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1 300 Northfield Road Bedford, OH 44146 MATERIAL SAFETY DATA SHEET Telephone: (800) 562-4797 -or- (440) 232-3320 Section I - IDENTITY Common/Trade Name: Mitoxantrone Hydrochloride for Injection, 2 mg/vial Chemical Names: Anthracenedione, 1,4-dihydroxy-5,8-bis((2-((2-hydroxyethyl)amino)ethyl) amino)-,dihydrochloride Synonyms: Novantrone, CL232315, NSC 301739 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 3, 2006 Section II - HAZARDOUS INGREDIENTS/COMPOSITION INFORMATION Other Limits Component % CAS# OSHA PEL ACGIH TLV Recommended Mitoxantrone Hydrochloride 0.233 70476-82-3 NONE NONE 0.2 ug/m3 (BVL OEL) Sodium Acetate (Anhydrous) 0.005 127-09-3 NONE NONE NONE Sodium Chloride 0.800 7647-14-5 NONE NONE NONE Acetic Acid (Glacial) 0.046 64-19-7 NONE NONE NONE Water for Injection 98.92 7732-18-5 NONE NONE NONE Mitoxantrone Hydrochloride is a sterile injectable liquid drug provided in 10, 12.5 and 15 mL vials. Section III - HEALTH HAZARD DATA Routes of Entry: Mitoxantrone Hydrochloride may be absorbed via inhalation, ingestion or skin or eye contact. Health Hazard (Acute & Chronic): Mitoxantrone Hydrochloride is a cytotoxic, genotoxic anticancer drug used to treat cancers and multiple sclerosis. It can produce a variety of effects upon excessive exposure. Mitoxantrone Hydrochloride may cause adverse effects including secondary leukemia and cardiotoxicity including congestive heart failure. It can affect the liver and blood forming systems. May cause birth defects in developing fetus. Carcinogenicity: NTP? NO IARC Monographs? NO OSHA Regulated? No 2 Signs & Symptoms of Exposure: May cause nausea, vomiting, loss of appetite, diarrhea, mouth ulcers, and heart palpations. Myelosuppression may also occur. Chronic exposure may cause allergic reaction in sensitive persons. It may also cause breathlessness and low pulse/blood pressure. Medical Conditions Generally Aggravated by Exposure: Hypersensitivity to the material, bone marrow depression, chicken pox, (including recent exposure), herpes zoster, infection, heart disease, and previous cytotoxic drug or radiation therapy. BVL Hazard Category: 4 BVL Occupational Exposure limit (OEL): 0.2 ug/m3 Section IV - FIRST AID MEASURES Eye Exposure: Flush eyes with large volumes of water for 15 or more minutes. Skin Exposure: Wash skin thoroughly with cool, soapy water. Ingestion: If ingestion occurs, induce vomiting immediately and seek medical attention. Never induce vomiting on an unconscious person. Inhalation: If difficulty breathing, administer oxygen. Seek the attention of a physician immediately. If excess exposure occurs, monitor blood and white blood cell count to assess the effects to the blood forming systems. Transfusions of white blood cells or platelets or leukocytes have proven beneficial. Section V - FIRE AND EXPLOSION HAZARD DATA Flash Point (Method Used): Not applicable Flammable Limits: Not applicable LEL: NA UEL: NA Extinguishing Media: Use water or multi-purpose ABC extinguisher. Special Fire Fighting Procedures: As with all fires, evacuate personnel to a safe area. Firefighters 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 Mitoxantrone Hydrochloride with absorbent wipes/towels. Prevent contact with sewers and waterways. Wash areas exposed to Mitoxantrone (not skin) with a 1% bleach solution. Follow by cleaning with soap and water. Release to air: If aerosols are generated, reduce exposures by ventilating and prevent further generation of aerosols. Wear respiratory protection. Release to water: Refer to local water authority; drain disposal is not recommended. Refer to federal, state and local 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 clothing, safety glasses and air-purifying respirator with HEPA filters (P100). Large spills require the use of self-contained breathing apparatus (SCBA). 3 Waste Disposal Method: Disposal via incineration is recommended. Follow federal, state and local regulations. Precautions to be taken in handling and storing: Store at temperatures between 15-25°C (59-77°F). Handle and store away from acidic substances. Other Precautions: Follow OSHA guidelines on the safe handling of cytotoxic/genotoxic products (see Section XVI). Section VIII - CONTROL MEASURES AND PERSONAL PROTECTIVE EQUIPMENT Respiratory Protection: Under normal use in a biological safety hood, respirators may not be necessary. If aerosols are generated and exposure levels exceeded, an air purifying respirator with HEPA filters (P100) must be worn. For large spills, 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 hood. Protective Gloves: Nitrile or latex (double layers) Eye Protection: Safety glasses or goggles Other Protective Clothing or Equipment: Lab coat Work/Hygienic Practices: No eating, drinking or smoking while handling this product. Use good personal hygiene. Section IX - PHYSICAL/CHEMICAL CHARACTERISTICS Physical State: Liquid Specific Gravity: Approximate to water Appearance and Odor: Dark blue solution 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: 3.0 – 4.5 Section X - STABILITY AND REACTIVITY DATA Stability: Stable up to 25 °C Incompatibility (Materials to Avoid): Oxidizers. Hazardous Decomposition or Byproducts: Decomposition products of Mitoxantrone Hydrochloride may include carbon monoxide, carbon dioxide, nitrogen oxides and hydrogen chloride. Phosphorous and sulfur oxides may also be generated. Hazardous Polymerization: Will not occur Conditions to Avoid: Avoid storage near moisture. 4 Section XI - TOXICOLOGICAL INFORMATION See RTECS (R) database for a complete list of toxicity data for Mitoxantrone Hydrochloride (RTECS # CB0386900) LD50 oral, rat = 682 mg/kg LD50 intravenous, mouse = 9.7 mg/kg LD50 intraperitoneal, rat = 8 mg/kg LD50 skin, mouse = 125 mg/kg LD50 subcutaneous, rat = 5.5 mg/kg LD50 oral, mouse = 502 mg/kg LD50 intravenous, rat = 4.8 mg/kg LD50 intraperitoneal, mouse = 15.6 mg/kg LD50 skin, rat = 1640 mg/kg LD50 subcutaneous, mouse = 19.7 mg/kg LD50 intravenous, dog = 375 ug/kg LD50 intravenous, monkey > 375 ug/kg LD50 intraperitoneal, dog > 1200 ug/kg Mitoxantrone Hydrochloride causes cancer in lab mice and rats upon injection. Mitoxantrone Hydrochloride is reported to be mutagenic in mammalian cells and brosphilia. Mitoxantrone Hydrochloride has significant embryotoxic and teratogenic properties. 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 not currently available on the environmental impact of Mitoxantrone Hydrochloride. Handle in a manner that prevents spills or released to the environment. Section XIII - DISPOSAL INFORMATION Dispose of via incineration according to federal, state and local guidelines. Section XIV - TRANSPORTATION INFORMATION Mitoxantrone Hydrochloride is not a DOT Hazardous Material. This material is not a Marine Pollutant. Section XV - REGULATORY INFORMATION SARA 313 listed?: NO CERCLA listed?: NO RCRA listed?: NO California Proposition 65 code: D 5 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 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.