APOMORPHINE HCL, USP (HEMIHYDRATE) 1GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name APOMORPHINE 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) Apomorphine hydrochloride; 4H-Dibenzo[de,g]quinoline-10,11-diol, 5,6,6a,7-tetrahydro-6-methyl-, hydrochloride, hydrate (2:1), (6aR)- 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 Dermal toxicity (Category 4), Acute Inhalation toxicity (Category 4), Respiratory Sensitization (Category 1), Skin sensitization (Category 1) Signal Word Danger Hazard Statement(s) H302 Harmf ul if swallowed H312 Harmf ul in contact with skin H317 May cause an allergic skin reaction H332 Harmf ul if inhaled H334 May cause allergy or asthma symptoms or breathing dif f iculties if inhaled 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. P272 Contaminated work clothing should not be allowed out of the workplace. P280 Wear protective gloves/protective clothing/eye protection/f ace protection. P285 In case of inadequate ventilation wear respiratory protection. P301+P312+P330 IF SWALLOWED Call a POISON CENTER or doctor/physician if you f eel unwell. Rinse mouth. P302+P352 IF ON SKIN Wash with soap and water. 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. P312 Call a POISON CENTER or doctor/physician if you f eel unwell. P362 Take of f contaminated clothing and wash bef ore reuse. P501 Dispose of contents/container to an approved waste disposal plant. Hazards Not Otherwise Classified Fine dust clouds may f orm explosive mixtures with air. Ingredient(s) with Unknown Toxicity No data Available Section 3: Composition/Information on Ingredients Chemical Name Apomorphine hydrochloride Common Name Apomorphine HCl CAS Number 41372-20-7 Impurities and/or Stabilizing Additives No data available Page 1 of 5 Section 4: First Aid Measures General Advice No data available. If Inhaled Remove person to fresh air. If breathing has stopped, perf orm artif icial respiration. Get immediate medical attention. In Case of Skin Contact Flush with copious amounts of soap and water f or at least 15 minutes while removing contaminated clothing and shoes. Get immediate medical attention. Dispose of contaminated clothing or shoes. In Case of Eye Contact Flush with plenty of water f or at least 15 minutes including beneath eyelids. Remove contacts/glasses while f lushing. Get immediate medical attention. If Swallowed Contact Poison Control Center and get immediate medical attention. Never make an unconscious person vomit. Do not give anything to an unconscious person. Most Important Symptoms and Effects Acute: May cause respiratory sensitization, asthma, skin and eye redness/irritation, allergic skin reaction, nausea/vomiting, drowsiness, unconsciousness, dizziness, conf usion, headache, or stupor. Chronic: Repeated or prolonged inhalation may lead to chronic respiratory irritation. IMMEDIATE MEDICAL ATTENTION NEEDED: Treat symptoms. Section 5: Fire Fighting Measures Suitable Extinguishing Media Use extinguishing media-regular dry chemical, carbon dioxide, alcohol f oam. Special Hazards Arising From the Substance/Mixture As with any organic solids, f ire is possible at elevated temperature or by contact with an ignition source. Dust air mixtures may be explosive. Burning may produce carbon dioxide, carbon monoxide, nitrogen oxides, and halogenated compounds. Special PPE and/or Precautions for Firefighters Use regular f oam or f lood with f ine water spray. Use normal procedures, which include wearing NIOSH/MSHA approved pressure-demand self-contained breathing apparatus, f lame and chemical resistant clothing; hat, boots and gloves. Avoid contact and inhalation of material or combustion by-products. Use water spray to cool unopened containers. Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Personal precautions, protective equipment, and emergency procedures: Ventilate area of leak or spill. Remove all sources of ignition. Wear appropriate personal protective equipment as specif ied in Section 8, and f ollow handling guidance appropriate f or pharmaceutical compounds (see Section 7). Isolate hazard area. Keep unnecessary and unprotected personnel from entering. Methods and Materials Used for Containment Use a vacuum cleaner equipped with a high ef f iciency particulate f ilter to collect solid material into an appropriate container and save f or reclamation or disposal. Do not sweep or shovel dry material. Use non-sparking tools and equipment. Do not f lush to sewer! Cleanup Procedures Clean surf aces and equipment used with an appropriate decontamination solution. Absorb decontamination solution and dispose of in accordance with f ederal, state and local regulations. Section 7: Handling and Storage Precautions for Safe Handling Harmf ul by inhalation, if swallowed, and in contact with skin. Do not breathe dust. Wash thoroughly af ter use. Take precautions against static discharge. To prevent contamination and overexposure, no open handling of powder should be allowed. Powder handling operations are to be done in a powders weighing hood, a glove box, or other equivalent ventilated containment system. High-energy operations such as milling, particle sizing, spraying or f luidizing should be done within a containment device such as a glove box or isolator. In situations where these ventilated containment hoods have not been installed, a non-ventilated enclosed containment hood should be used. A NIOSH-certif ied respirator should be worn by all personnel in the immediate area in cases where non-ventilated containment is used, where signif icant amounts of material (e.g., more than 2 grams) are used, or where the material may become airborne (as through grinding, etc.). Powder should be put into solution or a closed or covered container af ter handling. If using a ventilated enclosure that has not been validated, wear an appropriate, NIOSH-certif ied respirator until the enclosure is validated f or use. Wear an appropriate, NIOSH-certif ied respirator until processes have been monitored to show that respiratory protection is not required. Ensure gloves are protective against solvents in use. Conditions for Safe Storage Keep in a tightly closed container, stored in an area meeting USP requirements. Protect against physical damage. Containers of this material may be hazardous when empty since they retain product residues (dust, solids); observe all warnings and precautions listed f or the product. Page 2 of 5 Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters Occupational Exposure Limits: None established. Johnson Matthey has assigned Exposure Control Band 3 (10 �?¢?? 100 ug/m3) handling strategies, see Section 7. Appropriate Engineering Controls Where there is a possibility that an employee's eyes or skin may be exposed to the product, an emergency eyewash and a saf ety shower should be provided within the immediate work area. To prevent contamination and overexposure, no open handling of powder should be allowed. Powder handling operations are to be done in a powders weighing hood, a glove box, or other equivalent ventilated containment system. In situations where these ventilated containment hoods have not been installed, a non-ventilated enclosed containment hood should be used. Take all precautions to prevent inhalation, dermal exposure, or ingestion of this substance. Use rigorous decontamination procedures to prevent contamination spread to other areas. PPE - Eye/Face Protection OSHA, ANSI approved saf ety goggles/glasses. Contact lenses are not protective devices. Appropriate eyeand f aceprotection must be worn instead of , or in conjunction with contact lenses. Use chemical saf ety goggles. Maintain eye wash f ountain and quick-drench f acilities in work area. PPE - Skin Protection Wear disposable protective clothing to prevent exposure. Protective clothing may include lab coat and/or apron, f lame and chemical resistant coveralls, and boots/saf ety shoes to prevent prolonged or repeated skin contact. The actual protective clothing and equipment to be used must be determined by the user through a personal protective equipment assessment meeting the requirements of OSHA regulations at 29 CFR 1910.132(d). Wear appropriate gloves; lab coat, nylon coveralls or disposable Tyvek suit; saf ety glasses, saf ety shoes, and disposable booties. PPE - Body Protection Wear disposable protective clothing to prevent exposure. Protective clothing may include lab coat and/or apron, f lame and chemical resistant coveralls, and boots/saf ety shoes to prevent prolonged or repeated skin contact. The actual protective clothing and equipment to be used must be determined by the user through a personal protective equipment assessment meeting the requirements of OSHA regulations at 29 CFR 1910.132(d). PPE - Respiratory Protection For Unknown Concentrations or Immediately Dangerous to Lif e or Health (IDLH) atmospheres: �?¢?? A NIOSH certif ied supplied-air respirator with f ull f acepiece and operated in a pressure-demand or other positive-pressure mode in combination with a separate escape supply. - A NIOSH certif ied self-contained breathing apparatus with a f ull f acepiece. Where concentrations are known, and an IDLH atmosphere does not exist, an air purif ying respirator with N100 f ilters may be used if acceptable protection can be demonstrated. Section 9: Physical and Chemical Properties Appearance Solid, greyish-white, crystalline powder Upper/Lower Flammability or Explosive Limits Not established Odor Odorless Vapor Pressure Not established Odor Threshold Not established Vapor Density N/A pH pH (10 g/l; 20ºC): 4 - 6 Relative Density Not established Melting Point/Freezing Point 195 ° C Solubility Water Solubility: ca. 10 g/L @ 20 ° C Initial Boiling Point and Boiling Range Not established Flash Point Not established Evaporation Rate Not established Flammability (Solid, Gas) Not established Partition Coefficient Not established Auto-Ignition Temperature Not established Decomposition Temperature 225 ° C Viscosity N/A Section 10: Stability and Reactivity Reactivity No data available Chemical Stability Stable at ambient temperatures. Sensitive to air, heat, light, and moisture Possibility of Hazardous Reactions No data available Conditions to Avoid Avoid creating dust clouds. Incompatible Materials Strong oxidizing agents, strong bases, iron and iron salts. Hazardous Decomposition Products Burning may produce carbon oxides, nitrogen oxides, hydrogen chloride. Hazardous Polymerization: Will not occur Page 3 of 5 Section 11: Toxicological Information Acute Toxicity - LD50 Oral LD50 Oral - mouse - 300 mg/kg, LD50 IP - mouse - 160 mg/kg, LD50 IV - mouse - 56 mg/kg Acute Toxicity - Inhalation No data available Acute Toxicity - Dermal No data available Acute Toxicity - Eye No data available Skin Corrosion/Irritation May cause allergic skin reaction Serious Eye Damage/Irritation May cause eye redness/irritation Respiratory or Skin Sensitazation May cause respiratory sensitization Germ Cell Mutagenicity No data available Carcinogenicity IARC Not identif ied as a carcinogen or potential carcinogen by the International Agency f or Research on Cancer. Carcinogenicity ACGIH No data available Carcinogenicity NTP Not listed as a carcinogen or potential carcinogen in the Annual Report of the US National Toxicology Program Carcinogenicity OSHA Apomorphine HCl is not regulated as a carcinogen by OSHA Reproductive Toxicity No data available Specific Target Organ Toxicity - Single Exposure No data available Specific Target Organ Toxicity - Repeated Exposure Repeated or prolonged inhalation may lead to chronic respiratory irritation. Aspiration Hazard No data available Section 12: Ecological Information Toxicity No data available 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 This material is not a hazardous waste under RCRA. Waste Treatment Methods Packaging May be regulated by various state requirements. 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 EPA Regulations: RCRA Hazardous Waste Number: N/A RCRA Hazardous Waste Classif ication (40 CFR 261): N/A CERCLA Reportable Quantity (RQ): Not listed SARA 311/312 Codes: Acute health hazard, chronic health hazard SARA Toxic Chemical (40 CFR 372.65): Not listed SARA EHS (Extremely Hazardous Substance)(40 CFR 355): Not listed TSCA: Not listed OSHA Hazards: Respiratory and dermal sensitizer, harmf ul if inhaled, ingested, or on skin. State Regulations: New Jersey Right to Know: Apomorphine HCl, 41372-20-7 Pennsylvania Right to Know: Apomorphine HCl, 41372-20-7 Calif ornia Prop. 65 Components: This product does not contain any chemicals known to State of Calif ornia to cause cancer, birth def ects, or any other reproductive harm. Saf ety Phrases - Do not breathe dust (S22). - Wear suitable protective clothing, eye/f ace protection and gloves (S36/37/39). - If swallowed, seek medical advice immediately and show this container or label (S46). Risk Phrases - Harmf ul by inhalation, in contact with skin, and if swallowed (R20/21/22) -May cause sensitization by inhalation and by skin contact (R42/43) Page 4 of 5 Section 16: Other Information Additional Information N/A Prepared By Lisa Russell Revision Date 01/15/2019 14:55 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 5 of 5
