300 Northfield Road
Bedford, OH 44146 MATERIAL SAFETY DATA SHEET
Telephone: (440) 232-3320
-or- (800) 562-4797
Section I - IDENTITY
Common/Trade Name: Carboplatin 12.5 mg/mL; 4, 12, and 36 mL vials
Chemical Names: Platinum, diammine(1,1-cyclobutanedicarboxylato(2-)-O,O')-, (SP-4-2)-
Synonyms: Paraplatin 庐, Diammine (1,1-cyclobutanedicarboxylato)platinum (II), NSC-241240,
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: April 11, 2005
Section II - HAZARDOUS INGREDIENTS/COMPOSITION INFORMATION
Other Limits
Component % CAS# OSHA PEL ACGIH TLV
Recommended
2 ug/m3 2 ug/m3 0.9 ug/m3
Carboplatin 98.75 41575-94-4
(BVL OEL)
(as Platinum) (as Platinum)
Mannitol 1.25 69-65-8 NONE NONE NONE
Carboplatin is a sterile injectable lyophilized drug provided in a vial.
Section III - HEALTH HAZARD DATA
Routes of Entry: Product may be absorbed by ingestion, inhalation or injection.
Health Hazard (Acute & Chronic): Carboplatin is an anti-cancer drug used to treat ovarian cancer. May
cause irritation to eyes, skin, and respiratory system. May produce allergic response and effects the
kidneys, blood, and gastrointestinal and central nervous systems. Carboplatin is mutagenic and
teratogenic. It is a potential carcinogen and reproductive effector.
Carcinogenicity: NTP? NO IARC Monographs? NO OSHA Regulated? No
Signs & Symptoms of Exposure: Carboplatin 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, bone marrow depression, 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 Carboplatin.
BVL Hazard Category: 4
BVL Occupational Exposure limit (OEL): 0.9 ug/m3
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 not expected to
present a fire hazard concern.
Unusual Fire/Explosion Hazards: None
Section VI - ACCIDENTAL RELEASE INFORMATION
Release to Land: Wet Carboplatin with water and wipe up with absorbent materials. Prevent contact
with sewers and waterways. Wash area with soap and water. Wear personal protective
equipment.
Release to Air: If dusts are generated, reduce exposures by ventilating and preventing the
generation of dusts. 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.
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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). An interaction occurs between carboplatin and aluminum metal, resulting in
precipitate formation and loss of drug potency. Only administration equipment such as needles and
syringes that contain no aluminum should be used for this drug.
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: Solid Specific Gravity: Not applicable
Appearance and Odor: White odorless powder Melting Point: 235 掳C
Boiling Point: Not applicable Evaporation Rate: Not applicable
Vapor Pressure: Not applicable Solubility in Water: Soluble
Vapor Density: Not applicable pH: 5.0 鈥? 7.0
Section X - STABILITY AND REACTIVITY DATA
Stability: Stable
Incompatibility (Materials to Avoid): Aluminum metal.
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 Carboplatin: RTECS # TP2300000
LD50 oral, rat = 343 mg/kg LD50 intravenous, mouse = 90 mg/kg
LD50 subcutaneous, rat = 72 mg/kg LD50 intraperitoneal, mouse = 118 mg/kg
LD50 intravenous, rat = 61 mg/kg LD50 intravenous, dog = 31 mg/kg
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Carboplatin 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).
Section XII - ENVIRONMENTAL IMPACT INFORMATION
Information is currently not available on the environmental impact of Carboplatin. Handle in a manner that
prevents spills or releases to the environment.
Section XIII - DISPOSAL INFORMATION
Carboplatin 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
Carboplatin 10 mg/mL is not a DOT Hazardous Material.
Carboplatin is not a Marine Pollutant.
Section XV - REGULATORY INFORMATION
SARA 313 listed?: No
CERCLA listed?: No
RCRA listed?: No
TSCA listed: No
Carboplatin is subject to California Proposition 65 carcinogen warning and release requirements Code D.
Section XVI - OTHER DATA
1. 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
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. BVL Hazard Category Definitions (internal hazard ranking used by Ben Venue Laboratories):
1 = Low Toxicity
2.= Moderate Toxicity
3 = Potent or Toxic
4 = Highly Potent or Toxic
5 = Extremely Potent or Toxic
This document is generated to distribute health, safety and environmental data. It is not a specification sheet and
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none of the displayed data should be construed as a specification. Information on this MSDS sheet was obtained
from sources which we believe are reliable, and we believe that the information is complete and accurate.
However, the information is provided without any warranty, express or implied, regarding its correctness. Some
of the information presented and conclusions drawn are from sources other than direct test data of the substance.
The conditions or methods of handling, storage, use and disposal of the product are beyond our control and may
also be beyond our knowledge. It is the user鈥檚 responsibility to determine the suitability of any material for a
specific purpose and to adopt such safety
precautions as may be necessary. If the product is used as a component in another product, this MSDS
information may not be applicable. For these reasons, we do not assume any responsibility and expressly
disclaim liability for any loss, damage or expense arising out of or in any way connected with the handling,
storage, use or disposal of this product.
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