Material Safety Data Sheet
Revision date: 08/22/2006
Print Date: 02/14/2007
Version: 1
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Product name: VITAMIN B12 RACKPACK GEN 2
Product number: 04745736190
Business area: Centralized Diagnostics
Product line: Elecsys, Cobas
Instrument type: 2010, E170, e411/e601
Supplier: Emergency telephone number:
Roche Diagnostics Corporation CHEMTREC:
9115 Hague Road 1-800-424-9300 (U.S. or Canada)
Indianapolis, IN 46250 1-703-527-3887 (International)
Site Phone Number: 1-800-428-5074
2. COMPOSITION/INFORMATION ON INGREDIENTS
Description 1: R1
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Potassium phosphate, monobasic 7778-77-0 1-5 NA NA NA NA
Mannitol 87-78-5 1-5 NA NA NA NA
Methionine 63-68-3 1-5 NA NA NA NA
Human serum NONE 0.1-<1 None NA NA NA
Description 2: R2
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Potassium phosphate, dibasic 7758-11-4 1-5 NA NA NA NA
Description 3: PT1
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
2 mg/m3 2 mg/m3 Ceiling
Sodium hydroxide 1310-73-2 0.01-<0.1 NA NA
Dithiothreitol 3483-12-3 0.1-<1 NA NA NA NA
EDTA 60-00-4 0.1-<1 NA NA NA NA
Description 4: PT2
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
2 mg/m3 2 mg/m3 Ceiling
Sodium hydroxide 1310-73-2 1-5 NA NA
5 mg/m3 5 mg/m3 Ceiling as
Sodium cyanide 143-33-9 0.1-<1 NA Skin - potential
prevent or reduce significant CN, listed under
skin absorption contribution to hydrogen cyanide and
overall exposure cyanide salts
by the cutaneous
route
Description 5: Coated Beads
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
HEPES 7365-45-9 1-5 NA NA NA NA
15 mg/m3 total 10 mg/m3
Sucrose 57-50-1 1-5 NA NA
dust
5 mg/m3
respirable fraction
3. HAZARDS IDENTIFICATION
Emergency Overview
NFPA Ratings: Health= 3 Flammability= 0 Reactivity= 0 Special= CO, PB
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 and/or eye contact.
Inhalation: Bottle PT2. Avoid breathing vapors or mists. May cause severe irritation of the respiratory tract with sore
throat, coughing, shortness of breath and delayed lung edema. Other bottles are not expected to cause
respiratory irritation during normal use.
Ingestion: Bottle PT2. Can burn mouth, throat, and stomach. Ingestion may cause nausea, vomiting, sore throat,
stomach-ache and eventually lead to a perforation of the intestine. Other bottles may cause
gastrointestinal irritation, nausea, vomiting, and diarrhea.
Skin contact: Bottle PT2. Causes skin burns. Other bottles may cause slight skin irritation.
Eye contact: Bottle Bottle PT2. Avoid contact with skin and eyes. Risk of serious damage to eyes. Causes eye burns.
Corrosive to the eyes and may cause severe damage including blindness. Other bottles may cause eye
irritation.
Sensitization or Odor threshold: The following chemical(s) may cause sensitization, be absorbed via skin, and/or has an odor threshold for
detection:
Medical conditions aggravated by None known
exposure:
Additional information: 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: In the case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
Immediate medical treatment is necessary as untreated wounds from corrosion of the skin heal slowly and
badly.
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: 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: For human source material, handle as if containing infectious material. Protect from contamination. Wear personal
protective equipment. Handle as if containing infectious material.
Storage: Keep container tightly closed. Do not store near acids.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Engineering measures: Ensure adequate ventilation, especially in confined areas.
Personal Protective Equipment
Product number: 04745736190 Page 2 of 6
Product name: VITAMIN B12 RACKPACK GEN 2
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. Handle in accordance with good industrial hygiene and safety
practice.
9. PHYSICAL AND CHEMICAL PROPERTIES
pH: pH = 14 (PT2); pH = 5.5 (R1 and PT1); All other bottles are neutral
Physical state: Liquid.
10. STABILITY AND REACTIVITY
Stability: Stable under recommended storage conditions
Polymerization: Not applicable
Hazardous decomposition products: Carbon oxides
Materials to avoid: Bottle PT2. Incompatible with acids. Oxidising agents. Metals. Strong bases.
11. TOXICOLOGICAL INFORMATION
Description 1: R1
Components NIOSH - NIOSH Pocket Guide -
Selected LD50s and LC50s: Target Organs:
Potassium phosphate, monobasic >4640 mg/kg Dermal LD50 Rabbit
Methionine =36 g/kg Oral LD50 Rat
Description 2: R2
Description 3: PT1
Components NIOSH - NIOSH Pocket Guide -
Selected LD50s and LC50s: Target Organs:
Sodium hydroxide =1350 mg/kg Dermal LD50 Rabbit eyes, skin, respiratory system
EDTA =1658 mg/kg Oral LD50 Rat
>2000 mg/kg Dermal LD50 Rat
Description 4: PT2
Components NIOSH - NIOSH Pocket Guide -
Selected LD50s and LC50s: Target Organs:
Sodium hydroxide =1350 mg/kg Dermal LD50 Rabbit eyes, skin, respiratory system
Sodium cyanide =10.4 mg/kg Dermal LD50 Rabbit CVS, CNS, skin, eyes, thyroid, blood
=6.44 mg/kg Oral LD50 Rat
Description 5: Coated Beads
Components NIOSH - NIOSH Pocket Guide -
Selected LD50s and LC50s: Target Organs:
Sucrose =29700 mg/kg Oral LD50 Rat eyes, respiratory system
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:
Product number: 04745736190 Page 3 of 6
Product name: VITAMIN B12 RACKPACK GEN 2
Components IARC IARC IARC NTP OSHA EPA IRIS
Group 1 Group 2A or 2B Group 3 or 4 Select Carcinogen
Carcinogens Assessment
Classification: not
Sodium cyanide
classifiable as a human
carcinogen; basis:
pertinent data regarding
carcinogenicity have not
been located in the
available literature; last
revised: 03/01/1991
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
EDTA 129 mg/L LC50 channel 100 mg/L LC50 water flea
catfish 96 h 96 h Static, as trisodium
340 mg/L LC50 rainbow salt
trout 24 h
486 mg/L LC50 bluegill
sunfish 96 h
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: Bottle PT2
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)
Potassium phosphate, monobasic Listed
Mannitol Listed
Methionine Listed
Product number: 04745736190 Page 4 of 6
Product name: VITAMIN B12 RACKPACK GEN 2
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)
Listed
Potassium phosphate, dibasic
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 Listed
454 kg final RQ
Dithiothreitol Listed
EDTA 2270 kg final RQ Listed
5000 lb 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 hydroxide 1000 lb final RQ Listed
454 kg final RQ
100 lb TPQ This material is a
Sodium cyanide 10 lb final RQ Listed Listed
reactive solid. The TPQ does 4.54 kg final RQ
not default to 10000 pounds 4.54 kg final RQ
for non-powder, non-molten,
non-solvent form
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)
HEPES Listed
Sucrose Listed
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
EDTA Present
Components Clean Water Act Clean Water Act California Proposition 65
Hazardous Substances Priority Pollutants
Sodium hydroxide Present
Sodium cyanide 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:
Potassium phosphate, monobasic Uncontrolled product according to WHMIS classification criteria
Components Canada - WHMIS: Classifications of Substances:
Potassium phosphate, dibasic Uncontrolled product according to WHMIS classification criteria
Components Canada - WHMIS: Classifications of Substances:
Sodium hydroxide E (including 0.08%, 2%, 2.5%, 5%, 0.01 N, 0.04 N, 0.1 N, 10%, 16%, 1 N, 20%, 40%, 50%, 8.7%)
EDTA D2B
Components Canada - WHMIS: Classifications of Substances:
Sodium hydroxide E (including 0.08%, 2%, 2.5%, 5%, 0.01 N, 0.04 N, 0.1 N, 10%, 16%, 1 N, 20%, 40%, 50%, 8.7%)
Components Canada - WHMIS: Classifications of Substances:
Sucrose Uncontrolled product according to WHMIS classification criteria
Product number: 04745736190 Page 5 of 6
Product name: VITAMIN B12 RACKPACK GEN 2
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: 04745736190 Page 6 of 6
Product name: VITAMIN B12 RACKPACK GEN 2
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