Chiron Corporation
Material Safety Data Sheet
Prepared to U.S. OSHA, CMA, ANSI and Canadian
WHMIS, And European Union Standards
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RABAVERT庐
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Section 1 鈥? Chemical Product and Company
Emergency Phone:
Manufacturer: CHEMTREC: 1-800-424-9300
Chiron Corporation International: 1-703-527-3887
4560 Horton St. Customer Service: 1 800 244-7668
Emeryville, CA 94608 1-510-655-8729
Trade Name: RabAvert庐 Rabies Vaccine
Synonyms: Purified Chick Embryo Cell Vaccine (PCECV)
Chiron Product Codes: NDC Number: 53905-501-01
Section 2 鈥? Composition and Information on Ingredients
RabAvert庐 Rabies Vaccine is supplied as two separate components: one vial containing the lyophilized vaccine
and one vial containing Sterile Diluent for RabAvert (sterile water for injection). Refer to Package Insert (Prescribing
Information) for description of this product. The constituents for each component are described in the following
tables.
EU LABELING/CLASSIFICATION: According to Article 1 of European Union Council Directive 92/32/EEC, medical products in
the finished state for human use (as defined by European Union Council Directives 67/548/EEC and 87/21/EEC) are not subject
to the regulations and administrative provisions of European Union Council Directive 92/32/EEC.
EU Classification: Not Applicable
EU Risk Phrases: Not Applicable
This product contains no hazardous components. This material is not subject to the Federal OSHA Hazard Communication
Standard 29 CFR 1910.1200 (b)(5)(ii). Drugs are exempt from this requirement as determined by the Occupational Safety and
Health Administration (OSHA) and cited in 29 CRF 1910.1200(b)(5)(ii) as follows:
(5)This section does not require labeling of the following chemicals:
(ii) any food, food additive, color additive, drug, cosmetic, or medical or veterinary device, including materials intended
for use as ingredients in such products (e.g., flavors and fragrances) as such terms are defined in the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 302 et seq.) and regulations issued under that Act, when they are subject to the labeling requirements
under that Act by the Food and Drug Administration.
CHEMICAL NAME CAS # EINECS # % w/w EU CLASSIFICATION FOR COMPONENTS
COMPONENT 1: LYOPHILIZED VACCINE
Amphotericin B 1397-89-3 215-742-2 < 0.1 HAZARD CLASSIFICATION: Not applicable.
RISK PHRASES: Not applicable.
Chlortetracycline 57-62-5 200-341-7 < 0.1 HAZARD CLASSIFICATION: Not applicable.
RISK PHRASES: Not applicable.
119-04-0 204-292-2 < 0.1 HAZARD CLASSIFICATION: Not applicable.
Neomycin B Sulfate
RISK PHRASES: Not applicable.
Human Serum Albumin 70024-90-7 274-272-6 < 0.1 HAZARD CLASSIFICATION: Not applicable.
RISK PHRASES: Not applicable.
Ethylenediaminetetraacetic Acid, Disodium 6381-92-6 205-358-3 <1 HAZARD CLASSIFICATION: Not applicable.
Dihydrate RISK PHRASES: Not applicable.
Potassium Glutamate 19473-49-5 243-094-0 <2 HAZARD CLASSIFICATION: Not applicable.
RISK PHRASES: Not applicable.
Polygeline (processed bovine gelatin) 9000-70-8 232-554-6 < 25 HAZARD CLASSIFICATION: Not applicable.
RISK PHRASES: Not applicable.
鈥渋nactivated rabies virus鈥? NE NE Balance HAZARD CLASSIFICATION: Not applicable.
RISK PHRASES: Not applicable.
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RABAVERT RABIES VACCINE
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Section 2 鈥? Composition and Information on Ingredients (Continued)
CHEMICAL NAME CAS # EINECS # % w/w EU CLASSIFICATION FOR COMPONENTS
庐
COMPONENT 2: STERILE DILUENT FOR RABAVERT (WATER FOR INJECTION)
Water for Injection (WFI) N/A N/A 100 HAZARD CLASSIFICATION: Not applicable.
RISK PHRASES: Not applicable.
NE = Not Established. See Section 16 for Definitions of Terms Used.
NOTE: ALL WHMIS required information is included in appropriate sections based on the ANSI Z400.1-1998 format. This product has been
classified in accordance with the hazard criteria of the CPR and the MSDS contains all the information required by the CPR. All European EU
required information is also included.
Section 3 鈥? Hazard Identification
Emergency Overview
LYOPHILIZED STERILE DILUENT FOR RABAVERT庐
VACCINE (WATER FOR INJECTION)
0 0
0 0 0
0
Chiron Corporation Laboratory Labeling Codes:
LYOPHILIZED VACCINE:
Health: 0 Flammability: 0 Instability: 0 Special: None
STERILE DILUENT FOR RABAVERT庐 (WATER FOR INJECTION): Not applicable.
Health: 0 Flammability: 0 Instability: 0 Special: None
Product Description: This product is supplied as two separate components. The Sterile Diluent for RabAvert is
a clear, colorless liquid. The LYOPHILIZED VACCINE is a white, odorless solid. Health Hazards: None known.
Flammability Hazards: None known. Reactivity Hazards: None known. Emergency Response
Recommendations: This product poses no hazard if spilled and no unusual hazard if involved in a fire.
Numbering Guidelines: Based upon a nationally recognized color-coded 0鈥?4 scale: Blue represents Health, Red represents
flammability, Yellow represents instability (reactivity) and White represents a 鈥渟pecial鈥? hazard. 0 represents no hazard and 4
represents the most severe hazard for each category. Examples one might see in the 鈥渟pecial鈥? category include CA=potential
carcinogen, COR=corrosive, I=irritant, T=toxic, OXY=Oxidizer, PF=Peroxide Former, W = Water reactive, SEN= sensitizing
agent, REP=reproductive hazard and TER=harmful to the fetus
Symptoms of Overexposure: None known.
Inhalation: Unknown.
Contact with Skin or Eyes: Unknown.
Skin Absorption: Unknown.
Ingestion: Unknown.
Injection: Unknown.
Appropriate route of entry: Intramuscular injection:
See Package Insert (Prescribing Information) for Clinical Pharmacology, Indications and Usage, Contraindications,
Warnings, Precautions, Adverse Reactions and Dosage and Administration.
Acute: Unknown.
Chronic: Unknown.
Target Organs: Unknown.
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RABAVERT RABIES VACCINE
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Section 4 鈥? First Aid Measures
Persons who are exposed to this product should seek medical attention if any adverse health effects occur. Rescuers
should be taken for medical attention if necessary. In the event medical attention is sought, the physician or health
care professional should receive a copy of this product鈥檚 label and this MSDS.
Skin: Wash affected area with soap and water. If irritation or allergic skin reaction should develop, seek medical
attention.
Eyes: In case of contact, rinse immediately with plenty of water and seek medical attention if irritation develops.
Inhalation: If symptoms develop, remove to fresh air and obtain medical attention.
Ingestion: If swallowed, seek medical advice immediately and show package container or prescribing information.
Injection: In the event of accidental injection, wash the puncture site with soap and water and treat with a disinfectant.
If accidental injection occurs with a needle or syringe that has been previously used for injection, the requirements
of the OSHA Bloodborne Pathogen Standard (29 CFR 1910.1030) are applicable.
Medical conditions aggravated by exposure: No specific medical conditions are known to be aggravated by
exposure to this product.
Recommendations to Physicians: This product is not expected to cause clinical symptoms. If such symptoms
occur, treat the symptoms, while alleviating the cause.
Section 5 鈥? Fire Fighting Measures
Flash Point: Not established nor applicable.
Autoignition Temperature: Not established nor applicable.
Flammable Limits (in air by volume, %):
UEL: Not established nor applicable.
LEL: Not established nor applicable.
Fire Extinguishing Materials: Use any extinguishing agent which is suitable for the surrounding fire.
Unusual Fire and Explosion Hazards:
LYOPHILIZED VACCINE: This component must be significantly preheated for ignition to become a hazard.
When involved in a fire, this product may decompose and produce carbon oxides.
STERILE DILUENT FOR RABAVERT庐 (WATER FOR INJECTION): None.
Explosion Sensitivity to Mechanical Impact: Not sensitive.
Explosion Sensitivity to Static Discharge: Not sensitive.
Special Fire-Fighting Procedures: Incipient fire responders should wear eye protection. Structural firefighters
must wear Self-Contained breathing Apparatus and full protective equipment.
LYOPHILIZED VACCINE: NFPA Rating: HEALTH = 1 FIRE = 1 INSTABILITY = 0 Special = 0
STERILE DILUENT FOR RABAVERT庐 (WATER FOR INJECTION): NFPA Rating: HEALTH = 0 FIRE = 1
INSTABILITY = 0 Special = 0
Section 6 - Accidental Release Measures
Spill and Leak Response: Spill area can be washed to a sanitary sewer. Absorb material and place in appropriate
containers for disposal. Prevent from entering open drains and waterways. Use appropriate personal protective
equipment during clean up.
Section 7 鈥? Handling and Storage
Work Practices and Hygiene Practices: See Package Insert (Prescribing Information). This product should be
used in accordance with normal clinical practice.
Storage: Protect from light.
Temperature:
Minimum: 2 degrees Centigrade (36 degrees Fahrenheit)
Maximum: 8 degrees Centigrade (46 degrees Fahrenheit)
Shelf Life: The vaccine may not be used after the expiration date given on package and vials.
Special Sensitivity: Avoid freezing as breakage of the diluent container might occur.
Handling/Storage Precautions: Use normal precautions for storage of a drug or biologic. After reconstitution the
vaccine is to be used immediately.
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RABAVERT RABIES VACCINE
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Section 8 鈥? Exposure Controls 鈥? Personal Protection
Refer to Package Insert (Prescribing Information) for description of this product.
This product contains no hazardous components. This material is not subject to the Federal OSHA Hazard
Communication Standard 29 CFR 1910.1200 (b)(5)(ii). Drugs are exempt from this requirement as determined
by the Occupational Safety and Health Administration (OSHA) and cited in 29 CRF 1910.1200(b)(5)(ii).
Ventilation and Engineering Controls: Special ventilation is not required.
Exposure Limits/Guidelines:
CHEMICAL NAME CAS # % w/w EXPOSURE LIMITS IN AIR
ACGIH-TLV OSHA-PEL AIHA WEELs NIOSH OTHER
TWA STEL TWA STEL TWA STEL IDLH
3 3 3 3 3 3 3 3
mg/m mg/m mg/m mg/m mg/m mg/m mg/m mg/m
COMPONENT 1: LYOPHILIZED VACCINE
Amphotericin B 1397-89-3 < 0.1 NE NE NE NE NE NE NE NE
Chlortetracycline 57-62-5 < 0.1 NE NE NE NE NE NE NE NE
Neomycin B Sulfate 119-04-0 < 0.1 NE NE NE NE NE NE NE NE
Human Serum
70024-90-7 < 0.1 NE NE NE NE NE NE NE NE
Albumin
Ethylenediaminetetra 6381-92-6 <1 NE NE NE NE NE NE NE NE
acetic Acid, Disodium
Dihydrate
Potassium Glutamate 19473-49-5 <2 NE NE NE NE NE NE NE NE
Polygeline 9000-70-8 < 25 NE NE NE NE NE NE NE NE
(processed bovine
gelatin)
鈥渋nactivated rabies virus鈥? Balance NE NE NE NE NE NE NE NE
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COMPONENT 2: STERILE DILUENT FOR RABAVERT (WATER FOR INJECTION)
Water for Injection N/A 100 NE NE NE NE NE NE NE
NE = Not Established. See Section 16 for Definitions of Terms Used.
Respiratory Protection: Normal clinical practice.
Eye Protection: Normal clinical practice.
Hand Protection: Normal clinical practice.
Body Protection: Normal clinical practice.
Additional Protective Measures: Educate and train employees in the safe use and administration of this product.
Section 9 鈥? Physical and Chemical Properties
FOR LYOPHILIZED VACCINE:
Relative Vapor Density (Air = 1): Not established.
Evaporation Rate (nBuAc = 1): Not established.
Specific Gravity: Not established.
Melting/Freezing Point: Not established.
Solubility in Water: Soluble.
Boiling Point: Not established.
Vapor Pressure, mm Hg @ 20掳C: Not established.
pH: Not established.
Odor Threshold: Odorless.
Coefficient Water/Oil Distribution: Not established.
Appearance, Odor and Color: This component is a white, odorless, lyophilized solid.
How to Detect This Substance: To identify this material, an immunological assay would be required. The
appearance is not unlike many other lyophilized proteinaceous materials.
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RABAVERT RABIES VACCINE
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Section 9 鈥? Physical and Chemical Properties (Continued)
STERILE DILUENT FOR RABAVERT庐 (WATER FOR INJECTION):
Relative Vapor Density (Air = 1): Not established.
Evaporation Rate (nBuAc = 1): Not established.
Specific Gravity: 1.0
Melting/Freezing Point: 0掳C (32掳F)
Solubility in Water: Soluble (it is water)
Boiling Point: 100掳C (212掳F)
Vapor Pressure, mm Hg @ 20掳C: Not established.
pH: Not established.
Odor Threshold: Odorless.
Coefficient Water/Oil Distribution: Not established.
Appearance, Odor and Color: This component is a clear, colorless, odorless liquid.
How to Detect This Substance: There are no good identity properties for this component (it is water).
Section 10 鈥? Stability and Reactivity
Stability: Stable.
Decomposition Products: None known.
Incompatibility: Oxidizing agents, reducing agents, water reactive materials.
Hazardous Polymerization: Will not occur.
Conditions to Avoid: Exposure to or contact with incompatible chemicals.
Section 11 鈥? Toxicological Information
Refer to Package Insert (Prescribing Information) for description of this product.
This product contains no hazardous components. This material is not subject to the Federal OSHA Hazard
Communication Standard 29 CFR 1910.1200 (b)(5)(ii). Drugs are exempt from this requirement as determined by
the Occupational Safety and Health Administration (OSHA) and cited in 29 CRF 1910.1200(b)(5)(ii).
Toxicity Data: No data available for this product.
RabAvert庐 Rabies Vaccine is FDA classified as Pregnancy Category C. Animal reproductive studies have not
been conducted with RabAvert庐 Rabies Vaccine. It is not known whether RabAvert can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity. The CDC has issued recommendations
for use of rabies vaccine in pregnant women (ACIP 1999). This product should be given to a pregnant woman
only if clearly needed. However, because of the potential consequences of inadequately treated rabies exposure
and limited data that indicate fetal abnormalities have not been associated with rabies vaccination, pregnancy is
not considered a contraindication to post-exposure prophylaxis. If there is substantial risk of exposure to rabies,
pre-exposure prophylaxis may also be indicated during pregnancy. In such instances, consideration should be
given to removing the pregnant woman from the high risk environment.
Cancer Agent: The components in this product are not found on the following lists: NTP, IARC, FEDERAL OSHA Z-
List, and CAL-OSHA and therefore are not considered to be or suspected to be cancer causing agents by these
agencies.
Irritancy: No skin irritation studies have been performed. The product may mildly irritate skin and eyes.
Sensitization:
LYOPHILIZED VACCINE: This component is produced in primary chick embryo fibroblast cell culture. History of
anaphylaxis to the vaccine or any of the vaccine components constitutes a contraindication to pre-exposure
vaccination with this vaccine. There is no contraindication to post-exposure treatment with this vaccine; please see
package insert.
STERILE DILUENT FOR RABAVERT庐 (WATER FOR INJECTION): Not applicable.
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RABAVERT RABIES VACCINE
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Section 11 鈥? Toxicological Information (Continued)
Reproductive Information: Listed below is information concerning the effects of this product on the reproductive
system.
Mutagenicity: Unknown; no studies have been performed.
Embryotoxicity: Unknown; no studies have been performed.
Teratogenicity: Unknown; no studies have been performed.
Reproductive Toxicity: Unknown; no studies have been performed.
ACGIH Biological Exposure Indices: There are currently no ACGIH Biological Exposure Indices (BEIs) determined
for the components of this product.
Section 12 鈥? Ecological Information
All Work Practices Should be Aimed at Minimizing Environmental Releases
Ecological Note: No data available for this product.
Environmental Stability: The components of this product are relatively stable in the environment.
Effect of Material on Plants and Animals: The toxicological properties have not been fully investigated.
Effect of Chemical on Aquatic Life: The toxicological properties have not been fully investigated.
Section 13 鈥? Disposal Considerations
Waste Disposal: This product contains no hazardous material. Place in containers and dispose of in accordance
with existing federal, state and local environmental regulations.
Section 14 鈥? Transport Information
U.S. Department of Transportation Regulations: This product does not meet the definition of a 鈥渉azardous
material鈥? (49 CFR 171.8) and therefore is not subject to the U.S. DOT regulations.
Transport Canada, Transportation of Dangerous Goods Regulations: This product is not classified as
dangerous goods, per regulations of Transport Canada, but must be labeled as emergency biopharmaceutical
and be accompanied by a Letter of Authorization allowing its shipment into the country.
International Air Transport Association (IATA): This product does not meet the definition of dangerous goods, and
is therefore exempt from IATA/ICAO regulations.
International Maritime Organization (IMO): This product is not Dangerous Goods, per the IMO.
European Agreement Concerning The International Carriage Of Dangerous Goods By Road (ADR): This
product is not classified as Dangerous Goods, under regulations of the United Nations Economic Commission
for Europe.
Section 15 鈥? Regulatory Information
U.S. Regulations:
SARA Reporting Requirements: The constituents in this product are not subject to the reporting requirements of
Sections 302, 304, and 313 of Title III of the Superfund Amendments and Reauthorization Act.
SARA 302 Extremely Hazardous Threshold Planning Quantity (TPQ): Not applicable.
SARA 304 Extremely Hazardous Reportable Quantity (RQ): Not applicable.
CERCLA: Not applicable.
TSCA: This product is regulated by the Food and Drug Administration; it is exempt from the requirements of TSCA.
Other U.S. Federal Regulations: Not applicable.
California Safe Drinking Water and Toxic Enforcement Act (Proposition 65): The constituents in this product鈥檚
components are not on the California Proposition 65 lists.
Canadian Regulations:
Canadian DSL/NDSL Inventory Status: Some constituents in this product are listed on the DSL/NDSL Inventory.
Other Canadian Regulations: Not applicable.
Canadian Environmental Protection Act (CEPA) Priority Substances Lists: The constituents of this product are
not on the CEPA Priority Substances Lists.
Canadian WHMIS Classification and Symbols: Not applicable.
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Section 15 鈥? Regulatory Information (Continued)
European Union Information for Product:
EU Labeling and Classification: This product does not meet the criteria of hazardous according to current
European Union Guidelines.
EU Classification: Not applicable.
EU Risk Phrases: Not applicable.
EU Safety Phrases: Not applicable.
EU Hazard Symbol: Not applicable
Section 16 鈥? Other Information
This material is not subject to the Federal OSHA Hazard Communication Standard 29 CFR 1910.1200 (b)(5)(ii).
Drugs are exempt from this requirement as determined by the Occupational Safety and Health Administration
(OSHA) and cited in 29 CRF 1910.1200(b)(5)(ii) as follows:
(5)This section does not require labeling of the following chemicals:
(ii) any food, food additive, color additive, drug, cosmetic, or medical or veterinary device, including
materials intended for use as ingredients in such products (e.g., flavors and fragrances) as such terms are defined
in the Federal Food, Drug and Cosmetic Act (21 U.S.C. 302 et seq.) and regulations issued under that Act, when
they are subject to the labeling requirements under that Act by the Food and Drug Administration.
Prepared by: CHEMICAL SAFETY ASSOCIATES, Inc.
PO Box 3519, La Mesa, CA 91944-3519
800/441-3365
Date of Revision: January 25, 2005
Date of Preparation: April 14, 2000
Date of Printing: January 27, 2005
The information contained herein is based on data considered accurate. However, no warranty is expressed or implied regarding the accuracy
of these data or the results to be obtained from the use thereof. Chiron Corporation assumes no responsibility for injury to the vendee or third
persons proximately caused by the material if reasonable safety procedures are not adhered to as stipulated in the data sheet. Additionally,
Chiron Corporation assumes no responsibility for injury to vendee or third persons proximately caused by abnormal use of the material even if
reasonable safety procedures are followed. Furthermore, vendee assumes the risk in his use of the material.
Glossary:
ACGIH = American Conference of Governmental Industrial Hygienists
AIHA = American Industrial Hygiene Association
BEI = Biological Exposure Index
CAS Number = Chemical Abstract Service Registry Number
CERCLA = Comprehensive Environmental Response Compensation and Liability Act (of 1980)
CHEMTREC = Chemical Transportation Emergency Center
DOT = Department of Transportation
EU = European Union
EINECS = European Inventory of Existing Chemical Substances
ELINCS = European List of New Chemical Substances
EPA = Environmental Protection Agency
HEPA = High Efficiency Particulate Air (Filter)
IARC = International Agency for Research on Cancer
ICAO/IATA = International Civil Aviation Organization/International Air Transport Association
IMO = International Maritime Organization
LC50 = Lethal Concentration at 50 % of test population (gases and vapors)
LD50 = Lethal Dose at 50 % of test population
LEL = Lower Explosive Limit
MSDS = Material Safety Data Sheet
NA = Not Applicable, except in Section 14 where NA = North America
NADA = New Animal Drug Application
NAIF = No Applicable Information Found
NCI = National Cancer Institute
NE = Not Established
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NIOSH = National Institute for Occupational Safety and Health
NOS = Not Otherwise Specified
NTP = National Toxicology Program
OSHA = Occupational Safety and Health Administration
PEL = Permissible Exposure Limit (OSHA)
RCRA = Resource Conservation and Recovery Act
RQ = Reportable Quantity
RTECS = Registry of Toxic Effects of Chemical Substances
SARA = Superfund Amendments and Reauthorization Act
STEG = Lilly Short Term Exposure Guideline
STEL = Short Term Exposure Limit
TDLO = Toxic Dose (lowest) that caused a symptom
TLV = Threshold Limit Value (ACGIH)
TPQ = Threshold Planning Quantity
TSCA = Toxic Substances Control Act
TWA = Time Weighted Average/8 Hours Unless Otherwise Noted
UEL = Upper Explosive Limit
UN = United Nations
WEEL = Workplace Environmental Exposure Level (AIHA)
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