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300 Northfield Road Bedford, OH 44146 MATERIAL SAFETY DATA SHEET Telephone: (440) 232-3320 -or- (800) 562-4797 Section I - IDENTITY Common/Trade Name: Buprenorphine Hydrochloride Injection 0.3 mg/mL; 1.0 mL vials Chemical Names: 6,14-Ethenomorphinan-7-methanol, 17-(cyclopropylmethyl)-alpha-(1,1- dimethylethyl)-4,5-epoxy- 18,19-dihydro-3-hydroxy-6-methoxy-alpha-methyl-, hydrochloride, (5- alpha,7-alpha(S))- Synonyms: Buprenex®, NIH 8805, MR 56 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: October 29, 2004 Date Revised: June 27, 2007 Section II - HAZARDOUS INGREDIENTS/COMPOSITION INFORMATION Other Limits Component % CAS# OSHA PEL ACGIH TLV Recommended Buprenorphine 0.03 53152-21-9 NONE NONE 1 ug/m3 Hydrochloride (BVL OEL) Dextrose Anhydrous 5.0 50-99-7 NONE NONE NONE Water for Injection 94.97 7732-18-5 NONE NONE NONE Hydrochloric Acid added for pH adjustment. Buprenorphine Hydrochloride is a sterile injectable liquid drug provided in 1 mL vials. Section III - HEALTH HAZARD DATA Routes of Entry: Exposure may occur via inhalation, ingestion, or absorption through the skin or eyes. Product is an opiod analgesic drug used for pain management and is a Schedule IIIl Controlled Substance. Health Hazard (Acute & Chronic): Buprenorphine Hydrochloride is a potent drug used as an analgesic to treat pain. It affects the central nervous and digestive system. Chronic exposure to Buprenorphine Hydrochloride may cause physical dependence. Carcinogenicity: NTP? NO IARC Monographs? NO OSHA Regulated? NO Signs & Symptoms of Exposure: Exposure may cause Nausea and vomiting may occur. May cause tiredness, numbness, weakness of limbs, irritability, hallucinations, and rapid or shortened breathing. May also cause nausea, vomiting, headache, and sweating. Medical Conditions Generally Aggravated by Exposure: Persons sensitive to Buprenorphine 1 2 Hydrochloride may experience allergic reaction. Buprenorphine exposure may also aggravate liver, kidneys, and pulmonary disease conditions, pre-existing central nervous system, ocular, gastrointestinal ailments, hypothyroidism, and adrenocortical insufficiency... Exposure is not recommended for pregnant women since Buprenorphine can cross the placental barrier and increase the risk of congenital malformations. BVL Hazard Category: 4 BVL Occupational Exposure limit (OEL): 1 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. Naloxone may be given by a physician for complete or partial reversal of the effects of Buprenorphine Hydrochloride. 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 Buprenorphine Hydrochloride 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 aerosols. 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°C). Protect from 3 light and heat. Other Precautions: Store under security since Buprenorphine Hydrochloride is a Schedule III controlled substance. 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: 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. 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: 4.0 – 5.0 Section X - STABILITY AND REACTIVITY DATA Stability: Stable Incompatibility (Materials to Avoid): Hazardous Decomposition or Byproducts: Decomposition products of this compound may include potentially hazardous byproducts of nitrogen oxides, carbon monoxide, carbon dioxide, and hydrogen chloride. Hazardous Polymerization: Will not occur. Conditions to Avoid: Avoid contact with light and excessive heat. Section XI - TOXICOLOGICAL INFORMATION For Buprenorphine Hydrochloride: RTECS # KM7758000 LD50 oral, rat > 1 gm/kg LD50 oral, mouse = 800 mg/kg LD50 subcutaneous, rat > 1 gm/kg LD50 subcutaneous, mouse = > 1 gm/kg LD50 intravenous, rat = 62 mg/kg LD50 intravenous, mouse = 72 mg/kg LD50 intramuscular, rat > 600 mg/kg LD50 intramuscular, mouse > 600 mg/kg Buprenorphine Hydrochloride 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 4 Information is currently not available on the environmental impact of Buprenorphine Hydrochloride. Handle in a manner that prevents spills or releases to the environment. Section XIII - DISPOSAL INFORMATION Buprenorphine Hydrochloride 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 Buprenorphine Hydrochloride 0.3 mg/mL is not a DOT Hazardous Material. Buprenorphine Hydrochloride is not a Marine Pollutant. Section XV - REGULATORY INFORMATION SARA 313 listed?: No CERCLA listed?: No RCRA listed?: No TSCA listed: No 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 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. 5. Buprenorphine Hydrochloride may be considered a Hazardous Drug as described in the NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. Employees who prepare or administer hazardous drugs or who work in areas where these drugs are used should follow specific handling guidelines in order to prevent exposure to these agents in the air or on work surfaces, clothing, or equipment. 6. The Following Guidance Information is excerpted from the NIOSH Alert: 5 Elements of a Hazardous Drug Handling Program include: • Establishment and implementation of written policies and protocols to ensure the safe handling of oncolytic and/or potent drugs, including receipt of product. • Training and education of employees on the recognition, evaluation and control of Hazardous Drugs • Effective Planning and design of the workplace • Use of best practice control measures and specialized equipment such as ventilated cabinets or isolators designed for worker protection • Wearing recommended personal protective equipment • An integrated health surveillance program that: includes the assessment and counseling of prospective employees before they commence any work involving oncolytic and/or potent drugs and related waste 7. Published guidance on the handling and transport of cytotoxic drugs: NIOSH Alert – Preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings http://www.cdc.gov/niosh/docs/2004-165/ National Study Commission on Cytotoxic Exposure: Recommendation for handling Cytotoxic Agents: http://www.nih.gov/od/ors/ds/pubs/cyto/index.htm 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
