SELEGILINE HCL, USP 5GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name SELEGILINE HCL USP 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) Benzeneethanamine, N-alpha-dimethyl-N-2-propynyl-hydrochloridem, (R)- Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Acute tox. 4, Aquatic Chronic 2 Signal Word Warning Hazard Statement(s) H302 Harmf ul if swallowed H332 Harmf ul if inhaled H410 Very toxic to aquatic lif e with long lasting ef f ects Pictogram(s) Precautionary Statement(s) P261 Avoid breathing dust/f ume/gas/mist/vapours/spray. P273 Avoid release to the environment. 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. P402+P404 Store in a dry place. Store in a closed container. P501 Dispose of contents/container to an approved waste disposal plant. Hazards Not Otherwise Classified No data available Ingredient(s) with Unknown Toxicity No data available Section 3: Composition/Information on Ingredients Chemical Name (R)-(-)-1-phenyl-2[ N-(2-propionyl)-N-methylamino]-propane hydrochloride Common Name Selegiline hydrochloride CAS Number 14611-52-0 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice In case of accident or if you f eel unwell, seek medical advice immediately (show the label where possible). If Inhaled Interrupt an exposition. Take to the fresh air. Prevent victim from a cold. Seek f or medical help in case of coughing, breathlessness or other symptoms persist. In Case of Skin Contact Remove contaminated clothing. The af f licted surf ace rinse with lot of (if possible a lukewarm) water. If there is no lesion use soap or cream. If any irritation persists seek medical advice. In Case of Eye Contact Immediately, wash up thoroughly with water f or minimum 10 minutes. Remove contact lenses. Open eye-lids �?¢?? even though using f orce. Seek f or medical help immediately. If Swallowed Wash out mouth thoroughly (if a victim is conscious). Do not induce vomiting �?¢?? it can cause more hazard that the substance itself). If possible administer about 5 crushed tablets of activated charcoal suspended in water. Seek f or medical help. Most Important Symptoms and Effects Selegiline hydrochloride is used in manuf acture of medicines. At high dose (inhalation, swallowing, etc.) adverse ef f ect of over dosage can arise, i.e. disorder of CNS (agitation, conf usion) and cardiovascular system, alternatively adverse ef f ects within usage of Selegiline hydrochloride �?¢?? head aches, pain in stomach, nausea, dry mouth, skin reaction. Temporary sleep disorder, dizziness, or f urther ef f ect stated in the chapter No. 11 can occur. Page 1 of 4 Section 5: Fire Fighting Measures Suitable Extinguishing Media Suitable extinguishing media : Foam, dry powder, water f og, carbon dioxide.Extinguishing media which must not be used f or saf ety reasons : not known Special Hazards Arising From the Substance/Mixture Formation of toxic and corrosive gases is possible during heating or in case of f ire (CO, CO2, nitrogen oxides, hydrogen chloride ). Special PPE and/or Precautions for Firefighters A self-contained breathing apparatus and f ull protective clothing should be worn when f ighting the f ire. Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Use protective means �?¢?? aspirator against dust, protective gloves, protective clothing, work shoes, in case of big leakage use protective mask with f iltered air supply. Methods and Materials Used for Containment Do not allow the substance to reach soil, waters and sewage systems. Perf orm actions against entering washing water into soil, waters and sewage systems. Collect the material into original or similar containers, close and label. Dispose as a dangerous waste. Rinse the residua with water �?¢?? prevent entering into sewerage. Cleanup Procedures Collect the material into original or similar containers, close and label. Dispose as a dangerous waste. Rinse the residua with water �?¢?? prevent entering into sewerage. Section 7: Handling and Storage Precautions for Safe Handling Use protective means. Prevent to dispersion of powder. Do not eat, drink, and f ume in a working place, Take of f protective clothing and means bef ore entering into a dinning-room. Conditions for Safe Storage Preserve in tightly closed original containers on dry and well ventilated place up to 25 �??�?°C. Protect f orm light. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters Not determined. Appropriate Engineering Controls Ensure adequate ventilation. Prevent rising of dust. Use prescribed protective means. PPE - Eye/Face Protection protective mask with combined f ilter of protective glasses PPE - Skin Protection protective gloves (Nitrile, Butyl, PVC) PPE - Body Protection protective clothing, work shoes, kerchief PPE - Respiratory Protection protective mask with combined f ilter or an aspirator Section 9: Physical and Chemical Properties Appearance white to of f white crystalline substance Upper/Lower Flammability or Explosive Limits not determined Odor odourless Vapor Pressure No data available Odor Threshold No data available Vapor Density not applicable pH pH (c=5, water) : 3.5 �?? 4.5 Relative Density not applicable Melting Point/Freezing Point Melting point/freezing point : 142 �?? 147 °C Solubility Solubility �?? water : freely soluble in other solvents : soluble in ethanol, methanol, chlorof orm, 0.1 M HCl Initial Boiling Point and Boiling Range not applicable Flash Point Not determined Evaporation Rate Not applicable. Flammability (Solid, Gas) combustible organic substance Partition Coefficient No data available Auto-Ignition Temperature not determined Decomposition Temperature not determined Viscosity not applicable Page 2 of 4 Section 10: Stability and Reactivity Reactivity No inf ormation about dangerous reactivity are known. Chemical Stability Stable under storage conditions Possibility of Hazardous Reactions none Conditions to Avoid not known Incompatible Materials strong oxidants Hazardous Decomposition Products In event of f ire carbon oxide, carbon dioxide, nitrogen oxides and hydrogen chloride may develop. Section 11: Toxicological Information Acute Toxicity - LD50 Oral LD50 oral in rat : 385 mg/kg LD50 not stated mice: 121 mg/g LD50 intravenously in rat : 81 mg/kg TLD0 oral in rat: 1904 mg/kg LD50 subcutaneously in rat: 280 mg/kg Acute Toxicity - Inhalation No data available Acute Toxicity - Dermal No data available Acute Toxicity - Eye No data available Skin Corrosion/Irritation Inf ormation not f ound. Serious Eye Damage/Irritation Inf ormation not f ound. Respiratory or Skin Sensitazation Inf ormation not f ound. Germ Cell Mutagenicity Inf ormation not f ound. Carcinogenicity IARC No data available. Carcinogenicity ACGIH No data available. Carcinogenicity NTP No data available. Carcinogenicity OSHA No data available. Reproductive Toxicity Prenatal and postnatal studies in rat at 4, 16 and 64 mg/kg/day (4, 15 and 62 multiple of therapeutic dose f or human), the elevated number of dead neonates, lower number of cubs, lower number of survival cubs, lower weight at birth and during lactic period was f ound at two higher doses. As no one of the newly born cub survive more than the 4th day the postnatal development cannot been evaluated. At reproduction studies in rabbit at 5, 25 and 50 mg/kg/day (10, 48 and 95 multiple of therapeutic dose f or human), no teratogenic ef f ects were f ound. At the highest dose, a lower number of cubs was observed. The results of these tests are not suf f icient f or classif ication of the substance as toxic f or reproduction. Specific Target Organ Toxicity - Single Exposure Inf ormation not f ound. Specific Target Organ Toxicity - Repeated Exposure No data available Aspiration Hazard No data available Section 12: Ecological Information Toxicity LC50 (f ish �?¢?? 96h): 9.9 mg/l; EC50 (daphnies-48h): 33.4 mg/l; IC50 (algae-72h): 14.7 mg/l Persistence and Degradability Partially biodegradable (30 �?¢?? 40 % in 28 days). Bio-accumulative Potential Partition coef f icient n-octanol/water not determined. Further inf ormation not f ound. Mobility in Soil Inf ormation not f ound. Other Adverse Effects Inf ormation not f ound. Section 13: Disposal Considerations Waste Treatment Methods Product The product may be incinerated in a suitable incineration plant in accordance with local regulations. The packages can be reused af ter thorough cleaning or handled (contaminated) in the same way as the substance itself . Waste Treatment Methods Packaging LDPE bag inserted into a paper drum. Special Precautions Landfill or Incinerations No data available Other Information No data available Page 3 of 4 Section 14: Transport Information UN Number 3077 UN Proper Shipping Name Environmentally hazardous substance, solid, N.O.S. (selegiline hydrochloride) Transport Hazard Class(es) 9 Packaging Group III Environmental Hazards Environmentally hazardous substance. Section 15: Regulatory Information Saf ety, health and environmental regulations/legislation specif ic f or the substance or mixture (specif ic f or EU) The substance is a pharmaceutical ingredient and is liable to regulations on medicines. The substance is not mentioned in the list of substances in Directive of European Council No. 793/93 on evaluation and control of risks of existing chemical substances. This substance is not classif ied in Appendix 1 Directive of European Council No. 67/548/EEC. This substance is not resctricted by any prescript. Section 16: Other Information Additional Information N/A Prepared By Lisa Russell Revision Date 01/08/2019 13:47 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
