MATERIAL SAFETY DATA SHEET

Transcription

1 MATERIAL SAFETY DATA SHEET 1. CHEMICAL PRODUCT AND COMPANY INFORMATION Manufacturer Name And Address Hospira Inc. 275 North Field Drive Lake Forest, Illinois USA Emergency Telephone CHEMTREC: North America: ; International ; Australia (02) Hospira, Inc., Non-Emergency Product Name Synonyms Butorphanol Tartrate Injection (-)-17-(cyclobutylmethyl) morphinan-3, 14-diol [S-(R*,R*)] - 2,3 - dihydroxy butanedioate (1:1) (salt). 2. COMPOSITION/INFORMATION ON INGREDIENTS Active Ingredient Name Butorphanol Tartrate Chemical Formula C 21 H 29 NO 2 C 4 H 6 O 6 Preparation Non-hazardous ingredients include Water for Injection. Hazardous ingredients present at less than 1% include sodium citrate dihydrate, citric acid hydrous, and sodium chloride. Approximate Percent Component CAS Number RTECS Number by Weight Butorphanol Tartrate QC HAZARD INFORMATION Carcinogen List Substance Butorphanol Tartrate IARC NTP OSHA Emergency Overview Occupational Exposure Potential Signs and Symptoms Butorphanol Tartrate Injection is a solution containing butorphanol tartrate, a synthetic narcotic agonist that is a potent analgesic. Clinically, it is used to manage pain. In the United States, butorphanol is a Schedule IV controlled substance. In the workplace, butorphanol tartrate should be considered a potent drug, and possibly irritating to the eyes. Possible target organs include the central nervous system, cardiovascular system, respiratory system, and the gastrointestinal system. Information on the absorption of this product via inhalation or skin contact is not available. Published reports have indicated that butorphanol tartrate has some potential to be absorbed through intact skin. Avoid liquid aerosol generation and skin contact. During occupational use, this material should be considered potentially irritating to the eyes and respiratory tract. In clinical use, the most frequent adverse effects include sedation, tiredness, 1

2 dizziness, nausea, vomiting, constipation, abdominal pain, heart palpitations, sweating/clammy skin, vasodilation, palpitations, hypotension, skin rashes, hallucinations, euphoria, visual disturbances, headache, and pinpoint pupils. Butorphanol affects the central nervous system and can cause respiratory depression. Chronic use may lead to dependence. Medical Conditions Aggravated by Exposure Pre-existing hypersensitivity to butorphanol tartrate or other components in this product; preexisting respiratory, gastrointestinal, or cardiovascular ailments, pre-existing dependence on narcotics. 4. FIRST AID MEASURES Eye contact Skin contact Inhalation Ingestion Remove from source of exposure. Flush with copious amounts of water. If irritation persists or signs of toxicity occur, seek medical attention. Provide symptomatic/supportive care as needed. Remove from source of exposure. Flush with copious amounts of water. If irritation persists or signs of toxicity occur, seek medical attention. Provide symptomatic/supportive care as needed. Remove from source of exposure. If signs of toxicity occur, seek medical attention. Provide symptomatic/supportive care as needed. Remove from source of exposure. If signs of toxicity occur, seek medical attention. Provide symptomatic/supportive care as necessary. The management of suspected butorphanol overdosage includes maintenance of adequate ventilation, peripheral perfusion, normal body temperature, and protection of the airway. Patients should be under continuous observation with adequate serial measures of mental state, responsiveness and vital signs. Oxygen and ventilatory assistance should be available with continual monitoring by pulse oximetry if indicated. In the presence of coma, placement of an artificial airway may be required. An adequate intravenous portal should be maintained to facilitate treatment of hypotension associated with vasodilation. The use of a specific opioid antagonist such as naloxone should be considered. As the duration of butorphanol action usually exceeds the duration of action of naloxone, repeated dosing with naloxone may be required. In managing cases of suspected butorphanol overdosage, the possibility of multiple drug ingestion should always be considered. 5. FIRE FIGHTING MEASURES Flammability Fire & Explosion Hazard Extinguishing media Special Fire Fighting Procedures None anticipated for this aqueous product. None anticipated for this aqueous product. As with any fire, use extinguishing media appropriate for primary cause of fire. No special provisions required beyond normal fire fighting equipment such as flame and chemical resistant clothing and self contained breathing apparatus. 6. ACCIDENTAL RELEASE MEASURES Spill Cleanup and Disposal Isolate area around spill. Put on suitable protective clothing and equipment as specified by site spill procedures. Absorb the liquid with suitable material and clean affected area with soap and water. Dispose of spill materials according to 2

3 the applicable federal, state, or local regulations. 7. HANDLING AND STORAGE Handling Storage Special Precautions No special handling required under conditions of normal product use. In the United States, butorphanol tartrate is a Schedule IV controlled substance. Appropriate training and procedures may be required during the routine handling of this product. No special storage required for hazard control. For product protection, follow storage recommendations noted on the product case label, the primary container label, or the product insert. No special precautions required for hazard control. 8. EXPOSURE CONTROLS/PERSOL PROTECTION Exposure Guidelines Exposure limits Component Type mg/m3 ppm µg/m3 Note Butorphanol Tartrate Hospira EEL N/A N/A 2 8hr TWA Respiratory protection Skin protection Eye protection Engineering Controls Respiratory protection is normally not needed during intended product use. However, if the generation of dusts or aerosols is likely, and engineering controls are not considered adequate to control potential airborne exposures, the use of an approved air-purifying respirator with a HEPA cartridge (N99 or equivalent) is recommended under conditions where airborne dust or aerosol concentrations are not expected to be excessive. For uncontrolled release events, or if exposure levels are not known, provide respirators that offer a high protection factor such as a powered air purifying respirator or supplied air. A respiratory protection program that meets OSHA's 29 CFR and ANSI Z88.2 requirements must be followed whenever workplace conditions require respirator use. Personnel who wear respirators should be fit tested and approved for respirator use as required. If skin contact with the product solution is likely, the use of latex or nitrile gloves is recommended. Eye protection is normally not required during intended product use. However, if eye contact is likely to occur, the use of chemical safety goggles (as a minimum) is recommended. Engineering controls are normally not needed during the normal use of this product. 9. PHYSICAL/CHEMICAL PROPERTIES Appearance/Physical State Liquid Color Clear, colorless Odor Not determined Odor Threshold: ph: 4.5 ( ) Melting point/freezing point: Initial Boiling Point/Boiling Point Range: Evaporation Rate: Flammability (solid, gas): 3

4 Upper/Lower Flammability or Explosive Limits: Vapor Pressure: Vapor Density: Specific Gravity: Solubility: Soluble in water Partition coefficient: n-octanol/water: 180:1 at ph 7.5 Auto-ignition temperature: Decomposition temperature: 10. STABILITY AND REACTIVITY Reactivity Chemical Stability Hazardous Reactions Conditions to avoid Incompatibilities Hazardous decomposition products Hazardous Polymerization Stable under standard use and storage conditions. During thermal decomposition, it may be possible to generate irritating vapors and/or toxic fumes of carbon oxides (COx), nitrogen oxides (NOx), and hydrogen chloride. Not anticipated to occur with this product. 11. TOXICOLOGICAL INFORMATION Acute Toxicity Not determined for the product formulation. Information for the ingredients is as follows: Ingredient(s) Butorphanol Tartrate Butorphanol Tartrate Percent Test Type Route of Administration 100 LD50 Oral 100 LD50 Intravenous > Value Units Species Rat Mouse Dog, Monkey Rat Mouse Dog Aspiration Hazard Dermal Irritation/Corrosion Ocular Irritation/Corrosion Dermal or Respiratory Sensitization None anticipated from normal handling of this product. None anticipated from normal handling of this product. None anticipated from normal handling of this product. However, inadvertent contact of this product with eyes may produce irritation. None anticipated from normal handling of this product. Butorphanol tartrate is not a dermal sensitizer. 4

5 Reproductive Effects Mutagenicity Carcinogenicity Target Organ Effects In fertility studies, rats treated orally with a dosage of 160 /day had a reduced pregnancy rate. However, a similar effect was not observed with at a subcutaneous dosage of 2.5 /day. Reproduction studies in mice, rats, and rabbits treated with butorphanol during organogenesis did not show any teratogenic potential. However, pregnant rats treated subcutaneously with butorphanol at 1 had a higher frequency of stillbirths than controls. Butorphanol given at oral dosages of 30 and 60 also showed higher incidences of post-implantation loss in rabbits. Butorphanol was not genotoxic in S. typhimurium or E. coli assays or in unscheduled D synthesis and repair assays conducted in cultured human fibroblast cells. Two-year carcinogenicity studies were conducted in mice (up to 2 /day via oral gavage) and rats given butorphanol tartrate in the diet up to 60 /day. There was no evidence of treatment-related carcinogenicity in either species in these studies. Possible target organs include the central nervous system, cardiovascular system, respiratory system, and the gastrointestinal system. 12. ECOLOGICAL INFORMATION Aquatic Toxicity Persistence/Biodegradability Bioaccumulation Mobility in Soil Not determined for product. Information for butorphanol tartrate is provided below: EC50(48 hr) = 38.1 mg/l in Daphnia magna EC50(3 hr) = 878 mg/l for the inhibition of respiration in activated sludge. Not determined for product. Information for butorphanol tartrate is provided below: Butorphanol tartrate degraded < 10% in a 28-day biodegradation assay. Based on these results, butorphanol tartrate is not considered readily biodegradable. Not determined for product. Not determined for product. 13. DISPOSAL CONSIDERATIONS Waste Disposal Container Handling and Disposal All waste materials must be properly characterized. Further, disposal should be performed in accordance with the federal, state or local regulatory requirements. Dispose of container and unused contents in accordance with federal, state and local regulations. 14. TRANSPORTATION INFORMATION ADR/ADG/ DOT STATUS: IMDG STATUS: Not regulated Not regulated 5

6 ICAO/IATA STATUS: Transport Comments: Not regulated None 15. REGULATORY INFORMATION USA Regulations CERCLA SARA 302 SARA 313 PROP 65 Substance TSCA Status Status Status Status Status Butorphanol Tartrate RCRA Status U.S. OSHA Classification GHS Classification Possible Eye Irritant Target Organ Toxin *In the EU, classification under GHS/CLP does not apply to certain substances and mixtures, such as medicinal products as defined in Directive 2001/83/EC, which are in the finished state, intended for the final user: Hazard Class Hazard Category Signal Word Symbol Prevention Hazard Statement Response: P260 - Do not breathe dust/fume/gas/mist/vapors/spray. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists, get medical attention. Wash hands after handling. Get medical attention if you feel unwell. EU Classification* *Medicinal products are exempt from the requirements of the EU Dangerous Preparations Directive. Information provided below is for the pure drug substance Butorphanol Tartrate. Classification(s): Symbol: Indication of Danger: Risk Phrases: Safety Phrases: S23 - Do not breathe vapor. S24/25 - Avoid contact with skin and eyes. S37/39 - Wear suitable gloves and eye/face protection. 6

7 16. OTHER INFORMATION: Notes: ACGIH TLV American Conference of Governmental Industrial Hygienists Threshold Limit Value CAS Chemical Abstracts Service Number CERCLA US EPA law, Comprehensive Environmental Response, Compensation, and Liability Act DOT US Department of Transportation Regulations EEL Employee Exposure Limit IATA International Air Transport Association LD50 Dosage producing 50% mortality Not applicable/not available NE Not established NIOSH National Institute for Occupational Safety and Health OSHA PEL US Occupational Safety and Health Administration Permissible Exposure Limit Prop 65 California Proposition 65 RCRA US EPA, Resource Conservation and Recovery Act RTECS Registry of Toxic Effects of Chemical Substances SARA Superfund Amendments and Reauthorization Act STEL 15-minute Short Term Exposure Limit TSCA Toxic Substance Control Act TWA 8-hour Time Weighted Average MSDS Coordinator: Hospira GEHS Date Prepared: 09/02/2011 Obsolete Date: 01/06/2008 Disclaimer: The information and recommendations contained herein are based upon tests believed to be reliable. However, Hospira does not guarantee their accuracy or completeness NOR SHALL ANY OF THIS INFORMATION CONSTITUTE A WARRANTY, WHETHER EXPRESSED OR IMPLIED, AS TO THE SAFETY OF THE GOODS, THE MERCHANTABILITY OF THE GOODS, OR THE FITNESS OF THE GOODS FOR A PARTICULAR PURPOSE. Adjustment to conform to actual conditions of usage may be required. Hospira assumes no responsibility for results obtained or for incidental or consequential damages, including lost profits, arising from the use of these data. No warranty against infringement of any patent, copyright or trademark is made or implied. 7