SUMATRIPTAN USP 1KG by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name Sumatriptan Base 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) Sumatriptan Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Serious eye damage/eye irritation, Category 2B. Sensitization, respiratory, Category 1. Sensitization, skin, Category 1 Signal Word Danger Hazard Statement(s) H317 May cause an allergic skin reaction H320 Causes eye irritation 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. 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. P302+P352 IF ON SKIN Wash with soap and water. P304+P341 IF INHALED If breathing is dif f icult, remove victim to fresh air and keep at rest in a position comf ortable f or breathing. P305+P351+P338 IF IN EYES Rinse cautiously with water f or several minutes. Remove contact lenses if present and easy to do. continue rinsing. P333+P313 If skin irritation or a rash occurs Get medical advice/attention. P337+P313 If eye irritation persists Get medical advice/attention. P342+P311 If experiencing respiratory symptoms Call a POISON CENTER or doctor/physician. P363 Wash contaminated clothing bef ore reuse. 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 Sumatriptan. 3-(2-Dimethylamino)ethyl)-N-methyl-1H-indole-5-methanesulf onamide Common Name Sumatriptan CAS Number 103628-46-2 Impurities and/or Stabilizing Additives No data available Page 1 of 5 Section 4: First Aid Measures General Advice Remove from exposure. Remove contaminated clothing. For treatment advice, seek guidance from an occupational health physician or other licensed health-care provider f amiliar with workplace chemical exposures. In the United States, the national poison control center phone number is 1-800-222-1222. If person is not breathing, give artif icial respiration. If breathing is dif f icult, give oxygen if available. Persons developing serious hypersensitivity (anaphylactic) reactions must receive immediate medical attention. If Inhaled If breathing is dif f icult, remove to fresh air and keep at rest in a position comf ortable f or breathing.Call a physician if symptoms develop or persist. In Case of Skin Contact Rinse skin with water/shower. Get medical attention if irritation develops and persists. In Case of Eye Contact Rinse with water. Get medical attention if irritation develops and persists. If Swallowed Rinse mouth. If ingestion of a large amount does occur, call a poison control center immediately. Most Important Symptoms and Effects Most important symptoms/ef f ects, acute and delayed Irritation of eyes and mucous membranes. May cause allergic skin reaction. May cause allergic respiratory reaction. Indication of immediate medical attention and special treatment needed Overdose treatment should be symptomatic and supportive and may include the f ollowing: Administer activated charcoal, if recent ingestion. For severe hypertension: Monitor vital signs regularly and administer nitroprusside, nitroglycerin, or phentolamine. For ventricular arrhythmia: Obtain an ECG, institute continuous cardiac monitoring, and administer oxygen. Administer lidocaine and amiodarone, or sotalol f or monomorphic ventricular tachycardia (VT). Amiodarone and sotalol should generally not be used if QT prolongation or torsades de pointes is present. For serotonin syndrome: Administer benzodiazepines or cyproheptadine. Severe cases may be managed with benzodiazepine sedation and neuromuscular paralysis with non-depolarizing agents. Monitor f or hypertension, ventricular dysrhythmias, and clinical evidence of ischemia. Cardiac monitoring as indicated. Evaluate pulse oximetry and/or ABGs in patients with chest pain or shortness or breath. Monitor symptomatic patients f or acidosis/electrolyte disorders (particularly hypokalemia, hypocalcemia, and hypomagnesemia). [Drugdex 2008] Section 5: Fire Fighting Measures Suitable Extinguishing Media Use f ire-extinguishing media appropriate f or surrounding materials. Water. Foam. Dry chemical or CO2. Special Hazards Arising From the Substance/Mixture Explosion hazard: Avoid generating dust; f ine dust dispersed in air in suf f icient concentrations and in the presence of an ignition source is a potential dust explosion hazard. Special PPE and/or Precautions for Firefighters Wear suitable protective equipment. Fire-f ighting equipment/instructions Use water spray to cool unopened containers. As with all f ires, evacuate personnel to a saf e area. Firef ighters should use self-contained breathing equipment and protective clothing. Specif ic methods Use standard f iref ighting procedures and consider the hazards of other involved materials. Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Dust deposits should not be allowed to accumulate on surf aces, as these may f orm an explosive mixture if they are released into the atmosphere in suf f icient concentration. Keep unnecessary personnel away. Do not touch damaged containers or spilled material unless wearing appropriate protective clothing. Ensure adequate ventilation. Avoid inhalation of dust from the spilled material. Wear appropriate personal protective equipment. Methods and Materials Used for Containment Sweep up or vacuum up spillage and collect in suitable container f or disposal. Avoid the generation of dusts during clean-up. For waste disposal, see section 13 of the SDS. Clean surf ace thoroughly to remove residual contamination. Cleanup Procedures Sweep up or vacuum up spillage and collect in suitable container f or disposal. Avoid the generation of dusts during clean-up. For waste disposal, see section 13 of the SDS. Clean surf ace thoroughly to remove residual contamination. Section 7: Handling and Storage Precautions for Safe Handling Avoid all contact and inhalation of dust, mists, and/or vapors associated with the material. Clean equipment and work surf aces with suitable detergent or solvent af ter use. Af ter removing gloves, wash hands and other exposed skin thoroughly. Use of a designated area is recommended f or handling of potent materials. Combustible dust clouds may be created where operations produce f ine material (dust). Avoid signif icant deposits of material, especially on horizontal surf aces, which may become airborne and f orm combustible dust clouds and may contribute to secondary explosions. Conditions for Safe Storage Preserve in tight, light-resistant containers. Protect from freezing, and store below 30�?°C. Page 2 of 5 Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters STEL 100 micrograms/m3 (15 minutes) 103628-46-2) TWA 50 micrograms/m3. Biological limit values No biological exposure limits noted f or the ingredient(s). Appropriate Engineering Controls Airborne exposure should be controlled primarily by engineering controls such as general dilution ventilation, local exhaust ventilation, or process enclosure. Local exhaust ventilation is generally pref erred to general exhaust because it can control the contaminant at its source, preventing dispersion into the work area. An industrial hygiene survey involving air monitoring may be used to determine the ef f ectiveness of engineering controls. Ef f ectiveness of engineering controls intended f or use with highly potent materials should be assessed by use of nontoxic surrogate materials. Avoid any open handling of this material, particularly f or grinding, crushing, weighing, or other dustgenerating or aerosol-generating procedures. Use a laboratory f ume hood, vented enclosure, glovebox, or other ef f ective containment. Handle in accordance with good industrial hygiene and saf ety practice. PPE - Eye/Face Protection Saf ety glasses with sideshields are recommended. Face shields or goggles may be required if splash potential exists or if corrosive materials are present. Approved eye protection (e.g., bearing the ANSI Z87 or CSA stamp) is pref erred. Maintain eyewash f acilities in the work area. PPE - Skin Protection Chemically compatible gloves. For handling solutions, ensure that the glove material is protective against the solvent being used. Use handling practices that minimize direct hand contact. Employees who are sensitive to natural rubber (latex) should use nitrile or other synthetic nonlatex gloves. Use of powdered latex gloves should be avoided due to the risk of latex allergy. To reduce the risk of contamination of skin and surf aces, wear two pairs of gloves. Remove the outer gloves af ter handling and cleanup of the material, and remove the inner gloves only af ter removing other personal protective equipment. PPE - Body Protection For handling of laboratory scale quantities, a disposable lab coat or isolation gown over street clothes is recommended. Where signif icant quantities are handled, work clothing and booties may be necessary to prevent takehome contamination. PPE - Respiratory Protection Where respirators are deemed necessary to reduce or control occupational exposures, use NIOSH-approved respiratory protection and have an ef f ective respirator program in place (applicable U.S. regulation OSHA 29 CFR 1910.134). Section 9: Physical and Chemical Properties Appearance White to pale-white powder. Upper/Lower Flammability or Explosive Limits Not available. Odor Not available. Vapor Pressure < 0.0000001 kPa at 25 �C Odor Threshold Not available. Vapor Density Not available. pH 4.2 - 5.5 Relative Density Not available. Melting Point/Freezing Point 336.2 - 341.6 �F (169 - 172 �C) Solubility Solubility in water Very slightly soluble. Solubility (other) Soluble in dilute acid; readily soluble in saline. Initial Boiling Point and Boiling Range Not available. Flash Point Not available. Evaporation Rate Not available. Flammability (Solid, Gas) Not applicable. Partition Coefficient Not available. Auto-Ignition Temperature Not available. Decomposition Temperature Not available. Viscosity Not available. Section 10: Stability and Reactivity Reactivity No reactivity hazards known. Chemical Stability Material is stable under normal conditions. Possibility of Hazardous Reactions No dangerous reaction known under conditions of normal use. Conditions to Avoid None known. Incompatible Materials None known. Hazardous Decomposition Products NOx. SOx. Irritating and/or toxic f umes or gases. Emits toxic f umes under f ire conditions. Page 3 of 5 Section 11: Toxicological Information Acute Toxicity - LD50 Oral LD50 Mouse Oral > 1500 mg/kg Rat > 2000 mg/kg Acute Toxicity - Inhalation May cause allergy or asthma symptoms or breathing dif f iculties if inhaled. Acute Toxicity - Dermal May cause an allergic skin reaction. Acute Toxicity - Eye Causes eye irritation. Skin Corrosion/Irritation Based on available data, the classif ication criteria are not met. Serious Eye Damage/Irritation Causes eye irritation. Respiratory or Skin Sensitazation May cause allergy or asthma symptoms or breathing dif f iculties if inhaled. Anaphylactic reactions f ollowing therapeutic use have been reported. Germ Cell Mutagenicity Due to lack of data the classif ication is not possible. Data from germ cell mutagenicity tests were not f ound. Mutagenicity Human lymphocyte assay Result: Negative. Rat micronucleus assay Result: Negative. Carcinogenicity IARC Based on available data, the classif ication criteria are not met. This material is not considered to be a carcinogen by IARC, NTP, or OSHA. Carcinogenicity ACGIH No data available Carcinogenicity NTP Based on available data, the classif ication criteria are not met. This material is not considered to be a carcinogen by IARC, NTP, or OSHA. Carcinogenicity OSHA Based on available data, the classif ication criteria are not met. This material is not considered to be a carcinogen by IARC, NTP, or OSHA. Reproductive Toxicity Based on available data, the classif ication criteria are not met. Reproductivity 15 mg/kg/day Reproductivity study Result: Increased incidence of cervicothoracic vascular and skeletal abnormalities. Species: Rabbit 250 mg/kg/day Reproductivity study Result: Increased incidence of blood vessel abnormalities. Species: Rat <= 160 mg/kg/day Reproductivity study Result: No ef f ects on f ertility. Species: Rat Specific Target Organ Toxicity - Single Exposure Due to lack of data the classif ication is not possible. Specific Target Organ Toxicity - Repeated Exposure Due to lack of data the classif ication is not possible. Aspiration Hazard Based on available data, the classif ication criteria are not met. Section 12: Ecological Information Toxicity No ecotoxicity data noted f or the ingredient(s). Persistence and Degradability No data is available on the degradability of this product. Bio-accumulative Potential Not available. Mobility in Soil Not available. Other Adverse Effects Not available. Section 13: Disposal Considerations Waste Treatment Methods Product Dispose in accordance with all applicable regulations. 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. Waste Treatment Methods Packaging Dispose of in accordance with local regulations. Empty containers or liners may retain some product residues. This material and its container must be disposed of in a saf e manner (see: Disposal instructions). Contaminated packaging Empty containers should be taken to an approved waste handling site f or recycling or disposal. Since emptied containers may retain product residue, f ollow label warnings even af ter container is emptied. 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 Page 4 of 5 Section 15: Regulatory Information US f ederal regulations CERCLA/SARA Hazardous Substances - Not applicable. One or more components are not listed on TSCA. Superf und Amendments and Reauthorization Act of 1986 (SARA) Hazard categories Immediate Hazard - No Delayed Hazard - No Fire Hazard - Yes Pressure Hazard - No Reactivity Hazard - No SARA 302 Extremely hazardous substance No SARA 311/312 Hazardous chemical No Other f ederal regulations Saf e Drinking Water Act (SDWA) Not regulated. Food and Drug Administration (FDA) 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. International Inventories Country(s) or region Inventory name On inventory (yes/no)* Australia Australian Inventory of Chemical Substances (AICS) No Canada Domestic Substances List (DSL) No Canada Non-Domestic Substances List (NDSL) No China Inventory of Existing Chemical Substances in China (IECSC) No Europe European Inventory of Existing Commercial Chemical No Substances (EINECS) Europe European List of Notif ied Chemical Substances (ELINCS) No Japan Inventory of Existing and New Chemical Substances (ENCS) No Korea Existing Chemicals List (ECL) No New Zealand New Zealand Inventory Yes Philippines Philippine Inventory of Chemicals and Chemical Substances No (PICCS) United States & Puerto Rico Toxic Substances Control Act (TSCA) Inventory No *A "Yes" indicates that all components of this product comply with the inventory requirements administered by the governing country(s) Section 16: Other Information Additional Information Inf ormation on likely routes of exposure Ingestion Based on available data, the classif ication criteria are not met. Inhalation May cause allergy or asthma symptoms or breathing dif f iculties if inhaled. Skin contact May cause an allergic skin reaction. Eye contact Causes eye irritation. Symptoms related to the physical, chemical, and toxicological characteristics Chest pain. Heaviness, tightness, or pressure in chest or neck. Headache. Dizziness. Drowsiness. Flushing. Lightheadedness. Weakness. Muscle pain. Nausea. Vomiting. Dif f iculty swallowing. Delayed and immediate ef f ects of exposure High blood pressure. Medical conditions aggravated by exposure History of seizures. Decreased arterial f low. Coronary artery disease. Hypertension. Tachycardia. Cerebrovascular disorders. Impaired liver f unction. Impaired kidney f unction. Acute toxicity Based on available data, the classif ication criteria are not met. Prepared By Lisa Russell Revision Date 01/03/2019 15:58 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
