGENSA PCA3
Assay Kit CE 302355, PROGENSA PCA3 100-Reaction Kit 302354, PROGENSA PSA
100-Reaction Kit 302357, PCA3 ASR 302248, PSA ASR 302251.
Material uses : In vitro diagnostic.
Supplier/Manufacturer : Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121-4362
MSDS # : 0027
In case of emergency : CANUTEC (613) 996-6666
CHEMTREC, U.S. : (800) 424-9300 International: (703) 527-3887
2. Hazards identification
Physical state : Solid. [Lyophilized.]
OSHA/HCS status : While this material is not considered hazardous by the OSHA Hazard Communication
Standard (29 CFR 1910.1200), this MSDS contains valuable information critical to the
safe handling and proper use of the product. This MSDS should be retained and
available for employees and other users of this product.
Emergency overview : NOT EXPECTED TO PRODUCE SIGNIFICANT ADVERSE HEALTH EFFECTS WHEN
THE RECOMMENDED INSTRUCTIONS FOR USE ARE FOLLOWED.
No known significant effects or critical hazards. Avoid prolonged contact with eyes, skin
and clothing.
Routes of entry : Dermal contact. Eye contact. Inhalation. Ingestion.
Potential acute health effects
Inhalation : Exposure to decomposition products may cause a health hazard. Serious effects may
be delayed following exposure.
Ingestion : May cause burns to mouth, throat and stomach. Harmful if swallowed.
Skin : No known significant effects or critical hazards.
Eyes : No known significant effects or critical hazards.
Potential chronic health effects
Chronic effects : No known significant effects or critical hazards.
Carcinogenicity : No known significant effects or critical hazards.
Mutagenicity : No known significant effects or critical hazards.
Teratogenicity : No known significant effects or critical hazards.
Developmental effects : No known significant effects or critical hazards.
Fertility effects : No known significant effects or critical hazards.
Over-exposure signs/symptoms
Inhalation : No specific data.
Ingestion : No specific data.
Skin : No specific data.
Eyes : No specific data.
Medical conditions : None known.
aggravated by over-
exposure
: 01/15/2008 Page: 1/6
Date of issue
Probe Reagent
2. Hazards identification
See toxicological information (section 11)
3. Composition/information on ingredients
Name CAS number %
No hazardous ingredient
Due to differing non-hazardous components, the products listed in each part number in 鈥淯sed In鈥? section are not
interchangeable. See package insert for product use.
There are no ingredients present which, within the current knowledge of the supplier and in the concentrations
applicable, are classified as hazardous to health or the environment and hence require reporting in this section.
4. First aid measures
Eye contact : Check for and remove any contact lenses. In case of contact with eyes, rinse
immediately with plenty of water. Get medical attention if symptoms occur.
Skin contact : Wash with soap and water. Get medical attention if symptoms occur.
Inhalation : If inhaled, remove to fresh air. If not breathing, give artificial respiration. Get medical
attention if symptoms appear.
Ingestion : Do not induce vomiting. Never give anything by mouth to an unconscious person. Get
medical attention if symptoms appear.
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training.
Notes to physician : In case of inhalation of decomposition products in a fire, symptoms may be delayed.
The exposed person may need to be kept under medical surveillance for 48 hours.
5. Fire-fighting measures
Flammability of the product : Non-flammable.
Extinguishing media
Suitable : Use an extinguishing agent suitable for the surrounding fire.
Not suitable : None known.
Hazardous thermal : Decomposition products may include the following materials:
carbon dioxide
decomposition products
carbon monoxide
nitrogen oxides
sulfur oxides
metal oxide/oxides
Special protective : Fire-fighters should wear appropriate protective equipment and self-contained breathing
apparatus (SCBA) with a full face-piece operated in positive pressure mode.
equipment for fire-fighters
6. Accidental release measures
Personal precautions : No action shall be taken involving any personal risk or without suitable training.
Evacuate surrounding areas. Keep unnecessary and unprotected personnel from
entering. Do not touch or walk through spilled material. Provide adequate ventilation.
Wear appropriate respirator when ventilation is inadequate. Put on appropriate personal
protective equipment (see section 8).
Environmental precautions : Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains
and sewers. Inform the relevant authorities if the product has caused environmental
pollution (sewers, waterways, soil or air).
Methods for cleaning up
: 01/15/2008 Page: 2/6
Date of issue
Probe Reagent
6. Accidental release measures
Small spill : Move containers from spill area. Vacuum or sweep up material and place in a
designated, labeled waste container. Dispose of via a licensed waste disposal
contractor.
Large spill : Move containers from spill area. Approach release from upwind. Prevent entry into
sewers, water courses, basements or confined areas. Vacuum or sweep up material
and place in a designated, labeled waste container. Dispose of via a licensed waste
disposal contractor. Note: see section 1 for emergency contact information and section
13 for waste disposal.
7. Handling and storage
Handling : Put on appropriate personal protective equipment (see section 8). Eating, drinking and
smoking should be prohibited in areas where this material is handled, stored and
processed. Workers should wash hands and face before eating, drinking and smoking.
Do not ingest. Avoid contact with eyes, skin and clothing. Keep in the original container
or an approved alternative made from a compatible material, kept tightly closed when not
in use. Empty containers retain product residue and can be hazardous. Do not reuse
container.
Storage : Store in accordance with local regulations. Store in original container protected from
direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials
(see section 10) and food and drink. Keep container tightly closed and sealed until ready
for use. Containers that have been opened must be carefully resealed and kept upright
to prevent leakage. Do not store in unlabeled containers. Use appropriate containment
to avoid environmental contamination.
8. Exposure controls/personal protection
Consult local authorities for acceptable exposure limits.
Recommended monitoring : If this product contains ingredients with exposure limits, personal, workplace atmosphere
or biological monitoring may be required to determine the effectiveness of the ventilation
procedures
or other control measures and/or the necessity to use respiratory protective equipment.
Engineering measures : No special ventilation requirements. Good general ventilation should be sufficient to
control worker exposure to airborne contaminants. If this product contains ingredients
with exposure limits, use process enclosures, local exhaust ventilation or other
engineering controls to keep worker exposure below any recommended or statutory
limits.
Hygiene measures : Wash hands, forearms and face thoroughly after handling chemical products, before
eating, smoking and using the lavatory and at the end of the working period. Appropriate
techniques should be used to remove potentially contaminated clothing. Wash
contaminated clothing before reusing. Ensure that eyewash stations and safety showers
are close to the workstation location.
Personal protection
Eyes : Safety glasses.
Skin : Lab coat.
Respiratory : A respirator is not needed under normal and intended conditions of product use.
Hands : Disposable vinyl gloves.
Personal protective :
equipment (Pictograms)
HMIS Code/Personal :A
protective equipment
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Date of issue
Probe Reagent
8. Exposure controls/personal protection
Environmental exposure : Emissions from ventilation or work process equipment should be checked to ensure they
comply with the requirements of environmental protection legislation. In some cases,
controls
fume scrubbers, filters or engineering modifications to the process equipment will be
necessary to reduce emissions to acceptable levels.
9. Physical and chemical properties
Physical state : Solid. [Lyophilized.]
Color : White to off-white.
pH :5
10 . Stability and reactivity
Stability : The product is stable.
Hazardous polymerization : Under normal conditions of storage and use, hazardous polymerization will not occur.
Conditions to avoid : No specific data.
Materials to avoid : No specific data.
Hazardous decomposition : Under normal conditions of storage and use, hazardous decomposition products should
not be produced.
products
11 . Toxicological information
Acute toxicity
Inhalation : Exposure to decomposition products may cause a health hazard. Serious effects may
be delayed following exposure.
Ingestion : May cause burns to mouth, throat and stomach. Harmful if swallowed.
Skin : No known significant effects or critical hazards.
Eyes : No known significant effects or critical hazards.
12 . Ecological information
Environmental effects : No known significant effects or critical hazards.
Other adverse effects : No known significant effects or critical hazards.
13 . Disposal considerations
Waste disposal : The generation of waste should be avoided or minimized wherever possible. Empty
containers or liners may retain some product residues. This material and its container
must be disposed of in a safe way. Dispose of surplus and non-recyclable products via
a licensed waste disposal contractor. Disposal of this product, solutions and any by-
products should at all times comply with the requirements of environmental protection
and waste disposal legislation and any regional local authority requirements. Avoid
dispersal of spilled material and runoff and contact with soil, waterways, drains and
sewers.
Disposal should be in accordance with applicable regional, national and local laws and regulations.
Refer to Section 7: HANDLING AND STORAGE and Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
for additional handling information and protection of employees.
: 01/15/2008 Page: 4/6
Date of issue
Probe Reagent
14 . Transport information
AERG : Not applicable.
Regulatory information
DOT/ TDG / IMDG/ IATA : Not regulated.
15 . Regulatory information
United States
HCS Classification : Not regulated.
U.S. Federal regulations : United States inventory (TSCA 8b): All components listed.
SARA 302/304/311/312 extremely hazardous substances: No products were found.
SARA 302/304 emergency planning and notification: No products were found.
SARA 302/304/311/312 hazardous chemicals: No products were found.
SARA 311/312 MSDS distribution - chemical inventory - hazard identification: No
products were found.
Clean Water Act (CWA) 307: No products were found.
Clean Water Act (CWA) 311: No products were found.
Clean Air Act (CAA) 112 accidental release prevention: No products were found.
Clean Air Act (CAA) 112 regulated flammable substances: No products were found.
Clean Air Act (CAA) 112 regulated toxic substances: No products were found.
State regulations : Connecticut Carcinogen Reporting: None of the components are listed.
Connecticut Hazardous Material Survey: None of the components are listed.
Florida substances: None of the components are listed.
Illinois Chemical Safety Act: None of the components are listed.
Illinois Toxic Substances Disclosure to Employee Act: None of the components are
listed.
Louisiana Reporting: None of the components are listed.
Louisiana Spill: None of the components are listed.
Massachusetts Spill: None of the components are listed.
Massachusetts Substances: None of the components are listed.
Michigan Critical Material: None of the components are listed.
Minnesota Hazardous Substances: None of the components are listed.
New Jersey Hazardous Substances: None of the components are listed.
New Jersey Spill: None of the components are listed.
New Jersey Toxic Catastrophe Prevention Act: None of the components are listed.
New York Acutely Hazardous Substances: None of the components are listed.
New York Toxic Chemical Release Reporting: None of the components are listed.
Pennsylvania RTK Hazardous Substances: None of the components are listed.
Rhode Island Hazardous Substances: None of the components are listed.
Canada
WHMIS (Canada) : Not controlled under WHMIS (Canada).
Canadian lists : CEPA Toxic substances: None of the components are listed.
Canadian ARET: None of the components are listed.
Canadian NPRI: None of the components are listed.
Alberta Designated Substances: None of the components are listed.
Ontario Designated Substances: None of the components are listed.
Quebec Designated Substances: None of the components are listed.
Canada inventory : Canada inventory: All components listed.
This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations
and the MSDS contains all the information required by the Controlled Products Regulations.
International regulations
: 01/15/2008 Page: 5/6
Date of issue
Probe Reagent
15 . Regulatory information
International lists : This product, (and its ingredients) is (are) listed on national inventories, or is (are)
exempted from being listed, in Australia (AICS), in Europe (EINECS/ELINCS), in Korea
(TCCL), in Japan (METI), in the Philippines (RA6969).
16 . Other information
Label requirements : NOT EXPECTED TO PRODUCE SIGNIFICANT ADVERSE HEALTH EFFECTS WHEN
THE RECOMMENDED INSTRUCTIONS FOR USE ARE FOLLOWED.
Hazardous Material : HAZARD RATINGS
Information System (U.S.A.)
0
Health 4- Extreme
3- Serious
0
Fire hazard 2- Moderate
1- Slight
0
Physical Hazard 0- Minimal
See section 8 for more detailed
A
Personal protection information on personal protection.
The customer is responsible for determining the PPE code for this material.
National Fire Protection :
Association (U.S.A.)
Flammability
0
0 0
Health Instability
Special
References : ANSI Z400.5, MSDS Standard, 2004. - Manufacturer's Material Safety Data Sheet. -
29CFR Part1910.1200 OSHA MSDS Requirements. - 49CFR Table List of Hazardous
Materials, UN#, Proper Shipping Names, PG. - Canada Gazette Part II, Vol. 122, No. 2.
Registration SOR/88-64, 31 December 1987. Hazardous Products Act "Ingredient
Disclosure List" - Canadian Transport of Dangerous Goods, Regulations and Schedules,
Clear Language version 2005.
: 01/15/2008
Date of issue
Date of previous issue : 08/31/2007
Version : 1.1
Notice to reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above named
supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the
information contained herein. Final determination of suitability of any material is the sole responsibility of the
user. All materials may present unknown hazards and should be used with caution. Although certain hazards are
described herein, we cannot guarantee that these are the only hazards that exist.
: 01/15/2008 Page: 6/6
Date of issue
Conforms to ANSI Z400.5-2004 Standard (United States, Canada).
Material Safety Data Sheet
Probe Reconstitution Solution
1. Product and company identification
Product name : Probe Reconstitution Solution
Used in : APTIMA CT Assay 301088, APTIMA CT Assay TIGRIS 250-test kit 301199, APTIMA CT
Assay TIGRIS 2x50-test kit 302224, APTIMA GC Assay 301091, APTIMA GC Assay
TIGRIS 250-test kit 301196, APTIMA GC Assay TIGRIS 2x50-test kit 302225, APTIMA
Combo 2 301032, APTIMA Combo 2 TIGRIS 250-test kit 301130, PROGENSA PCA3
Assay Kit CE 302355, PROGENSA PCA3 100-Reaction Kit 302354, PROGENSA PSA
100-Reaction Kit 302357, PCA3/PSA Supplemental Fluids Kit 302030.
Material uses : In vitro diagnostic.
Supplier/Manufacturer : Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121-4362
MSDS # : 0028
In case of emergency : CANUTEC (613) 996-6666
CHEMTREC, U.S. : (800) 424-9300 International: (703) 527-3887
2. Hazards identification
Physical state : Liquid.
OSHA/HCS status : This material is considered hazardous by the OSHA Hazard Communication Standard
(29 CFR 1910.1200).
Emergency overview : WARNING!
CAUSES EYE IRRITATION. MAY BE HARMFUL IF ABSORBED THROUGH SKIN OR IF
SWALLOWED. MAY CAUSE SKIN IRRITATION. CONTAINS MATERIAL THAT CAN
CAUSE TARGET ORGAN DAMAGE.
Irritating to eyes. Moderately irritating to the skin. May be harmful if absorbed through
skin. Avoid exposure - obtain special instructions before use. Do not breathe vapor or
mist. Do not ingest. Do not get in eyes. Avoid contact with skin and clothing. Contains
material that can cause target organ damage. Wash thoroughly after handling.
Potential acute health effects
Inhalation No known significant effects or critical hazards.
:
Ingestion : May be harmful if swallowed.
Skin : May be harmful if absorbed through skin. Moderately irritating to the skin.
Eyes : Irritating to eyes.
Potential chronic health effects
Chronic effects : Contains material that can cause target organ damage.
Carcinogenicity : No known significant effects or critical hazards.
Mutagenicity : No known significant effects or critical hazards.
Teratogenicity : No known significant effects or critical hazards.
Developmental effects : No known significant effects or critical hazards.
Fertility effects : No known significant effects or critical hazards.
Target organs : Contains material which causes damage to the following organs: blood, the reproductive
system, liver, upper respiratory tract, skin, central nervous system (CNS), eye, lens or
cornea.
Over-exposure signs/symptoms
Inhalation : No specific data.
Ingestion : No specific data.
Skin : Adverse symptoms may include the following:
irritation
redness
Eyes : Adverse symptoms may include the following:
pain or irritation
watering
redness
: 01/15/2008 Page: 1/7
Date of issue
Probe Reconstitution Solution
2. Hazards identification
Medical conditions : Pre-existing disorders involving any target organs mentioned in this MSDS as being at risk
aggravated by over- may be aggravated by over-exposure to this product.
exposure
See toxicological information (section 11)
3. Composition/information on ingredients
United States
Name CAS number %
Lithium chloride 7447-41-8 1-5
Ethanol 64-17-5 1-5
Canada
Name CAS number %
Lithium chloride 7447-41-8 1-5
Ethanol 64-17-5 1-5
Succinic acid 110-15-6 1-5
Hazardous materials listed are the same in each part number in " Used In " section, however due to differing non-
hazardous components, the use of these products are not interchangeable. See package insert for product use.
There are no additional ingredients present which, within the current knowledge of the supplier and in the
concentrations applicable, are classified as hazardous to health or the environment and hence require reporting in
this section.
4. First aid measures
Eye contact : Check for and remove any contact lenses. In case of contact with eyes, rinse
immediately with plenty of water. Get medical attention if symptoms occur.
Skin contact : Wash with soap and water. Get medical attention if symptoms occur.
Inhalation : If inhaled, remove to fresh air. If not breathing, give artificial respiration. Get medical
attention if symptoms appear.
Ingestion : Do not induce vomiting. Never give anything by mouth to an unconscious person. Get
medical attention if symptoms appear.
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training. It may be
dangerous to the person providing aid to give mouth-to-mouth resuscitation. Wash
contaminated clothing thoroughly with water before removing it, or wear gloves.
Notes to physician : No specific treatment. Treat symptomatically. Contact poison treatment specialist
immediately if large quantities have been ingested or inhaled.
5. Fire-fighting measures
Flammability of the product : Non-flammable.
Extinguishing media
Suitable : Use an extinguishing agent suitable for the surrounding fire.
Not suitable : None known.
Hazardous thermal : Decomposition products may include the following materials:
decomposition products carbon dioxide
carbon monoxide
sulfur oxides
halogenated compounds
metal oxide/oxides
Special protective : Fire-fighters should wear appropriate protective equipment and self-contained breathing
equipment for fire-fighters apparatus (SCBA) with a full face-piece operated in positive pressure mode.
: 01/15/2008 Page: 2/7
Date of issue
Probe Reconstitution Solution
6. Accidental release measures
Personal precautions : No action shall be taken involving any personal risk or without suitable training. Evacuate
surrounding areas. Keep unnecessary and unprotected personnel from entering. Do not
touch or walk through spilled material. Avoid breathing vapor or mist. Provide adequate
ventilation. Wear appropriate respirator when ventilation is inadequate. Put on
appropriate personal protective equipment (see section 8).
Environmental precautions : Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains and
sewers. Inform the relevant authorities if the product has caused environmental pollution
(sewers, waterways, soil or air).
Methods for cleaning up
Small spill : Stop leak if without risk. Move containers from spill area. Dilute with water and mop up if
water-soluble or absorb with an inert dry material and place in an appropriate waste
disposal container. Dispose of via a licensed waste disposal contractor.
Large spill : Stop leak if without risk. Move containers from spill area. Approach release from upwind.
Prevent entry into sewers, water courses, basements or confined areas. Wash spillages
into an effluent treatment plant or proceed as follows. Contain and collect spillage with
non-combustible, absorbent material e.g. sand, earth, vermiculite or diatomaceous earth
and place in container for disposal according to local regulations (see section 13).
Dispose of via a licensed waste disposal contractor. Contaminated absorbent material
may pose the same hazard as the spilled product. Note: see section 1 for emergency
contact information and section 13 for waste disposal.
7. Handling and storage
Handling : Put on appropriate personal protective equipment (see section 8). Eating, drinking and
smoking should be prohibited in areas where this material is handled, stored and
processed. Workers should wash hands and face before eating, drinking and smoking.
Do not get in eyes or on skin or clothing. Do not breathe vapor or mist. Do not ingest. If
during normal use the material presents a respiratory hazard, use only with adequate
ventilation or wear appropriate respirator. Keep in the original container or an approved
alternative made from a compatible material, kept tightly closed when not in use. Empty
containers retain product residue and can be hazardous. Do not reuse container.
Storage : Store in accordance with local regulations. Store in original container protected from
direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials
(see section 10) and food and drink. Keep container tightly closed and sealed until ready
for use. Containers that have been opened must be carefully resealed and kept upright
to prevent leakage. Do not store in unlabeled containers. Use appropriate containment
to avoid environmental contamination.
8. Exposure controls/personal protection
United States
Product name Exposure limits
Ethanol ACGIH TLV (United States, 1/2006).
TWA: 1880 mg/m鲁 8 hour(s).
NIOSH REL (United States, 12/2001).
TWA: 1900 mg/m鲁 10 hour(s).
OSHA PEL (United States, 11/2006).
TWA: 1900 mg/m鲁 8 hour(s).
Canada
Product name Exposure limits
Ethanol CSST (Canada, 2001).
TWA: 1880 mg/m鲁 8 hour(s).
Consult local authorities for acceptable exposure limits.
Recommended monitoring : If this product contains ingredients with exposure limits, personal, workplace atmosphere
procedures or biological monitoring may be required to determine the effectiveness of the ventilation
or other control measures and/or the necessity to use respiratory protective equipment.
Engineering measures : If user operations generate dust, fumes, gas, vapor or mist, use process enclosures, local
exhaust ventilation or other engineering controls to keep worker exposure to airborne
contaminants below any recommended or statutory limits.
: 01/15/2008 Page: 3/7
Date of issue
Probe Reconstitution Solution
8. Exposure controls/personal protection
Hygiene measures : Wash hands, forearms and face thoroughly after handling chemical products, before
eating, smoking and using the lavatory and at the end of the working period. Appropriate
techniques should be used to remove potentially contaminated clothing. Wash
contaminated clothing before reusing. Ensure that eyewash stations and safety showers
are close to the workstation location.
Personal protection
Eyes : Safety glasses.
Skin : Lab coat.
Respiratory : A respirator is not needed under normal and intended conditions of product use.
Hands : Natural rubber (latex).
Personal protective :
equipment (Pictograms)
HMIS Code/Personal :B
protective equipment
Environmental exposure : Emissions from ventilation or work process equipment should be checked to ensure they
controls comply with the requirements of environmental protection legislation. In some cases,
fume scrubbers, filters or engineering modifications to the process equipment will be
necessary to reduce emissions to acceptable levels.
9. Physical and chemical properties
Physical state : Liquid.
Color : Colorless to light yellow.
pH : 4.7
10 . Stability and reactivity
Stability : The product is stable.
Hazardous polymerization : Under normal conditions of storage and use, hazardous polymerization will not occur.
Conditions to avoid : No specific data.
Materials to avoid : No specific data.
Hazardous decomposition : Under normal conditions of storage and use, hazardous decomposition products should
products not be produced.
11 . Toxicological information
Acute toxicity
Product/ingredient name Species Dose Result Exposure
Lithium chloride Rabbit 1629 mg/kg LD50 Dermal -
Rat 1488 mg/kg LD50 Dermal -
Rat 4800 ug/kg LD50 Intracerebral -
Rat 925 mg/kg LD50 Intraperitoneal -
Rat 514 mg/kg LD50 Intraperitoneal -
Rat 205 mg/kg LD50 Intratracheal -
Rat 526 mg/kg LD50 Oral -
Rat 1530 mg/kg LD50 Oral -
Rat 499 mg/kg LD50 Subcutaneous -
Ethanol Rat 11 mg/kg LD50 Intra-arterial -
Rat 3600 ug/kg LD50 Intraperitoneal -
Rat 1440 mg/kg LD50 Intravenous -
Rat 7060 mg/kg LD50 Oral -
Rat 7 g/kg LD50 Oral -
Inhalation : No known significant effects or critical hazards.
Ingestion : May be harmful if swallowed.
Skin : May be harmful if absorbed through skin. Moderately irritating to the skin.
Eyes : Irritating to eyes.
: 01/15/2008 Page: 4/7
Date of issue
Probe Reconstitution Solution
11 . Toxicological information
Carcinogenicity
Classification
Product/ingredient name ACGIH IARC EPA NIOSH NTP OSHA
Ethanol A4 - - - - -
12 . Ecological information
Environmental effects : No known significant effects or critical hazards.
Aquatic ecotoxicity
Product/ingredient name Test Species Exposure Result
Ethanol Intoxication Daphnia 48 hours Acute EC50 >100 mg/L
Intoxication Daphnia 48 hours Acute EC50 9.3 mg/L
Physiology Daphnia 48 hours Acute EC50 2 mg/L
Mortality Fish 96 hours Acute LC50 13000 mg/L
Mortality Fish 96 hours Acute LC50 >100 mg/L
Mortality Daphnia 96 hours Acute LC50 >100 mg/L
Other adverse effects : No known significant effects or critical hazards.
13 . Disposal considerations
Waste disposal : The generation of waste should be avoided or minimized wherever possible. Empty
containers or liners may retain some product residues. This material and its container
must be disposed of in a safe way. Dispose of surplus and non-recyclable products via a
licensed waste disposal contractor. Disposal of this product, solutions and any by-
products should at all times comply with the requirements of environmental protection
and waste disposal legislation and any regional local authority requirements. Avoid
dispersal of spilled material and runoff and contact with soil, waterways, drains and
sewers.
Disposal should be in accordance with applicable regional, national and local laws and regulations.
Refer to Section 7: HANDLING AND STORAGE and Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION for
additional handling information and protection of employees.
14 . Transport information
AERG : Not applicable.
Regulatory information
DOT/ TDG / IMDG/ IATA : Not regulated.
15 . Regulatory information
United States
HCS Classification : Irritating material
Target organ effects
U.S. Federal regulations : United States inventory (TSCA 8b): All components are listed or exempted.
SARA 302/304/311/312 extremely hazardous substances: No products were found.
SARA 302/304 emergency planning and notification: No products were found.
SARA 302/304/311/312 hazardous chemicals: Lithium chloride; Ethanol; Succinic acid
SARA 311/312 MSDS distribution - chemical inventory - hazard identification:
Lithium chloride: Immediate (acute) health hazard, Delayed (chronic) health hazard;
Ethanol: Fire hazard, Immediate (acute) health hazard, Delayed (chronic) health hazard;
Succinic acid: Immediate (acute) health hazard, Delayed (chronic) health hazard
Clean Water Act (CWA) 307: No products were found.
Clean Water Act (CWA) 311: EDTA Calibration Sample
Clean Air Act (CAA) 112 accidental release prevention: No products were found.
Clean Air Act (CAA) 112 regulated flammable substances: No products were found.
Clean Air Act (CAA) 112 regulated toxic substances: No products were found.
: 01/15/2008 Page: 5/7
Date of issue
Probe Reconstitution Solution
15 . Regulatory information
State regulations : Connecticut Carcinogen Reporting: None of the components are listed.
Connecticut Hazardous Material Survey: None of the components are listed.
Florida substances: None of the components are listed.
Illinois Chemical Safety Act: None of the components are listed.
Illinois Toxic Substances Disclosure to Employee Act: None of the components are
listed.
Louisiana Reporting: None of the components are listed.
Louisiana Spill: None of the components are listed.
Massachusetts Spill: None of the components are listed.
Massachusetts Substances: The following components are listed: Ethanol
Michigan Critical Material: None of the components are listed.
Minnesota Hazardous Substances: None of the components are listed.
New Jersey Hazardous Substances: The following components are listed: Ethanol
New Jersey Spill: None of the components are listed.
New Jersey Toxic Catastrophe Prevention Act: None of the components are listed.
New York Acutely Hazardous Substances: None of the components are listed.
New York Toxic Chemical Release Reporting: None of the components are listed.
Pennsylvania RTK Hazardous Substances: The following components are listed:
Ethanol
Rhode Island Hazardous Substances: None of the components are listed.
Canada
WHMIS (Canada) : Class D-2B: Material causing other toxic effects (Toxic).
Canadian lists : CEPA Toxic substances: None of the components are listed.
Canadian ARET: None of the components are listed.
Canadian NPRI: The following components are listed: Ethanol
Alberta Designated Substances: None of the components are listed.
Ontario Designated Substances: None of the components are listed.
Quebec Designated Substances: None of the components are listed.
Canada inventory : Canada inventory: All components listed.
This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations and
the MSDS contains all the information required by the Controlled Products Regulations.
International regulations
International lists : This product, (and its ingredients) is (are) listed on national inventories, or is (are)
exempted from being listed, in Australia (AICS), in Europe (EINECS/ELINCS), in Korea
(TCCL), in Japan (METI), in the Philippines (RA6969).
16 . Other information
Label requirements : CAUSES EYE IRRITATION. MAY BE HARMFUL IF ABSORBED THROUGH SKIN OR IF
SWALLOWED. MAY CAUSE SKIN IRRITATION. CONTAINS MATERIAL THAT CAN
CAUSE TARGET ORGAN DAMAGE.
Hazardous Material : HAZARD RATINGS
Information System (U.S.A.)
* 1
Health 4- Extreme
3- Serious
0
Fire hazard 2- Moderate
1- Slight
0
Physical Hazard 0- Minimal
See section 8 for more detailed
B
Personal protection information on personal protection.
The customer is responsible for determining the PPE code for this material.
National Fire Protection :
Association (U.S.A.)
Flammability
0
1 0
Health Instability
Special
: 01/15/2008 Page: 6/7
Date of issue
Probe Reconstitution Solution
16 . Other information
References : ANSI Z400.5, MSDS Standard, 2004. - Manufacturer's Material Safety Data Sheet. -
29CFR Part1910.1200 OSHA MSDS Requirements. - 49CFR Table List of Hazardous
Materials, UN#, Proper Shipping Names, PG. - Canada Gazette Part II, Vol. 122, No. 2.
Registration SOR/88-64, 31 December 1987. Hazardous Products Act "Ingredient
Disclosure List" - Canadian Transport of Dangerous Goods, Regulations and Schedules,
Clear Language version 2005.
: 01/15/2008
Date of issue
Date of previous issue : 08/15/2007
Version : 1.1
Notice to reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above named
supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the
information contained herein. Final determination of suitability of any material is the sole responsibility of the user.
All materials may present unknown hazards and should be used with caution. Although certain hazards are
described herein, we cannot guarantee that these are the only hazards that exist.
: 01/15/2008 Page: 7/7
Date of issue
Conforms to ANSI Z400.5-2004 Standard (United States, Canada).
Material Safety Data Sheet
Target Capture Reagent
1. Product and company identification
Product name : Target Capture Reagent
Used in : APTIMA CT Assay 301088, APTIMA CT Assay TIGRIS 250-test kit 301199, APTIMA CT
Assay TIGRIS 2x50-test kit 302224, APTIMA GC Assay 301091, APTIMA GC Assay
TIGRIS 250-test kit 301196, APTIMA GC Assay TIGRIS 2x50-test kit 302225, APTIMA
Combo 2 301032, APTIMA Combo 2 TIGRIS 250-test kit 301130, PROGENSA PCA3
Assay Kit CE 302355, PROGENSA PCA3 100-Reaction Kit 302354, PROGENSA PSA
100-Reaction Kit 302357, PCA3 ASR 302249, PSA ASR 302252.
Material uses : In vitro diagnostic.
Supplier/Manufacturer : Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121-4362
MSDS # : 0029
In case of emergency : CANUTEC (613) 996-6666
CHEMTREC, U.S. : (800) 424-9300 International: (703) 527-3887
2. Hazards identification
Physical state : Liquid. [Suspension.]
OSHA/HCS status : This material is considered hazardous by the OSHA Hazard Communication Standard
(29 CFR 1910.1200).
Emergency overview : WARNING!
CAUSES EYE IRRITATION. MAY BE HARMFUL IF ABSORBED THROUGH SKIN OR
IF SWALLOWED. CONTAINS MATERIAL THAT CAN CAUSE TARGET ORGAN
DAMAGE.
May be harmful if absorbed through skin or if swallowed. Irritating to eyes. Avoid
exposure - obtain special instructions before use. Do not breathe vapor or mist. Do not
ingest. Do not get in eyes. Avoid contact with skin and clothing. Contains material that
can cause target organ damage. Wash thoroughly after handling.
Routes of entry : Dermal contact. Eye contact. Inhalation. Ingestion.
Potential acute health effects
Inhalation : Exposure to decomposition products may cause a health hazard. Serious effects may
be delayed following exposure.
Ingestion : Harmful if swallowed.
Skin : Harmful in contact with skin.
Eyes : Irritating to eyes.
Potential chronic health effects
Chronic effects : Contains material that can cause target organ damage.
Carcinogenicity : No known significant effects or critical hazards.
Mutagenicity : No known significant effects or critical hazards.
Teratogenicity : No known significant effects or critical hazards.
Developmental effects : No known significant effects or critical hazards.
Fertility effects : No known significant effects or critical hazards.
Target organs : Contains material which causes damage to the following organs: central nervous system
(CNS).
Over-exposure signs/symptoms
Inhalation : No specific data.
Ingestion : No specific data.
Skin : No specific data.
: 01/15/2008 Page: 1/7
Date of issue
Target Capture Reagent
2. Hazards identification
Eyes : Adverse symptoms may include the following:
pain or irritation
watering
redness
Medical conditions : Pre-existing disorders involving any target organs mentioned in this MSDS as being at
risk may be aggravated by over-exposure to this product.
aggravated by over-
exposure
See toxicological information (section 11)
3. Composition/information on ingredients
United States
Name CAS number %
Lithium chloride 7447-41-8 5 - 10
Canada
Name CAS number %
Lithium chloride 7447-41-8 5 - 10
Hazardous materials listed are the same in each part number in " Used In " section, however due to differing non-
hazardous components, the use of these products are not interchangeable. See package insert for product use.
There are no additional ingredients present which, within the current knowledge of the supplier and in the
concentrations applicable, are classified as hazardous to health or the environment and hence require reporting in
this section.
4. First aid measures
Eye contact : Check for and remove any contact lenses. In case of contact with eyes, rinse
immediately with plenty of water. Get medical attention.
Skin contact : In case of contact, immediately flush skin with plenty of water for at least 20 minutes.
Get medical attention.
Inhalation : If inhaled, remove to fresh air. If not breathing, give artificial respiration. Get medical
attention.
Ingestion : Do not induce vomiting. Never give anything by mouth to an unconscious person. Get
medical attention.
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training. It may
be dangerous to the person providing aid to give mouth-to-mouth resuscitation. Wash
contaminated clothing thoroughly with water before removing it, or wear gloves.
Notes to physician : In case of inhalation of decomposition products in a fire, symptoms may be delayed.
The exposed person may need to be kept under medical surveillance for 48 hours.
5. Fire-fighting measures
Flammability of the product : Non-flammable.
Extinguishing media
Suitable : Use an extinguishing agent suitable for the surrounding fire.
Not suitable : None known.
: 01/15/2008 Page: 2/7
Date of issue
Target Capture Reagent
5. Fire-fighting measures
Hazardous thermal : Decomposition products may include the following materials:
carbon dioxide
decomposition products
carbon monoxide
nitrogen oxides
sulfur oxides
halogenated compounds
metal oxide/oxides
Special protective : Fire-fighters should wear appropriate protective equipment and self-contained breathing
apparatus (SCBA) with a full face-piece operated in positive pressure mode.
equipment for fire-fighters
6. Accidental release measures
Personal precautions : No action shall be taken involving any personal risk or without suitable training.
Evacuate surrounding areas. Keep unnecessary and unprotected personnel from
entering. Do not touch or walk through spilled material. Avoid breathing vapor or mist.
Provide adequate ventilation. Wear appropriate respirator when ventilation is
inadequate. Put on appropriate personal protective equipment (see section 8).
Environmental precautions : Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains
and sewers. Inform the relevant authorities if the product has caused environmental
pollution (sewers, waterways, soil or air).
Methods for cleaning up
Small spill : Stop leak if without risk. Move containers from spill area. Dilute with water and mop up
if water-soluble or absorb with an inert dry material and place in an appropriate waste
disposal container. Dispose of via a licensed waste disposal contractor.
Large spill : Stop leak if without risk. Move containers from spill area. Approach release from
upwind. Prevent entry into sewers, water courses, basements or confined areas. Wash
spillages into an effluent treatment plant or proceed as follows. Contain and collect
spillage with non-combustible, absorbent material e.g. sand, earth, vermiculite or
diatomaceous earth and place in container for disposal according to local regulations
(see section 13). Dispose of via a licensed waste disposal contractor. Contaminated
absorbent material may pose the same hazard as the spilled product. Note: see section
1 for emergency contact information and section 13 for waste disposal.
7. Handling and storage
Handling : Put on appropriate personal protective equipment (see section 8). Eating, drinking and
smoking should be prohibited in areas where this material is handled, stored and
processed. Workers should wash hands and face before eating, drinking and smoking.
Do not get in eyes or on skin or clothing. Do not breathe vapor or mist. Do not ingest. If
during normal use the material presents a respiratory hazard, use only with adequate
ventilation or wear appropriate respirator. Keep in the original container or an approved
alternative made from a compatible material, kept tightly closed when not in use. Empty
containers retain product residue and can be hazardous. Do not reuse container.
Storage : Store in accordance with local regulations. Store in original container protected from
direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials
(see section 10) and food and drink. Keep container tightly closed and sealed until ready
for use. Containers that have been opened must be carefully resealed and kept upright
to prevent leakage. Do not store in unlabeled containers. Use appropriate containment
to avoid environmental contamination.
: 01/15/2008 Page: 3/7
Date of issue
Target Capture Reagent
8. Exposure controls/personal protection
Consult local authorities for acceptable exposure limits.
Recommended monitoring : If this product contains ingredients with exposure limits, personal, workplace atmosphere
or biological monitoring may be required to determine the effectiveness of the ventilation
procedures
or other control measures and/or the necessity to use respiratory protective equipment.
Engineering measures : If user operations generate dust, fumes, gas, vapor or mist, use process enclosures,
local exhaust ventilation or other engineering controls to keep worker exposure to
airborne contaminants below any recommended or statutory limits.
Hygiene measures : Wash hands, forearms and face thoroughly after handling chemical products, before
eating, smoking and using the lavatory and at the end of the working period. Appropriate
techniques should be used to remove potentially contaminated clothing. Wash
contaminated clothing before reusing. Ensure that eyewash stations and safety showers
are close to the workstation location.
Personal protection
Eyes : Safety glasses.
Skin : Lab coat.
Respiratory : A respirator is not needed under normal and intended conditions of product use.
Hands : Natural rubber (latex).
Personal protective :
equipment (Pictograms)
HMIS Code/Personal :B
protective equipment
Environmental exposure : Emissions from ventilation or work process equipment should be checked to ensure they
comply with the requirements of environmental protection legislation. In some cases,
controls
fume scrubbers, filters or engineering modifications to the process equipment will be
necessary to reduce emissions to acceptable levels.
9. Physical and chemical properties
Physical state : Liquid. [Suspension.]
Color : Brown.
pH : ~ 6.4.
Relative density : 1.07
10 . Stability and reactivity
Stability : The product is stable.
Hazardous polymerization : Under normal conditions of storage and use, hazardous polymerization will not occur.
Conditions to avoid : No specific data.
Materials to avoid : No specific data.
Hazardous decomposition : Under normal conditions of storage and use, hazardous decomposition products should
not be produced.
products
: 01/15/2008 Page: 4/7
Date of issue
Target Capture Reagent
11 . Toxicological information
Acute toxicity
Product/ingredient name Species Dose Result Exposure
Lithium chloride Rabbit 1629 mg/kg LD50 Dermal -
Rat 1488 mg/kg LD50 Dermal -
Rat 4800 ug/kg LD50 Intracerebral -
Rat 925 mg/kg LD50 Intraperitoneal -
Rat 514 mg/kg LD50 Intraperitoneal -
Rat 205 mg/kg LD50 Intratracheal -
Rat 526 mg/kg LD50 Oral -
Rat 1530 mg/kg LD50 Oral -
Rat 499 mg/kg LD50 Subcutaneous -
Inhalation Exposure to decomposition products may cause a health hazard. Serious effects may
:
be delayed following exposure.
Ingestion : Harmful if swallowed.
Skin : Harmful in contact with skin.
Eyes : Irritating to eyes.
12 . Ecological information
Environmental effects : No known significant effects or critical hazards.
Other adverse effects : No known significant effects or critical hazards.
13 . Disposal considerations
Waste disposal : The generation of waste should be avoided or minimized wherever possible. Empty
containers or liners may retain some product residues. This material and its container
must be disposed of in a safe way. Dispose of surplus and non-recyclable products via
a licensed waste disposal contractor. Disposal of this product, solutions and any by-
products should at all times comply with the requirements of environmental protection
and waste disposal legislation and any regional local authority requirements. Avoid
dispersal of spilled material and runoff and contact with soil, waterways, drains and
sewers.
Disposal should be in accordance with applicable regional, national and local laws and regulations.
Refer to Section 7: HANDLING AND STORAGE and Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
for additional handling information and protection of employees.
14 . Transport information
AERG : Not applicable.
Regulatory information
DOT/ TDG / IMDG/ IATA : Not regulated.
15 . Regulatory information
United States
HCS Classification : Irritating material
Target organ effects
U.S. Federal regulations : United States inventory (TSCA 8b): All components listed.
SARA 302/304/311/312 extremely hazardous substances: No products were found.
SARA 302/304 emergency planning and notification: No products were found.
SARA 302/304/311/312 hazardous chemicals: Lithium chloride
SARA 311/312 MSDS distribution - chemical inventory - hazard identification:
Lithium chloride: Immediate (acute) health hazard, Delayed (chronic) health hazard
Clean Water Act (CWA) 307: No products were found.
Clean Water Act (CWA) 311: EDTA Calibration Sample
: 01/15/2008 Page: 5/7
Date of issue
Target Capture Reagent
15 . Regulatory information
Clean Air Act (CAA) 112 accidental release prevention: No products were found.
Clean Air Act (CAA) 112 regulated flammable substances: No products were found.
Clean Air Act (CAA) 112 regulated toxic substances: No products were found.
State regulations : Connecticut Carcinogen Reporting: None of the components are listed.
Connecticut Hazardous Material Survey: None of the components are listed.
Florida substances: None of the components are listed.
Illinois Chemical Safety Act: None of the components are listed.
Illinois Toxic Substances Disclosure to Employee Act: None of the components are
listed.
Louisiana Reporting: None of the components are listed.
Louisiana Spill: None of the components are listed.
Massachusetts Spill: None of the components are listed.
Massachusetts Substances: None of the components are listed.
Michigan Critical Material: None of the components are listed.
Minnesota Hazardous Substances: None of the components are listed.
New Jersey Hazardous Substances: None of the components are listed.
New Jersey Spill: None of the components are listed.
New Jersey Toxic Catastrophe Prevention Act: None of the components are listed.
New York Acutely Hazardous Substances: None of the components are listed.
New York Toxic Chemical Release Reporting: None of the components are listed.
Pennsylvania RTK Hazardous Substances: None of the components are listed.
Rhode Island Hazardous Substances: None of the components are listed.
Canada
WHMIS (Canada) : Class D-2B: Material causing other toxic effects (Toxic).
Canadian lists : CEPA Toxic substances: None of the components are listed.
Canadian ARET: None of the components are listed.
Canadian NPRI: None of the components are listed.
Alberta Designated Substances: None of the components are listed.
Ontario Designated Substances: None of the components are listed.
Quebec Designated Substances: None of the components are listed.
Canada inventory : Canada inventory: All components listed.
This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations
and the MSDS contains all the information required by the Controlled Products Regulations.
International regulations
International lists : This product, (and its ingredients) is (are) listed on national inventories, or is (are)
exempted from being listed, in Australia (AICS), in Europe (EINECS/ELINCS), in Korea
(TCCL), in Japan (METI), in the Philippines (RA6969).
16 . Other information
Label requirements : CAUSES EYE IRRITATION. MAY BE HARMFUL IF ABSORBED THROUGH SKIN OR
IF SWALLOWED. CONTAINS MATERIAL THAT CAN CAUSE TARGET ORGAN
DAMAGE.
Hazardous Material : HAZARD RATINGS
Information System (U.S.A.)
* 2
Health 4- Extreme
3- Serious
0
Fire hazard 2- Moderate
1- Slight
0
Physical Hazard 0- Minimal
See section 8 for more detailed
B
Personal protection information on personal protection.
: 01/15/2008 Page: 6/7
Date of issue
Target Capture Reagent
16 . Other information
The customer is responsible for determining the PPE code for this material.
National Fire Protection :
Association (U.S.A.)
Flammability
0
2 0
Health Instability
Special
References : ANSI Z400.5, MSDS Standard, 2004. - Manufacturer's Material Safety Data Sheet. -
29CFR Part1910.1200 OSHA MSDS Requirements. - 49CFR Table List of Hazardous
Materials, UN#, Proper Shipping Names, PG. - Canada Gazette Part II, Vol. 122, No. 2.
Registration SOR/88-64, 31 December 1987. Hazardous Products Act "Ingredient
Disclosure List" - Canadian Transport of Dangerous Goods, Regulations and Schedules,
Clear Language version 2005.
: 01/15/2008
Date of issue
Date of previous issue : 08/15/2007
Version : 1.1
Notice to reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above named
supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the
information contained herein. Final determination of suitability of any material is the sole responsibility of the
user. All materials may present unknown hazards and should be used with caution. Although certain hazards are
described herein, we cannot guarantee that these are the only hazards that exist.
: 01/15/2008 Page: 7/7
Date of issue
Conforms to ANSI Z400.5-2004 Standard (United States, Canada).
Material Safety Data Sheet
Controls
1. Product and company identification
Product name : Controls
Used in : APTIMA CT Assay 301088, APTIMA CT Assay TIGRIS 250-test kit 301199, APTIMA CT
Assay TIGRIS 2x50-test kit 302224, APTIMA GC Assay 301091, APTIMA GC Assay
TIGRIS 250-test kit 301196, APTIMA GC Assay TIGRIS 2x50-test kit 302225, APTIMA
Combo 2 301032, APTIMA Combo 2 TIGRIS 250-test kit 301130, PROGENSA PCA3
Assay Kit CE 302355, PROGENSA PCA3 Calibrators and Controls Kit 302353,
PROGENSA PSA Calibrators and Controls Kit 302356.
Material uses : In vitro diagnostic.
Supplier/Manufacturer : Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121-4362
MSDS # : 0035
In case of emergency : CANUTEC (613) 996-6666
CHEMTREC, U.S. : (800) 424-9300 International: (703) 527-3887
2. Hazards identification
Physical state : Liquid.
OSHA/HCS status : While this material is not considered hazardous by the OSHA Hazard Communication
Standard (29 CFR 1910.1200), this MSDS contains valuable information critical to the
safe handling and proper use of the product. This MSDS should be retained and available
for employees and other users of this product.
Emergency overview : NOT EXPECTED TO PRODUCE SIGNIFICANT ADVERSE HEALTH EFFECTS WHEN
THE RECOMMENDED INSTRUCTIONS FOR USE ARE FOLLOWED.
No known significant effects or critical hazards. Avoid prolonged contact with eyes, skin
and clothing.
Routes of entry : Dermal contact. Eye contact. Inhalation. Ingestion.
Potential acute health effects
Inhalation : No known significant effects or critical hazards.
Ingestion : No known significant effects or critical hazards.
Skin : No known significant effects or critical hazards.
Eyes : No known significant effects or critical hazards.
Potential chronic health effects
Chronic effects : No known significant effects or critical hazards.
Carcinogenicity : No known significant effects or critical hazards.
Mutagenicity : No known significant effects or critical hazards.
Teratogenicity : No known significant effects or critical hazards.
Developmental effects : No known significant effects or critical hazards.
Fertility effects : No known significant effects or critical hazards.
Over-exposure signs/symptoms
Inhalation : No specific data.
Ingestion : No specific data.
Skin : No specific data.
Eyes : No specific data.
Medical conditions : None known.
aggravated by over-
exposure
See toxicological information (section 11)
: 01/15/2008 Page: 1/6
Date of issue
Controls
3. Composition/information on ingredients
Name CAS number %
No hazardous ingredient
Due to differing non-hazardous components, the products listed in each part number in 鈥淯sed In鈥? section are not
interchangeable. See package insert for product use.
There are no ingredients present which, within the current knowledge of the supplier and in the concentrations
applicable, are classified as hazardous to health or the environment and hence require reporting in this section.
4. First aid measures
Eye contact : Check for and remove any contact lenses. In case of contact with eyes, rinse
immediately with plenty of water. Get medical attention if symptoms occur.
Skin contact : Wash with soap and water. Get medical attention if symptoms occur.
Inhalation : If inhaled, remove to fresh air. If not breathing, give artificial respiration. Get medical
attention if symptoms appear.
Ingestion : Do not induce vomiting. Never give anything by mouth to an unconscious person. Get
medical attention if symptoms appear.
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training.
Notes to physician : No specific treatment. Treat symptomatically. Contact poison treatment specialist
immediately if large quantities have been ingested or inhaled.
5. Fire-fighting measures
Flammability of the product : Non-flammable.
Extinguishing media
Suitable : Use an extinguishing agent suitable for the surrounding fire.
Not suitable : None known.
Hazardous thermal : Decomposition products may include the following materials:
decomposition products carbon dioxide
carbon monoxide
sulfur oxides
metal oxide/oxides
Special protective : Fire-fighters should wear appropriate protective equipment and self-contained breathing
equipment for fire-fighters apparatus (SCBA) with a full face-piece operated in positive pressure mode.
6. Accidental release measures
Personal precautions : No action shall be taken involving any personal risk or without suitable training. Evacuate
surrounding areas. Keep unnecessary and unprotected personnel from entering. Do not
touch or walk through spilled material. Avoid breathing vapor or mist. Provide adequate
ventilation. Wear appropriate respirator when ventilation is inadequate. Put on
appropriate personal protective equipment (see section 8).
Environmental precautions : Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains and
sewers. Inform the relevant authorities if the product has caused environmental pollution
(sewers, waterways, soil or air).
Methods for cleaning up
Small spill : Stop leak if without risk. Move containers from spill area. Dilute with water and mop up if
water-soluble or absorb with an inert dry material and place in an appropriate waste
disposal container. Dispose of via a licensed waste disposal contractor.
Large spill : Stop leak if without risk. Move containers from spill area. Approach release from upwind.
Prevent entry into sewers, water courses, basements or confined areas. Wash spillages
into an effluent treatment plant or proceed as follows. Contain and collect spillage with
non-combustible, absorbent material e.g. sand, earth, vermiculite or diatomaceous earth
and place in container for disposal according to local regulations (see section 13).
Dispose of via a licensed waste disposal contractor. Contaminated absorbent material
may pose the same hazard as the spilled product. Note: see section 1 for emergency
contact information and section 13 for waste disposal.
: 01/15/2008 Page: 2/6
Date of issue
Controls
7. Handling and storage
Handling : Put on appropriate personal protective equipment (see section 8). Eating, drinking and
smoking should be prohibited in areas where this material is handled, stored and
processed. Workers should wash hands and face before eating, drinking and smoking.
Do not ingest. Avoid contact with eyes, skin and clothing. Avoid breathing vapor or mist.
Keep in the original container or an approved alternative made from a compatible
material, kept tightly closed when not in use. Empty containers retain product residue and
can be hazardous. Do not reuse container.
Storage : Store in accordance with local regulations. Store in original container protected from
direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials
(see section 10) and food and drink. Keep container tightly closed and sealed until ready
for use. Containers that have been opened must be carefully resealed and kept upright
to prevent leakage. Do not store in unlabeled containers. Use appropriate containment
to avoid environmental contamination.
8. Exposure controls/personal protection
Consult local authorities for acceptable exposure limits.
Recommended monitoring : If this product contains ingredients with exposure limits, personal, workplace atmosphere
procedures or biological monitoring may be required to determine the effectiveness of the ventilation
or other control measures and/or the necessity to use respiratory protective equipment.
Engineering measures : No special ventilation requirements. Good general ventilation should be sufficient to
control worker exposure to airborne contaminants. If this product contains ingredients
with exposure limits, use process enclosures, local exhaust ventilation or other
engineering controls to keep worker exposure below any recommended or statutory
limits.
Hygiene measures : Wash hands, forearms and face thoroughly after handling chemical products, before
eating, smoking and using the lavatory and at the end of the working period. Appropriate
techniques should be used to remove potentially contaminated clothing. Wash
contaminated clothing before reusing. Ensure that eyewash stations and safety showers
are close to the workstation location.
Personal protection
Eyes : Safety glasses.
Skin : Lab coat.
Respiratory : A respirator is not needed under normal and intended conditions of product use.
Hands : Disposable vinyl gloves.
Personal protective :
equipment (Pictograms)
HMIS Code/Personal :A
protective equipment
Environmental exposure : Emissions from ventilation or work process equipment should be checked to ensure they
controls comply with the requirements of environmental protection legislation. In some cases,
fume scrubbers, filters or engineering modifications to the process equipment will be
necessary to reduce emissions to acceptable levels.
9. Physical and chemical properties
Physical state : Liquid.
Color : Colorless.
pH : ~ 6.7.
Relative density : ~ 1.
: 01/15/2008 Page: 3/6
Date of issue
Controls
10 . Stability and reactivity
Stability : The product is stable.
Hazardous polymerization : Under normal conditions of storage and use, hazardous polymerization will not occur.
Conditions to avoid : No specific data.
Materials to avoid : No specific data.
Hazardous decomposition : Under normal conditions of storage and use, hazardous decomposition products should
products not be produced.
11 . Toxicological information
Acute toxicity
Inhalation No known significant effects or critical hazards.
:
Ingestion : No known significant effects or critical hazards.
Skin : No known significant effects or critical hazards.
Eyes : No known significant effects or critical hazards.
12 . Ecological information
Environmental effects : No known significant effects or critical hazards.
Other adverse effects : No known significant effects or critical hazards.
13 . Disposal considerations
Waste disposal : The generation of waste should be avoided or minimized wherever possible. Empty
containers or liners may retain some product residues. This material and its container
must be disposed of in a safe way. Dispose of surplus and non-recyclable products via a
licensed waste disposal contractor. Disposal of this product, solutions and any by-
products should at all times comply with the requirements of environmental protection
and waste disposal legislation and any regional local authority requirements. Avoid
dispersal of spilled material and runoff and contact with soil, waterways, drains and
sewers.
Disposal should be in accordance with applicable regional, national and local laws and regulations.
Refer to Section 7: HANDLING AND STORAGE and Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION for
additional handling information and protection of employees.
14 . Transport information
AERG : Not applicable.
Regulatory information
DOT/ TDG / IMDG/ IATA : Not regulated.
15 . Regulatory information
United States
HCS Classification : Not regulated.
U.S. Federal regulations : United States inventory (TSCA 8b): All components listed.
SARA 302/304/311/312 extremely hazardous substances: No products were found.
SARA 302/304 emergency planning and notification: No products were found.
SARA 302/304/311/312 hazardous chemicals: No products were found.
SARA 311/312 MSDS distribution - chemical inventory - hazard identification: No
products were found.
Clean Water Act (CWA) 307: No products were found.
Clean Water Act (CWA) 311: Disodium Phosphate
Clean Air Act (CAA) 112 accidental release prevention: No products were found.
Clean Air Act (CAA) 112 regulated flammable substances: No products were found.
Clean Air Act (CAA) 112 regulated toxic substances: No products were found.
: 01/15/2008 Page: 4/6
Date of issue
Controls
15 . Regulatory information
State regulations : Connecticut Carcinogen Reporting: None of the components are listed.
Connecticut Hazardous Material Survey: None of the components are listed.
Florida substances: None of the components are listed.
Illinois Chemical Safety Act: None of the components are listed.
Illinois Toxic Substances Disclosure to Employee Act: None of the components are
listed.
Louisiana Reporting: None of the components are listed.
Louisiana Spill: None of the components are listed.
Massachusetts Spill: None of the components are listed.
Massachusetts Substances: None of the components are listed.
Michigan Critical Material: None of the components are listed.
Minnesota Hazardous Substances: None of the components are listed.
New Jersey Hazardous Substances: None of the components are listed.
New Jersey Spill: None of the components are listed.
New Jersey Toxic Catastrophe Prevention Act: None of the components are listed.
New York Acutely Hazardous Substances: None of the components are listed.
New York Toxic Chemical Release Reporting: None of the components are listed.
Pennsylvania RTK Hazardous Substances: None of the components are listed.
Rhode Island Hazardous Substances: None of the components are listed.
Canada
WHMIS (Canada) : Not controlled under WHMIS (Canada).
Canadian lists : CEPA Toxic substances: None of the components are listed.
Canadian ARET: None of the components are listed.
Canadian NPRI: None of the components are listed.
Alberta Designated Substances: None of the components are listed.
Ontario Designated Substances: None of the components are listed.
Quebec Designated Substances: None of the components are listed.
Canada inventory : Canada inventory: All components listed.
This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations and
the MSDS contains all the information required by the Controlled Products Regulations.
International regulations
International lists : This product, (and its ingredients) is (are) listed on national inventories, or is (are)
exempted from being listed, in Australia (AICS), in Europe (EINECS/ELINCS), in Korea
(TCCL), in Japan (METI), in the Philippines (RA6969).
16 . Other information
Label requirements : NOT EXPECTED TO PRODUCE SIGNIFICANT ADVERSE HEALTH EFFECTS WHEN
THE RECOMMENDED INSTRUCTIONS FOR USE ARE FOLLOWED.
Hazardous Material : HAZARD RATINGS
Information System (U.S.A.)
0
Health 4- Extreme
3- Serious
0
Fire hazard 2- Moderate
1- Slight
0
Physical Hazard 0- Minimal
See section 8 for more detailed
A
Personal protection information on personal protection.
The customer is responsible for determining the PPE code for this material.
National Fire Protection :
Association (U.S.A.)
Flammability
0
0 0
Health Instability
Special
References : ANSI Z400.5, MSDS Standard, 2004. - Manufacturer's Material Safety Data Sheet. -
29CFR Part1910.1200 OSHA MSDS Requirements. - 49CFR Table List of Hazardous
Materials, UN#, Proper Shipping Names, PG. - Canada Gazette Part II, Vol. 122, No. 2.
Registration SOR/88-64, 31 December 1987. Hazardous Products Act "Ingredient
Disclosure List" - Canadian Transport of Dangerous Goods, Regulations and Schedules,
Clear Language version 2005.
: 01/15/2008 Page: 5/6
Date of issue
Controls
16 . Other information
: 01/15/2008
Date of issue
Date of previous issue : 08/15/2007
Version : 1.1
Notice to reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above named
supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the
information contained herein. Final determination of suitability of any material is the sole responsibility of the user.
All materials may present unknown hazards and should be used with caution. Although certain hazards are
described herein, we cannot guarantee that these are the only hazards that exist.
: 01/15/2008 Page: 6/6
Date of issue
Conforms to ANSI Z400.5-2004 Standard (United States, Canada).
Material Safety Data Sheet
Selection Reagent
1. Product and company identification
Product name : Selection Reagent
Used in : APTIMA CT Assay 301088, APTIMA CT Assay TIGRIS 250-test kit 301199, APTIMA CT
Assay TIGRIS 2x50-test kit 302224, APTIMA GC Assay 301091, APTIMA GC Assay
TIGRIS 250-test kit 301196, APTIMA GC Assay TIGRIS 2x50-test kit 302225, APTIMA
Combo 2 301032, APTIMA Combo 2 TIGRIS 250-test kit 301130, PROGENSA PCA3
Assay Kit CE 302355, PROGENSA PCA3 100-Reaction Kit 302354, PROGENSA PSA
100-Reaction Kit 302357, PCA3/PSA Supplemental Fluids Kit 302030.
Material uses : In vitro diagnostic.
Supplier/Manufacturer : Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121-4362
MSDS # : 0038
In case of emergency : CANUTEC (613) 996-6666
CHEMTREC, U.S. : (800) 424-9300 International: (703) 527-3887
2. Hazards identification
Physical state : Liquid. [Clear.]
Odor : Odorless.
OSHA/HCS status : This material is considered hazardous by the OSHA Hazard Communication Standard
(29 CFR 1910.1200).
Emergency overview : WARNING!
CAUSES EYE IRRITATION.
Severely irritating to eyes. Avoid exposure - obtain special instructions before use. Do
not breathe vapor or mist. Do not get in eyes. Avoid contact with skin and clothing.
Contains material that can cause target organ damage. Wash thoroughly after handling.
Potential acute health effects
Inhalation : No known significant effects or critical hazards.
Ingestion : No known significant effects or critical hazards.
Skin : No known significant effects or critical hazards.
Eyes : Severely irritating to eyes. Risk of serious damage to eyes.
Potential chronic health effects
Chronic effects : Contains material that can cause target organ damage.
Carcinogenicity : No known significant effects or critical hazards.
Mutagenicity : No known significant effects or critical hazards.
Teratogenicity : No known significant effects or critical hazards.
Developmental effects : No known significant effects or critical hazards.
Fertility effects : No known significant effects or critical hazards.
Over-exposure signs/symptoms
Inhalation : No specific data.
Ingestion : No specific data.
Skin : No specific data.
Eyes : Adverse symptoms may include the following:
pain or irritation
watering
redness
: 01/15/2008 Page: 1/7
Date of issue
Selection Reagent
2. Hazards identification
Medical conditions : None known.
aggravated by over-
exposure
See toxicological information (section 11)
3. Composition/information on ingredients
United States
Name CAS number %
Boric Acid 10043-35-3 1-5
Triton X-100 9002-93-1 1-5
Canada
Name CAS number %
Boric Acid 10043-35-3 1-5
Triton X-100 9002-93-1 1-5
Hazardous materials listed are the same in each part number in " Used In " section, however due to differing non-
hazardous components, the use of these products are not interchangeable. See package insert for product use.
There are no additional ingredients present which, within the current knowledge of the supplier and in the
concentrations applicable, are classified as hazardous to health or the environment and hence require reporting in
this section.
4. First aid measures
Eye contact : Check for and remove any contact lenses. In case of contact with eyes, rinse
immediately with plenty of water. Get medical attention if symptoms occur.
Skin contact : Wash with soap and water. Get medical attention if symptoms occur.
Inhalation : If inhaled, remove to fresh air. If not breathing, give artificial respiration. Get medical
attention if symptoms appear.
Ingestion : Do not induce vomiting. Never give anything by mouth to an unconscious person. Get
medical attention if symptoms appear.
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training. It may
be dangerous to the person providing aid to give mouth-to-mouth resuscitation.
Notes to physician : No specific treatment. Treat symptomatically. Contact poison treatment specialist
immediately if large quantities have been ingested or inhaled.
5. Fire-fighting measures
Flammability of the product : Non-flammable.
Extinguishing media
Suitable : Use an extinguishing agent suitable for the surrounding fire.
Not suitable : None known.
Hazardous thermal : Decomposition products may include the following materials:
carbon dioxide
decomposition products
carbon monoxide
Special protective : Fire-fighters should wear appropriate protective equipment and self-contained breathing
apparatus (SCBA) with a full face-piece operated in positive pressure mode.
equipment for fire-fighters
: 01/15/2008 Page: 2/7
Date of issue
Selection Reagent
6. Accidental release measures
Personal precautions : No action shall be taken involving any personal risk or without suitable training.
Evacuate surrounding areas. Keep unnecessary and unprotected personnel from
entering. Do not touch or walk through spilled material. Avoid breathing vapor or mist.
Provide adequate ventilation. Wear appropriate respirator when ventilation is
inadequate. Put on appropriate personal protective equipment (see section 8).
Environmental precautions : Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains
and sewers. Inform the relevant authorities if the product has caused environmental
pollution (sewers, waterways, soil or air).
Methods for cleaning up
Small spill : Stop leak if without risk. Move containers from spill area. Dilute with water and mop up
if water-soluble or absorb with an inert dry material and place in an appropriate waste
disposal container. Dispose of via a licensed waste disposal contractor.
Large spill : Stop leak if without risk. Move containers from spill area. Approach release from
upwind. Prevent entry into sewers, water courses, basements or confined areas. Wash
spillages into an effluent treatment plant or proceed as follows. Contain and collect
spillage with non-combustible, absorbent material e.g. sand, earth, vermiculite or
diatomaceous earth and place in container for disposal according to local regulations
(see section 13). Dispose of via a licensed waste disposal contractor. Contaminated
absorbent material may pose the same hazard as the spilled product. Note: see section
1 for emergency contact information and section 13 for waste disposal.
7. Handling and storage
Handling : Put on appropriate personal protective equipment (see section 8). Eating, drinking and
smoking should be prohibited in areas where this material is handled, stored and
processed. Workers should wash hands and face before eating, drinking and smoking.
Do not get in eyes or on skin or clothing. Do not breathe vapor or mist. Do not ingest. If
during normal use the material presents a respiratory hazard, use only with adequate
ventilation or wear appropriate respirator. Keep in the original container or an approved
alternative made from a compatible material, kept tightly closed when not in use. Empty
containers retain product residue and can be hazardous. Do not reuse container.
Storage : Store in accordance with local regulations. Store in original container protected from
direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials
(see section 10) and food and drink. Keep container tightly closed and sealed until ready
for use. Containers that have been opened must be carefully resealed and kept upright
to prevent leakage. Do not store in unlabeled containers. Use appropriate containment
to avoid environmental contamination.
8. Exposure controls/personal protection
United States
Product name Exposure limits
Boric Acid ACGIH TLV (United States, 1/2006).
STEL: 6 mg/m鲁 15 minute(s).
TWA: 2 mg/m鲁 8 hour(s).
Canada
Product name Exposure limits
Boric Acid ACGIH TLV (United States, 1/2006).
STEL: 6 mg/m鲁 15 minute(s).
TWA: 2 mg/m鲁 8 hour(s).
Consult local authorities for acceptable exposure limits.
Recommended monitoring : If this product contains ingredients with exposure limits, personal, workplace atmosphere
or biological monitoring may be required to determine the effectiveness of the ventilation
procedures
or other control measures and/or the necessity to use respiratory protective equipment.
: 01/15/2008 Page: 3/7
Date of issue
Selection Reagent
8. Exposure controls/personal protection
Engineering measures : If user operations generate dust, fumes, gas, vapor or mist, use process enclosures,
local exhaust ventilation or other engineering controls to keep worker exposure to
airborne contaminants below any recommended or statutory limits.
Hygiene measures : Wash hands, forearms and face thoroughly after handling chemical products, before
eating, smoking and using the lavatory and at the end of the working period. Appropriate
techniques should be used to remove potentially contaminated clothing. Wash
contaminated clothing before reusing. Ensure that eyewash stations and safety showers
are close to the workstation location.
Personal protection
Eyes : Safety glasses.
Skin : Lab coat.
Respiratory : A respirator is not needed under normal and intended conditions of product use.
Hands : Natural rubber (latex).
Personal protective :
equipment (Pictograms)
HMIS Code/Personal :B
protective equipment
Environmental exposure : Emissions from ventilation or work process equipment should be checked to ensure they
comply with the requirements of environmental protection legislation. In some cases,
controls
fume scrubbers, filters or engineering modifications to the process equipment will be
necessary to reduce emissions to acceptable levels.
9. Physical and chemical properties
Physical state : Liquid. [Clear.]
Color : Colorless.
Odor : Odorless.
pH : 8.5
Solubility : Miscible in water.
10 . Stability and reactivity
Stability : The product is stable.
Hazardous polymerization : Under normal conditions of storage and use, hazardous polymerization will not occur.
Conditions to avoid : No specific data.
Materials to avoid : No specific data.
Hazardous decomposition : Under normal conditions of storage and use, hazardous decomposition products should
not be produced.
products
11 . Toxicological information
Acute toxicity
Inhalation No known significant effects or critical hazards.
:
Ingestion : No known significant effects or critical hazards.
Skin : No known significant effects or critical hazards.
Eyes : Severely irritating to eyes. Risk of serious damage to eyes.
Carcinogenicity
: 01/15/2008 Page: 4/7
Date of issue
Selection Reagent
11 . Toxicological information
Classification
Product/ingredient name ACGIH IARC EPA NIOSH NTP OSHA
Boric Acid A4 - - - - -
12 . Ecological information
Environmental effects : No known significant effects or critical hazards.
Aquatic ecotoxicity
Product/ingredient name Test Species Exposure Result
Boric Acid Intoxication Daphnia 48 hours Acute EC50 777 mg/L
Intoxication Daphnia 48 hours Acute EC50 226 mg/L
Intoxication Daphnia 48 hours Acute EC50 133 mg/L
Mortality Fish 96 hours Acute LC50 >1100 mg/L
Mortality Fish 96 hours Acute LC50 >1021 mg/L
Mortality Fish 96 hours Acute LC50 >800 mg/L
Triton X-100 Mortality Fish 96 hours Acute LC50 531 mg/L
Mortality Fish 96 hours Acute LC50 12 mg/L
Mortality Fish 96 hours Acute LC50 >10 mg/L
Mortality Fish 96 hours Acute LC50 6 mg/L
Mortality Fish 96 hours Acute LC50 5.38 mg/L
Mortality Fish 96 hours Acute LC50 4.5 mg/L
Other adverse effects : No known significant effects or critical hazards.
13 . Disposal considerations
Waste disposal : The generation of waste should be avoided or minimized wherever possible. Empty
containers or liners may retain some product residues. This material and its container
must be disposed of in a safe way. Dispose of surplus and non-recyclable products via
a licensed waste disposal contractor. Disposal of this product, solutions and any by-
products should at all times comply with the requirements of environmental protection
and waste disposal legislation and any regional local authority requirements. Avoid
dispersal of spilled material and runoff and contact with soil, waterways, drains and
sewers.
Disposal should be in accordance with applicable regional, national and local laws and regulations.
Refer to Section 7: HANDLING AND STORAGE and Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
for additional handling information and protection of employees.
14 . Transport information
AERG : Not applicable.
Regulatory information
DOT/ TDG / IMDG/ IATA : Not regulated.
15 . Regulatory information
United States
HCS Classification : Irritating material
U.S. Federal regulations : TSCA 8(a) PAIR: Triton X-100
United States inventory (TSCA 8b): All components listed.
SARA 302/304/311/312 extremely hazardous substances: No products were found.
SARA 302/304 emergency planning and notification: No products were found.
SARA 302/304/311/312 hazardous chemicals: Boric Acid; Triton X-100
SARA 311/312 MSDS distribution - chemical inventory - hazard identification: Boric
Acid: Immediate (acute) health hazard, Delayed (chronic) health hazard; Triton X-100:
Immediate (acute) health hazard, Delayed (chronic) health hazard
: 01/15/2008 Page: 5/7
Date of issue
Selection Reagent
15 . Regulatory information
Clean Water Act (CWA) 307: No products were found.
Clean Water Act (CWA) 311: Sodium hydroxide
Clean Air Act (CAA) 112 accidental release prevention: No products were found.
Clean Air Act (CAA) 112 regulated flammable substances: No products were found.
Clean Air Act (CAA) 112 regulated toxic substances: No products were found.
State regulations : Connecticut Carcinogen Reporting: None of the components are listed.
Connecticut Hazardous Material Survey: None of the components are listed.
Florida substances: None of the components are listed.
Illinois Chemical Safety Act: None of the components are listed.
Illinois Toxic Substances Disclosure to Employee Act: None of the components are
listed.
Louisiana Reporting: None of the components are listed.
Louisiana Spill: None of the components are listed.
Massachusetts Spill: None of the components are listed.
Massachusetts Substances: None of the components are listed.
Michigan Critical Material: None of the components are listed.
Minnesota Hazardous Substances: None of the components are listed.
New Jersey Hazardous Substances: None of the components are listed.
New Jersey Spill: None of the components are listed.
New Jersey Toxic Catastrophe Prevention Act: None of the components are listed.
New York Acutely Hazardous Substances: None of the components are listed.
New York Toxic Chemical Release Reporting: None of the components are listed.
Pennsylvania RTK Hazardous Substances: None of the components are listed.
Rhode Island Hazardous Substances: None of the components are listed.
California Prop. 65
California prop. 65: No products were found.
Canada
WHMIS (Canada) : Class D-2B: Material causing other toxic effects (Toxic).
Canadian lists : CEPA Toxic substances: None of the components are listed.
Canadian ARET: None of the components are listed.
Canadian NPRI: The following components are listed: Triton X-100
Alberta Designated Substances: None of the components are listed.
Ontario Designated Substances: None of the components are listed.
Quebec Designated Substances: None of the components are listed.
Canada inventory : Canada inventory: All components listed.
This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations
and the MSDS contains all the information required by the Controlled Products Regulations.
International regulations
International lists : This product, (and its ingredients) is (are) listed on national inventories, or is (are)
exempted from being listed, in Australia (AICS), in Europe (EINECS/ELINCS), in Korea
(TCCL), in Japan (METI), in the Philippines (RA6969).
: 01/15/2008 Page: 6/7
Date of issue
Selection Reagent
16 . Other information
Label requirements : CAUSES EYE IRRITATION.
Hazardous Material : HAZARD RATINGS
Information System (U.S.A.)
* 1
Health 4- Extreme
3- Serious
0
Fire hazard 2- Moderate
1- Slight
0
Physical Hazard 0- Minimal
See section 8 for more detailed
B
Personal protection information on personal protection.
The customer is responsible for determining the PPE code for this material.
National Fire Protection :
Association (U.S.A.)
Flammability
0
1 0
Health Instability
Special
References : ANSI Z400.5, MSDS Standard, 2004. - Manufacturer's Material Safety Data Sheet. -
29CFR Part1910.1200 OSHA MSDS Requirements. - 49CFR Table List of Hazardous
Materials, UN#, Proper Shipping Names, PG. - Canada Gazette Part II, Vol. 122, No. 2.
Registration SOR/88-64, 31 December 1987. Hazardous Products Act "Ingredient
Disclosure List" - Canadian Transport of Dangerous Goods, Regulations and Schedules,
Clear Language version 2005.
: 01/15/2008
Date of issue
Date of previous issue : 08/15/2007
Version : 1.1
Notice to reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above named
supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the
information contained herein. Final determination of suitability of any material is the sole responsibility of the
user. All materials may present unknown hazards and should be used with caution. Although certain hazards are
described herein, we cannot guarantee that these are the only hazards that exist.
: 01/15/2008 Page: 7/7
Date of issue
Conforms to ANSI Z400.5-2004 Standard (United States, Canada).
Material Safety Data Sheet
Enzyme Reconstitution Solution
1. Product and company identification
Product name : Enzyme Reconstitution Solution
Used in : APTIMA CT Assay 301088, APTIMA CT Assay TIGRIS 250-test kit 301199, APTIMA CT
Assay TIGRIS 2x50-test kit 302224, APTIMA GC Assay 301091, APTIMA GC Assay
TIGRIS 250-test kit 301196, APTIMA GC Assay TIGRIS 2x50-test kit 302225, APTIMA
Combo 2 301032, APTIMA Combo 2 TIGRIS 250-test kit 301130, PROGENSA PCA3
Assay Kit CE 302355, PROGENSA PCA3 100-Reaction Kit 302354, PROGENSA PSA
100-Reaction Kit 302357, PCA3/PSA Supplemental Fluids Kit 302030.
Material uses : In vitro diagnostic.
Supplier/Manufacturer : Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121-4362
MSDS # : 0039
In case of emergency : CANUTEC (613) 996-6666
CHEMTREC, U.S. : (800) 424-9300 International: (703) 527-3887
2. Hazards identification
Physical state : Liquid. [Clear.]
OSHA/HCS status : This material is considered hazardous by the OSHA Hazard Communication Standard
(29 CFR 1910.1200).
Emergency overview : WARNING!
CAUSES EYE IRRITATION. CONTAINS MATERIAL THAT CAN CAUSE TARGET
ORGAN DAMAGE.
Irritating to eyes. Avoid exposure - obtain special instructions before use. Do not
breathe vapor or mist. Do not get in eyes. Avoid contact with skin and clothing.
Contains material that can cause target organ damage. Wash thoroughly after handling.
Potential acute health effects
Inhalation : Exposure to decomposition products may cause a health hazard. Serious effects may
be delayed following exposure.
Ingestion : No known significant effects or critical hazards.
Skin : No known significant effects or critical hazards.
Eyes : Irritating to eyes.
Potential chronic health effects
Chronic effects : Contains material that can cause target organ damage.
Carcinogenicity : No known significant effects or critical hazards.
Mutagenicity : No known significant effects or critical hazards.
Teratogenicity : No known significant effects or critical hazards.
Developmental effects : No known significant effects or critical hazards.
Fertility effects : No known significant effects or critical hazards.
Target organs : Contains material which causes damage to the following organs: kidneys, upper
respiratory tract, skin, eye, lens or cornea.
Over-exposure signs/symptoms
Inhalation : No specific data.
Ingestion : No specific data.
Skin : No specific data.
: 01/15/2008 Page: 1/7
Date of issue
Enzyme Reconstitution Solution
2. Hazards identification
Eyes : Adverse symptoms may include the following:
pain or irritation
watering
redness
Medical conditions : Pre-existing disorders involving any target organs mentioned in this MSDS as being at
risk may be aggravated by over-exposure to this product.
aggravated by over-
exposure
See toxicological information (section 11)
3. Composition/information on ingredients
United States
Name CAS number %
Glycerin 56-81-5 10 - 30
Triton X-100 9002-93-1 5 - 10
Canada
Name CAS number %
Glycerin 56-81-5 10 - 30
Triton X-100 9002-93-1 5 - 10
Hazardous materials listed are the same in each part number in " Used In " section, however due to differing non-
hazardous components, the use of these products are not interchangeable. See package insert for product use.
There are no additional ingredients present which, within the current knowledge of the supplier and in the
concentrations applicable, are classified as hazardous to health or the environment and hence require reporting in
this section.
4. First aid measures
Eye contact : Check for and remove any contact lenses. In case of contact with eyes, rinse
immediately with plenty of water. Get medical attention if symptoms occur.
Skin contact : Wash with soap and water. Get medical attention if symptoms occur.
Inhalation : If inhaled, remove to fresh air. If not breathing, give artificial respiration. Get medical
attention if symptoms appear.
Ingestion : Do not induce vomiting. Never give anything by mouth to an unconscious person. Get
medical attention if symptoms appear.
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training. It may
be dangerous to the person providing aid to give mouth-to-mouth resuscitation.
Notes to physician : In case of inhalation of decomposition products in a fire, symptoms may be delayed.
The exposed person may need to be kept under medical surveillance for 48 hours.
5. Fire-fighting measures
Flammability of the product : Non-flammable.
Extinguishing media
Suitable : Use an extinguishing agent suitable for the surrounding fire.
Not suitable : None known.
Hazardous thermal : Decomposition products may include the following materials:
carbon dioxide
decomposition products
carbon monoxide
nitrogen oxides
sulfur oxides
: 01/15/2008 Page: 2/7
Date of issue
Enzyme Reconstitution Solution
5. Fire-fighting measures
Special protective : Fire-fighters should wear appropriate protective equipment and self-contained breathing
apparatus (SCBA) with a full face-piece operated in positive pressure mode.
equipment for fire-fighters
6. Accidental release measures
Personal precautions : No action shall be taken involving any personal risk or without suitable training.
Evacuate surrounding areas. Keep unnecessary and unprotected personnel from
entering. Do not touch or walk through spilled material. Avoid breathing vapor or mist.
Provide adequate ventilation. Wear appropriate respirator when ventilation is
inadequate. Put on appropriate personal protective equipment (see section 8).
Environmental precautions : Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains
and sewers. Inform the relevant authorities if the product has caused environmental
pollution (sewers, waterways, soil or air).
Methods for cleaning up
Small spill : Stop leak if without risk. Move containers from spill area. Dilute with water and mop up
if water-soluble or absorb with an inert dry material and place in an appropriate waste
disposal container. Dispose of via a licensed waste disposal contractor.
Large spill : Stop leak if without risk. Move containers from spill area. Approach release from
upwind. Prevent entry into sewers, water courses, basements or confined areas. Wash
spillages into an effluent treatment plant or proceed as follows. Contain and collect
spillage with non-combustible, absorbent material e.g. sand, earth, vermiculite or
diatomaceous earth and place in container for disposal according to local regulations
(see section 13). Dispose of via a licensed waste disposal contractor. Contaminated
absorbent material may pose the same hazard as the spilled product. Note: see section
1 for emergency contact information and section 13 for waste disposal.
7. Handling and storage
Handling : Put on appropriate personal protective equipment (see section 8). Eating, drinking and
smoking should be prohibited in areas where this material is handled, stored and
processed. Workers should wash hands and face before eating, drinking and smoking.
Do not get in eyes or on skin or clothing. Do not breathe vapor or mist. Do not ingest. If
during normal use the material presents a respiratory hazard, use only with adequate
ventilation or wear appropriate respirator. Keep in the original container or an approved
alternative made from a compatible material, kept tightly closed when not in use. Empty
containers retain product residue and can be hazardous. Do not reuse container.
Storage : Store in accordance with local regulations. Store in original container protected from
direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials
(see section 10) and food and drink. Keep container tightly closed and sealed until ready
for use. Containers that have been opened must be carefully resealed and kept upright
to prevent leakage. Do not store in unlabeled containers. Use appropriate containment
to avoid environmental contamination.
8. Exposure controls/personal protection
United States
Product name Exposure limits
Glycerin ACGIH TLV (United States, 1/2006).
TWA: 10 mg/m鲁 8 hour(s). Form: Mist
OSHA PEL (United States, 11/2006).
TWA: 5 mg/m鲁 8 hour(s). Form: Respirable fraction
Canada
Product name Exposure limits
Glycerin ACGIH TLV (United States, 1/2006).
TWA: 10 mg/m鲁 8 hour(s). Form: Mist
: 01/15/2008 Page: 3/7
Date of issue
Enzyme Reconstitution Solution
8. Exposure controls/personal protection
Consult local authorities for acceptable exposure limits.
Recommended monitoring : If this product contains ingredients with exposure limits, personal, workplace atmosphere
or biological monitoring may be required to determine the effectiveness of the ventilation
procedures
or other control measures and/or the necessity to use respiratory protective equipment.
Engineering measures : If user operations generate dust, fumes, gas, vapor or mist, use process enclosures,
local exhaust ventilation or other engineering controls to keep worker exposure to
airborne contaminants below any recommended or statutory limits.
Hygiene measures : Wash hands, forearms and face thoroughly after handling chemical products, before
eating, smoking and using the lavatory and at the end of the working period. Appropriate
techniques should be used to remove potentially contaminated clothing. Wash
contaminated clothing before reusing. Ensure that eyewash stations and safety showers
are close to the workstation location.
Personal protection
Eyes : Safety glasses.
Skin : Lab coat.
Respiratory : A respirator is not needed under normal and intended conditions of product use.
Hands : Natural rubber (latex).
Personal protective :
equipment (Pictograms)
HMIS Code/Personal :B
protective equipment
Environmental exposure : Emissions from ventilation or work process equipment should be checked to ensure they
comply with the requirements of environmental protection legislation. In some cases,
controls
fume scrubbers, filters or engineering modifications to the process equipment will be
necessary to reduce emissions to acceptable levels.
9. Physical and chemical properties
Physical state : Liquid. [Clear.]
Color : Colorless.
pH : 7.
Relative density : 1.071
Solubility : Miscible in water.
10 . Stability and reactivity
Stability : The product is stable.
Hazardous polymerization : Under normal conditions of storage and use, hazardous polymerization will not occur.
Conditions to avoid : No specific data.
Materials to avoid : No specific data.
Hazardous decomposition : Under normal conditions of storage and use, hazardous decomposition products should
not be produced.
products
: 01/15/2008 Page: 4/7
Date of issue
Enzyme Reconstitution Solution
11 . Toxicological information
Acute toxicity
Product/ingredient name Species Dose Result Exposure
Glycerin Rabbit >10 g/kg LD50 Dermal -
Rat 4420 mg/kg LD50 Intraperitoneal -
Rat 5566 mg/kg LD50 Intravenous -
Rat 12600 mg/kg LD50 Oral -
Rat 100 mg/kg LD50 Subcutaneous -
Inhalation Exposure to decomposition products may cause a health hazard. Serious effects may
:
be delayed following exposure.
Ingestion : No known significant effects or critical hazards.
Skin : No known significant effects or critical hazards.
Eyes : Irritating to eyes.
12 . Ecological information
Environmental effects : No known significant effects or critical hazards.
Aquatic ecotoxicity
Product/ingredient name Test Species Exposure Result
Glycerin Mortality Fish 96 hours Acute LC50 54000 mg/L
Triton X-100 Mortality Fish 96 hours Acute LC50 531 mg/L
Mortality Fish 96 hours Acute LC50 12 mg/L
Mortality Fish 96 hours Acute LC50 >10 mg/L
Mortality Fish 96 hours Acute LC50 6 mg/L
Mortality Fish 96 hours Acute LC50 5.38 mg/L
Mortality Fish 96 hours Acute LC50 4.5 mg/L
Other adverse effects : No known significant effects or critical hazards.
13 . Disposal considerations
Waste disposal : The generation of waste should be avoided or minimized wherever possible. Empty
containers or liners may retain some product residues. This material and its container
must be disposed of in a safe way. Dispose of surplus and non-recyclable products via
a licensed waste disposal contractor. Disposal of this product, solutions and any by-
products should at all times comply with the requirements of environmental protection
and waste disposal legislation and any regional local authority requirements. Avoid
dispersal of spilled material and runoff and contact with soil, waterways, drains and
sewers.
Disposal should be in accordance with applicable regional, national and local laws and regulations.
Refer to Section 7: HANDLING AND STORAGE and Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
for additional handling information and protection of employees.
14 . Transport information
AERG : Not applicable.
Regulatory information
DOT/ TDG / IMDG/ IATA : Not regulated.
: 01/15/2008 Page: 5/7
Date of issue
Enzyme Reconstitution Solution
15 . Regulatory information
United States
HCS Classification : Irritating material
Target organ effects
U.S. Federal regulations : TSCA 8(a) PAIR: Triton X-100
United States inventory (TSCA 8b): All components listed.
SARA 302/304/311/312 extremely hazardous substances: No products were found.
SARA 302/304 emergency planning and notification: No products were found.
SARA 302/304/311/312 hazardous chemicals: Glycerin; Triton X-100
SARA 311/312 MSDS distribution - chemical inventory - hazard identification:
Glycerin: Immediate (acute) health hazard, Delayed (chronic) health hazard; Triton X-
100: Immediate (acute) health hazard, Delayed (chronic) health hazard
Clean Water Act (CWA) 307: No products were found.
Clean Water Act (CWA) 311: Sodium hydroxide; Ethylenediamine tetraacetic acid
Clean Air Act (CAA) 112 accidental release prevention: No products were found.
Clean Air Act (CAA) 112 regulated flammable substances: No products were found.
Clean Air Act (CAA) 112 regulated toxic substances: No products were found.
State regulations : Connecticut Carcinogen Reporting: None of the components are listed.
Connecticut Hazardous Material Survey: None of the components are listed.
Florida substances: None of the components are listed.
Illinois Chemical Safety Act: None of the components are listed.
Illinois Toxic Substances Disclosure to Employee Act: None of the components are
listed.
Louisiana Reporting: None of the components are listed.
Louisiana Spill: None of the components are listed.
Massachusetts Spill: None of the components are listed.
Massachusetts Substances: The following components are listed: Glycerin
Michigan Critical Material: None of the components are listed.
Minnesota Hazardous Substances: None of the components are listed.
New Jersey Hazardous Substances: None of the components are listed.
New Jersey Spill: None of the components are listed.
New Jersey Toxic Catastrophe Prevention Act: None of the components are listed.
New York Acutely Hazardous Substances: None of the components are listed.
New York Toxic Chemical Release Reporting: None of the components are listed.
Pennsylvania RTK Hazardous Substances: The following components are listed:
Glycerin
Rhode Island Hazardous Substances: None of the components are listed.
California Prop. 65
California prop. 65: No products were found.
Canada
WHMIS (Canada) : Class D-2B: Material causing other toxic effects (Toxic).
Canadian lists : CEPA Toxic substances: None of the components are listed.
Canadian ARET: None of the components are listed.
Canadian NPRI: The following components are listed: Triton X-100
Alberta Designated Substances: None of the components are listed.
Ontario Designated Substances: None of the components are listed.
Quebec Designated Substances: None of the components are listed.
Canada inventory : Canada inventory: All components listed.
This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations
and the MSDS contains all the information required by the Controlled Products Regulations.
: 01/15/2008 Page: 6/7
Date of issue
Enzyme Reconstitution Solution
15 . Regulatory information
International regulations
International lists : This product, (and its ingredients) is (are) listed on national inventories, or is (are)
exempted from being listed, in Australia (AICS), in Europe (EINECS/ELINCS), in Korea
(TCCL), in Japan (METI), in the Philippines (RA6969).
16 . Other information
Label requirements : CAUSES EYE IRRITATION. CONTAINS MATERIAL THAT CAN CAUSE TARGET
ORGAN DAMAGE.
Hazardous Material : HAZARD RATINGS
Information System (U.S.A.)
* 1
Health 4- Extreme
3- Serious
0
Fire hazard 2- Moderate
1- Slight
0
Physical Hazard 0- Minimal
See section 8 for more detailed
B
Personal protection information on personal protection.
The customer is responsible for determining the PPE code for this material.
National Fire Protection :
Association (U.S.A.)
Flammability
0
1 0
Health Instability
Special
References : ANSI Z400.5, MSDS Standard, 2004. - Manufacturer's Material Safety Data Sheet. -
29CFR Part1910.1200 OSHA MSDS Requirements. - 49CFR Table List of Hazardous
Materials, UN#, Proper Shipping Names, PG. - Canada Gazette Part II, Vol. 122, No. 2.
Registration SOR/88-64, 31 December 1987. Hazardous Products Act "Ingredient
Disclosure List" - Canadian Transport of Dangerous Goods, Regulations and Schedules,
Clear Language version 2005.
: 01/15/2008
Date of issue
Date of previous issue : 08/15/2007
Version : 1.1
Notice to reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above named
supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the
information contained herein. Final determination of suitability of any material is the sole responsibility of the
user. All materials may present unknown hazards and should be used with caution. Although certain hazards are
described herein, we cannot guarantee that these are the only hazards that exist.
: 01/15/2008 Page: 7/7
Date of issue
Conforms to ANSI Z400.5-2004 Standard (United States, Canada).
Material Safety Data Sheet
Enzyme Reagent
1. Product and company identification
Product name : Enzyme Reagent
Used in : APTIMA CT Assay 301088, APTIMA CT Assay TIGRIS 250-test kit 301199, APTIMA CT
Assay TIGRIS 2x50-test kit 302224, APTIMA GC Assay 301091, APTIMA GC Assay
TIGRIS 250-test kit 301196, APTIMA GC Assay TIGRIS 2x50-test kit 302225, APTIMA
Combo 2 301032, APTIMA Combo 2 TIGRIS 250-test kit 301130, PROGENSA PCA3
Assay Kit CE 302355, PROGENSA PCA3 100-Reaction Kit 302354, PROGENSA PSA
100-Reaction Kit 302357, PCA3/PSA Supplemental Fluids Kit 302030.
Material uses : In vitro diagnostic.
Supplier/Manufacturer : Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121-4362
MSDS # : 0040
In case of emergency : CANUTEC (613) 996-6666
CHEMTREC, U.S. : (800) 424-9300 International: (703) 527-3887
2. Hazards identification
Physical state : Solid. [Lyophilized.]
OSHA/HCS status : While this material is not considered hazardous by the OSHA Hazard Communication
Standard (29 CFR 1910.1200), this MSDS contains valuable information critical to the
safe handling and proper use of the product. This MSDS should be retained and
available for employees and other users of this product.
Emergency overview : NOT EXPECTED TO PRODUCE SIGNIFICANT ADVERSE HEALTH EFFECTS WHEN
THE RECOMMENDED INSTRUCTIONS FOR USE ARE FOLLOWED.
No known significant effects or critical hazards. Avoid prolonged contact with eyes, skin
and clothing.
Potential acute health effects
Inhalation : Exposure to decomposition products may cause a health hazard. Serious effects may
be delayed following exposure.
Ingestion : No known significant effects or critical hazards.
Skin : Slightly irritating to the skin.
Eyes : No known significant effects or critical hazards.
Potential chronic health effects
Chronic effects : No known significant effects or critical hazards.
Carcinogenicity : No known significant effects or critical hazards.
Mutagenicity : No known significant effects or critical hazards.
Teratogenicity : No known significant effects or critical hazards.
Developmental effects : No known significant effects or critical hazards.
Fertility effects : No known significant effects or critical hazards.
Over-exposure signs/symptoms
Inhalation : No specific data.
Ingestion : No specific data.
Skin : No specific data.
Eyes : No specific data.
Medical conditions : None known.
aggravated by over-
exposure
See toxicological information (section 11)
: 01/15/2008 Page: 1/6
Date of issue
Enzyme Reagent
3. Composition/information on ingredients
Name CAS number %
No hazardous ingredient
Due to differing non-hazardous components, the products listed in each part number in 鈥淯sed In鈥? section are not
interchangeable. See package insert for product use.
There are no ingredients present which, within the current knowledge of the supplier and in the concentrations
applicable, are classified as hazardous to health or the environment and hence require reporting in this section.
4. First aid measures
Eye contact : Check for and remove any contact lenses. In case of contact with eyes, rinse
immediately with plenty of water. Get medical attention if symptoms occur.
Skin contact : Wash with soap and water. Get medical attention if symptoms occur.
Inhalation : If inhaled, remove to fresh air. If not breathing, give artificial respiration. Get medical
attention if symptoms appear.
Ingestion : Do not induce vomiting. Never give anything by mouth to an unconscious person. Get
medical attention if symptoms appear.
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training.
Notes to physician : In case of inhalation of decomposition products in a fire, symptoms may be delayed.
The exposed person may need to be kept under medical surveillance for 48 hours.
5. Fire-fighting measures
Flammability of the product : Non-flammable.
Extinguishing media
Suitable : Use an extinguishing agent suitable for the surrounding fire.
Not suitable : None known.
Hazardous thermal : Decomposition products may include the following materials:
carbon dioxide
decomposition products
carbon monoxide
nitrogen oxides
sulfur oxides
Special protective : Fire-fighters should wear appropriate protective equipment and self-contained breathing
apparatus (SCBA) with a full face-piece operated in positive pressure mode.
equipment for fire-fighters
6. Accidental release measures
Personal precautions : No action shall be taken involving any personal risk or without suitable training.
Evacuate surrounding areas. Keep unnecessary and unprotected personnel from
entering. Do not touch or walk through spilled material. Provide adequate ventilation.
Wear appropriate respirator when ventilation is inadequate. Put on appropriate personal
protective equipment (see section 8).
Environmental precautions : Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains
and sewers. Inform the relevant authorities if the product has caused environmental
pollution (sewers, waterways, soil or air).
Methods for cleaning up
Small spill : Move containers from spill area. Vacuum or sweep up material and place in a
designated, labeled waste container. Dispose of via a licensed waste disposal
contractor.
: 01/15/2008 Page: 2/6
Date of issue
Enzyme Reagent
6. Accidental release measures
Large spill : Move containers from spill area. Approach release from upwind. Prevent entry into
sewers, water courses, basements or confined areas. Vacuum or sweep up material
and place in a designated, labeled waste container. Dispose of via a licensed waste
disposal contractor. Note: see section 1 for emergency contact information and section
13 for waste disposal.
7. Handling and storage
Handling : Put on appropriate personal protective equipment (see section 8). Eating, drinking and
smoking should be prohibited in areas where this material is handled, stored and
processed. Workers should wash hands and face before eating, drinking and smoking.
Do not ingest. Avoid contact with eyes, skin and clothing. Keep in the original container
or an approved alternative made from a compatible material, kept tightly closed when not
in use. Empty containers retain product residue and can be hazardous. Do not reuse
container.
Storage : Store in accordance with local regulations. Store in original container protected from
direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials
(see section 10) and food and drink. Keep container tightly closed and sealed until ready
for use. Containers that have been opened must be carefully resealed and kept upright
to prevent leakage. Do not store in unlabeled containers. Use appropriate containment
to avoid environmental contamination.
8. Exposure controls/personal protection
Consult local authorities for acceptable exposure limits.
Recommended monitoring : If this product contains ingredients with exposure limits, personal, workplace atmosphere
or biological monitoring may be required to determine the effectiveness of the ventilation
procedures
or other control measures and/or the necessity to use respiratory protective equipment.
Engineering measures : No special ventilation requirements. Good general ventilation should be sufficient to
control worker exposure to airborne contaminants. If this product contains ingredients
with exposure limits, use process enclosures, local exhaust ventilation or other
engineering controls to keep worker exposure below any recommended or statutory
limits.
Hygiene measures : Wash hands, forearms and face thoroughly after handling chemical products, before
eating, smoking and using the lavatory and at the end of the working period. Appropriate
techniques should be used to remove potentially contaminated clothing. Wash
contaminated clothing before reusing. Ensure that eyewash stations and safety showers
are close to the workstation location.
Personal protection
Eyes : Safety glasses.
Skin : Lab coat.
Respiratory : A respirator is not needed under normal and intended conditions of product use.
Hands : Disposable vinyl gloves.
Personal protective :
equipment (Pictograms)
HMIS Code/Personal :A
protective equipment
Environmental exposure : Emissions from ventilation or work process equipment should be checked to ensure they
comply with the requirements of environmental protection legislation. In some cases,
controls
fume scrubbers, filters or engineering modifications to the process equipment will be
necessary to reduce emissions to acceptable levels.
: 01/15/2008 Page: 3/6
Date of issue
Enzyme Reagent
9. Physical and chemical properties
Physical state : Solid. [Lyophilized.]
Color : White to off-white.
pH :7
10 . Stability and reactivity
Stability : The product is stable.
Hazardous polymerization : Under normal conditions of storage and use, hazardous polymerization will not occur.
Conditions to avoid : No specific data.
Materials to avoid : No specific data.
Hazardous decomposition : Under normal conditions of storage and use, hazardous decomposition products should
not be produced.
products
11 . Toxicological information
Acute toxicity
Inhalation : Exposure to decomposition products may cause a health hazard. Serious effects may
be delayed following exposure.
Ingestion : No known significant effects or critical hazards.
Skin : Slightly irritating to the skin.
Eyes : No known significant effects or critical hazards.
12 . Ecological information
Environmental effects : No known significant effects or critical hazards.
Other adverse effects : No known significant effects or critical hazards.
13 . Disposal considerations
Waste disposal : The generation of waste should be avoided or minimized wherever possible. Empty
containers or liners may retain some product residues. This material and its container
must be disposed of in a safe way. Dispose of surplus and non-recyclable products via
a licensed waste disposal contractor. Disposal of this product, solutions and any by-
products should at all times comply with the requirements of environmental protection
and waste disposal legislation and any regional local authority requirements. Avoid
dispersal of spilled material and runoff and contact with soil, waterways, drains and
sewers.
Disposal should be in accordance with applicable regional, national and local laws and regulations.
Refer to Section 7: HANDLING AND STORAGE and Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
for additional handling information and protection of employees.
14 . Transport information
AERG : Not applicable.
Regulatory information
DOT/ TDG / IMDG/ IATA : Not regulated.
: 01/15/2008 Page: 4/6
Date of issue
Enzyme Reagent
15 . Regulatory information
United States
HCS Classification : Not regulated.
U.S. Federal regulations : TSCA 8(a) PAIR: Triton X-100
United States inventory (TSCA 8b): All components listed.
SARA 302/304/311/312 extremely hazardous substances: No products were found.
SARA 302/304 emergency planning and notification: No products were found.
SARA 302/304/311/312 hazardous chemicals: N-Acetyl-L-Cysteine
SARA 311/312 MSDS distribution - chemical inventory - hazard identification: N-
Acetyl-L-Cysteine: Delayed (chronic) health hazard
Clean Water Act (CWA) 307: No products were found.
Clean Water Act (CWA) 311: Sodium hydroxide
Clean Air Act (CAA) 112 accidental release prevention: No products were found.
Clean Air Act (CAA) 112 regulated flammable substances: No products were found.
Clean Air Act (CAA) 112 regulated toxic substances: No products were found.
State regulations : Connecticut Carcinogen Reporting: None of the components are listed.
Connecticut Hazardous Material Survey: None of the components are listed.
Florida substances: None of the components are listed.
Illinois Chemical Safety Act: None of the components are listed.
Illinois Toxic Substances Disclosure to Employee Act: None of the components are
listed.
Louisiana Reporting: None of the components are listed.
Louisiana Spill: None of the components are listed.
Massachusetts Spill: None of the components are listed.
Massachusetts Substances: None of the components are listed.
Michigan Critical Material: None of the components are listed.
Minnesota Hazardous Substances: None of the components are listed.
New Jersey Hazardous Substances: None of the components are listed.
New Jersey Spill: None of the components are listed.
New Jersey Toxic Catastrophe Prevention Act: None of the components are listed.
New York Acutely Hazardous Substances: None of the components are listed.
New York Toxic Chemical Release Reporting: None of the components are listed.
Pennsylvania RTK Hazardous Substances: None of the components are listed.
Rhode Island Hazardous Substances: None of the components are listed.
California Prop. 65
California prop. 65: No products were found.
Canada
WHMIS (Canada) : Not controlled under WHMIS (Canada).
Canadian lists : CEPA Toxic substances: None of the components are listed.
Canadian ARET: None of the components are listed.
Canadian NPRI: None of the components are listed.
Alberta Designated Substances: None of the components are listed.
Ontario Designated Substances: None of the components are listed.
Quebec Designated Substances: None of the components are listed.
Canada inventory : Canada inventory: All components listed.
This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations
and the MSDS contains all the information required by the Controlled Products Regulations.
International regulations
International lists : This product, (and its ingredients) is (are) listed on national inventories, or is (are)
exempted from being listed, in Australia (AICS), in Europe (EINECS/ELINCS), in Korea
(TCCL), in Japan (METI), in the Philippines (RA6969).
: 01/15/2008 Page: 5/6
Date of issue
Enzyme Reagent
16 . Other information
Label requirements : NOT EXPECTED TO PRODUCE SIGNIFICANT ADVERSE HEALTH EFFECTS WHEN
THE RECOMMENDED INSTRUCTIONS FOR USE ARE FOLLOWED.
Hazardous Material : HAZARD RATINGS
Information System (U.S.A.)
1
Health 4- Extreme
3- Serious
0
Fire hazard 2- Moderate
1- Slight
0
Physical Hazard 0- Minimal
See section 8 for more detailed
A
Personal protection information on personal protection.
The customer is responsible for determining the PPE code for this material.
National Fire Protection :
Association (U.S.A.)
Flammability
0
1 0
Health Instability
Special
References : ANSI Z400.5, MSDS Standard, 2004. - Manufacturer's Material Safety Data Sheet. -
29CFR Part1910.1200 OSHA MSDS Requirements. - 49CFR Table List of Hazardous
Materials, UN#, Proper Shipping Names, PG. - Canada Gazette Part II, Vol. 122, No. 2.
Registration SOR/88-64, 31 December 1987. Hazardous Products Act "Ingredient
Disclosure List" - Canadian Transport of Dangerous Goods, Regulations and Schedules,
Clear Language version 2005.
: 01/15/2008
Date of issue
Date of previous issue : 08/31/2007
Version : 1.2
Notice to reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above named
supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the
information contained herein. Final determination of suitability of any material is the sole responsibility of the
user. All materials may present unknown hazards and should be used with caution. Although certain hazards are
described herein, we cannot guarantee that these are the only hazards that exist.
: 01/15/2008 Page: 6/6
Date of issue
Conforms to ANSI Z400.5-2004 Standard (United States, Canada).
Material Safety Data Sheet
Wash Solution
1. Product and company identification
Product name : Wash Solution
Used in : APTIMA HIV-1 RNA Qualitative Assay 302178, APTIMA HCV RNA Qualitative Assay
302179, APTIMA CT Assay 301088, APTIMA GC Assay 301091, APTIMA Combo 2
301032, APTIMA Assay Fluids Kit 302002C, APTIMA Assay Fluids Kit TIGRIS 302382,
PROGENSA PCA3 Assay Kit CE 302355, PCA3/PSA Supplemental Fluids Kit 302030.
Material uses : In vitro diagnostic.
Supplier/Manufacturer : Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121-4362
MSDS # : 0041
In case of emergency : CANUTEC (613) 996-6666
CHEMTREC, U.S. : (800) 424-9300 International: (703) 527-3887
2. Hazards identification
Physical state : Liquid. [Clear.]
OSHA/HCS status : While this material is not considered hazardous by the OSHA Hazard Communication
Standard (29 CFR 1910.1200), this MSDS contains valuable information critical to the
safe handling and proper use of the product. This MSDS should be retained and
available for employees and other users of this product.
Emergency overview : NOT EXPECTED TO PRODUCE SIGNIFICANT ADVERSE HEALTH EFFECTS WHEN
THE RECOMMENDED INSTRUCTIONS FOR USE ARE FOLLOWED.
No known significant effects or critical hazards. Avoid prolonged contact with eyes, skin
and clothing.
Potential acute health effects
Inhalation : No known significant effects or critical hazards.
Ingestion : No known significant effects or critical hazards.
Skin : No known significant effects or critical hazards.
Eyes : No known significant effects or critical hazards.
Potential chronic health effects
Chronic effects : No known significant effects or critical hazards.
Carcinogenicity : No known significant effects or critical hazards.
Mutagenicity : No known significant effects or critical hazards.
Teratogenicity : No known significant effects or critical hazards.
Developmental effects : No known significant effects or critical hazards.
Fertility effects : No known significant effects or critical hazards.
Over-exposure signs/symptoms
Inhalation : No specific data.
Ingestion : No specific data.
Skin : No specific data.
Eyes : No specific data.
Medical conditions : None known.
aggravated by over-
exposure
See toxicological information (section 11)
: 01/15/2008 Page: 1/6
Date of issue
Wash Solution
3. Composition/information on ingredients
Name CAS number %
No hazardous ingredient
Due to differing non-hazardous components, the products listed in each part number in 鈥淯sed In鈥? section are not
interchangeable. See package insert for product use.
There are no ingredients present which, within the current knowledge of the supplier and in the concentrations
applicable, are classified as hazardous to health or the environment and hence require reporting in this section.
4. First aid measures
Eye contact : Check for and remove any contact lenses. In case of contact with eyes, rinse
immediately with plenty of water. Get medical attention if symptoms occur.
Skin contact : Wash with soap and water. Get medical attention if symptoms occur.
Inhalation : If inhaled, remove to fresh air. If not breathing, give artificial respiration. Get medical
attention if symptoms appear.
Ingestion : Do not induce vomiting. Never give anything by mouth to an unconscious person. Get
medical attention if symptoms appear.
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training.
Notes to physician : No specific treatment. Treat symptomatically. Contact poison treatment specialist
immediately if large quantities have been ingested or inhaled.
5. Fire-fighting measures
Flammability of the product : Non-flammable.
Extinguishing media
Suitable : Use an extinguishing agent suitable for the surrounding fire.
Not suitable : None known.
Hazardous thermal : No specific data.
decomposition products
Special protective : Fire-fighters should wear appropriate protective equipment and self-contained breathing
apparatus (SCBA) with a full face-piece operated in positive pressure mode.
equipment for fire-fighters
6. Accidental release measures
Personal precautions : No action shall be taken involving any personal risk or without suitable training.
Evacuate surrounding areas. Keep unnecessary and unprotected personnel from
entering. Do not touch or walk through spilled material. Avoid breathing vapor or mist.
Provide adequate ventilation. Wear appropriate respirator when ventilation is
inadequate. Put on appropriate personal protective equipment (see section 8).
Environmental precautions : Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains
and sewers. Inform the relevant authorities if the product has caused environmental
pollution (sewers, waterways, soil or air).
Methods for cleaning up
Small spill : Stop leak if without risk. Move containers from spill area. Dilute with water and mop up
if water-soluble or absorb with an inert dry material and place in an appropriate waste
disposal container. Dispose of via a licensed waste disposal contractor.
: 01/15/2008 Page: 2/6
Date of issue
Wash Solution
6. Accidental release measures
Large spill : Stop leak if without risk. Move containers from spill area. Approach release from
upwind. Prevent entry into sewers, water courses, basements or confined areas. Wash
spillages into an effluent treatment plant or proceed as follows. Contain and collect
spillage with non-combustible, absorbent material e.g. sand, earth, vermiculite or
diatomaceous earth and place in container for disposal according to local regulations
(see section 13). Dispose of via a licensed waste disposal contractor. Contaminated
absorbent material may pose the same hazard as the spilled product. Note: see section
1 for emergency contact information and section 13 for waste disposal.
7. Handling and storage
Handling : Put on appropriate personal protective equipment (see section 8). Eating, drinking and
smoking should be prohibited in areas where this material is handled, stored and
processed. Workers should wash hands and face before eating, drinking and smoking.
Do not ingest. Avoid contact with eyes, skin and clothing. Avoid breathing vapor or mist.
Keep in the original container or an approved alternative made from a compatible
material, kept tightly closed when not in use. Empty containers retain product residue
and can be hazardous. Do not reuse container.
Storage : Store in accordance with local regulations. Store in original container protected from
direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials
(see section 10) and food and drink. Keep container tightly closed and sealed until ready
for use. Containers that have been opened must be carefully resealed and kept upright
to prevent leakage. Do not store in unlabeled containers. Use appropriate containment
to avoid environmental contamination.
8. Exposure controls/personal protection
Consult local authorities for acceptable exposure limits.
Recommended monitoring : If this product contains ingredients with exposure limits, personal, workplace atmosphere
or biological monitoring may be required to determine the effectiveness of the ventilation
procedures
or other control measures and/or the necessity to use respiratory protective equipment.
Engineering measures : No special ventilation requirements. Good general ventilation should be sufficient to
control worker exposure to airborne contaminants. If this product contains ingredients
with exposure limits, use process enclosures, local exhaust ventilation or other
engineering controls to keep worker exposure below any recommended or statutory
limits.
Hygiene measures : Wash hands, forearms and face thoroughly after handling chemical products, before
eating, smoking and using the lavatory and at the end of the working period. Appropriate
techniques should be used to remove potentially contaminated clothing. Wash
contaminated clothing before reusing. Ensure that eyewash stations and safety showers
are close to the workstation location.
Personal protection
Eyes : Safety glasses.
Skin : Lab coat.
Respiratory : A respirator is not needed under normal and intended conditions of product use.
Hands : Disposable vinyl gloves.
Personal protective :
equipment (Pictograms)
HMIS Code/Personal :A
protective equipment
: 01/15/2008 Page: 3/6
Date of issue
Wash Solution
8. Exposure controls/personal protection
Environmental exposure : Emissions from ventilation or work process equipment should be checked to ensure they
comply with the requirements of environmental protection legislation. In some cases,
controls
fume scrubbers, filters or engineering modifications to the process equipment will be
necessary to reduce emissions to acceptable levels.
9. Physical and chemical properties
Physical state : Liquid. [Clear.]
Color : Colorless.
pH : ~ 7.5.
Relative density : ~ 1.
Solubility : Miscible in water.
10 . Stability and reactivity
Stability : The product is stable.
Hazardous polymerization : Under normal conditions of storage and use, hazardous polymerization will not occur.
Conditions to avoid : No specific data.
Materials to avoid : No specific data.
Hazardous decomposition : Under normal conditions of storage and use, hazardous decomposition products should
not be produced.
products
11 . Toxicological information
Acute toxicity
Inhalation No known significant effects or critical hazards.
:
Ingestion : No known significant effects or critical hazards.
Skin : No known significant effects or critical hazards.
Eyes : No known significant effects or critical hazards.
12 . Ecological information
Environmental effects : No known significant effects or critical hazards.
Other adverse effects : No known significant effects or critical hazards.
13 . Disposal considerations
Waste disposal : The generation of waste should be avoided or minimized wherever possible. Empty
containers or liners may retain some product residues. This material and its container
must be disposed of in a safe way. Dispose of surplus and non-recyclable products via
a licensed waste disposal contractor. Disposal of this product, solutions and any by-
products should at all times comply with the requirements of environmental protection
and waste disposal legislation and any regional local authority requirements. Avoid
dispersal of spilled material and runoff and contact with soil, waterways, drains and
sewers.
Disposal should be in accordance with applicable regional, national and local laws and regulations.
Refer to Section 7: HANDLING AND STORAGE and Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
for additional handling information and protection of employees.
: 01/15/2008 Page: 4/6
Date of issue
Wash Solution
14 . Transport information
AERG : Not applicable.
Regulatory information
DOT/ TDG / IMDG/ IATA : Not regulated.
15 . Regulatory information
United States
HCS Classification : Not regulated.
U.S. Federal regulations : United States inventory (TSCA 8b): All components are listed or exempted.
SARA 302/304/311/312 extremely hazardous substances: No products were found.
SARA 302/304 emergency planning and notification: No products were found.
SARA 302/304/311/312 hazardous chemicals: No products were found.
SARA 311/312 MSDS distribution - chemical inventory - hazard identification: No
products were found.
Clean Water Act (CWA) 307: No products were found.
Clean Water Act (CWA) 311: Sodium hydroxide; Ethylenediamine tetraacetic acid
Clean Air Act (CAA) 112 accidental release prevention: No products were found.
Clean Air Act (CAA) 112 regulated flammable substances: No products were found.
Clean Air Act (CAA) 112 regulated toxic substances: No products were found.
State regulations : Connecticut Carcinogen Reporting: None of the components are listed.
Connecticut Hazardous Material Survey: None of the components are listed.
Florida substances: None of the components are listed.
Illinois Chemical Safety Act: None of the components are listed.
Illinois Toxic Substances Disclosure to Employee Act: None of the components are
listed.
Louisiana Reporting: None of the components are listed.
Louisiana Spill: None of the components are listed.
Massachusetts Spill: None of the components are listed.
Massachusetts Substances: None of the components are listed.
Michigan Critical Material: None of the components are listed.
Minnesota Hazardous Substances: None of the components are listed.
New Jersey Hazardous Substances: None of the components are listed.
New Jersey Spill: None of the components are listed.
New Jersey Toxic Catastrophe Prevention Act: None of the components are listed.
New York Acutely Hazardous Substances: None of the components are listed.
New York Toxic Chemical Release Reporting: None of the components are listed.
Pennsylvania RTK Hazardous Substances: None of the components are listed.
Rhode Island Hazardous Substances: None of the components are listed.
California Prop. 65
California prop. 65: No products were found.
Canada
WHMIS (Canada) : Not controlled under WHMIS (Canada).
Canadian lists : CEPA Toxic substances: None of the components are listed.
Canadian ARET: None of the components are listed.
Canadian NPRI: None of the components are listed.
Alberta Designated Substances: None of the components are listed.
Ontario Designated Substances: None of the components are listed.
Quebec Designated Substances: None of the components are listed.
Canada inventory : Canada inventory: All components listed.
This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations
and the MSDS contains all the information required by the Controlled Products Regulations.
International regulations
: 01/15/2008 Page: 5/6
Date of issue
Wash Solution
15 . Regulatory information
International lists : This product, (and its ingredients) is (are) listed on national inventories, or is (are)
exempted from being listed, in Australia (AICS), in Europe (EINECS/ELINCS), in Korea
(TCCL), in Japan (METI), in the Philippines (RA6969).
16 . Other information
Label requirements : NOT EXPECTED TO PRODUCE SIGNIFICANT ADVERSE HEALTH EFFECTS WHEN
THE RECOMMENDED INSTRUCTIONS FOR USE ARE FOLLOWED.
Hazardous Material : HAZARD RATINGS
Information System (U.S.A.)
0
Health 4- Extreme
3- Serious
0
Fire hazard 2- Moderate
1- Slight
0
Physical Hazard 0- Minimal
See section 8 for more detailed
A
Personal protection information on personal protection.
The customer is responsible for determining the PPE code for this material.
National Fire Protection :
Association (U.S.A.)
Flammability
0
0 0
Health Instability
Special
References : ANSI Z400.5, MSDS Standard, 2004. - Manufacturer's Material Safety Data Sheet. -
29CFR Part1910.1200 OSHA MSDS Requirements. - 49CFR Table List of Hazardous
Materials, UN#, Proper Shipping Names, PG. - Canada Gazette Part II, Vol. 122, No. 2.
Registration SOR/88-64, 31 December 1987. Hazardous Products Act "Ingredient
Disclosure List" - Canadian Transport of Dangerous Goods, Regulations and Schedules,
Clear Language version 2005.
: 01/15/2008
Date of issue
Date of previous issue : 08/15/2007
Version : 1.1
Notice to reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above named
supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the
information contained herein. Final determination of suitability of any material is the sole responsibility of the
user. All materials may present unknown hazards and should be used with caution. Although certain hazards are
described herein, we cannot guarantee that these are the only hazards that exist.
: 01/15/2008 Page: 6/6
Date of issue
Conforms to ANSI Z400.5-2004 Standard (United States, Canada).
Material Safety Data Sheet
Oil Reagent
1. Product and company identification
Product name : Oil Reagent
Used in : APTIMA HIV-1 RNA Qualitative Assay 302178, APTIMA HCV RNA Qualitative Assay
302179, APTIMA CT Assay 301088, APTIMA GC Assay 301091, APTIMA Combo 2
301032, APTIMA Assay Fluids Kit 302002C, APTIMA Assay Fluids Kit TIGRIS 302382,
PROGENSA PCA3 Assay Kit CE 302355, PCA3/PSA Supplemental Fluids Kit 302030.
Material uses : In vitro diagnostic.
Supplier/Manufacturer : Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121-4362
MSDS # : 0042
In case of emergency : CANUTEC (613) 996-6666
CHEMTREC, U.S. : (800) 424-9300 International: (703) 527-3887
2. Hazards identification
Physical state : Liquid. [Clear.]
Odor : Odorless.
OSHA/HCS status : While this material is not considered hazardous by the OSHA Hazard Communication
Standard (29 CFR 1910.1200), this MSDS contains valuable information critical to the
safe handling and proper use of the product. This MSDS should be retained and
available for employees and other users of this product.
Emergency overview : NOT EXPECTED TO PRODUCE SIGNIFICANT ADVERSE HEALTH EFFECTS WHEN
THE RECOMMENDED INSTRUCTIONS FOR USE ARE FOLLOWED.
No known significant effects or critical hazards. Avoid prolonged contact with eyes, skin
and clothing.
Potential acute health effects
Inhalation : No known significant effects or critical hazards.
Ingestion : No known significant effects or critical hazards.
Skin : No known significant effects or critical hazards.
Eyes : No known significant effects or critical hazards.
Potential chronic health effects
Chronic effects : No known significant effects or critical hazards.
Carcinogenicity : No known significant effects or critical hazards.
Mutagenicity : No known significant effects or critical hazards.
Teratogenicity : No known significant effects or critical hazards.
Developmental effects : No known significant effects or critical hazards.
Fertility effects : No known significant effects or critical hazards.
Over-exposure signs/symptoms
Inhalation : No specific data.
Ingestion : No specific data.
Skin : No specific data.
Eyes : No specific data.
Medical conditions : None known.
aggravated by over-
exposure
See toxicological information (section 11)
: 01/15/2008 Page: 1/6
Date of issue
Oil Reagent
3. Composition/information on ingredients
Name CAS number %
No hazardous ingredient
Due to differing non-hazardous components, the products listed in each part number in 鈥淯sed In鈥? section are not
interchangeable. See package insert for product use.
There are no ingredients present which, within the current knowledge of the supplier and in the concentrations
applicable, are classified as hazardous to health or the environment and hence require reporting in this section.
4. First aid measures
Eye contact : Check for and remove any contact lenses. In case of contact with eyes, rinse
immediately with plenty of water. Get medical attention if symptoms occur.
Skin contact : Wash with soap and water. Get medical attention if symptoms occur.
Inhalation : If inhaled, remove to fresh air. If not breathing, give artificial respiration. Get medical
attention if symptoms appear.
Ingestion : Do not induce vomiting. Never give anything by mouth to an unconscious person. Get
medical attention if symptoms appear.
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training.
Notes to physician : No specific treatment. Treat symptomatically. Contact poison treatment specialist
immediately if large quantities have been ingested or inhaled.
5. Fire-fighting measures
Flammability of the product : Non-flammable.
Extinguishing media
Suitable : Use an extinguishing agent suitable for the surrounding fire.
Not suitable : None known.
Hazardous thermal : No specific data.
decomposition products
Special protective : Fire-fighters should wear appropriate protective equipment and self-contained breathing
apparatus (SCBA) with a full face-piece operated in positive pressure mode.
equipment for fire-fighters
6. Accidental release measures
Personal precautions : No action shall be taken involving any personal risk or without suitable training.
Evacuate surrounding areas. Keep unnecessary and unprotected personnel from
entering. Do not touch or walk through spilled material. Avoid breathing vapor or mist.
Provide adequate ventilation. Wear appropriate respirator when ventilation is
inadequate. Put on appropriate personal protective equipment (see section 8).
Environmental precautions : Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains
and sewers. Inform the relevant authorities if the product has caused environmental
pollution (sewers, waterways, soil or air).
Methods for cleaning up
Small spill : Stop leak if without risk. Move containers from spill area. Dilute with water and mop up
if water-soluble or absorb with an inert dry material and place in an appropriate waste
disposal container. Dispose of via a licensed waste disposal contractor.
: 01/15/2008 Page: 2/6
Date of issue
Oil Reagent
6. Accidental release measures
Large spill : Stop leak if without risk. Move containers from spill area. Approach release from
upwind. Prevent entry into sewers, water courses, basements or confined areas. Wash
spillages into an effluent treatment plant or proceed as follows. Contain and collect
spillage with non-combustible, absorbent material e.g. sand, earth, vermiculite or
diatomaceous earth and place in container for disposal according to local regulations
(see section 13). Dispose of via a licensed waste disposal contractor. Contaminated
absorbent material may pose the same hazard as the spilled product. Note: see section
1 for emergency contact information and section 13 for waste disposal.
7. Handling and storage
Handling : Put on appropriate personal protective equipment (see section 8). Eating, drinking and
smoking should be prohibited in areas where this material is handled, stored and
processed. Workers should wash hands and face before eating, drinking and smoking.
Do not ingest. Avoid contact with eyes, skin and clothing. Avoid breathing vapor or mist.
Keep in the original container or an approved alternative made from a compatible
material, kept tightly closed when not in use. Empty containers retain product residue
and can be hazardous. Do not reuse container.
Storage : Store in accordance with local regulations. Store in original container protected from
direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials
(see section 10) and food and drink. Keep container tightly closed and sealed until ready
for use. Containers that have been opened must be carefully resealed and kept upright
to prevent leakage. Do not store in unlabeled containers. Use appropriate containment
to avoid environmental contamination.
8. Exposure controls/personal protection
Consult local authorities for acceptable exposure limits.
Recommended monitoring : If this product contains ingredients with exposure limits, personal, workplace atmosphere
or biological monitoring may be required to determine the effectiveness of the ventilation
procedures
or other control measures and/or the necessity to use respiratory protective equipment.
Engineering measures : No special ventilation requirements. Good general ventilation should be sufficient to
control worker exposure to airborne contaminants. If this product contains ingredients
with exposure limits, use process enclosures, local exhaust ventilation or other
engineering controls to keep worker exposure below any recommended or statutory
limits.
Hygiene measures : Wash hands, forearms and face thoroughly after handling chemical products, before
eating, smoking and using the lavatory and at the end of the working period. Appropriate
techniques should be used to remove potentially contaminated clothing. Wash
contaminated clothing before reusing. Ensure that eyewash stations and safety showers
are close to the workstation location.
Personal protection
Eyes : Safety glasses.
Skin : Lab coat.
Respiratory : A respirator is not needed under normal and intended conditions of product use.
Hands : Disposable vinyl gloves.
Personal protective :
equipment (Pictograms)
HMIS Code/Personal :A
protective equipment
: 01/15/2008 Page: 3/6
Date of issue
Oil Reagent
8. Exposure controls/personal protection
Environmental exposure : Emissions from ventilation or work process equipment should be checked to ensure they
comply with the requirements of environmental protection legislation. In some cases,
controls
fume scrubbers, filters or engineering modifications to the process equipment will be
necessary to reduce emissions to acceptable levels.
9. Physical and chemical properties
Physical state : Liquid. [Clear.]
Color : Colorless.
Odor : Odorless.
Solubility : Insoluble in the following materials: cold water and hot water.
10 . Stability and reactivity
Stability : The product is stable.
Hazardous polymerization : Under normal conditions of storage and use, hazardous polymerization will not occur.
Conditions to avoid : No specific data.
Materials to avoid : No specific data.
Hazardous decomposition : Under normal conditions of storage and use, hazardous decomposition products should
not be produced.
products
11 . Toxicological information
Acute toxicity
Inhalation No known significant effects or critical hazards.
:
Ingestion : No known significant effects or critical hazards.
Skin : No known significant effects or critical hazards.
Eyes : No known significant effects or critical hazards.
12 . Ecological information
Environmental effects : No known significant effects or critical hazards.
Other adverse effects : No known significant effects or critical hazards.
13 . Disposal considerations
Waste disposal : The generation of waste should be avoided or minimized wherever possible. Empty
containers or liners may retain some product residues. This material and its container
must be disposed of in a safe way. Dispose of surplus and non-recyclable products via
a licensed waste disposal contractor. Disposal of this product, solutions and any by-
products should at all times comply with the requirements of environmental protection
and waste disposal legislation and any regional local authority requirements. Avoid
dispersal of spilled material and runoff and contact with soil, waterways, drains and
sewers.
Disposal should be in accordance with applicable regional, national and local laws and regulations.
Refer to Section 7: HANDLING AND STORAGE and Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
for additional handling information and protection of employees.
: 01/15/2008 Page: 4/6
Date of issue
Oil Reagent
14 . Transport information
AERG : Not applicable.
Regulatory information
DOT/ TDG / IMDG/ IATA : Not regulated.
15 . Regulatory information
United States
HCS Classification : Not regulated.
U.S. Federal regulations : TSCA 8(a) PAIR: Dimethyl silicone and siloxanes
United States inventory (TSCA 8b): All components listed.
SARA 302/304/311/312 extremely hazardous substances: No products were found.
SARA 302/304 emergency planning and notification: No products were found.
SARA 302/304/311/312 hazardous chemicals: No products were found.
SARA 311/312 MSDS distribution - chemical inventory - hazard identification: No
products were found.
Clean Water Act (CWA) 307: No products were found.
Clean Water Act (CWA) 311: No products were found.
Clean Air Act (CAA) 112 accidental release prevention: No products were found.
Clean Air Act (CAA) 112 regulated flammable substances: No products were found.
Clean Air Act (CAA) 112 regulated toxic substances: No products were found.
State regulations : Connecticut Carcinogen Reporting: None of the components are listed.
Connecticut Hazardous Material Survey: None of the components are listed.
Florida substances: None of the components are listed.
Illinois Chemical Safety Act: None of the components are listed.
Illinois Toxic Substances Disclosure to Employee Act: None of the components are
listed.
Louisiana Reporting: None of the components are listed.
Louisiana Spill: None of the components are listed.
Massachusetts Spill: None of the components are listed.
Massachusetts Substances: None of the components are listed.
Michigan Critical Material: None of the components are listed.
Minnesota Hazardous Substances: None of the components are listed.
New Jersey Hazardous Substances: None of the components are listed.
New Jersey Spill: None of the components are listed.
New Jersey Toxic Catastrophe Prevention Act: None of the components are listed.
New York Acutely Hazardous Substances: None of the components are listed.
New York Toxic Chemical Release Reporting: None of the components are listed.
Pennsylvania RTK Hazardous Substances: None of the components are listed.
Rhode Island Hazardous Substances: None of the components are listed.
California Prop. 65
California prop. 65: No products were found.
Canada
WHMIS (Canada) : Not controlled under WHMIS (Canada).
Canadian lists : CEPA Toxic substances: None of the components are listed.
Canadian ARET: None of the components are listed.
Canadian NPRI: None of the components are listed.
Alberta Designated Substances: None of the components are listed.
Ontario Designated Substances: None of the components are listed.
Quebec Designated Substances: None of the components are listed.
Canada inventory : Canada inventory: All components listed.
This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations
and the MSDS contains all the information required by the Controlled Products Regulations.
: 01/15/2008 Page: 5/6
Date of issue
Oil Reagent
15 . Regulatory information
International regulations
International lists : This product, (and its ingredients) is (are) listed on national inventories, or is (are)
exempted from being listed, in Australia (AICS), in Europe (EINECS/ELINCS), in Korea
(TCCL), in Japan (METI), in the Philippines (RA6969).
16 . Other information
Label requirements : NOT EXPECTED TO PRODUCE SIGNIFICANT ADVERSE HEALTH EFFECTS WHEN
THE RECOMMENDED INSTRUCTIONS FOR USE ARE FOLLOWED.
Hazardous Material : HAZARD RATINGS
Information System (U.S.A.)
0
Health 4- Extreme
3- Serious
0
Fire hazard 2- Moderate
1- Slight
0
Physical Hazard 0- Minimal
See section 8 for more detailed
A
Personal protection information on personal protection.
The customer is responsible for determining the PPE code for this material.
National Fire Protection :
Association (U.S.A.)
Flammability
0
0 0
Health Instability
Special
References : ANSI Z400.5, MSDS Standard, 2004. - Manufacturer's Material Safety Data Sheet. -
29CFR Part1910.1200 OSHA MSDS Requirements. - 49CFR Table List of Hazardous
Materials, UN#, Proper Shipping Names, PG. - Canada Gazette Part II, Vol. 122, No. 2.
Registration SOR/88-64, 31 December 1987. Hazardous Products Act "Ingredient
Disclosure List" - Canadian Transport of Dangerous Goods, Regulations and Schedules,
Clear Language version 2005.
: 01/15/2008
Date of issue
Date of previous issue : 08/15/2007
Version : 1.1
Notice to reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above named
supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the
information contained herein. Final determination of suitability of any material is the sole responsibility of the
user. All materials may present unknown hazards and should be used with caution. Although certain hazards are
described herein, we cannot guarantee that these are the only hazards that exist.
: 01/15/2008 Page: 6/6
Date of issue
Conforms to ANSI Z400.5-2004 Standard (United States, Canada).
Material Safety Data Sheet
Buffer for Deactivation Fluid
1. Product and company identification
Product name : Buffer for Deactivation Fluid
Used in : APTIMA HIV-1 RNA Qualitative Assay 302178, APTIMA HCV RNA Qualitative Assay
302179, APTIMA CT Assay 301088, APTIMA GC Assay 301091, APTIMA Combo 2
301032, APTIMA Assay Fluids Kit 302002C, APTIMA Assay Fluids Kit TIGRIS 302382,
PROGENSA PCA3 Assay Kit CE 302355, PCA3/PSA Supplemental Fluids Kit 302030.
Material uses : In vitro diagnostic.
Supplier/Manufacturer : Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121-4362
MSDS # : 0043
In case of emergency : CANUTEC (613) 996-6666
CHEMTREC, U.S. : (800) 424-9300 International: (703) 527-3887
2. Hazards identification
Physical state : Liquid. [Clear.]
OSHA/HCS status : While this material is not considered hazardous by the OSHA Hazard Communication
Standard (29 CFR 1910.1200), this MSDS contains valuable information critical to the
safe handling and proper use of the product. This MSDS should be retained and
available for employees and other users of this product.
Emergency overview : NOT EXPECTED TO PRODUCE SIGNIFICANT ADVERSE HEALTH EFFECTS WHEN
THE RECOMMENDED INSTRUCTIONS FOR USE ARE FOLLOWED.
No known significant effects or critical hazards. Avoid prolonged contact with eyes, skin
and clothing.
Routes of entry : Dermal contact. Eye contact. Inhalation. Ingestion.
Potential acute health effects
Inhalation : No known significant effects or critical hazards.
Ingestion : No known significant effects or critical hazards.
Skin : No known significant effects or critical hazards.
Eyes : No known significant effects or critical hazards.
Potential chronic health effects
Chronic effects : No known significant effects or critical hazards.
Carcinogenicity : No known significant effects or critical hazards.
Mutagenicity : No known significant effects or critical hazards.
Teratogenicity : No known significant effects or critical hazards.
Developmental effects : No known significant effects or critical hazards.
Fertility effects : No known significant effects or critical hazards.
Over-exposure signs/symptoms
Inhalation : No specific data.
Ingestion : No specific data.
Skin : No specific data.
Eyes : No specific data.
Medical conditions : None known.
aggravated by over-
exposure
See toxicological information (section 11)
: 01/15/2008 Page: 1/6
Date of issue
Buffer for Deactivation Fluid
3. Composition/information on ingredients
Name CAS number %
No hazardous ingredient
Due to differing non-hazardous components, the products listed in each part number in 鈥淯sed In鈥? section are not
interchangeable. See package insert for product use.
There are no ingredients present which, within the current knowledge of the supplier and in the concentrations
applicable, are classified as hazardous to health or the environment and hence require reporting in this section.
4. First aid measures
Eye contact : Check for and remove any contact lenses. In case of contact with eyes, rinse
immediately with plenty of water. Get medical attention if symptoms occur.
Skin contact : Wash with soap and water. Get medical attention if symptoms occur.
Inhalation : If inhaled, remove to fresh air. If not breathing, give artificial respiration. Get medical
attention if symptoms appear.
Ingestion : Do not induce vomiting. Never give anything by mouth to an unconscious person. Get
medical attention if symptoms appear.
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training.
Notes to physician : No specific treatment. Treat symptomatically. Contact poison treatment specialist
immediately if large quantities have been ingested or inhaled.
5. Fire-fighting measures
Flammability of the product : Non-flammable.
Extinguishing media
Suitable : Use an extinguishing agent suitable for the surrounding fire.
Not suitable : None known.
Hazardous thermal : Decomposition products may include the following materials:
carbon dioxide
decomposition products
carbon monoxide
metal oxide/oxides
Special protective : Fire-fighters should wear appropriate protective equipment and self-contained breathing
apparatus (SCBA) with a full face-piece operated in positive pressure mode.
equipment for fire-fighters
6. Accidental release measures
Personal precautions : No action shall be taken involving any personal risk or without suitable training.
Evacuate surrounding areas. Keep unnecessary and unprotected personnel from
entering. Do not touch or walk through spilled material. Avoid breathing vapor or mist.
Provide adequate ventilation. Wear appropriate respirator when ventilation is
inadequate. Put on appropriate personal protective equipment (see section 8).
Environmental precautions : Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains
and sewers. Inform the relevant authorities if the product has caused environmental
pollution (sewers, waterways, soil or air).
Methods for cleaning up
Small spill : Stop leak if without risk. Move containers from spill area. Dilute with water and mop up
if water-soluble or absorb with an inert dry material and place in an appropriate waste
disposal container. Dispose of via a licensed waste disposal contractor.
: 01/15/2008 Page: 2/6
Date of issue
Buffer for Deactivation Fluid
6. Accidental release measures
Large spill : Stop leak if without risk. Move containers from spill area. Approach release from
upwind. Prevent entry into sewers, water courses, basements or confined areas. Wash
spillages into an effluent treatment plant or proceed as follows. Contain and collect
spillage with non-combustible, absorbent material e.g. sand, earth, vermiculite or
diatomaceous earth and place in container for disposal according to local regulations
(see section 13). Dispose of via a licensed waste disposal contractor. Contaminated
absorbent material may pose the same hazard as the spilled product. Note: see section
1 for emergency contact information and section 13 for waste disposal.
7. Handling and storage
Handling : Put on appropriate personal protective equipment (see section 8). Eating, drinking and
smoking should be prohibited in areas where this material is handled, stored and
processed. Workers should wash hands and face before eating, drinking and smoking.
Do not ingest. Avoid contact with eyes, skin and clothing. Avoid breathing vapor or mist.
Keep in the original container or an approved alternative made from a compatible
material, kept tightly closed when not in use. Empty containers retain product residue
and can be hazardous. Do not reuse container.
Storage : Store in accordance with local regulations. Store in original container protected from
direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials
(see section 10) and food and drink. Keep container tightly closed and sealed until ready
for use. Containers that have been opened must be carefully resealed and kept upright
to prevent leakage. Do not store in unlabeled containers. Use appropriate containment
to avoid environmental contamination.
8. Exposure controls/personal protection
Consult local authorities for acceptable exposure limits.
Recommended monitoring : If this product contains ingredients with exposure limits, personal, workplace atmosphere
or biological monitoring may be required to determine the effectiveness of the ventilation
procedures
or other control measures and/or the necessity to use respiratory protective equipment.
Engineering measures : No special ventilation requirements. Good general ventilation should be sufficient to
control worker exposure to airborne contaminants. If this product contains ingredients
with exposure limits, use process enclosures, local exhaust ventilation or other
engineering controls to keep worker exposure below any recommended or statutory
limits.
Hygiene measures : Wash hands, forearms and face thoroughly after handling chemical products, before
eating, smoking and using the lavatory and at the end of the working period. Appropriate
techniques should be used to remove potentially contaminated clothing. Wash
contaminated clothing before reusing. Ensure that eyewash stations and safety showers
are close to the workstation location.
Personal protection
Eyes : Safety glasses.
Skin : Lab coat.
Respiratory : A respirator is not needed under normal and intended conditions of product use.
Hands : Disposable vinyl gloves.
Personal protective :
equipment (Pictograms)
HMIS Code/Personal :A
protective equipment
: 01/15/2008 Page: 3/6
Date of issue
Buffer for Deactivation Fluid
8. Exposure controls/personal protection
Environmental exposure : Emissions from ventilation or work process equipment should be checked to ensure they
comply with the requirements of environmental protection legislation. In some cases,
controls
fume scrubbers, filters or engineering modifications to the process equipment will be
necessary to reduce emissions to acceptable levels.
9. Physical and chemical properties
Physical state : Liquid. [Clear.]
Color : Colorless.
pH : ~ 9.3.
Relative density : ~ 1.
10 . Stability and reactivity
Stability : The product is stable.
Hazardous polymerization : Under normal conditions of storage and use, hazardous polymerization will not occur.
Conditions to avoid : No specific data.
Materials to avoid : No specific data.
Hazardous decomposition : Under normal conditions of storage and use, hazardous decomposition products should
not be produced.
products
11 . Toxicological information
Acute toxicity
Inhalation No known significant effects or critical hazards.
:
Ingestion : No known significant effects or critical hazards.
Skin : No known significant effects or critical hazards.
Eyes : No known significant effects or critical hazards.
12 . Ecological information
Environmental effects : No known significant effects or critical hazards.
Other adverse effects : No known significant effects or critical hazards.
13 . Disposal considerations
Waste disposal : The generation of waste should be avoided or minimized wherever possible. Empty
containers or liners may retain some product residues. This material and its container
must be disposed of in a safe way. Dispose of surplus and non-recyclable products via
a licensed waste disposal contractor. Disposal of this product, solutions and any by-
products should at all times comply with the requirements of environmental protection
and waste disposal legislation and any regional local authority requirements. Avoid
dispersal of spilled material and runoff and contact with soil, waterways, drains and
sewers.
Disposal should be in accordance with applicable regional, national and local laws and regulations.
Refer to Section 7: HANDLING AND STORAGE and Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
for additional handling information and protection of employees.
: 01/15/2008 Page: 4/6
Date of issue
Buffer for Deactivation Fluid
14 . Transport information
AERG : Not applicable.
Regulatory information
DOT/ TDG / IMDG/ IATA : Not regulated.
15 . Regulatory information
United States
HCS Classification : Not regulated.
U.S. Federal regulations : United States inventory (TSCA 8b): All components listed.
SARA 302/304/311/312 extremely hazardous substances: No products were found.
SARA 302/304 emergency planning and notification: No products were found.
SARA 302/304/311/312 hazardous chemicals: No products were found.
SARA 311/312 MSDS distribution - chemical inventory - hazard identification: No
products were found.
Clean Water Act (CWA) 307: No products were found.
Clean Water Act (CWA) 311: Sodium hydroxide; Sodium Hypochlorite
Clean Air Act (CAA) 112 accidental release prevention: No products were found.
Clean Air Act (CAA) 112 regulated flammable substances: No products were found.
Clean Air Act (CAA) 112 regulated toxic substances: No products were found.
State regulations : Connecticut Carcinogen Reporting: None of the components are listed.
Connecticut Hazardous Material Survey: None of the components are listed.
Florida substances: None of the components are listed.
Illinois Chemical Safety Act: None of the components are listed.
Illinois Toxic Substances Disclosure to Employee Act: None of the components are
listed.
Louisiana Reporting: None of the components are listed.
Louisiana Spill: None of the components are listed.
Massachusetts Spill: None of the components are listed.
Massachusetts Substances: None of the components are listed.
Michigan Critical Material: None of the components are listed.
Minnesota Hazardous Substances: None of the components are listed.
New Jersey Hazardous Substances: None of the components are listed.
New Jersey Spill: None of the components are listed.
New Jersey Toxic Catastrophe Prevention Act: None of the components are listed.
New York Acutely Hazardous Substances: None of the components are listed.
New York Toxic Chemical Release Reporting: None of the components are listed.
Pennsylvania RTK Hazardous Substances: None of the components are listed.
Rhode Island Hazardous Substances: None of the components are listed.
Canada
WHMIS (Canada) : Not controlled under WHMIS (Canada).
Canadian lists : CEPA Toxic substances: None of the components are listed.
Canadian ARET: None of the components are listed.
Canadian NPRI: None of the components are listed.
Alberta Designated Substances: None of the components are listed.
Ontario Designated Substances: None of the components are listed.
Quebec Designated Substances: None of the components are listed.
Canada inventory : Canada inventory: All components listed.
This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations
and the MSDS contains all the information required by the Controlled Products Regulations.
International regulations
: 01/15/2008 Page: 5/6
Date of issue
Buffer for Deactivation Fluid
15 . Regulatory information
International lists : This product, (and its ingredients) is (are) listed on national inventories, or is (are)
exempted from being listed, in Australia (AICS), in Europe (EINECS/ELINCS), in Korea
(TCCL), in Japan (METI), in the Philippines (RA6969).
16 . Other information
Label requirements : NOT EXPECTED TO PRODUCE SIGNIFICANT ADVERSE HEALTH EFFECTS WHEN
THE RECOMMENDED INSTRUCTIONS FOR USE ARE FOLLOWED.
Hazardous Material : HAZARD RATINGS
Information System (U.S.A.)
0
Health 4- Extreme
3- Serious
0
Fire hazard 2- Moderate
1- Slight
0
Physical Hazard 0- Minimal
See section 8 for more detailed
A
Personal protection information on personal protection.
The customer is responsible for determining the PPE code for this material.
National Fire Protection :
Association (U.S.A.)
Flammability
0
0 0
Health Instability
Special
References : ANSI Z400.5, MSDS Standard, 2004. - Manufacturer's Material Safety Data Sheet. -
29CFR Part1910.1200 OSHA MSDS Requirements. - 49CFR Table List of Hazardous
Materials, UN#, Proper Shipping Names, PG. - Canada Gazette Part II, Vol. 122, No. 2.
Registration SOR/88-64, 31 December 1987. Hazardous Products Act "Ingredient
Disclosure List" - Canadian Transport of Dangerous Goods, Regulations and Schedules,
Clear Language version 2005.
: 01/15/2008
Date of issue
Date of previous issue : 08/15/2007
Version : 1.1
Notice to reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above named
supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the
information contained herein. Final determination of suitability of any material is the sole responsibility of the
user. All materials may present unknown hazards and should be used with caution. Although certain hazards are
described herein, we cannot guarantee that these are the only hazards that exist.
: 01/15/2008 Page: 6/6
Date of issue
Conforms to ANSI Z400.5-2004 Standard (United States, Canada).
Material Safety Data Sheet
Calibrators
1. Product and company identification
Product name : Calibrators
Used in : PROGENSA PCA3 Assay Kit 302355; PROGENSA PCA3 Calibrators and Controls Kit
302353; PROGENSA PSA Calibrators and Controls Kit 302356.
Material uses : In vitro diagnostic.
Supplier/Manufacturer : Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121-4362
MSDS # : 0055
In case of emergency : CANUTEC (613) 996-6666
CHEMTREC, U.S. : (800) 424-9300 International: (703) 527-3887
2. Hazards identification
Physical state : Liquid.
OSHA/HCS status : While this material is not considered hazardous by the OSHA Hazard Communication
Standard (29 CFR 1910.1200), this MSDS contains valuable information critical to the
safe handling and proper use of the product. This MSDS should be retained and
available for employees and other users of this product.
Emergency overview : NOT EXPECTED TO PRODUCE SIGNIFICANT ADVERSE HEALTH EFFECTS WHEN
THE RECOMMENDED INSTRUCTIONS FOR USE ARE FOLLOWED.
No known significant effects or critical hazards. Avoid prolonged contact with eyes, skin
and clothing.
Routes of entry : Dermal contact. Eye contact. Inhalation. Ingestion.
Potential acute health effects
Inhalation : No known significant effects or critical hazards.
Ingestion : No known significant effects or critical hazards.
Skin : No known significant effects or critical hazards.
Eyes : No known significant effects or critical hazards.
Potential chronic health effects
Chronic effects : No known significant effects or critical hazards.
Carcinogenicity : No known significant effects or critical hazards.
Mutagenicity : No known significant effects or critical hazards.
Teratogenicity : No known significant effects or critical hazards.
Developmental effects : No known significant effects or critical hazards.
Fertility effects : No known significant effects or critical hazards.
Over-exposure signs/symptoms
Inhalation : No specific data.
Ingestion : No specific data.
Skin : No specific data.
Eyes : No specific data.
Medical conditions : None known.
aggravated by over-
exposure
See toxicological information (section 11)
: 01/15/2008 Page: 1/6
Date of issue
Calibrators
3. Composition/information on ingredients
Name CAS number %
No hazardous ingredient
Due to differing non-hazardous components, the products listed in each part number in 鈥淯sed In鈥? section are not
interchangeable. See package insert for product use.
There are no ingredients present which, within the current knowledge of the supplier and in the concentrations
applicable, are classified as hazardous to health or the environment and hence require reporting in this section.
4. First aid measures
Eye contact : Check for and remove any contact lenses. In case of contact with eyes, rinse
immediately with plenty of water. Get medical attention if symptoms occur.
Skin contact : Wash with soap and water. Get medical attention if symptoms occur.
Inhalation : If inhaled, remove to fresh air. If not breathing, give artificial respiration. Get medical
attention if symptoms appear.
Ingestion : Do not induce vomiting. Never give anything by mouth to an unconscious person. Get
medical attention if symptoms appear.
Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training.
Notes to physician : No specific treatment. Treat symptomatically. Contact poison treatment specialist
immediately if large quantities have been ingested or inhaled.
5. Fire-fighting measures
Flammability of the product : Non-flammable.
Extinguishing media
Suitable : Use an extinguishing agent suitable for the surrounding fire.
Not suitable : None known.
Hazardous thermal : Decomposition products may include the following materials:
carbon dioxide
decomposition products
carbon monoxide
sulfur oxides
metal oxide/oxides
Special protective : Fire-fighters should wear appropriate protective equipment and self-contained breathing
apparatus (SCBA) with a full face-piece operated in positive pressure mode.
equipment for fire-fighters
6. Accidental release measures
Personal precautions : No action shall be taken involving any personal risk or without suitable training.
Evacuate surrounding areas. Keep unnecessary and unprotected personnel from
entering. Do not touch or walk through spilled material. Avoid breathing vapor or mist.
Provide adequate ventilation. Wear appropriate respirator when ventilation is
inadequate. Put on appropriate personal protective equipment (see section 8).
Environmental precautions : Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains
and sewers. Inform the relevant authorities if the product has caused environmental
pollution (sewers, waterways, soil or air).
Methods for cleaning up
Small spill : Stop leak if without risk. Move containers from spill area. Dilute with water and mop up
if water-soluble or absorb with an inert dry material and place in an appropriate waste
disposal container. Dispose of via a licensed waste disposal contractor.
: 01/15/2008 Page: 2/6
Date of issue
Calibrators
6. Accidental release measures
Large spill : Stop leak if without risk. Move containers from spill area. Approach release from
upwind. Prevent entry into sewers, water courses, basements or confined areas. Wash
spillages into an effluent treatment plant or proceed as follows. Contain and collect
spillage with non-combustible, absorbent material e.g. sand, earth, vermiculite or
diatomaceous earth and place in container for disposal according to local regulations
(see section 13). Dispose of via a licensed waste disposal contractor. Contaminated
absorbent material may pose the same hazard as the spilled product. Note: see section
1 for emergency contact information and section 13 for waste disposal.
7. Handling and storage
Handling : Put on appropriate personal protective equipment (see section 8). Eating, drinking and
smoking should be prohibited in areas where this material is handled, stored and
processed. Workers should wash hands and face before eating, drinking and smoking.
Do not ingest. Avoid contact with eyes, skin and clothing. Avoid breathing vapor or mist.
Keep in the original container or an approved alternative made from a compatible
material, kept tightly closed when not in use. Empty containers retain product residue
and can be hazardous. Do not reuse container.
Storage : Store in accordance with local regulations. Store in original container protected from
direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials
(see section 10) and food and drink. Keep container tightly closed and sealed until ready
for use. Containers that have been opened must be carefully resealed and kept upright
to prevent leakage. Do not store in unlabeled containers. Use appropriate containment
to avoid environmental contamination.
8. Exposure controls/personal protection
Consult local authorities for acceptable exposure limits.
Recommended monitoring : If this product contains ingredients with exposure limits, personal, workplace atmosphere
or biological monitoring may be required to determine the effectiveness of the ventilation
procedures
or other control measures and/or the necessity to use respiratory protective equipment.
Engineering measures : No special ventilation requirements. Good general ventilation should be sufficient to
control worker exposure to airborne contaminants. If this product contains ingredients
with exposure limits, use process enclosures, local exhaust ventilation or other
engineering controls to keep worker exposure below any recommended or statutory
limits.
Hygiene measures : Wash hands, forearms and face thoroughly after handling chemical products, before
eating, smoking and using the lavatory and at the end of the working period. Appropriate
techniques should be used to remove potentially contaminated clothing. Wash
contaminated clothing before reusing. Ensure that eyewash stations and safety showers
are close to the workstation location.
Personal protection
Eyes : Safety glasses.
Skin : Lab coat.
Respiratory : A respirator is not needed under normal and intended conditions of product use.
Hands : Disposable vinyl gloves.
Personal protective :
equipment (Pictograms)
HMIS Code/Personal :A
protective equipment
: 01/15/2008 Page: 3/6
Date of issue
Calibrators
8. Exposure controls/personal protection
Environmental exposure : Emissions from ventilation or work process equipment should be checked to ensure they
comply with the requirements of environmental protection legislation. In some cases,
controls
fume scrubbers, filters or engineering modifications to the process equipment will be
necessary to reduce emissions to acceptable levels.
9. Physical and chemical properties
Physical state : Liquid.
Color : Colorless.
pH : ~ 6.7.
Relative density : ~ 1.
10 . Stability and reactivity
Stability : The product is stable.
Hazardous polymerization : Under normal conditions of storage and use, hazardous polymerization will not occur.
Conditions to avoid : No specific data.
Materials to avoid : No specific data.
Hazardous decomposition : Under normal conditions of storage and use, hazardous decomposition products should
not be produced.
products
11 . Toxicological information
Acute toxicity
Inhalation No known significant effects or critical hazards.
:
Ingestion : No known significant effects or critical hazards.
Skin : No known significant effects or critical hazards.
Eyes : No known significant effects or critical hazards.
12 . Ecological information
Environmental effects : No known significant effects or critical hazards.
Other adverse effects : No known significant effects or critical hazards.
13 . Disposal considerations
Waste disposal : The generation of waste should be avoided or minimized wherever possible. Empty
containers or liners may retain some product residues. This material and its container
must be disposed of in a safe way. Dispose of surplus and non-recyclable products via
a licensed waste disposal contractor. Disposal of this product, solutions and any by-
products should at all times comply with the requirements of environmental protection
and waste disposal legislation and any regional local authority requirements. Avoid
dispersal of spilled material and runoff and contact with soil, waterways, drains and
sewers.
Disposal should be in accordance with applicable regional, national and local laws and regulations.
Refer to Section 7: HANDLING AND STORAGE and Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
for additional handling information and protection of employees.
: 01/15/2008 Page: 4/6
Date of issue
Calibrators
14 . Transport information
AERG : Not applicable.
Regulatory information
DOT/ TDG / IMDG/ IATA : Not regulated.
15 . Regulatory information
United States
HCS Classification : Not regulated.
U.S. Federal regulations : United States inventory (TSCA 8b): All components listed.
SARA 302/304/311/312 extremely hazardous substances: No products were found.
SARA 302/304 emergency planning and notification: No products were found.
SARA 302/304/311/312 hazardous chemicals: No products were found.
SARA 311/312 MSDS distribution - chemical inventory - hazard identification: No
products were found.
Clean Water Act (CWA) 307: No products were found.
Clean Water Act (CWA) 311: Disodium Phosphate
Clean Air Act (CAA) 112 accidental release prevention: No products were found.
Clean Air Act (CAA) 112 regulated flammable substances: No products were found.
Clean Air Act (CAA) 112 regulated toxic substances: No products were found.
State regulations : Connecticut Carcinogen Reporting: None of the components are listed.
Connecticut Hazardous Material Survey: None of the components are listed.
Florida substances: None of the components are listed.
Illinois Chemical Safety Act: None of the components are listed.
Illinois Toxic Substances Disclosure to Employee Act: None of the components are
listed.
Louisiana Reporting: None of the components are listed.
Louisiana Spill: None of the components are listed.
Massachusetts Spill: None of the components are listed.
Massachusetts Substances: None of the components are listed.
Michigan Critical Material: None of the components are listed.
Minnesota Hazardous Substances: None of the components are listed.
New Jersey Hazardous Substances: None of the components are listed.
New Jersey Spill: None of the components are listed.
New Jersey Toxic Catastrophe Prevention Act: None of the components are listed.
New York Acutely Hazardous Substances: None of the components are listed.
New York Toxic Chemical Release Reporting: None of the components are listed.
Pennsylvania RTK Hazardous Substances: None of the components are listed.
Rhode Island Hazardous Substances: None of the components are listed.
Canada
WHMIS (Canada) : Not controlled under WHMIS (Canada).
Canadian lists : CEPA Toxic substances: None of the components are listed.
Canadian ARET: None of the components are listed.
Canadian NPRI: None of the components are listed.
Alberta Designated Substances: None of the components are listed.
Ontario Designated Substances: None of the components are listed.
Quebec Designated Substances: None of the components are listed.
Canada inventory : Canada inventory: All components listed.
This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations
and the MSDS contains all the information required by the Controlled Products Regulations.
International regulations
: 01/15/2008 Page: 5/6
Date of issue
Calibrators
15 . Regulatory information
International lists : This product, (and its ingredients) is (are) listed on national inventories, or is (are)
exempted from being listed, in Australia (AICS), in Europe (EINECS/ELINCS), in Korea
(TCCL), in Japan (METI), in the Philippines (RA6969).
16 . Other information
Label requirements : NOT EXPECTED TO PRODUCE SIGNIFICANT ADVERSE HEALTH EFFECTS WHEN
THE RECOMMENDED INSTRUCTIONS FOR USE ARE FOLLOWED.
Hazardous Material : HAZARD RATINGS
Information System (U.S.A.)
0
Health 4- Extreme
3- Serious
0
Fire hazard 2- Moderate
1- Slight
0
Physical Hazard 0- Minimal
See section 8 for more detailed
A
Personal protection information on personal protection.
The customer is responsible for determining the PPE code for this material.
National Fire Protection :
Association (U.S.A.)
Flammability
0
0 0
Health Instability
Special
References : ANSI Z400.5, MSDS Standard, 2004. - Manufacturer's Material Safety Data Sheet. -
29CFR Part1910.1200 OSHA MSDS Requirements. - 49CFR Table List of Hazardous
Materials, UN#, Proper Shipping Names, PG. - Canada Gazette Part II, Vol. 122, No. 2.
Registration SOR/88-64, 31 December 1987. Hazardous Products Act "Ingredient
Disclosure List" - Canadian Transport of Dangerous Goods, Regulations and Schedules,
Clear Language version 2005.
: 01/15/2008
Date of issue
Version :1
Notice to reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above named
supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the
information contained herein. Final determination of suitability of any material is the sole responsibility of the
user. All materials may present unknown hazards and should be used with caution. Although certain hazards are
described herein, we cannot guarantee that these are the only hazards that exist.
: 01/15/2008 Page: 6/6
Date of issue
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