Material Safety Data Sheet
Revision date: 05/04/2006
Print Date: 08/29/2006
Version: 1
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Product name: Kit CAP-G/CTM HCV 48 TESTS RUO
Product number: 04864158190
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: Magnetic Glass Particle Reagent
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Isopropanol 67-63-0 99-100 400 ppm 1225 mg/m鲁 200 ppm 400 ppm STEL
980 mg/m鲁 500 ppm
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
Dithiothreitol 3483-12-3 <1 NA NA NA NA
Description 3: Protease Reagent
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Glycerol 56-81-5 40-60 15 mg/m鲁 NA 10 mg/m鲁 NA
5 mg/m鲁
Subtilisins (proteolytic enzymes) 9014-01-1 5-20 NA 0.00006 mg/m鲁 NA 0.00006 mg/m鲁
Ceiling
Description 4: Elution Buffer
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Methylparaben 99-76-3 <1 NA NA NA NA
Description 5: Master Mix
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Glycerol 56-81-5 5-20 15 mg/m鲁 NA 10 mg/m鲁 NA
5 mg/m鲁
Dimethyl Sulfoxide (DMSO) 67-68-5 15-40 NA NA NA NA
Potassium acetate 127-08-2 1-5 NA NA NA NA
Tricine 5704-04-1 1-5 NA NA NA NA
Description 6: Control Solutions (Low Control, High Control, & Negative Control)
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Human plasma NONE 99-100 NA NA NA NA
Description 7: All other components
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:
Magnetic Glass Particle Reagent: Health= 1 Flammability= 3 Reactivity= 0 Special= F
Lysis Reagent & Protease Reagent: Health= 1 Flammability= 0 Reactivity= 0 Special= I
3. HAZARDS IDENTIFICATION
Protease Reagent & Master Mix: Health= 0 Flammability= 1 Reactivity= 0 Special= I
Control Solutions: Health= 1 Flammability= 0 Reactivity= 0 Special= PB
All other components: 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: Avoid breathing vapors or mists. Bottles containing isopropanol, guanidine thiocyanate, glycerol,
polidocanol, or dimethylsufoxide may cause irritation.
Ingestion: Ingestion may cause gastrointestinal irritation, nausea, vomiting and diarrhea
Skin contact: Bottles containing isopropanol, glycerol, or dimethylsufoxide may cause irritation. May be absorbed
through the skin. Chronic exposure may cause dermatitis.
Eye contact: Contact may cause severe irritation. Bottles containing isopropanol may cause severe irritation, possible
corneal burns and eye damage.
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) Sensitizer (as crystalline
active Enzyme)
Components ACGIH - Germany (DFG) - Switzerland - AIHA - Odor Threshold
Sensitizer Designation: Skin/Sensitizers: Sensitizers: Values:
Dimethyl Sulfoxide (DMSO) danger of percutaneous
absorption
Medical conditions aggravated by Persons with pre-existing skin disorders, eye problems, impaired liver, kidney, or respiratory function may
exposure: be more susceptible to the effects of the substance.
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: Rinse with plenty of water. If skin irritation persists, call a physician. Remove and wash contaminated
clothing before re-use
Ingestion: Consult a physician. Do not induce vomiting without medical advice
Eye contact: In the case of contact with eyes, rinse immediately with plenty of water and seek medical advice
Notes to physician: None determined
5. FIRE-FIGHTING MEASURES
Suitable extinguishing media: Use dry chemical, CO2, water spray or `alcohol` foam
Unusual hazards: Combustible material. Flammable.
Special protective equipment for Wear self contained breathing apparatus for fire fighting if necessary
firefighters:
Product number: 04864158190 Page 2 of 6
Product name: Kit CAP-G/CTM HCV 48 TESTS RUO
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: Bottles with human blood or serum. For human source material, handle as if containing infectious material. Protect from
contamination. Wear personal protective equipment.
Storage: No special precautions required
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Engineering measures: Not applicable
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 (Isopropanol)
Color: Protease Reagent - yellow to brown. Manganese Solution - red. Control solutions - clear to yellow.
Melting point/range: - 127.3 F (Isopropanol)
Odor: Magnetic Glass Particle solution - alcohol odor. Lysis Reagent - sulfur odor. Master Mix solution - garlic
odor.
pH: Lysis Reagent = 5. Protease Reagent = 5.5. Master Mix = 7.8. Manganese Solutin = 6.8. All other
solutions = 5-9.
Physical state: Liquid.
Solubility in water: Soluble in water unless noted otherwise.
Autoignition temperature: 750 F (Isopropanol)
Flash point: 53 F (Isopropanol)
LEL (%): 2.5% (Isopropanol)
UEL (%): 12% (Isopropanol)
10. STABILITY AND REACTIVITY
Stability: Stable under recommended storage conditions
Polymerization: Not applicable
Hazardous decomposition products: Carbon dioxide. Carbon monoxide. Cyanides. Nitrogen oxides (nox). Sodium oxides. Phosphorus oxides.
Dimethyl amine. Hydrogen sulfide.
Materials to avoid: Strong acids. Strong bases. Strong oxidising 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.
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
= 16000 ppm Inhalation LC50 Rat 8 h
= 3600 mg/kg Oral LD50 Mouse
= 5045 mg/kg Oral LD50 Rat
Product number: 04864158190 Page 3 of 6
Product name: Kit CAP-G/CTM HCV 48 TESTS RUO
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
Subtilisins (proteolytic enzymes) = 3700 mg/kg Oral LD50 Rat
Components NIOSH - NIOSH Pocket Guide -
Selected LD50s and LC50s: Target Organs:
Methylparaben > 8 g/kg Oral LD50 Mouse
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
Dimethyl Sulfoxide (DMSO) = 14500 mg/kg Oral LD50 Rat
= 7920 mg/kg Oral LD50 Mouse
Potassium acetate = 3250 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
Monograph 71,
Isopropanol
1999; Supplement
7, 1987; Monograph
15, 1977
12. ECOLOGICAL INFORMATION
Bioaccumulation: No data available
Aquatic toxicity: Not applicable
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 = 35390 mg/L EC50
fathead minnow (31 days Photobacterium
old) 96 h flow-through phosphoreum 5 min
= 94900 mg/L LC50
fathead minnow (29 days
old) 96 h flow-through
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
Product number: 04864158190 Page 4 of 6
Product name: Kit CAP-G/CTM HCV 48 TESTS RUO
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 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: Magnetic Glass Particle 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 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)
Present
Polidocanol
Present
Guanidine thiocyanate
Present
Dithiothreitol
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 Present
Subtilisins (proteolytic enzymes) XU
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)
Methylparaben Present
Product number: 04864158190 Page 5 of 6
Product name: Kit CAP-G/CTM HCV 48 TESTS RUO
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 Present
Dimethyl Sulfoxide (DMSO) Present
Potassium acetate Present
Tricine Present
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
Components Canada - WHMIS: Classifications of Substances:
Polidocanol D2B
Guanidine thiocyanate D1B; D2B
Dithiothreitol D2B
Components Canada - WHMIS: Classifications of Substances:
Glycerol Uncontrolled product according to WHMIS classification criteria.
Subtilisins (proteolytic enzymes) D2A
Components Canada - WHMIS: Classifications of Substances:
Methylparaben D2B
Components Canada - WHMIS: Classifications of Substances:
Glycerol Uncontrolled product according to WHMIS classification criteria.
Dimethyl Sulfoxide (DMSO) D2B
Potassium acetate 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: 04864158190 Page 6 of 6
Product name: Kit CAP-G/CTM HCV 48 TESTS RUO
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