MATERIAL SAFETY DATA
SHEET
Prepared to U.S. OSHA, CMA, ANSI and Canadian WHMIS Standards
PART I What is the material and what do I need to know in an emergency?
1. PRODUCT IDENTIFICATION
PRODUCT NAME (AS LABELED): VINORELBINE TARTRATE INJECTION
PRODUCT USE: Antineoplastic Agent
SUPPLIER/MANUFACTURER'S NAME: Sicor Pharmaceuticals, Inc.
ADDRESS: 19 Hughes.
Irvine, CA 92618
1-800-424-9300 (United States)**
CHEMTREC EMERGENCY NO.:
1-202-483-7616 (International Collect)
BUSINESS PHONE: 1-800-729-9991
FAX: 1-949-855-8210
Common Names: Navelbine Tartrate, 5鈥?-Noranhydrovinoblastine Tartrate, KW-2307,
Vinorelbine Ditartrate
Chemical Name: For Active Ingredient: 3鈥?,4鈥?-didehydro-4鈥?-deoxy-C鈥?-
norvincaleukoblastine [R-(R*,R*)-2,3-dihydroxybutanedioate (1:2)
(salt)]
For Active Ingredient: C45H54N4O8鈥?2C4H6O6
Chemical Formula:
Chemical Family: For Active Ingredient: Vinca Alkaloid
How Supplied: 10 mg/mL solution in a 2 mL vial
50 mg/5 mL solution in a 5 mL vial
DATE OF PREPARATION: December 7, 1999
2. COMPOSITION and INFORMATION ON INGREDIENTS
CHEMICAL NAME CAS # % by weight EXPOSURE LIMITS IN AIR
ACGIH-TLV OSHA-PEL
TWA STEL TWA STEL IDLH OTHER
3 3 3 3 3
mg/m mg/m mg/m mg/m mg/m
Vinorelbine Tartrate 125317-39-7 1 VINORELBINE TARTRATE IS A CYTOTOXIC AGENT. ALL WORK
PRACTICES MUST BE DESIGNED TO REDUCE HUMAN EXPOSURE TO
THE LOWEST LEVEL.
Water for Injection 7732-18-5 Balance NE NE NE NE NE NE
NE = Not Established C = Ceiling Limit mppcf: Millions of Particles per Cubic Foot See Section 16 for Definitions of Terms Used
NOTE: All WHMIS required information is included. It is located in appropriate sections based on the ANSI Z400.1-1998 format.
**CHEMTREC NUMBER: Use only in the event of a chemical emergency involving a spill, leak, fire, exposure or accident involving this chemical.
3. HAZARD IDENTIFICATION
EMERGENCY OVERVIEW: This is a clear, colorless to pale yellow, odorless liquid. The primary health hazard
associated with exposure to this product during an emergency response situation would be mild irritation of
contaminated skin or eyes. Vinorelbine Tartrate is a potential reproductive toxin, based on animal data. This product is
neither flammable nor reactive. Emergency responders must wear adequate personal protective equipment for the
situation to which they are responding.
SYMPTOMS OF OVEREXPOSURE BY ROUTE OF EXPOSURE: This material is a powerful cytotoxic and antineoplastic
agent. The extent of entry into the body by most routes has not been fully investigated. Since the toxicological properties
of this compound have not been fully investigated, all exposures must be minimized. Occupational exposures to this
product may cause acute or chronic effects in humans, as described in the following paragraphs.
INHALATION: Inhalation of mists or sprays of this product may irritate the nose and throat. Symptoms of such exposure
may include coughing, sneezing, and other toxic effects described in 鈥淥ther Potential Health Effects鈥?.
VINORELBINE TARTRATE FOR INJECTION MSDS
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3. HAZARD IDENTIFICATION (Continued)
CONTACT WITH SKIN or EYES: Contact of this product with the skin
may cause redness, discomfort, and irritation. Prolonged or repeated skin HAZARDOUS MATERIAL IDENTIFICATION SYSTEM
contact may cause dermatitis (dry, red skin). Contact of this product with
the eyes may cause irritation, redness, and tearing.
HEALTH (BLUE) 2
SKIN ABSORPTION: This product is not known to be absorbed through
intact skin.
INGESTION: Ingestion is not anticipated to be a likely route of
occupational exposure. If this product is swallowed, it may cause
FLAMMABILITY (RED) 0
gastrointestinal distress and diarrhea. Symptoms of such overexposure
may also include the toxic effects described in 鈥淥ther Potential Health
Effects鈥?.
INJECTION: In terms of anticipated occupational overexposure effects,
REACTIVITY
local redness and pain are the primary symptoms of accidental injection. (YELLOW) 0
Symptoms of such overexposure may also include the toxic effects
described in 鈥淥ther Potential Health Effects鈥?.
OTHER POTENTIAL HEALTH EFFECTS: Vinorelbine Tartrate is a
PROTECTIVE EQUIPMENT X
pharmacological product used in the treatment of cancer. The most
common dose-dependent adverse effects associated with therapeutic
treatments include hair loss, nausea, constipation, vomiting, diarrhea, loss EYES HANDS BODY
RESPIRATORY
of appetite, inflammation of the mouth, difficulty swallowing, sleepiness,
shortness of breath, chest pain, jaw pain, headache, rash, muscle SEE SECTION 8 SEE SECTION 8
weakness, muscle or joint pain, partial paralysis of the lower limbs,
impaired reflexes, loss of deep tendon reflexes, decreased granulocyte,
For medical treatment of cancer.
red blood, and platelet cell counts, elevation of liver enzymes, and fever.
An acute overdose of Vinorelbine Tartrate can cause irreversible bone See Section 16 for Definition of Ratings
marrow suppression and peripheral nerve damage.
HEALTH EFFECTS OR RISKS FROM EXPOSURE (An explanation in lay terms).
ACUTE: The primary health effects that may be experienced by medical personnel exposed to this product are irritation
of contaminated skin and eyes or pain, redness, and local swelling after accidental injection. In the event of exposures via
injection to therapeutic doses of this product, effects described in 鈥淥ther Potential Health Effects鈥? may result.
CHRONIC: Vinorelbine Tartrate is a potential carcinogen and reproductive toxin, based on animal data. This compound
has been rated as a Category D Reproductive Toxin, with possible reproductive effects in humans. Refer to Section 11
(Toxicological Information) for additional information on this product.
TARGET ORGANS: Skin, eyes (anticipated occupational exposures). Blood system, nervous system, skin, and
reproductive system (therapeutic doses).
PART II What should I do if a hazardous situation occurs?
4. FIRST-AID MEASURES
PERSONS ACCIDENTALLY EXPOSED TO VINORELBINE TARTRATE MUST RECEIVE PROMPT MEDICAL
ATTENTION!
Victims of chemical exposure must be taken for medical attention. Rescuers should be taken for medical attention, if they
have been exposed to this product. Take copy of label and MSDS to physician or health professional with victim.
SKIN EXPOSURE: If the product contaminates the skin, immediately begin decontamination with running water. Remove
exposed or contaminated clothing, taking care not to contaminate eyes. The minimum recommended flushing time is 15
minutes. Victims must seek immediate medical attention, especially if an adverse reaction occurs.
EYE EXPOSURE: If this product contaminates the eyes, open victim's eyes while under gently running water. Use
sufficient force to open eyelids. Have victim "roll" eyes. Minimum flushing is for 15 minutes. If necessary, consult an
ophthalmologist.
INHALATION: If this product is inhaled, remove victim to fresh air. If necessary, use artificial respiration to support vital
functions.
INGESTION: If the product is swallowed, CALL PHYSICIAN OR POISON CONTROL CENTER FOR MOST CURRENT
INFORMATION. If professional advice is not available, DO NOT induce vomiting. Have victim rinse mouth with water, if
conscious. Never induce vomiting or give diluents (milk or water) to someone who is unconscious, having convulsions, or
unable to swallow. If vomiting occurs, lean patient forward or place on left side (head-down position, if possible) to
maintain an open airway and prevent aspiration. If contaminated individual is convulsing, maintain an open airway and
obtain immediate medical attention.
VINORELBINE TARTRATE FOR INJECTION MSDS
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4. FIRST-AID MEASURES (Continued)
INJECTION: In the event of accidental injection, wash contaminated area with soap and water.
MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: Disorders involving the Target Organs of this product (see
Section 3, Hazard Information) can be aggravated by exposures to this product (especially in doses approaching
therapeutic levels for this product).
RECOMMENDATIONS TO PHYSICIANS: Vinorelbine Tartrate is a potent cytotoxic antineoplastic drug. It should only be
administered under the supervision of physicians experienced in cancer chemotherapy. Employees should receive
routine medical surveillance before job placement, periodically (especially following acute exposures) and the termination
of job or transfer. If necessary, cardiac evaluations, blood tests should be conducted. Consult the Package Insert for
additional information which can assist with treatment of overexposure.
5. FIRE-FIGHTING MEASURES
FLASH POINT: Not applicable.
NFPA RATING
AUTOIGNITION TEMPERATURE: Not applicable. FLAMMABILITY
FLAMMABLE LIMITS (in air by volume, %): Lower: Not applicable.
Upper: Not applicable. 0
FIRE EXTINGUISHING EQUIPMENT: 0
2
HEALTH REACTIVITY
Water Spray: OK Carbon Dioxide: OK
Foam: OK Dry Chemical: OK
Halon: OK Other: Any "ABC" Class
UNUSUAL FIRE and EXPLOSION HAZARDS: This substance must be viewed OTHER
as a potential irritant, presenting a contact hazard to firefighters. Vinorelbine Tartrate is a potential carcinogen and
reproductive toxin, based on animal data. Thermal decomposition of this product will produce irritating vapors and toxic
gases (carbon oxides, nitrogen oxides).
See Section 16 for
Explosion Sensitivity to Mechanical Impact: Not sensitive.
Definition of Ratings
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 (SCBA) and full protective equipment. If protective equipment is
contaminated by this product, it should be thoroughly washed with running water prior to removal of SCBA respiratory
protection. Firefighters whose protective equipment becomes contaminated should thoroughly shower with warm, soapy
water and should receive medical evaluation.
6. ACCIDENTAL RELEASE MEASURES
SPILL AND LEAK RESPONSE: Cleanup of Small Spills. Spills of less than 5 mL or 5 gm outside a hood should be
cleaned immediately by personnel wearing gowns and double surgical latex gloves and eye protection. Liquids should be
wiped with absorbent gauze pads; solids should be wiped with wet absorbent gauze. The spill areas should then be
cleaned (three times) using a detergent solution followed by clean water. Cleanup of Large Spills. For spills of amounts
larger than 5 mL or 5 gm, spread should be limited by gently covering with absorbent sheets or spill-control pads or
pillows or, if a powder is involved, with damp cloths or towels. Be sure not to generate aerosols. Access to the spill areas
should be restricted. Protective apparel should be used with the addition of a respirator when there is any danger of
airborne powder or an aerosol being generated. The dispersal of mists into surrounding air and the possibility of inhalation
is a serious matter and should be treated as such. Chemical inactivators may produce hazardous by-products and should
not be applied to the absorbed Vinorelbine Tartrate. Proper protective equipment should be used, including double latex
or nitrile gloves, full body gown, and full-face respirator equipped with a High Efficiency Particulate (HEPA) filter. Self-
Contained Breathing Apparatus (SCBA) can be used instead of an air-purifying respirator. All contaminated surfaces
should be thoroughly cleaned with detergent solution and then wiped with clean water. All contaminated absorbents and
other materials should be disposed of in the cytotoxic compound disposal bag. Spills in Hoods. Decontamination of all
interior hood surfaces may be required after the above procedures have been followed. If the HEPA filter of a hood is
contaminated, the unit must be labeled "Do not use--contaminated," and the filter must be changed and disposed of
properly as soon as possible by trained personnel wearing protective equipment. Protective goggles should be cleaned
with an alcohol wipe after the cleanup. Spill kits, clearly labeled, should be kept in or near preparation and administrative
areas. It is suggested that kits include a respirator, chemical splash goggles, two pairs of gloves, two sheets (12 x 12) of
absorbent material, 250-mL and 1-liter spill control pillows and a small scoop to collect glass fragments (if applicable).
Absorbents should be incinerable. Finally, the kit should contain two large cytotoxic compound waste-disposal bags.
VINORELBINE TARTRATE FOR INJECTION MSDS
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6. ACCIDENTAL RELEASE MEASURES
SPILL AND LEAK RESPONSE (continued): Avoid generating airborne dusts of this product during spill response
procedures. Decontaminate the area of the spill thoroughly by using detergent and water. Place all spill residue in an
appropriate container and seal. Dispose of in accordance with U.S. Federal, State, and local or Canadian waste disposal
regulations (refer to Section 13, Disposal Considerations).
PART III How can I prevent hazardous situations from occurring?
7. HANDLING and STORAGE
WORK and HYGIENE PRACTICES: VINORELBINE TARTRATE IS A CYTOTOXIC AGENT. ALL WORK PRACTICES
MUST BE DESIGNED TO REDUCE HUMAN EXPOSURE TO THE LOWEST LEVEL. As with all chemicals, avoid
getting this material ON YOU or IN YOU. Do not eat, smoke or drink while handling this product. Wash thoroughly after
handling this product or equipment and containers that contain this product. In addition, smokers who do not take simple
protective measures such as gloving and handwashing may take in additional amounts of the drug orally through
contaminated cigarettes, resulting in exposure. Particular care in working with this product must be practiced in
pharmacies and other preparation areas, and while manufacturing this product. Precautions should be taken during the
following activities:
鈥? Withdrawal of needles from drug vials;
鈥? Drug transfers using syringes and needles or filter straws; and
鈥? Expulsion of air from drug-filled syringes.
鈥? Opening vials.
DO NOT CLIP OR CRUSH NEEDLE WITH WHICH THIS PRODUCT WAS IN CONTACT. Use of this product should
meet the following provisions.
鈥? Work should be performed in an appropriate, designated area;
鈥? Contaminated waste must be properly handled; and,
鈥? If necessary, work areas must be regularly decontaminated.
STORAGE and HANDLING PRACTICES: Employees must be trained to properly use this product. Contaminated waste
must be properly handled. Work areas must be regularly decontaminated. Ensure vials are properly labeled. Store this
product away from incompatible materials. Store containers at 2-8掳C (36-46掳F) and protect from light. DO NOT FREEZE.
PROTECTIVE PRACTICES DURING MAINTENANCE OF CONTAMINATED EQUIPMENT: When cleaning non-
disposable equipment, wear latex or nitrile gloves (double gloving is recommended), goggles, and lab coat.
Decontaminate equipment with a soapy water. All needles, syringes, vials, and other disposable items contaminated with
this product should be disposed of properly.
8. EXPOSURE CONTROLS - PERSONAL PROTECTION
VENTILATION and ENGINEERING CONTROLS: Use with adequate ventilation. Follow standard medical product
handling procedures. Admixtures or manipulations of this drug should be carried out in a cytotoxic drug safety cabinet.
The cabinet should be cleaned regularly following the manufacturer's recommendations, at least weekly. All surfaces
should be thoroughly washed with water and detergent and triple rinsed. During decontamination, workers should wear
the same equipment recommended in Section 6 (Accidental Release Measures) of this MSDS for the clean up of a large
spill. HEPA filters on the cytotoxic drug safety cabinet should be changed every six months. The safety cabinet should
be tested and certified as recommended by the National Sanitation Foundation in Standard Number 49.
RESPIRATORY PROTECTION: A full-face respirator with a HEPA filter should be used until a Biological Safety Cabinet
is installed. A respirator is not required for routine conditions if used in a Biological Safety Cabinet. If respiratory
protection is needed, use only protection authorized in the U.S. Federal OSHA Standard (29 CFR 1910.134), applicable U.S.
State regulations, or the Canadian CSA Standard Z94.4-93 and applicable standards of Canadian Provinces. Oxygen
levels below 19.5% are considered IDLH by OSHA. In such atmospheres, use of a full-facepiece pressure/demand SCBA or
a full facepiece, supplied air respirator with auxiliary self-contained air supply is required under OSHA鈥檚 Respiratory
Protection Standard (1910.134-1998).
EYE PROTECTION: Chemical splash goggles, or regular splash goggles, with a full face-shield. An eyewash station
must be available in areas where this compound is used.
VINORELBINE TARTRATE FOR INJECTION MSDS
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8. EXPOSURE CONTROLS - PERSONAL PROTECTION (Continued)
HAND PROTECTION: Double glove, using latex, nitrile, or rubber gloves (powderless). Check gloves for leaks. Wash
hands before putting on gloves and after removing gloves. Gloves should cover the gown cuff. Because all gloves are to
some extent permeable and their permeability increases with time, they should be changed regularly (hourly is preferable)
or immediately if they are torn or punctured.
BODY PROTECTION: A protective disposable gown made of lint-free low permeability fabric with a closed front, long
sleeves, and elastic or knit-closed cuffs must be worn, with the cuffs tucked under the gloves. The gown should be made
of Tyvek(TM), PE-Coated Tyvek(TM), or SARANEX(TM). Gowns and gloves in use should not be worn outside the preparation
area.
PRODUCT PREPARATION INSTRUCTIONS FOR MEDICAL PERSONNEL: Handle this material following standard
medical practices and following the recommendations presented on the Package Insert.
9. PHYSICAL and CHEMICAL PROPERTIES
RELATIVE VAPOR DENSITY (air = 1): Not determined. EVAPORATION RATE (n-BuAc=1): Not determined.
SPECIFIC GRAVITY: Not determined. MELTING/FREEZING POINT: Not determined.
SOLUBILITY IN WATER: Soluble. BOILING POINT: Not determined.
VAPOR PRESSURE, mm Hg @ 25掳C: Not determined. pH: Approximately 3.5
ODOR THRESHOLD: Odorless.
COEFFICIENT OF OIL/WATER DISTRIBUTION (Partition Coefficient): Not determined.
APPEARANCE, ODOR and COLOR: This is a clear, colorless to pale yellow, odorless liquid.
HOW TO DETECT THIS SUBSTANCE (warning properties): There are no distinguishing characteristic associated with
this product.
10. STABILITY and REACTIVITY
STABILITY: This product is stable, when stored at the recommended temperature and protected from light.
DECOMPOSITION PRODUCTS: When heated to decomposition temperatures, this product will emit carbon oxides and
nitrogen oxides.
MATERIALS WITH WHICH SUBSTANCE IS INCOMPATIBLE: This product is generally compatible with other common
materials in a medical facility. This product would not be compatible with strong oxidizers.
HAZARDOUS POLYMERIZATION: Will not occur.
CONDITIONS TO AVOID: Heat may cause this product to decompose, destroying the product and producing irritating
vapors and toxic gases (e.g., carbon oxides, nitrogen oxides). Avoid contact with incompatible chemicals.
PART IV Is there any other useful information about this material?
11. TOXICOLOGICAL INFORMATION
TOXICITY DATA: The following data are available for Vinorelbine Tartrate, the active ingredient in this product.
VINORELBINE TARTRATE: VINORELBINE TARTRATE (continued): VINORELBINE TARTRATE(continued):
TDLo (intravenous, rat) = 2 mg/kg/female 7-16 LD50 (oral, rat) = 26-34 mg/kg LD50 (oral, mouse) = 77-89 mg/kg
days after conception; Reproductive: LD50 (intravenous, rat) = 11-12 mg/kg LD50 (intravenous, mouse) = 32-42 mg/kg
Specific Developmental Abnormalities: LD (intravenous, beagle) = 1-2 mg/kg
musculoskeletal system
SUSPECTED CANCER AGENT: Vinorelbine Tartrate is cytotoxic, DNA-damaging, and should be handled as a suspect
carcinogen.
This product's ingredients are not found on the following lists: U.S. FEDERAL OSHA Z LIST, NTP, IARC, and CAL/OSHA
and therefore are neither considered to be nor suspected to be cancer-causing agents by these agencies.
IRRITANCY OF PRODUCT: This product may be irritating to contaminated skin, eyes, and other tissue.
SENSITIZATION TO THE PRODUCT: This product may cause allergic reactions in sensitive individuals.
REPRODUCTIVE TOXICITY INFORMATION: Vinorelbine Tartrate is rated as Pregnancy Category D (Risk to Pregnancy
Cannot Be Ruled Out). Listed below is information concerning the effects of Vinorelbine Tartrate, the active ingredient of
this product, on animal or human reproductive systems.
Mutagenicity: Vinorelbine Tartrate has been shown to affect chromosome number and possibly structure in vivo.
Embryotoxicity: A single dose of Vinorelbine Tartrate has been shown to be embryotoxic in mice and rabbits at doses of 9
mg/m2 and 5.5 mg/m2, respectively (1/3 and 1/6 the human dose). Refer to 鈥淭eratogenicity鈥? for additional information.
Teratogenicity: At non-maternotoxic doses, fetal weight was reduced and ossification was delayed. There are no
adequate and well-controlled studies in pregnant women.
Reproductive Toxicity: Biweekly administration of Vinorelbine Tartrate for 13 or 26 weeks in the rat at 2.1 and 7.2 mg/m2
resulted in decreased spermatogenesis and prostate/seminal vesicle secretion.
VINORELBINE TARTRATE FOR INJECTION MSDS
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11. TOXICOLOGICAL INFORMATION (Continued)
REPRODUCTIVE TOXICITY INFORMATION (continued):
A mutagen is a chemical which causes permanent changes to genetic material (DNA) such that the changes will
propagate through generational lines. An embryotoxin is a chemical which causes damage to a developing embryo (i.e.
within the first eight weeks of pregnancy in humans), but the damage does not propagate across generational lines. A
teratogen is a chemical which causes damage to a developing fetus, but the damage does not propagate across
generational lines. A reproductive toxin is any substance which interferes in any way with the reproductive process.
ACGIH BIOLOGICAL EXPOSURE INDICES (BEIs): Currently there are no ACGIH Biological Exposure Indices (BEIs)
associated with the components of this product.
12. ECOLOGICAL INFORMATION
ALL WORK PRACTICES MUST BE AIMED AT ELIMINATING ENVIRONMENTAL CONTAMINATION.
ENVIRONMENTAL STABILITY: This product will be relatively stable under ambient environmental conditions.
EFFECT OF MATERIAL ON PLANTS or ANIMALS: No specific information is currently available on the effect of
Vinorelbine Tartrate on plants or animals in the environment. This product may be harmful or fatal to contaminated plant
and animal life. Refer to Section 11 (Toxicological Information) for additional information on Vinorelbine Tartrate and its
effects on test animals.
EFFECT OF CHEMICAL ON AQUATIC LIFE: No information is currently available on the effect of Vinorelbine Tartrate on
aquatic plants or animals in the environment. This product may be harmful to aquatic plant and animal life in
contaminated bodies of water, especially in large quantities.
13. DISPOSAL CONSIDERATIONS
PREPARING WASTES FOR DISPOSAL: Cytotoxic waste must be disposed in sealable plastic or wire tie bags of 4-mil
thick polyethylene or 2-mil polypropylene, labeled with a cytotoxic hazard label, colored differently from other hospital
trash bags, and used for the routine accumulation and collection of used containers, syringes, discarded gloves, gowns,
goggles and any other disposable material. All Vinorelbine Tartrate-related wastes should be placed in approved bags
only. This product, if unaltered by handling, may be disposed of by treatment at a permitted facility or as advised by your
local hazardous waste regulatory authority. Incineration is recommended for the product and disposable equipment
contaminated with this product. Waste disposal must be in accordance with appropriate U.S. Federal, State, and local
regulations or those of Canada and its Provinces. Reusable equipment should be cleaned with soap and water.
U.S. EPA WASTE NUMBER: Not applicable to wastes consisting only of this product.
14. TRANSPORTATION INFORMATION
THIS MATERIAL IS NOT HAZARDOUS, PER THE U.S. DEPARTMENT OF TRANSPORTATION (49 CFR 172.101)
PROPER SHIPPING NAME: Not Regulated
HAZARD CLASS NUMBER and DESCRIPTION: Not Applicable
UN IDENTIFICATION NUMBER: Not Applicable
PACKING GROUP: Not Applicable
DOT LABEL(S) REQUIRED: Not Applicable
NORTH AMERICAN EMERGENCY RESPONSE GUIDEBOOK NUMBER (1996): Not Applicable
MARINE POLLUTANT: No component of this product is listed as a Marine Pollutant (49 CFR 172.101, Appendix B).
TRANSPORT CANADA TRANSPORTATION OF DANGEROUS GOODS REGULATIONS: THIS MATERIAL IS NOT
CONSIDERED AS DANGEROUS GOODS.
15. REGULATORY INFORMATION
ADDITIONAL U.S. REGULATIONS:
U.S. SARA REPORTING REQUIREMENTS: The components of 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.
U.S. TSCA STATUS: Vinorelbine Tartrate is a 鈥渄rug鈥? as defined by the Federal Food, Drug and Cosmetic Act (21 USC
321 et. Seq.); therefore, it is not a chemical substance under TSCA (40 CFR 720.3 (e)).
U.S. SARA THRESHOLD PLANNING QUANTITY: There are no specific Threshold Planning Quantities for any component
of this product. The default Federal MSDS submission and inventory requirement filing threshold of 10,000 lbs. (4,540 kg)
therefore applies, per 40 CFR 370.20.
U.S. CERCLA REPORTABLE QUANTITIES (RQ): Not applicable.
VINORELBINE TARTRATE FOR INJECTION MSDS
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15. REGULATORY INFORMATION (Continued)
ADDITIONAL U.S. REGULATIONS(continued):
OTHER U.S. FEDERAL REGULATIONS: Requirements under FDA regulations may apply to this compound. In addition,
when used as an injectable drug, the requirements of the OSHA Bloodborne Pathogen Standard (29 CFR 1910.1030) are
applicable. Employers should refer to OSHA Technical Instructions, TED 1.15, when employees are working with
hazardous drugs.
CALIFORNIA SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT (PROPOSITION 65): No component of this
product is on the California Proposition 65 lists.
U.S. STATE REGULATORY INFORMATION: The components of this product are covered under the following specific
State regulations (NONE indicates no special regulations were noted).
Alaska - Designated Toxic and Hazardous Minnesota - List of Hazardous Substances: Pennsylvania - Hazardous Substance List:
Substances: None. None. None.
California - Permissible Exposure Limits for Missouri - Employer Information/Toxic Rhode Island - Hazardous Substance List:
Chemical Contaminants: None. Substance List: None. None.
Florida - Substance List: None. New Jersey - Right to Know Hazardous Texas - Hazardous Substance List: None.
Illinois - Toxic Substance List: None. Substance List: None. West Virginia - Hazardous Substance List:
Kansas - Section 302/313 List: None. North Dakota - List of Hazardous Chemicals, None.
Massachusetts - Substance List: None. Reportable Quantities: None. Wisconsin - Toxic and Hazardous
Michigan - Critical Materials Register: None. Substances: None.
ANSI LABELING (Based on 129.1, Provided to Summarize Occupational Exposure Hazards): DANGER! CYTOTOXIC
AGENT. ALL EXPOSURE MUST BE MINIMIZED. ACCIDENTAL INJECTION CAN CAUSE SERIOUS HEALTH
EFFECTS. MAY BE HARMFUL IF SWALLOWED. MAY CAUSE RESPIRATORY SYSTEM, EYE, AND SKIN
IRRITATION. MAY CAUSE REPRODUCTIVE EFFECTS, BASED ON ANIMAL DATA, AND CAN CAUSE HARM DURING
PREGNANCY. CAN CAUSE NERVOUS SYSTEM AND BLOOD EFFECTS. Do not taste or swallow. Do not accidentally
get on skin, in eyes, or on clothes. Avoid prolonged or repeated skin contact. Avoid breathing mists or sprays. Keep
container closed. Use only with adequate ventilation. Wash thoroughly after handling. If necessary, wear gloves, goggles,
and appropriate body protection. Store containers in a cool location, tightly closed, away from direct light. FIRST-AID: In
case of contact, immediately flush skin or eyes with plenty of water. If inhaled, remove to fresh air. If ingested, do not induce
vomiting. Get medical attention if necessary. IN CASE OF FIRE: Use water fog, dry chemical, CO2, or 鈥渁lcohol鈥? foam. IN
CASE OF SPILL: Absorb spill with polypads and place in suitable container. Consult Material Safety Data Sheet for
additional information.
ADDITIONAL CANADIAN REGULATIONS:
CANADIAN DSL STATUS: Vinorelbine Tartrate is regulated by the Food and Drug Administration of Health Canada; it is
exempt from the requirements of CEPA.
OTHER CANADIAN REGULATIONS: Not Applicable.
CANADIAN ENVIRONMENTAL PROTECTION ACT (CEPA) PRIORITIES SUBSTANCES LISTS: The components of this
product are not on the CEPA Priorities Substances Lists.
CANADIAN WHMIS SYMBOLS: Class D2A: Materials Causing Other Toxic Effects (Irritant, Nervous System
Effects)
16. OTHER INFORMATION
PREPARED BY: CHEMICAL SAFETY ASSOCIATES, Inc.
9163 Chesapeake Drive, San Diego, CA 92123-1002
(619) 565 - 0302
DATE OF PRINTING: July 14, 2004
VINORELBINE TARTRATE FOR INJECTION MSDS
PAGE 7 OF 8
DEFINITIONS OF TERMS
A large number of abbreviations and acronyms appear on a MSDS. Some of these which are commonly used include the following:
CAS #: This is the Chemical Abstract Service Number which uniquely identifies each constituent. It is used for computer-related searching.
EXPOSURE LIMITS IN AIR: FLAMMABILITY LIMITS IN AIR:
ACGIH - American Conference of Governmental Industrial Hygienists, a Much of the information related to fire and explosion is derived from the
professional association which establishes exposure limits. National Fire Protection Association (NFPA). Flash Point - Minimum
TLV - Threshold Limit Value - an airborne concentration of a substance temperature at which a liquid gives off sufficient vapors to form an
which represents conditions under which it is generally believed that ignitable mixture with air. Autoignition Temperature: The minimum
nearly all workers may be repeatedly exposed without adverse effect. temperature required to initiate combustion in air with no other source of
The duration must be considered, including the 8-hour Time Weighted ignition. LEL - the lowest percent of vapor in air, by volume, that will
Average (TWA), the 15-minute Short Term Exposure Limit, and the explode or ignite in the presence of an ignition source. UEL - the highest
instantaneous Ceiling Level. Skin absorption effects must also be percent of vapor in air, by volume, that will explode or ignite in the
considered. presence of an ignition source.
OSHA - U.S. Occupational Safety and Health Administration.
TOXICOLOGICAL INFORMATION:
PEL - Permissible Exposure Limit - This exposure value means
Human and Animal Toxicology: Possible health hazards as derived
exactly the same as a TLV, except that it is enforceable by OSHA. The
from human data, animal studies, or from the results of studies with
OSHA Permissible Exposure Limits are based in the 1989 PELs and the
similar compounds are presented. Definitions of some terms used in this
June, 1993 Air Contaminants Rule (Federal Register: 58: 35338-35351
section are: LD50 - Lethal Dose (solids & liquids) which kills 50% of the
and 58: 40191). Both the current PELs and the vacated PELs are
exposed animals; LC50 - Lethal Concentration (gases) which kills 50% of
indicated. The phrase, 鈥淰acated 1989 PEL,鈥? is placed next to the PEL
the exposed animals; ppm concentration expressed in parts of material
which was vacated by Court Order. 3
per million parts of air or water; mg/m concentration expressed in weight
IDLH - Immediately Dangerous to Life and Health - This level
of substance per volume of air; mg/kg quantity of material, by weight,
represents a concentration from which one can escape within 30-minutes
administered to a test subject, based on their body weight in kg. Other
without suffering escape-preventing or permanent injury. The DFG -
measures of toxicity include TDLo, the lowest dose to cause a symptom
MAK is the Republic of Germany鈥檚 Maximum Exposure Level, similar to
and TCLo the lowest concentration to cause a symptom; TDo, LDLo,
the U.S. PEL. NIOSH is the National Institute of Occupational Safety
and LDo, or TC, TCo, LCLo, and LCo, the lowest dose (or
and Health, which is the research arm of the U.S. Occupational Safety
concentration) to cause lethal or toxic effects. Cancer Information:
and Health Administration (OSHA). NIOSH issues exposure guidelines
The sources are: IARC - the International Agency for Research on
called Recommended Exposure Levels (RELs). When no exposure
Cancer; NTP - the National Toxicology Program, RTECS - the Registry
guidelines are established, an entry of NE is made for reference.
of Toxic Effects of Chemical Substances, OSHA and CAL/OSHA. IARC
HAZARD RATINGS: and NTP rate chemicals on a scale of decreasing potential to cause
HAZARDOUS MATERIALS IDENTIFICATION SYSTEM: This rating human cancer with rankings from 1 to 4. Subrankings (2A, 2B, etc.) are
system was developed by the National Paint and Coating Association also used. Other Information: BEI - ACGIH Biological Exposure
and has been adopted by industry to identify the degree of chemical Indices, represent the levels of determinants which are most likely to be
hazards. Health Hazard: 0 (minimal acute or chronic exposure hazard); observed in specimens collected from a healthy worker who has been
1 (slight acute or chronic exposure hazard); 2 (moderate acute or exposed to chemicals to the same extent as a worker with inhalation
significant chronic exposure hazard); 3 (severe acute exposure hazard; exposure to the TLV. Ecological Information: EC is the effect
onetime overexposure can result in permanent injury and may be fatal); concentration in water. BCF = Bioconcentration Factor, which is used to
4 (extreme acute exposure hazard; onetime overexposure can be fatal). determine if a substance will concentrate in lifeforms which consume
Flammability Hazard: 0 (minimal hazard); 1 (materials that require contaminated plant or animal matter. Coefficient of Oil/Water
substantial pre-heating before burning); 2 (combustible liquid or solids; Distribution is represented by log Kow or log Koc and is used to assess
a substance鈥檚 behavior in the environment.
liquids with a flash point of 38-93掳C [100-200掳F]); 3 (Class IB and IC
flammable liquids with flash points below 38掳C [100掳F]); 4 (Class IA
REGULATORY INFORMATION:
flammable liquids with flash points below 23掳C [73掳F] and boiling points
This section explains the impact of various laws and regulations on the
below 38掳C [100掳F]. Reactivity Hazard: 0 (normally stable); 1 (material material. U.S.: EPA is the U.S. Environmental Protection Agency. DOT
that can become unstable at elevated temperatures or which can react is the U.S. Department of Transportation. SARA is the Superfund
slightly with water); 2 (materials that are unstable but do not detonate or Amendments and Reauthorization Act. TSCA is the U.S. Toxic
which can react violently with water); 3 (materials that can detonate when Substance Control Act. CERCLA (or Superfund) refers to the
initiated or which can react explosively with water); 4 (materials that can Comprehensive Environmental Response, Compensation, and Liability
detonate at normal temperatures or pressures). PPE Rating X: Special Act. Labeling is per the American National Standards Institute (ANSI
attention should be given to PPE, based on product use. Z129.1). CANADA: CEPA is the Canadian Environmental Protection
NATIONAL FIRE PROTECTION ASSOCIATION: Health Hazard: 0 Act. WHMIS is the Canadian Workplace Hazardous Materials
(material that on exposure under fire conditions would offer no hazard Information System. TC is Transport Canada. DSL/NDSL are the
beyond that of ordinary combustible materials); 1 (materials that on Canadian Domestic/Non-Domestic Substances Lists.
exposure under fire conditions could cause irritation or minor residual
injury); 2 (materials that on intense or continued exposure under fire
conditions could cause temporary incapacitation or possible residual
injury); 3 (materials that can on short exposure could cause serious
temporary or residual injury); 4 (materials that under very short exposure
could cause death or major residual injury). Flammability Hazard and
Reactivity Hazard: Refer to definitions for 鈥淗azardous Materials
Identification System鈥?.
VINORELBINE TARTRATE FOR INJECTION MSDS
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