Material Safety Data Sheet
Revision date:
Print Date: 07/27/2007
Version: 0
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Product name: KIT COBAS T-SCRN WNV 96 TESTS US-IVD
Product number: 04741722190
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
Description 1: MGP Reagent
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Isopropanol 67-63-0 95-99 400 ppm 500 ppm 200 ppm 400 ppm
980 mg/m3 1225 mg/m3
Description 2: Lysis Reagent
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Polidocanol 5274-68-0 5-20 NA NA NA NA
Guanidine thiocyanate 593-84-0 40-60 NA NA NA NA
Description 3: Protease Reagent
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
15 mg/m3 total 10 mg/m3
Glycerol 56-81-5 40-60 NA NA
dust
5 mg/m3
respirable fraction
0.00006 mg/m3 0.00006 mg/m3
Subtilisins (proteolytic enzymes) 9014-01-1 1-10 NA NA
Ceiling as crystalline
active enzyme, listed
under subtilisins
Description 4: Master Mix
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
15 mg/m3 total 10 mg/m3
Glycerol 56-81-5 5-20 NA NA
dust
5 mg/m3
respirable fraction
Tricine 5704-04-1 1-5 NA NA NA NA
Potassium acetate 127-08-2 1-5 NA NA NA NA
Dimethyl Sulfoxide (DMSO) 67-68-5 5-20 NA NA NA NA
Description 5: 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:
MGP Reagent: Health= 1 Flammability= 3 Reactivity= 0 Special= F
All other solutions not in section 2: Health= 0 Flammability= 0 Reactivity= 0
All other solutions in section 2 Health= 1 Flammability= 0 Reactivity= 0 Special= I
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
3. HAZARDS IDENTIFICATION
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. ISOPROPANOL - Inhalation of vapors irritates the respiratory tract. At high
concentrations has a narcotic effect, producing symptoms of dizziness, drowsiness, headache, staggering,
unconsciousness and possibly death.
Ingestion: All solutions with NFPA rating of 1 or higher... Ingestion may cause gastrointestinal irritation, nausea,
vomiting and diarrhea. 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. ISOPROPANOL - Can cause drowsiness, unconsciousness, and death.
Gastrointestinal pain, cramps, nausea, vomiting, and diarrhea may also result. The single lethal dose for a
human adult = about 250 mls (8 ounces).
Skin contact: ALL OTHER SOLUTIONS with NFPA rating of 1 or higher... May cause irritation. ISOPROPANOL - May
cause irritation with redness and pain. May be absorbed through the skin with possible systemic effects.
Chronic exposure may cause skin effects.
Eye contact: ISOPROPANOL - Vapors cause eye irritation. Splashes cause severe irritation, possible corneal burns and
eye damage. 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:
Isopropanol geometric mean air odor
threshold = 43 ppm
(detectable); 19 ppm
(recognizable)
Components ACGIH - Germany (DFG) - Switzerland - AIHA - Odor Threshold
Sensitizer Designation: Skin/Sensitizers: Sensitizers: Values:
Subtilisins (proteolytic enzymes) respiratory sensitizer Sensitizer
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: None
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: Flammable.
Special protective equipment for Wear self contained breathing apparatus for fire fighting if necessary
firefighters:
Product number: 04741722190 Page 2 of 6
Product name: KIT COBAS T-SCRN WNV 96 TESTS US-IVD
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
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
Boiling point/range: 181 F (82.8 C) [Isopropanol]
Color: Control solutions = yellow. Protease reagent = yellow to brown. All other solutions = colorless.
Melting point/range: -127.3 F (88.5 C) [Isopropanol]
Odor: MGP Reagent = rubbing alcohol odor. Lysis Reagent = sulfur odor. All other solutions = none.
pH: 5-8.5
Physical state: Liquid.
Solubility in water: Soluble.
Autoignition temperature: 399C (750F) [Isopropanol]
Flash point: 12C (54F) [Isopropanol]
LEL (%): 2.0 [Isopropanol]
UEL (%): 12 [Isopropanol]
10. STABILITY AND REACTIVITY
Stability: Stable under recommended storage conditions
Polymerization: Not applicable
Hazardous decomposition products: GUANIDINE THIOCYANATE - Burning may produce fumes of cyanide, carbon monoxide, carbon dioxide,
nitrogen oxides and sulfur oxides. ALL OTHER SOLUTIONS... Carbon oxides.
Materials to avoid: GUANIDINE THIOCYANATE - Iron and oxidizing agents. ISOPROPANOL: heat, flame, strong oxidizers,
acetaldehyde, acids, chlorine, ethylene oxide, hydrogen-palladium combination, hydrogen peroxide-sulfuric
acid combination, potassium tert-butoxide, hypochlorous acid, isocyanates, nitroform, phosgene,
aluminum, oleum and perchloric acid. 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:
Isopropanol =12800 mg/kg Dermal LD50 Rabbit eyes, skin, respiratory system
=12800 mg/kg Dermal LD50 Rat
=4396 mg/kg Oral LD50 Rat
=72.6 mg/L Inhalation LC50 Rat 4h
Product number: 04741722190 Page 3 of 6
Product name: KIT COBAS T-SCRN WNV 96 TESTS US-IVD
Components NIOSH - NIOSH Pocket Guide -
Selected LD50s and LC50s: Target Organs:
Glycerol =12600 mg/kg Oral LD50 Rat respiratory system, skin, eyes, kidneys
>10 g/kg Dermal LD50 Rabbit
>21900 mg/kg Dermal LD50 Rat
>570 mg/m3 Inhalation LC50 Rat 1h
Subtilisins (proteolytic enzymes) =3700 mg/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
>10 g/kg Dermal LD50 Rabbit
>21900 mg/kg Dermal LD50 Rat
>570 mg/m3 Inhalation LC50 Rat 1h
Potassium acetate =3250 mg/kg Oral LD50 Rat
Dimethyl Sulfoxide (DMSO) =14500 mg/kg Oral LD50 Rat
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
Isopropanol Supplement 7, 1987 Monograph 71, Present
1999; Supplement
7, 1987; Monograph
15, 1977
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
Isopropanol 61200 mg/L LC50 fathead 35390 mg/L EC50
minnow (31 days old) 96 h Photobacterium
94900 mg/L LC50 fathead phosphoreum 5 min
minnow (29 days old) 96 h
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
Glycerol 50 mg/L LC50 rainbow
trout 96 h
5000 mg/L LC50 goldfish
96 h
Dimethyl Sulfoxide (DMSO) 34.0 mg/L LC50 fathead
minnow 96 h
13. DISPOSAL CONSIDERATIONS
Product number: 04741722190 Page 4 of 6
Product name: KIT COBAS T-SCRN WNV 96 TESTS US-IVD
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: MGP Reagent
DOT
Proper shipping name: Chemical Kit
UN Number: UN 3316 Hazard class: 9 Subsidiary risk: Not applicable Packing group: II
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)
Isopropanol Listed Listed
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)
Polidocanol Listed
Guanidine thiocyanate Listed
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)
Glycerol Listed
Subtilisins (proteolytic enzymes) Listed
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)
Glycerol Listed
Tricine Listed
Potassium acetate Listed
Dimethyl Sulfoxide (DMSO) Listed
U.S. Clean Water Act (CWA)/ California The following chemicals are listed under the CWA and/or California Proposition 65:
Proposition 65:
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:
Isopropanol B2, D2B
Product number: 04741722190 Page 5 of 6
Product name: KIT COBAS T-SCRN WNV 96 TESTS US-IVD
Components Canada - WHMIS: Classifications of Substances:
Glycerol Uncontrolled product according to WHMIS classification criteria
Subtilisins (proteolytic enzymes) D2A
Components Canada - WHMIS: Classifications of Substances:
Glycerol Uncontrolled product according to WHMIS classification criteria
Potassium acetate Uncontrolled product according to WHMIS classification criteria
Dimethyl Sulfoxide (DMSO) B3, D2B
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: 04741722190 Page 6 of 6
Product name: KIT COBAS T-SCRN WNV 96 TESTS US-IVD
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