Material Safety Data Sheet
Revision date:
Print Date: 08/29/2006
Version: 0
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Product name: COBAS AMPLICOR HIV MONITOR Test, v1.5 (US-IVD)
Product number: 03155935018
Business area: Molecular Diagnostics.
Supplier: Emergency telephone number:
Roche Molecular Systems, Inc. CHEMTREC:
1080 US Highway 202 South 1-800-424-9300 (U.S. or Canada)
Branchburg, NJ 08876-3733 1-703-527-3887 (International)
Technical Support: 1-800-526-1247
2. COMPOSITION/INFORMATION ON INGREDIENTS
Internal Kit Description: Specimen Preparation Reagents
Description 1: Lysis Reagent
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Dithiothreitol 3483-12-3 1-5 NA NA NA NA
Guanidine thiocyanate 593-84-0 60-90 NA NA NA NA
Description 2: Negative Plasma
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Human plasma NONE 99-100 NA NA NA NA
Internal Kit Description: Amplification Reagents
Description 3: Manganese Solution
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Manganese acetate tetrahydrate 6156-78-1 1-5 NA 5 mg/m鲁 Ceiling 0.2 mg/m鲁 NA
5 mg/m鲁 Ceiling
Description 4: Master Mix
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Bicine 150-25-4 1-5 NA NA NA NA
Glycerol 56-81-5 15-40 15 mg/m鲁 NA 10 mg/m鲁 NA
5 mg/m鲁
Potassium acetate 127-08-2 1-5 NA NA NA NA
Internal Kit Description: Detection Reagents
Description 5: Denaturation Solution
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Sodium hydroxide 1310-73-2 1-5 2 mg/m鲁 NA NA 2 mg/m鲁 Ceiling
EDTA disodium dihydrate 6381-92-6 1-5 NA NA NA NA
Description 6: Probe Suspension 2 Solutions
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Sodium phosphate, monobasic, 10049-21-5 1-5 NA NA NA NA
monohydrate
Sodium thiocyanate 540-72-7 15-40 NA NA NA NA
Description 7: Avidin-HRP Conjugate
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Phenol 108-95-2 <1 19 mg/m鲁 NA 5 ppm NA
5 ppm skin - potential for
prevent or reduce cutaneous
skin absorption absorption
Tris 77-86-1 1-5 NA NA NA NA
Description 8: Substrate A
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Citric acid 77-92-9 1-5 NA NA NA NA
Description 9: Substrate B
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Tetramethyl benzidine (TMB) 54827-17-7 <1 NA NA NA NA
Dimethylformamide 68-12-2 35-45 10 ppm NA 10 ppm NA
30 mg/m鲁 skin - potential for
prevent or reduce cutaneous
skin absorption absorption
Description 10: Dilution Reagent
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
EDTA disodium dihydrate 6381-92-6 1-5 NA NA NA NA
Description 11: Probe Suspension 1 Solutions
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Boric Acid 10043-35-3 <1 NA NA NA NA
0.29 mg/m3 Ceiling
Sodium azide 26628-22-8 <1 NA NA NA
0.11 ppm Ceiling
MES (4-Morpholineethanesulfonic 4432-31-9 1-5 NA NA NA NA
Acid)
Sodium chloride 7647-14-5 5-20 NA NA NA NA
Tween 20 9005-64-5 1-5 NA NA NA NA
Description 12: All other solutions
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
No hazardous components >1%, NONE N/A NA NA NA NA
>0.1% carcinogen
3. HAZARDS IDENTIFICATION
Emergency Overview
NFPA Ratings:
Denaturation Solutiont: Health= 3 Flammability= 0 Reactivity= 0 Special= CO
Substrate B: Health= 1 Flammability= 1 Reactivity= 0 Special= I
Negative plasma: Health= 1 Flammability= 0 Reactivity= 0 Special= PB
All other solutions in section 2: Health= 1 Flammability= 0 Reactivity= 0 Special= I
All other solutions not in section: Health= 0 Flammability= 0 Reactivity= 0
Special Definitions: A=Allergen CA=Carcinogen CO=Corrosive F=Flammable H=Harmful I=Irritant Ox=Oxidizer PB=Potential Biohazard
R=Reproductive S=Sensitizer T=Toxic T+=Highly Toxic W=Water Reactive
Principle routes of exposure: Ingestion, inhalation, skin absorption, skin and/or eye contact.
Inhalation: All solutions with NFPA rating of 1 or higher... Avoid breathing vapors or mists. May cause irritation of
respiratory tract. SODIUM HYDROXIDE - Severe irritant. Effects from inhalation of mist vary from mild
irritation to serious damage of the upper respiratory tract, depending on severity of exposure. Symptoms
may include sneezing, sore throat or runny nose. Severe pneumonitis may occur.
DIMETHYLFORMAMIDE- Symptoms may include coughing, shortness of breath. Causes liver, kidney,
cardiovascular system and central nervous system disorders. May cause abdominal pain, loss of appetite,
nausea, weakness, dizziness, headache, constipation, vomiting, diarrhea, increased blood pressure
anxiety, and palpitations. A flushing of the face and skin may occur, especially with coincident ingestion of
alcoholic beverages.
Ingestion: All solutions with NFPA rating of 1 or higher... Ingestion may cause gastrointestinal irritation, nausea,
vomiting and diarrhea. DIMETHYLFORMAMIDE - Symptoms parallel inhalation. Has a fatal estimated
ingestion dose at 10 grams. SODIUM HYDROXIDE - Swallowing may cause severe burns of mouth,
throat, and stomach. Severe scarring of tissue and death may result. Symptoms may include bleeding,
vomiting, diarrhea, fall in blood pressure. Damage may appears days after exposure. GUANIDINE
THIOCYANATE - The probable lethal dose is between 15-30 grams. May cause pshycosis, vomiting,
disorientation, weakness, low blood pressure, convulsions and death which may be delayed.
Skin contact: All solutions with NFPA rating of 1 or higher... May cause irritation. SODIUM HYDROXIDE - Contact with
skin can cause severe irritation or severe burns and scarring with greater exposures.
DIMETHYLFORMAMIDE - Symptoms include redness, itching and pain. Can cause skin problems.
Absorption through the skin can readily occur, resulting in symptoms paralleling inhalation. PHENOL -
Rapidly absorbs through the skin but adverse affects (i.e. systemic poisoning) are unlikely with this diluted
solution.
Product number: 03155935018 Page 2 of 9
Product name: COBAS AMPLICOR HIV MONITOR Test, v1.5 (US-IVD)
Eye contact: SODIUM HYDROXIDE - Causes severe irritation of eyes, and with greater exposures it can cause burns
that may result in permanent impairment of vision, even blindness. DIMETHYLFORMAMIDE - Causes
irritation, redness, and pain. May cause severe irritation and blurred vision. ALL OTHER SOLUTIONS may
cause eye irritation upon contact.
Sensitization or Odor threshold: The following chemical(s) may cause sensitization, be absorbed via skin, and/or has an odor threshold for
detection:
Components ACGIH - Germany (DFG) - Switzerland - AIHA - Odor Threshold
Sensitizer Designation: Skin/Sensitizers: Sensitizers: Values:
Phenol danger of percutaneous geometric mean air odor
absorption threshold = 0.060 ppm
(detectable)
Components ACGIH - Germany (DFG) - Switzerland - AIHA - Odor Threshold
Sensitizer Designation: Skin/Sensitizers: Sensitizers: Values:
Dimethylformamide danger of percutaneous no geometric mean air odor
absorption threshold
Medical conditions aggravated by Persons with pre-existing skin disorders or impaired liver, kidney, and pulmonary function may be more
exposure: susceptible to the effects of this material.
Additional information: DIMETHYLFORMAMIDE - Repeated skin contact may cause dermatitis. Repeated or prolonged exposure
to vapors may cause damage to the liver and kidney. With FDA approved methods, the human source
material in this product has been tested and is shown to be free from HBsAg and antibodies to HCV and
HIV. All human material should be considered potentially infectious. It is recommended to handle this
product in accordance with Universal Precautions and the OSHA Bloodborne Pathogen Standard
(29CFR1910.1030).
4. FIRST AID MEASURES
Inhalation: Consult a physician. Move to fresh air. If not breathing, give artificial respiration. If breathing is difficult,
give oxygen
Skin contact: Corrosive solutions - Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician.
Remove and wash contaminated clothing before re-use. All other solutions - Rinse with plenty of water. If
skin irritation persists, call a physician. Remove and wash contaminated clothing before re-use.
Ingestion: Corrosive solutions - Consult a physician. Drink plenty of water. Never give anything by mouth to an
unconscious person. Do not induce vomiting without medical advice. All other solutions - Consult a
physician.
Eye contact: Corrosive solutions - Rinse immediately with plenty of water, also under the eyelids, for at least 15
minutes. Call a physician immediately. All other solutions - Rinse thoroughly with plenty of water, also
under the eyelids. If eye irritation persists, consult a physician.
Notes to physician: None determined
5. FIRE-FIGHTING MEASURES
Suitable extinguishing media: Use dry chemical, CO2, water spray or `alcohol` foam
Unusual hazards: None known
Special protective equipment for Wear self contained breathing apparatus for fire fighting if necessary
firefighters:
6. ACCIDENTAL RELEASE MEASURES
Personal precautions: Use personal protective equipment. Evacuate personnel to safe areas
Environmental precautions: Prevent further leakage or spillage if safe to do so. Prevent product from entering drains.
Methods for cleaning up: Never return spills in original containers for re-use. Sweep up or vacuum (if powder) or soak up with inert
absorbent material (if liquid), then place into a suitable clean, dry, closed container, and label for disposal
7. HANDLING AND STORAGE
Handling: Protect from contamination. Wear personal protective equipment
Storage: No special precautions required
Product number: 03155935018 Page 3 of 9
Product name: COBAS AMPLICOR HIV MONITOR Test, v1.5 (US-IVD)
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Engineering measures: Ensure adequate ventilation. Where reasonably practicable this should be achieved by the use of local
exhaust ventilation and good general extraction.
Personal Protective Equipment
Respiratory protection: Respiratory protection is not required under normal use of this product. If respiratory protection is needed,
follow the OSHA regulation, 29CFR1910.134. Always use a NIOSH approved respirator when necessary
Hand protection: Wear appropriate protective gloves to prevent skin contact. Replace torn or punctured gloves promptly
Skin and body protection: Wear appropriate body protection to prevent skin contact
Eye protection: Wear appropriate eye protection to prevent eye contact
Hygiene measures: Avoid contact with skin, eyes and clothing
9. PHYSICAL AND CHEMICAL PROPERTIES
Color: Denaturation solution = red. Quantitation standard = red to pink. Manganese solution = red. Negative
plasma = yellow. Probe suspension 1 = rusty brown particles suspended in clear solution. All other
solutions = colorless.
Odor: Substrate B=mild fish odor. Avidin-HRP Conjugate=phenolic odor. Lysis Reagent=sulfur odor.
pH: Denaturation solution =>12. All other solutions = 4-10.
Physical state: Liquid.
Solubility in water: Soluble.
Specific gravity: Denaturation solution =>1. All other solutions = ~1
10. STABILITY AND REACTIVITY
Stability: Stable under recommended storage conditions
Polymerization: Not applicable
Hazardous decomposition products: DIMETHYLFORMAMIDE - May form ammonia, carbon oxides, amines, and nitrogen oxides when heated
to decomposition. Above 350C (662F), DMF begins to degrade with formation of dimethylamine and
carbon monoxide. SODIUM THIOCYANATE - nitrogen oxides, sulfur compounds, and possibly cyanides.
ALL OTHER SOLUTIONS... Carbon oxides.
Materials to avoid: DIMETHYLFORMAMIDE - Bromine, carbon tetrachloride, chromic anhydride, 2,5-dimethylpyrrole,
phosphorus oxychloride, hexachlorobenzene, magnesium nitrate, methylene diisocyanate, phosphorus
trioxide, triethyl aluminum, organic nitrates, acidic and alkaline materials, and other halogenated
compounds. Contact with iron or strong oxidizers may cause fires and explosions; may react violently with
alkyl aluminums. Methylene diisocyanate can polymerize violently on contact with DMF. SODIUM
HYDROXIDE - acids and organic halogen compounds, especially trichloroethylene, may causes violent
reactions. Contact with nitromethane and other similar nitro compounds causes formation of shock-
sensitive salts. Contact with metals such as aluminum, magnesium, tin, and zinc cause formation of
flammable hydrogen gas. Sodium hydroxide, even in fairly dilute solution, reacts readily with various
sugars to produce carbon monoxide. THIOCYANATE compounds are incompatible with chlorates, nitrates,
nitric acid, organic peroxides, oxidizing agents, peroxides, potassium chlorate, sodium chlorate; and can
develop poisonous gas in contact with strong acids. SODIUM AZIDE (<1%) - strong acids, acid chlorides,
and heavy metals (especially brass, copper, and lead). ALL OTHER SOLUTIONS - strong acids, strong
bases, strong oxidising agents, and strong water reactive substances.
11. TOXICOLOGICAL INFORMATION
Components NIOSH - NIOSH Pocket Guide -
Selected LD50s and LC50s: Target Organs:
Manganese acetate tetrahydrate 3730 mg/kg Oral LD50 Rat respiratory system, CNS, blood, kidneys
9 g/kg Oral LD50 Rat
Components NIOSH - NIOSH Pocket Guide -
Selected LD50s and LC50s: Target Organs:
Glycerol = 12600 mg/kg Oral LD50 Rat respiratory system, skin, eyes, kidneys
= 4090 mg/kg Oral LD50 Mouse
> 10 g/kg Dermal LD50 Rabbit
> 570 mg/m鲁 Inhalation LC50 Rat 1 h
Potassium acetate = 3250 mg/kg Oral LD50 Rat
Product number: 03155935018 Page 4 of 9
Product name: COBAS AMPLICOR HIV MONITOR Test, v1.5 (US-IVD)
Components NIOSH - NIOSH Pocket Guide -
Selected LD50s and LC50s: Target Organs:
Sodium hydroxide eyes, skin, respiratory system
Components NIOSH - NIOSH Pocket Guide -
Selected LD50s and LC50s: Target Organs:
Sodium thiocyanate 764 mg/kg Oral LD50 Rat
Components NIOSH - NIOSH Pocket Guide -
Selected LD50s and LC50s: Target Organs:
Phenol = 270 mg/kg Oral LD50 Mouse liver, kidneys, skin, eyes, respiratory system
= 317 mg/kg Oral LD50 Rat
= 630 mg/kg Dermal LD50 Rabbit
Tris = 5900 mg/kg Oral LD50 Rat
Components NIOSH - NIOSH Pocket Guide -
Selected LD50s and LC50s: Target Organs:
Citric acid = 3 g/kg Oral LD50 Rat
= 5040 mg/kg Oral LD50 Mouse
Components NIOSH - NIOSH Pocket Guide -
Selected LD50s and LC50s: Target Organs:
Dimethylformamide = 2800 mg/kg Oral LD50 Rat liver, kidneys, CVS, skin, eyes, respiratory system
= 3700 mg/kg Oral LD50 Mouse
= 4720 mg/kg Dermal LD50 Rabbit
= 9400 mg/m鲁 Inhalation LC50 Mouse 2 h
Components NIOSH - NIOSH Pocket Guide -
Selected LD50s and LC50s: Target Organs:
Boric Acid = 2660 mg/kg Oral LD50 Rat
= 3450 mg/kg Oral LD50 Mouse
Sodium azide = 20 mg/kg Dermal LD50 Rabbit eyes, skin, CNS, CVS, kidneys
= 27 mg/kg Oral LD50 Mouse
= 27 mg/kg Oral LD50 Rat
Sodium chloride = 3 g/kg Oral LD50 Rat
= 4 g/kg Oral LD50 Mouse
> 10 g/kg Dermal LD50 Rabbit
> 42 g/m3 Inhalation LC50 Rat 1 h
Tween 20 = 36700 碌L/kg Oral LD50 Rat
> 33 g/kg Oral LD50 Mouse
Inhalation: No additional data available
Skin: No additional data available
Oral: No additional data available
Mutagenic effects: No data is available on the product itself
Reproductive toxicity: No data is available on the product itself
Carcinogenic effects:
Components IARC IARC IARC NTP OSHA EPA IRIS
Group 1 Group 2A or 2B Group 3 or 4 Select Carcinogen
Carcinogens Assessment
Classification: not
Manganese acetate tetrahydrate
classifiable as to human
carcinogenicity; last revised:
12/01/1996; basis: existing
studies are inadequate to
assess the carcinogenicity of
manganese
Components IARC IARC IARC NTP OSHA EPA IRIS
Group 1 Group 2A or 2B Group 3 or 4 Select Carcinogen
Carcinogens Assessment
Monograph 71, Classification = D; not
Phenol
1999; Monograph classifiable as to human
47, 1989 carcinogenicity; last
revised = 09/30/2002;
basis = based on no
human carcinogenicity
data and inadequate
animal data
Product number: 03155935018 Page 5 of 9
Product name: COBAS AMPLICOR HIV MONITOR Test, v1.5 (US-IVD)
Components IARC IARC IARC NTP OSHA EPA IRIS
Group 1 Group 2A or 2B Group 3 or 4 Select Carcinogen
Carcinogens Assessment
Monograph 71,
Dimethylformamide
1999; Monograph
47, 1989
12. ECOLOGICAL INFORMATION
Bioaccumulation: Components of this product will degrade in the environment to smaller organic and inorganic constituents.
Aquatic toxicity: Because of the small volume of solutions in this product, no unusual effects on aquatic plants or animals
are expected if this product is released into the environment.
Ecotoxicity effects: No data is available on the product itself
Components Ecotoxicity - Ecotoxicity - Ecotoxicity - Ecotoxicity -
Fish Species Data Microtox Data Water Flea Data Freshwater Algae Data
Glycerol = 50 mg/L LC50 rainbow
trout 96 h
> 5000 mg/L LC50 goldfish
96 h
Components Ecotoxicity - Ecotoxicity - Ecotoxicity - Ecotoxicity -
Fish Species Data Microtox Data Water Flea Data Freshwater Algae Data
Phenol = 23.88 mg/L LC50 bluegill = 28.8 mg/L EC50 = 23.0 mg/L LC50 water
96 h Static Photobacterium flea 48 h
= 24 mg/L LC50 fathead phosphoreum 5 min
minnow 96 h flow-through = 31.6 mg/L EC50
= 8.9 mg/L LC50 rainbow Photobacterium
trout 96 h flow-through phosphoreum 15 min
Components Ecotoxicity - Ecotoxicity - Ecotoxicity - Ecotoxicity -
Fish Species Data Microtox Data Water Flea Data Freshwater Algae Data
Citric acid = 14 mg/L EC50
Photobacterium
phosphoreum 15 min
Components Ecotoxicity - Ecotoxicity - Ecotoxicity - Ecotoxicity -
Fish Species Data Microtox Data Water Flea Data Freshwater Algae Data
Boric Acid = 115.0 mg/L LC50 water
flea 48 h Static
Sodium azide = 0.7 mg/L LC50 bluegill
96 h
= 0.8 mg/L LC50 rainbow
trout 96 h
= 5.46 mg/L LC50 fathead
minnow 96 h flow-through
13. DISPOSAL CONSIDERATIONS
Waste from residues / unused products: Waste disposal must be in accordance with appropriate Federal, State, and local regulations. This product,
if unaltered by use, may be disposed of by treatment at a permitted facility or as advised by your local
hazardous waste regulatory authority. Residue from fires extinguished with this material may be
hazardous.
14. TRANSPORT INFORMATION
Is product hazardous to ship? Yes
Component(s) hazardous to ship: Denaturation Solution
DOT
Proper shipping name: Chemical Kit
UN Number: UN 3316 Hazard class: 9 Subsidiary risk: Not applicable Packing group: II
Product number: 03155935018 Page 6 of 9
Product name: COBAS AMPLICOR HIV MONITOR Test, v1.5 (US-IVD)
ICAO/IATA
Proper shipping name: Chemical Kit
UN Number: UN 3316 Hazard class: 9 Subsidiary risk: Not applicable Packing group: II
15. REGULATORY INFORMATION
U.S. Regulations:
U.S. CERCLA/SARA/TSCA Regulatory Information: The following chemicals are listed under the following TSCA/SARA/CERCLA lists. Refer to
TSCA regulation if you need a definition for acronyms that may be shown in the TSCA Inventory field in the table below
Components CERCLA/SARA 302 CERCLA/SARA 304 SARA 313 TSCA Inventory
RQ and TPQ RQ Emission reporting
(40 CFR 355, App.A) (40 CFR Table 302.4)
Dithiothreitol Present
Guanidine thiocyanate Present
Components CERCLA/SARA 302 CERCLA/SARA 304 SARA 313 TSCA Inventory
RQ and TPQ RQ Emission reporting
(40 CFR 355, App.A) (40 CFR Table 302.4)
Bicine Present
Glycerol Present
Potassium acetate Present
Components CERCLA/SARA 302 CERCLA/SARA 304 SARA 313 TSCA Inventory
RQ and TPQ RQ Emission reporting
(40 CFR 355, App.A) (40 CFR Table 302.4)
Sodium hydroxide = 1000 lb final RQ XU
= 454 kg final RQ
Components CERCLA/SARA 302 CERCLA/SARA 304 SARA 313 TSCA Inventory
RQ and TPQ RQ Emission reporting
(40 CFR 355, App.A) (40 CFR Table 302.4)
Sodium thiocyanate Present
Components CERCLA/SARA 302 CERCLA/SARA 304 SARA 313 TSCA Inventory
RQ and TPQ RQ Emission reporting
(40 CFR 355, App.A) (40 CFR Table 302.4)
= 10,000 lb TPQ upper
Phenol = 0.454 kg final RQ Listed Present
threshold = 1 lb final RQ
= 500 lb TPQ lower = 100 lb final RQ
threshold
= 1000 lb final RQ
= 45.4 kg final RQ
= 454 kg final RQ
Tris Present
Components CERCLA/SARA 302 CERCLA/SARA 304 SARA 313 TSCA Inventory
RQ and TPQ RQ Emission reporting
(40 CFR 355, App.A) (40 CFR Table 302.4)
Citric acid Present
Components CERCLA/SARA 302 CERCLA/SARA 304 SARA 313 TSCA Inventory
RQ and TPQ RQ Emission reporting
(40 CFR 355, App.A) (40 CFR Table 302.4)
Tetramethyl benzidine (TMB) Present
Dimethylformamide = 100 lb final RQ Listed Present
= 45.4 kg final RQ
Product number: 03155935018 Page 7 of 9
Product name: COBAS AMPLICOR HIV MONITOR Test, v1.5 (US-IVD)
Components CERCLA/SARA 302 CERCLA/SARA 304 SARA 313 TSCA Inventory
RQ and TPQ RQ Emission reporting
(40 CFR 355, App.A) (40 CFR Table 302.4)
Boric Acid XU
= 500 lb TPQ This material
Sodium azide = 1000 lb final RQ = 1.0 percent de minimis XU
is a reactive solid. The TPQ = 454 kg final RQ concentration
does not default to 10,000
pounds for non-powder, non-
molten, non-solvent form
MES (4-Morpholineethanesulfonic Present
Acid)
Sodium chloride XU
Tween 20 XU
U.S. Clean Water Act (CWA)/ California The following chemicals are listed under the CWA and/or California Proposition 65:
Proposition 65:
Components Clean Water Act Clean Water Act California Proposition 65
Hazardous Substances Priority Pollutants
Sodium hydroxide Present
Components Clean Water Act Clean Water Act California Proposition 65
Hazardous Substances Priority Pollutants
Phenol Present Present
Canadian Regulations:
Canada DSL Inventory List - This product does not comply with DSL
Canada NDSL Inventory List - This product does not comply with NDSL
Components Canada - WHMIS: Classifications of Substances:
Dithiothreitol D2B
Guanidine thiocyanate D1B; D2B
Components Canada - WHMIS: Classifications of Substances:
Manganese acetate tetrahydrate D2A (including powder)
Components Canada - WHMIS: Classifications of Substances:
Glycerol Uncontrolled product according to WHMIS classification criteria.
Potassium acetate Uncontrolled product according to WHMIS classification criteria.
Components Canada - WHMIS: Classifications of Substances:
Sodium hydroxide E
EDTA disodium dihydrate Uncontrolled product according to WHMIS classification criteria.
Components Canada - WHMIS: Classifications of Substances:
Sodium thiocyanate Uncontrolled product according to WHMIS classification criteria
Components Canada - WHMIS: Classifications of Substances:
Phenol D1A; E; B3; D2A
Tris D2B
Components Canada - WHMIS: Classifications of Substances:
Citric acid E
Components Canada - WHMIS: Classifications of Substances:
Dimethylformamide B2; D2B
Components Canada - WHMIS: Classifications of Substances:
EDTA disodium dihydrate Uncontrolled product according to WHMIS classification criteria.
Product number: 03155935018 Page 8 of 9
Product name: COBAS AMPLICOR HIV MONITOR Test, v1.5 (US-IVD)
Components Canada - WHMIS: Classifications of Substances:
Boric Acid D2A
Sodium azide D1A
Sodium chloride Uncontrolled product according to WHMIS classification criteria.
Tween 20 Uncontrolled product according to WHMIS classification criteria.
16. OTHER INFORMATION
Reason for revision: Not applicable
References: None
Additional advice: None
Prepared by: Roche Diagnostics, Health & Safety Department, MSDS Contact: 317-521-7425 or 317-521-7505
The information, data and recommendations contained herein are based upon information believed by Roche Diagnostics Corporation, after reasonable investigation and
research, to be accurate; however, Roche Diagnostics Corporation does not warrant the accuracy of this information. All materials and mixtures may present unknown
hazards and should be used with caution. When necessary or appropriate, independent opinions regarding the risk of handling or exposure should be obtained from trained
professionals. Roche Diagnostics Corporation disclaims any warranty against patent infringement and the implied warranties of merchantability and fitness for a particular
purpose. Customer's sole and exclusive remedy shall be replacement of the product or return of the product and refund of the purchase price, at Roche Diagnostics
Corporation's option. In no case shall Roche Diagnostics Corporation be liable for incidental or consequential damages, including lost profits.
End of Safety Data Sheet
Product number: 03155935018 Page 9 of 9
Product name: COBAS AMPLICOR HIV MONITOR Test, v1.5 (US-IVD)
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