300 Northfield Road
Bedford, OH 44146 MATERIAL SAFETY DATA SHEET
Telephone: (440) 232-3320
-or- (800) 562-4797
Section I - IDENTITY
Common/Trade Name: Cisplatin 1mg/mL; 50, 100 and 200mL vials
Chemical Names: Platinum (II),diaminedichloro-cis-
Synonyms: Platinol-AQ, BMY25936, NSC-119875, CDDP, NCI-C55776
Manufacturer's Name: BEN VENUE LABORATORIES, INC.
Address: 300 NORTHFIELD ROAD
BEDFORD, OH 44146
Emergency Telephone Number: Chemtrec: 1(800)424-9300
Telephone Number for Info.: (800)562-4797 or (440)232-3320
Medical Emergency: Professional Services: 1(800)521-5169
Date Prepared: January 3, 2001
Date Revised: September 23, 2004
Section II - HAZARDOUS INGREDIENTS/COMPOSITION INFORMATION
Other Limits
Component % CAS# OSHA PEL ACGIH TLV Recommended
0.002mg/m3 0.002mg/m3
Cisplatin 1 15663-27-1 NONE
(as Platinum) (as Platinum)
Sodium Chloride 9 7647-14-5 NONE NONE NONE
Water for Injection 90 7732-18-5 NONE NONE NONE
Hydrochloric Acid or Sodium Hydroxide for pH adjustment
Cisplatin is a sterile injectable liquid drug provided in 50, 100 or 200 mL vials.
Section III - HEALTH HAZARD DATA
Routes of Entry: Product may be absorbed by ingestion, inhalation or injection.
Health Hazard (Acute & Chronic): Cisplatin is an anti-cancer drug used to treat testicular, ovarian and
bladder cancers. May cause irritation to eyes, skin, and respiratory system. May produce an
allergic response and effects the kidneys, blood, and gastrointestinal and central nervous systems.
Cisplatin is mutagenic and teratogenic. It is a potential carcinogen and reproductive effector.
Carcinogenicity: NTP? Yes - Rating 2 IARC Monographs? Yes - Group 2A; Reasonably
reasonably anticipated anticipated carcinogen.
carcinogen. OSHA Regulated? No
Signs & Symptoms of Exposure: Cisplatin is a potent anti-cancer drug and is highly toxic upon acute
exposures. Nausea and vomiting may occur. Allergic reactions may cause facial edema,
flushing, wheezing/difficulty in breathing, tachycardia, and hypotension are possible. May cause
ringing in the ears. Irritation to eyes, skin and respiratory system may occur. Chronic exposures may
cause kidney disorders, peripheral neuropathy and moderate, reversible blood changes.
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Medical Conditions Generally Aggravated by Exposure: Kidney disease, hearing disorders,
neurological and blood diseases may be aggravated due to exposure to Cisplatin.
BVL Hazard Category: 4
Section IV - FIRST AID MEASURES
Eye Exposure: Flush eyes with large volumes of water for 15 minutes or more. Seek treatment from
a physician.
Skin Exposure: Wash skin with cool, soapy water. Remove contaminated clothing.
Ingestion: If ingestion occurs, flush mouth with water and seek medical attention immediately.
If person in conscious, induce vomiting; never induce vomiting on in unconscious person.
Inhalation: If difficulty breathing, administer oxygen. Seek medical attention immediately.
If necessary, provide artificial respiration.
Overdose should be treated symptomatically.
Section V - FIRE AND EXPLOSION HAZARD DATA
Flash Point (Method Used): Not applicable LEL: Not Applicable UEL: Not Applicable
Flammable Limits: Not applicable
Extinguishing Media: Use water or multi-purpose ABC extinguisher
Special Fire Fighting Procedures: As with all fires, evacuate personnel to a safe area. Fire fighters
must wear self-contained breathing apparatus to avoid inhalation of smoke. Product is aqueous-
based and is not expected to present a fire hazard concern.
Unusual Fire/Explosion Hazards: None
Section VI - ACCIDENTAL RELEASE INFORMATION
Release to Land: Absorb Cisplatin with absorbent wipes/towels. Prevent contact with sewers and
waterways. Wash area with soap and water. Wear personal protective equipment.
Release to Air: If aerosols are generated, reduce exposures by ventilating and preventing the
generation of dust. Wear respiratory protection.
Release to Water: Refer to the local water authority; drain disposal is not recommended. Refer to
local, state, and federal guidelines.
Section VII - PRECAUTIONS FOR SAFE HANDLING AND USE
Steps to be taken in case material is released or spilled: See Section VI above. Wear all necessary
protective equipment including nitrile or latex gloves, protective clothing, safety glasses, and an
air-purifying respirator with HEPA (P100) cartridges. Large spills may require the use of
protective coveralls, boots, double gloves and SCBAs.
Waste Disposal Method: Dispose of according to local, state, and federal guidelines. Incineration at
a licensed facility is recommended.
Precautions to be taken in handling and storing: Store at room temperature (15-25掳C).
Do not refrigerate. Protect from light.
Other Precautions: Follow the recommended guidelines on the safe handling of cytotoxic products
(see Section XVI).
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Section VIII - CONTROL MEASURES AND PERSONAL PROTECTIVE EQUIPMENT
Respiratory Protection: Under normal use, respirators should not be required if adequate ventilation is
available. If dust generation is likely, air-purifying respirators with HEPA cartridge (P100) must
be worn. For large spill emergencies, self-contained breathing apparatus (SCBA) may be required.
Personnel wearing respirators should be fit tested and approved for respirator use under the OSHA
Respiratory Protection Standard, 29 CFR 1910.134.
Ventilation: Use with adequate ventilation such as in a Class II Type B biological safety cabinet.
Protective Gloves: Nitrile or latex
Eye Protection: Safety glasses or goggles
Other Protective Clothing or Equipment: Lab coat
Work/Hygienic Practices: Wash hands following use. No eating, drinking, or smoking when
handling this product.
Section IX - PHYSICAL/CHEMICAL CHARACTERISTICS
Physical State: Liquid Specific Gravity: Approximate to water
Appearance and Odor: Clear, colorless, with no odor Melting Point: Not applicable
Boiling Point: Approximate to water Evaporation Rate: Approximate to water
Vapor Pressure: Approximate to water Solubility in Water: Soluble
Vapor Density: Approximate to water pH: 3.5
Section X - STABILITY AND REACTIVITY DATA
Stability: Stable
Incompatibility (Materials to Avoid): Oxidizers and water reactive materials
Hazardous Decomposition or Byproducts: Decomposition products of this compound may include
potentially hazardous byproducts of nitrogen oxides, carbon monoxide, and carbon oxide.
Hazardous Polymerization: Will not occur
Conditions to Avoid: Avoid contact with oxidizers and water reactive materials
Section XI - TOXICOLOGICAL INFORMATION
For Cisplatin:
LD50 oral, rat = 25.8 mg/kg LD50 intraperitoneal, guinea pig = 9.7 mg/kg
LD50 oral, mouse = 32.7 mg/kg LD50 intramuscular, rat = 9.2 mg/kg
LD50 intravenous, rat = 8 mg/kg LD50 intramuscular, mouse = 17.9 mg/kg
LD50 intravenous, mouse = 11 mg/kg LD50 subcutaneous, rat = 8.1 mg/kg
LD50 intraperitoneal, rat = 6.4 mg/kg LD50 subcutaneous, mouse = 13 mg/kg
LD50 intraperitoneal, mouse = 6.6 mg/kg LD50 oral, rat = 500 mg/kg
Cisplatin was positive in genetic toxicity tests. It has been shown to be mutagenic in bacteria and has
produced chromosomal aberrations in animal cells in culture. It may cause fetal harm in pregnant
women.
Additional reproductive health and toxicity data is available from the National Institute for Occupational
Safety and Health (NIOSH) Registry of Toxic Effects of Chemical Substances (RTECS).
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Section XII - ENVIRONMENTAL IMPACT INFORMATION
Information is currently not available on the environmental impact of Cisplatin. Handle in a manner that
prevents spills or releases to the environment.
Section XIII - DISPOSAL INFORMATION
Cisplatin should be disposed of in accordance with national, state, local, or applicable regulations.
Incineration at an approved, permitted facility is recommended.
Section XIV - TRANSPORTATION INFORMATION
Cisplatin 1 mg/mL is not a DOT Hazardous Material.
Cisplatin is not a Marine Pollutant.
Section XV - REGULATORY INFORMATION
SARA 313 listed?: No
CERCLA listed?: No
RCRA listed?: No
TSCA listed: Yes
Cisplatin is listed on Section 8(b) of EPAs TSCA Chemical Inventory
Cisplatin is subject to California Proposition 65 carcinogen warning and release requirements Code C.
Listed on Florida toxic substance list.
Listed as Massachusetts Hazardous Substances: Code 1,3,*E*C*
Listed as a Minnesota Hazardous Substance: Code R
Listed as a Pennsylvania Hazardous Substance: Code S
Section XVI - OTHER DATA
1. Hospital personnel preparing or administering parenteral antineoplastic agents should wear
disposable latex gloves, safety glasses, a closed-front gown with cuffs, and respiratory protection.
Preparation of all antineoplastic agents should be done in a Class II laminar flow hood or
biological safety cabinet with exhaust air discharged external to the room environment. All
needles, syringes, vials, and other equipment or disposable clothing that have contacted this agent
should be segregated for incineration.
2. Persons administering this drug to patients must be careful to avoid needle sticks to syringes and
other sharps used in the administration. All needle sticks must be reported to your company
Management.
3. Use of this product should be through or under the direction of a physician.
This MSDS does not address the therapeutic use of this material
The information provided is believed to be complete and accurate. It is the user's responsibility
to use the information according to their application. Bedford Laboratories and Ben Venue Labs,
Inc. assumes no additional liability or responsibility resulting from the use of or reliance on this
information.
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