NALTREXONE HCL, USP (DIHYDRATE) 25GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name NALTREXONE HCL (ANHYDROUS) 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) 17-9cyclopropylmethyl)-4, 5alpha-epoxy-3,14-dihydroxy-morphinian-6-one-hydrochloride; naltrexone hcl milled; naltrexone hydrochloride cru; naltrexone hydrochloride 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) Signal Word Warning Hazard Statement(s) H302 Harmf ul if swallowed Pictogram(s) Precautionary Statement(s) P264 Wash hands thoroughly af ter handling. P301+P312+P330 IF SWALLOWED Call a POISON CENTER or doctor/physician if you f eel unwell. Rinse mouth. P501 Dispose of contents/container to an approved waste disposal plant. Hazards Not Otherwise Classified Not classif ied Ingredient(s) with Unknown Toxicity No data available Section 3: Composition/Information on Ingredients Chemical Name (5ALPHA)-17-(CYCLOPROPYLMETHYL)-4,5-EPOXY-3, 14-DIHYDROXYMORPHINAN-6-ONE HYDROCHLORIDE Common Name NALTREXONE HYDROCHLORIDE CAS Number 16676-29-2 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice No data available. If Inhaled Remove to fresh air. Administer artif icial respiration if breathing has ceased. IMMEDIATELY consult a physician. In Case of Skin Contact In case of skin contact, IMMEDIATELY f lush exposed skin thoroughly with plenty of water. While wearing protective gloves, remove any contaminated clothing, including shoes and continue to wash skin thoroughly with soap and water f or at least 15 minutes. Get IMMEDIATE medical attention. In Case of Eye Contact In case of eye contact, immediately rinse eyes thoroughly with plenty of water. If wearing contact lenses, remove only af ter initial rinse, and continue rinsing eyes f or at least 15 minutes. If irritation occurs or persists, consult a physician. If Swallowed Do not induce vomiting unless under the direction of a qualif ied medical prof essional or Poison Control Center. IMMEDIATELY consult a physician. Do not attempt to give anything by mouth to a seizing, drowsy or unconscious person. If alert, rinse mouth and drink a glass of water. Most Important Symptoms and Effects The toxicological properties of this material have not been f ully characterized in humans and animals. Theref ore, laboratory or process control systems and appropriate work practices should be in place to minimize the potential f or inhalation exposure, skin contact, eye contact, or ingestion when working with this material. Naltrexone hydrochloride is harmf ul by inhalation, in contact with skin, and if swallowed. It may cause sensitization by inhalation and by contact . Naltrexone hydrochloride is an opioid antagonist and is used f or the treatment of opiate and alcohol dependence. Acute exposure to naltrexone hydrochloride may cause f atigue, sleepiness, decreased concentration, dizziness, lightheadedness, motor dysf unction, f ainting, headache, pain, nervousness, agitation, behavioral changes, anxiety, depression, conf usion, hallucinations, constriction of pupils, seizure disorders, dry mouth, gastrointestinal discomf ort, nausea, loss of appetite, vomiting, abdominal pain, diarrhea, joint pain, respiratory depression, inf lammation of the throat, rash, sweating, cardiac irregularities, lung edema, changes in reproductive hormones, and reproductive f unction changes. Chronic exposure may cause dif f iculty in sleeping, joint and muscle pain and muscle cramps. Page 1 of 4 Section 5: Fire Fighting Measures Suitable Extinguishing Media Suitable Extinguishing media: Carbon dioxide (CO2), extinguishing powder or water spray. Special Hazards Arising From the Substance/Mixture Thermal Decomposition products: Hydrogen chloride (HCl). Nitrogen oxides (NOx). Carbon monoxide (CO). Carbon dioxide (CO2). Under normal conditions of use, this material does not present a signif icant f ire or explosion hazard. However, like most organic compounds, this material may present a dust def lagration hazard if suf f icient quantities are suspended in air. This hazard may exist where suf f icient quantities of f inely divided material are (or may become) suspended in air during typical process operations. An assessment of each operation should be conducted and suitable def lagration prevention and protection techniques employed. This material has been shown to be particularly sensitive to ignition by electrostatic discharges. All conductive plant items and operations personnel handling this material should be suitably grounded. Consideration should also be given to the possibility of ignition due to electrostatic discharges from accumulating powder and restricting the use of low-conductivity materials of construction. Special PPE and/or Precautions for Firefighters Wear f ull protective clothing and self-contained breathing apparatus (SCBA). Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Avoid generation of dust during clean-up. Wear appropriate personal protective equipment as specif ied in section 8. Keep personnel away from the cleanup area. Methods and Materials Used for Containment All spills should be handled according to site requirements and based on precautions cited in the SDS. In the case of liquids, use proper absorbent materials. For laboratories and small-scale operations, incidental spills within a hood or enclosure should be cleaned by using a HEPA f iltered vacuum or wet cleaning methods as appropriate. For large dry or liquid spills or those spills outside enclosure or hood, appropriate emergency response personnel should be notif ied. In manuf acturing and large-scale operations, HEPA vacuuming prior to wet mopping or cleaning is required. Cleanup Procedures All spills should be handled according to site requirements and based on precautions cited in the SDS. In the case of liquids, use proper absorbent materials. For laboratories and small-scale operations, incidental spills within a hood or enclosure should be cleaned by using a HEPA f iltered vacuum or wet cleaning methods as appropriate. For large dry or liquid spills or those spills outside enclosure or hood, appropriate emergency response personnel should be notif ied. In manuf acturing and large-scale operations, HEPA vacuuming prior to wet mopping or cleaning is required. Section 7: Handling and Storage Precautions for Safe Handling Avoid dust generation. Avoid breathing dust. Avoid contact with skin and clothing. Keep containers adequately sealed during material transf er, transport, or when not in use. Wash f ace, hands, and any exposed skin af ter handling. Do not eat, drink, or smoke when using this substance or mixture. Appropriate handling of this material is dependent on many f actors, including physical f orm, duration and frequency of process or task, and ef f ectiveness of engineering controls. Site-specif ic risk assessments should be conducted to determine the f easibility and the appropreateness of all exposure control measures. See Section 8 (Exposure Controls) f or additional guidance. Conditions for Safe Storage Store at 15-25 deg. C. Store in a cool, dry, well-ventilated area. Store in adequately sealed container. Avoid moisture. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters Occupational Exposure Band (OEB): OEB 3: 10-100 mcg/m. Materials in an OEB 3 Category are considered moderate health hazards. The OEB is a range of airborne concentrations expressed as an 8-hour Time Weighted Average (8-hr. TWA) and is intended to be used with Industrial Hygiene Risk Assessment to assist with industrial hygiene sampling and selection of proper controls f or worker protection. Consult your site and industrial hygiene staf f f or guidance on handling and control strategies. Internal Occupational Exposure Limit (8-hr TWA): 50.0 mcg/m. Appropriate Engineering Controls The health hazard risks of handling this material are dependent on many f actors, including physical f orm, duration and frequency of process or task, and ef f ectiveness of engineering controls. Site-specif ic risk assessments should be conducted to determine the f easibility and the appropriateness of all exposure control measures. Exposure controls f or normal operating or routine procedures f ollow a tiered strategy. Engineering controls are the pref erred means of long-term or permanent exposure control. If engineering controls are not f easible, appropriate use of PPE may be considered as alternative control measures. Exposure controls f or non-routine operations must be evaluated and addressed as part of the site-specif ic risk assessment. PPE - Eye/Face Protection Saf ety glasses with side shields. Use of goggles or f ull f ace protection may be required based on hazard, potential f or contact, or level of exposure. Consult your site saf ety staf f f or guidance. PPE - Skin Protection Gloves that provide an appropriate barrier to the skin are recommended if there is potential f or contact with this material. Consult your site saf ety staf f f or guidance. PPE - Body Protection In small-scale or laboratory operations, lab coats or equivalent protection is required. Disposable Tyvek or other dust impermeable suit should be considered based on procedure or level of exposure. Use of additional PPE such as shoe coverings, gauntlets, hood, or head covering may be necessary. Consult your site saf ety staf f f or guidance. In largescale or manuf acturing operations, disposable Tyvek or other dust impermeable suite is recommended and based on level of exposure. Use of additional PPE such as shoe coverings, gauntlets, hood, or head covering may be necessary. Consult your site saf ety staf f f or guidance. PPE - Respiratory Protection Respiratory protective equipment (RPE) may be required f or certain laboratory and large-scale manuf acturing tasks if potential airborne breathing zone concentrations of substances exceed the relevant exposure limit(s). Workplace risk assessment should be completed bef ore specif ying and implementing RPE usage. Potential exposure points and pathways, task duration and frequency, potential employee contact with the substance, and the ability of the substance to be rendered airborne during specif ic tasks should be evaluated. Initial and ongoing strategies of quantitative exposure measurement should be obtained as required by the workplace risk assessment. All RPE must conf orm to local and regional specif ications f or ef f icacy and perf ormance. Consult your site or corporate health and saf ety prof essional f or additional guidance. Page 2 of 4 Section 9: Physical and Chemical Properties Appearance White to of f-white crystalline solid, Crystalline powder Upper/Lower Flammability or Explosive Limits See Section 5 f or f lammability/explosivity inf ormation. Odor Odorless Vapor Pressure No data available Odor Threshold No data available Vapor Density No data available pH No data available Relative Density No data available Melting Point/Freezing Point 274-276 Solubility >5 g/100 ml @ 20 deg C Initial Boiling Point and Boiling Range No data available Flash Point No data available Evaporation Rate No data available Flammability (Solid, Gas) No data available Partition Coefficient No data available Auto-Ignition Temperature No data available Decomposition Temperature No data available Viscosity No data available Section 10: Stability and Reactivity Reactivity Stable under normal conditions. Chemical Stability Stable under normal conditions. Possibility of Hazardous Reactions No dangerous decomposition is expected if used according to manuf acturer's specif ications. Conditions to Avoid None known. Incompatible Materials None known. Hazardous Decomposition Products No dangerous decomposition is expected if used according to manuf acturer's specif ications. Section 11: Toxicological Information Acute Toxicity - LD50 Oral Oral LD50: 1450 mg/kg (rat); Oral LD50: 1100 mg/kg (mouse) Acute Toxicity - Inhalation No data available Acute Toxicity - Dermal Alkaloids/opioids may cause allergic reactions. Acute Toxicity - Eye No data available Skin Corrosion/Irritation No data available Serious Eye Damage/Irritation No data available Respiratory or Skin Sensitazation Alkaloids/opioids may cause allergic reactions. Germ Cell Mutagenicity No data available Carcinogenicity IARC This material or product has not been evaluated f or carcinogenicity. Carcinogenicity ACGIH This material or product has not been evaluated f or carcinogenicity. Carcinogenicity NTP This material or product has not been evaluated f or carcinogenicity. Carcinogenicity OSHA This material or product has not been evaluated f or carcinogenicity. Reproductive Toxicity Naltrexone Hydrochloride: Intraperitoneal TDLo (1-22 days post conception): 1100 mg/kg (f emale rat). Naltrexone hydrochloride anhydrous caused ef f ects on newborns including decreased weight gain. Specific Target Organ Toxicity - Single Exposure No data available Specific Target Organ Toxicity - Repeated Exposure No data available Aspiration Hazard No data available Page 3 of 4 Section 12: Ecological Information Toxicity This material has not been tested f or ecotoxicity. Persistence and Degradability No data available Bio-accumulative Potential No data available Mobility in Soil No data available Other Adverse Effects No data available Section 13: Disposal Considerations Waste Treatment Methods Product Disposal must be in accordance with applicable f ederal, state/provincial, and/or local regulations. Incineration is the pref erred method of disposal, when appropriate. Operations that involve the crushing or shredding of waste materials or returned goods must be handled to meet the recommended exposure limit(s). Waste Treatment Methods Packaging Disposal must be in accordance with applicable f ederal, state/provincial, and/or local regulations. 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 No data available Section 15: Regulatory Information TSCA Listing: This material or product is not subject to TSCA requirements. Section 16: Other Information Additional Information N/A Prepared By Lisa Russell Revision Date 01/03/2019 15:06 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
