MATERIAL SAFETY DATA SHEET
300 Northfield Road
Bedford, OH 44146
Telephone: (440) 232-3320
Section I - IDENTITY
Common/Trade Name: Ondansetron Injection (2 mg/mL in 20 ml/vial, multidose vial)
Chemical Names: 4H-Carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1H-imidazol-1-yl) methyl)
Synonyms: Zofran? GR 38032X
Manufacturer's Name: BEN VENUE LABORATORIES, INC.
Address: 300 NORTHFIELD ROAD
BEDFORD, OH 44146
Emergency Telephone Number: Chemtrec: (800)-424-9300 or Chemtrec International: 011-703-527-3887
Telephone Number for Information: (800)562-4797 or (440)232-3320
Medical Emergency: Professional Services: 1(800)521-5169
Date Prepared: December 22, 2006
Date Updated: October 13, 2009
Section II - HAZARDOUS INGREDIENTS/COMPOSITION INFORMATION
Component Percent CAS# OSHA PEL ACGIH TLV? Other
Ondansetron Hydrochloride 0.2 103639-04-9 N/L N/L 20 礸/m3
(BVL OEL)
Citric Acid, Monohydrate 0.05 5949-29-1 N/L N/L N/L
Sodium Citrate, Dihydrate 0.02 6132-04-3 N/L N/L N/L
Sodium Chloride 0.83 7647-14-5 N/L N/L N/L
Methyl Paraben 0.12 99-76-3 N/L N/L N/L
Propyl Paraben 0.01 94-13-3 N/L N/L N/L
Water for Injection USP/EP 98.97 7732-18-5 N/L N/L N/L
N/L = None Listed, OEL = Occupational Exposure Limit
Ondansetron is a sterile injectable liquid drug provided in a vial.
Section III - HEALTH HAZARD DATA
Routes of Entry: Ondansetron Injection may be absorbed via contact with skin or eyes; inhalation of aerosols or accidentally ingested.
Under normal use with supervision of a physician, Ondansetron Injection presents little hazard.
Health Hazard (Acute & Chronic): Ondansetron is used for treating nausea and vomiting for patients undergoing chemotherapy. It affects
the digestive system and may affect the central nervous system. Minimal health hazard is expected upon occupational exposure.
Carcinogenicity: NTP? NO IARC Monographs? NO OSHA Regulated? NO
Signs & Symptoms of Exposure: Acute signs and symptoms of exposure may include irritation to eyes, skin, and respiratory tract. May
cause allergic reaction in sensitized individuals.
Medical Conditions Generally Aggravated by Exposure: Ondansetron is not recommended for use in patients who have exhibited
hypersensitivity to other selective 5-HT3 receptor antagonists.
BVL Hazard Category: 3A
BVL Occupational Exposure limit (OEL): 20 礸/m3
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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: Absorb Ondansetron with absorbent materials and dispose according to local, state, and federal guidelines. Prevent
contact with sewers and waterways. Wash area with soap and water. Wear personal protective equipment.
Release to Air: If aerosolized, reduce exposures by ventilating area; clean up spill immediately to prevent evaporation. Wear respiratory
protection as necessary.
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. A dust/mist respirator (N95) may be necessary if excessive aerosols are generated.
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 (2 - 30癈). Protect from light.
Other Precautions: None identified.
Section VIII - CONTROL MEASURES AND PERSONAL PROTECTIVE EQUIPMENT
Respiratory Protection: Under normal use, respirators should not be required if adequate ventilation is available. A dust/mist respirator
(N95) may be necessary if excessive aerosols are generated. 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: Handle product in a well-ventilated area.
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.
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Section IX - PHYSICAL/CHEMICAL CHARACTERISTICS
Physical State: Liquid Specific Gravity: Approx. to water
Appearance and Odor: Clear, colorless, no odor Melting Point: Approx. to water
Boiling Point: Approx. to water Evaporation Rate: Approx. to water
Vapor Pressure: Approx. to water Solubility in Water: Soluble
Vapor Density: Approx. to water pH: 3.3 ?4.0
Section X - STABILITY AND REACTIVITY DATA
Stability: Stable
Incompatibility (Materials to Avoid): None identified
Hazardous Decomposition or Byproducts: Decomposition products of this compound may include potentially hazardous byproducts of
carbon monoxide and carbon dioxide.
Hazardous Polymerization: Will not occur.
Conditions to Avoid: None identified.
Section XI - TOXICOLOGICAL INFORMATION
For Ondansetron: RTECS # FE6375400
LDLO, intravenous, mouse = 2500 mg/kg LDLO, intravenous, rat = 20 mg/kg
LDLO, intraperitoneal, mouse > 5 kg mg/kg LDLO, oral, mouse = 10 mg/kg
Section XII - ENVIRONMENTAL IMPACT INFORMATION
Information is currently not available on the environmental impact of Ondansetron. Handle in a manner that prevents spills or releases to the
environment.
Section XIII - DISPOSAL INFORMATION
Ondansetron 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
Ondansetron is not a DOT Hazardous Material.
Ondansetron is not a Marine Pollutant.
Section XV - REGULATORY INFORMATION
SARA 313 listed?: NO
CERCLA listed?: NO
RCRA listed?: NO
TSCA Inventory NO
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Section XVI - OTHER DATA
1. Use of this product should be through or under the direction of a physician.
This MSDS does not address 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
4. OEL=Occupational Exposure Limit. An internal limit set by Ben Venue Laboratories for the recommended limit of employee
exposure to airborne dusts or aerosols that should not be exceeded over an eight-hour time-weighted average.
This document is generated to distribute health, safety and environmental data. It is not a specification sheet and 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's 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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