NALBUPHINE HCL 1GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name NALBUPHINE HCL Supplier Information Letco Medical, LLC 1316 Commerce Drive NW Decatur, AL 35601 1 (800) 239-5288 +1 (734) 843-4693 IN CASE OF EMERGENCY: Chemtrec 1 (800) 424-9300 (24 hours) Product Synonym(s) opioid agonist/antagonist analgesic* (5.alpha.,6.alpha.)-17-(Cyclobutylmethyl)-4,5-epoxymorphinian-3,6,14-triol hydrochloride * Nalbuphine Hydrochloride Analytical Research Standard-(FOR R&D USE ONLY) Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Acute toxicity, Oral (Category 4), Acute toxicity, Inhalation (Category 4), Specif ic target organ toxicity, single exposure (Category 3) narcotic ef f ects Signal Word Warning Hazard Statement(s) H302 Harmf ul if swallowed H332 Harmf ul if inhaled H336 May cause drowsiness or dizziness Pictogram(s) Precautionary Statement(s) P261 Avoid breathing dust/f ume/gas/mist/vapours/spray. P264 Wash hands thoroughly af ter handling. P270 Do not eat, drink or smoke when using this product. P271 Use only outdoors or in a well-ventilated area. P301+P312 IF SWALLOWED Call a POISON CENTER or doctor/physician if you f eel unwell. P304+P340 IF INHALED Remove victim to fresh air and keep at rest in a position comf ortable f or breathing. P312 Call a POISON CENTER or doctor/physician if you f eel unwell. P330 Rinse mouth. P405 Store locked up. P501 Dispose of contents/container to an approved waste disposal plant. Hazards Not Otherwise Classified None known. Ingredient(s) with Unknown Toxicity No data available Section 3: Composition/Information on Ingredients Chemical Name Nalbuphine Hydrochloride Common Name Nalbuphine Hydrochloride CAS Number 23277-43-2 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice Call a POISON CENTER or doctor/physician if you f eel unwell. Ensure that medical personnell are aware of the material(s) involved, and take precautions to protect themselves. If Inhaled If dust from the material is inhaled, remove the af f ected person immediately to fresh air. Oxygen or artif icial respiration if needed. Call a POISON CENTER or doctor/physician if you f eel unwell. In Case of Skin Contact Wash of f with soap and water. Get medical attention if irritation develops and persists. In Case of Eye Contact Flush eyes with water as a precaution. Get medical attention if irritation develops and persists. If Swallowed IF SWALLOWED: Call a POISON CENTER or doctor/physician if you f eel unwell. Never give anything by mouth to a victim who is unconscious or is having convulsions. Do not induce vomiting without advice from poison control center. Rinse mouth thoroughly. If vomiting occurs, keep head low so that stomach content doesn't get into lungs. Most Important Symptoms and Effects Not Available Page 1 of 4 Section 5: Fire Fighting Measures Suitable Extinguishing Media Water. Dry chemical powder. Alcohol f oam. Carbon dioxide (CO2). Special Hazards Arising From the Substance/Mixture Not applicable. Special PPE and/or Precautions for Firefighters In the event of f ire, cool tanks with water spray. Move containers from f ire area if you can do so without risk. As in any f ire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and f ull protective gear. Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Ensure adequate ventilation. Keep unnecesary personnel away. Do not touch damaged containers or spilled material unless wearing appropriate protective clothing. Wear appropriate protective equipment and clothing during clean-up. Avoid inhalation of dust from the spilled material. Ventilate closed spaces bef ore entering them. Follow handling guidance: LABORATORY: *Wear appropriate gloves, lab coat, and saf ety glasses. Use good lab practices. *No local exhaust ventilation required f or transf er/handling of quantities of powder less than 100g (total weight transf erred or handled). However, if the source container contains 2kg or more, pilot plant practices apply. *No local exhaust ventilation required f or solutions of these compounds. *Quantities of solid above 100g require use of a powders weighing hood or other approved containment/ventilation system. *High-enerty operations such as milling, particlesizing, spraying or f luidizing should be done within an approved emission control or containment system. *Develop cleaning procedures and techniques that limit potential exposure. PILOT PLANT PRODUCTION: *Wear appropriate gloves; lab coat, nylon coveralls or disposable Tyvek suit; saf ety glasses and saf ety shoes. Use good manuf acturing practices (i.e., cGMPs). *Use local exhaust and/or enclosure at dust-generating points. Emphasis is to be placed on closed material transf er systems and process containment, with limited open handling of powders. *Where open handling of powders occurs, use a powdered, air-purif ying respirator (PAPR) with HEPA cartridges or a supplied-air respirator (SAR), unless air-monitoring data has shown that a lower level of respiratory protection is adequate. *Protective garments (coveralls, Tyveks, lab coat) are not to be worn in common areas (e.g., caf eterias) or out-ofdoors. *High energy operations such as milling, particle-sizing, spraying or f luidizing should be done within an approved emission control or containment system. *Develop cleaning procdures and techniques that limit potential exposure. Methods and Materials Used for Containment ELIMINATE all ignition sources (no smoking, f lares, sparks or f lames in immediate area). If sweeping of a contaminated area is necessary use a dust suppressant agent which does not react with the product. Prevent entry into waterways, sewer, basements or conf ined areas. Sweep up or vacuum up spillage and collect in suitable container f or disposal. Avoid dust f ormation. Collect dust using a vacuum cleaner equipped with HEPA f ilter. Use only non-sparking tools. Do not f lush to sewer. Clean surf ace thoroughly to remove residual contamination. Cleanup Procedures ELIMINATE all ignition sources (no smoking, f lares, sparks or f lames in immediate area). If sweeping of a contaminated area is necessary use a dust suppressant agent which does not react with the product. Prevent entry into waterways, sewer, basements or conf ined areas. Sweep up or vacuum up spillage and collect in suitable container f or disposal. Avoid dust f ormation. Collect dust using a vacuum cleaner equipped with HEPA f ilter. Use only non-sparking tools. Do not f lush to sewer. Clean surf ace thoroughly to remove residual contamination. Section 7: Handling and Storage Precautions for Safe Handling Do not use in areas without adequate ventilation. Avoid breathing dust. Keep f ormation of airborne dusts to a minimum. Provide appropriate exhaust ventilation at places where dust is f ormed. Avoid contact with eyes. Do not ingest. In case of insuf f icient ventilation, wear suitable respiratory equipment. Wash hands thoroughly af ter handling. When using, do not eat, drink or smoke. DO NOT handle, store or open near an open f lame, sources of heat or sources of ignition. Protect material from direct sunlight. Handle and open container with care. Conditions for Safe Storage Store locked up. Keep container tightly closed. Store up to 25�??�?°C. Store in a well-ventilated place. Keep away from heat and sources of ignition. Use care in handling/storage. Store in accordance with local/regional/national/international regulation. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters No data available Appropriate Engineering Controls Good general ventilation (typically 10 air changes per hour) should be used. Ventilation rates should be matched to conditions. If applicable, use process enclosures, local exhaust ventilation, or other engineering controls to maintain airborne levels below recommended exposure limits. If exposure limits have not been established, maintain airborne levels to an acceptable level. If material is ground, cut, or used in any operation which may generate dusts, use appropriate local exhaust ventilation to keep exposures below the recommended exposure limits. Ensure adequate ventilation, especially in conf ined areas. PPE - Eye/Face Protection Chemical goggles are recommended. Provide eyewash station and saf ety shower. PPE - Skin Protection Wear protective gloves. PPE - Body Protection Wear appropriate gloves; lab coat, nylon coveralls or disposable Tyvek suit; saf ety glasses, saf ety shoes, and disposable booties. PPE - Respiratory Protection Where open handling of powder occurs, use a powdered, air-purif ying respirator (PAPR) with HEPA cartridges or a supplied-air respirator (SAR), unless air-monitoring data has shown that a lower level of respiratory protection is adequate. Page 2 of 4 Section 9: Physical and Chemical Properties Appearance Powder. White. Upper/Lower Flammability or Explosive Limits Not available Odor Odorless Vapor Pressure Not available. Odor Threshold Not available Vapor Density Not available. pH Not available Relative Density Not available Melting Point/Freezing Point 440.6-449.6 °F (227-232°C) Solubility Water Soluble Initial Boiling Point and Boiling Range Not available Flash Point Not available Evaporation Rate Not available Flammability (Solid, Gas) Not available Partition Coefficient Not available Auto-Ignition Temperature Not available Decomposition Temperature Not available Viscosity Not available Section 10: Stability and Reactivity Reactivity Not available Chemical Stability Material is stable under normal conditions. Possibility of Hazardous Reactions Not available Conditions to Avoid Not available. Incompatible Materials Strong oxidizing agents. Hazardous Decomposition Products Carbon oxides. Nitrogen oxides (NOx). Halogens. Section 11: Toxicological Information Acute Toxicity - LD50 Oral Not available Acute Toxicity - Inhalation Harmf ul if inhaled. Inhalation of dusts may cause respiratory irritation. Acute Toxicity - Dermal Health injuries are not known or expected under normal use. Acute Toxicity - Eye Dust or powder may irritate eye tissue. Skin Corrosion/Irritation Due to lack of data the classif ication is not possible. Serious Eye Damage/Irritation Due to lack of data the classif ication is not possible. Respiratory or Skin Sensitazation Due to lack of data the classif ication is not possible. Germ Cell Mutagenicity Due to the lack of data the classif ication is not possible. Carcinogenicity IARC This product is not considered to be a carcinogen by IARC. Carcinogenicity ACGIH This product is not considered to be a carcinogen by ACGIH Carcinogenicity NTP This product is not considered to be a carcinogen by NTP. Carcinogenicity OSHA This product is not considered to be a carcinogen by OSHA. Reproductive Toxicity Due to lack of data the classif ication is not possible. Specific Target Organ Toxicity - Single Exposure Narcotic ef f ects. Specific Target Organ Toxicity - Repeated Exposure Due to lack of data the classif ication is not possible. Aspiration Hazard Due to lack of data the classif ication is not possible. Page 3 of 4 Section 12: Ecological Information Toxicity This product has no known eco-toxicological ef f ects. Persistence and Degradability No data is available on the degradability of this product. Bio-accumulative Potential Not established. Mobility in Soil Not available. Other Adverse Effects An environmental hazard cannot be excluded in the event of unprof essional handling or disposal. Section 13: Disposal Considerations Waste Treatment Methods Product This product, in its present state, when discarded or disposed of , is not a hazardous waste according to Federal regulations (40 CFR 261.4 (b) (4). Under RCRA, it is the responsibility of the user of the product to determine, at the time of disposal, whether the product meets RCRA criteria f or hazardous waste. Dispose in accordance with all applicable regulations. Waste Treatment Methods Packaging Empty containers should be taken to an approved waste handling site f or recycling or disposal. Special Precautions Landfill or Incinerations No data available Other Information No data available Section 14: Transport Information UN Number Not dangerous goods. UN Proper Shipping Name N/A Transport Hazard Class(es) N/A Packaging Group N/A Environmental Hazards N/A Section 15: Regulatory Information US f ederal regulations: This product is a "Hazardous Chemical" as def ined by the OSHA Hazard Communication Standard, 29 CFR 1910.1200. CERCLA/SARA Hazardous Substances - Not applicable. TSCA exempt status. TSCA Section 12(b) Export Notif ication (40CFR 707, Subpt. D) Not regulated. CERCLA Hazardous Substance List (40 CFR 302.4) Not listed. SARA 304 Emergency release notif ication Not regulated. OSHA Specif ically Regulated Substances (29 CFR 1910.1001-1050) Not listed. CERCLA (Superf und) reportable quantity None. Superf und Amendments and Reauthorization Act of 1986 (SARA) Hazard categories: Immediate Hazard - Yes, Delayed Hazard-No, Fire Hazard - No, Pressure Hazard - No, Reactivity Hazard - No. SARA 302 Extremely hazardous substance: Not listed. SARA 311/312 Hazardous chemical: Yes. Other f ederal regulations: Clean Air Act (CAA) Section 112 Hazardous Air Pollutants (HAPs) List: Not regulated. Clean Air Act (CAA) Section 112(r) Accidental Release Prevention (40 CFR 68.130): Not regulated. Saf e Drinking Water Act (SDWA): Not regulated. US state regulations: Calif ornia Saf e Drinking Water and Toxic Enf orcement Act of 1986 (Proposition 65): This material is not known to contain any chemicals currently listed as carcinogens or reproductive toxins. US. Massachusetts RTK-Substance List: Not regulated. US. New Jersey Worker and Community Right-to Know Act: Not listed. US. Pennsylvania Worker and Community Right-to-Know Law: Not listed. US. Rhode Island RTK: Not regulated. US. Calif ornia Proposition 65: Not Listed. International Inventories: Australia: Australian Inventory of Chemical Substances (AICS), On inventory (yes/no)*: No. Canada Domestic Substances List (DSL), On inventory (yes/no)*: No. Canada Non-Domestic Substances List (NDSL), On inventory (yes/no)*: No. China Inventory of Existing Chemical Substances in China (IECSC), On inventory (yes/no)*: No. Europe European Inventory of Existing Commercial Chemical Substances (EINECS), On inventory (yes/no)*: Yes. Europe European List of Notif ied Chemical Substances (ELINCS), On inventory (yes/no)*: No. Japan Inventory of Existing and New Chemical Substances (ENCS), On inventory (yes/no)*: No. Korea Existing Chemicals List (ECL), On inventory (yes/no)*: No. New Zealand, New Zealand Inventory, On inventory (yes/no)*: No. Philippines, Philippine Inventory of Chemicals and Chemical Substances (PICCS), On inventory(yes/no)*: No. United States & Puerto Rico Toxic Substances Control Act (TSCA) Inventory, On inventory (yes/no)*: No. *A "Yes" indicates that all components of this product comply with the inventory requirements administered by the governing country(s). A "No" indicates that one or more components of the product are not listed or exempt from listing on the inventory administered by the governing country(s). Section 16: Other Information Additional Information N/A Prepared By Lisa Russell Revision Date 01/10/2019 16:55 Disclaimer Letco Medical, LLC believes that the above information is correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. If the product is used as a component in another product, this information may not be applicable. NO WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE, WARRANTY OF MERCHANTABILITY OR ANY OTHER WARRANTY, EXPRESSED OR IMPLIED, IS MADE CONCERNING THE INFORMATION PROVIDED ABOVE. Letco Medical shall not be held liable for any loss or damage resulting from handling, storage, use or from contact with the above product. Page 4 of 4
