TACROLIMUS, USP (MONOHYDRATE) 1GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name TACROLIMUS 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) 15,19-Epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-m monohydrate, [3S- [3R*,[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]- Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Acute toxicity, Oral (Category 3), Serious eye damage/eye irritation (Category 2B), Specif ic target organ toxicity, repeated exposure (Category 1) Immune system Signal Word Danger Hazard Statement(s) H301 Toxic if swallowed H320 Causes eye irritation H372 Causes damage to organs through prolonged or repeated exposure Pictogram(s) Precautionary Statement(s) P264 Wash hands thoroughly af ter handling. P270 Do not eat, drink or smoke when using this product. 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. P314 Get Medical advice/attention if you f eel unwell. P330 Rinse mouth. P337+P313 If eye irritation persists Get medical advice/attention. P405 Store locked up. 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 15,19-Epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-m monohydrate, Common Name Tacrolimus CAS Number 109581-93-3 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 hypersensitity (anaphylactic) reactions must receive immediate medical attention. If Inhaled Move to fresh air. 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 cautiously with water f or several minutes. Get medical attention if irritations develops and persists. If Swallowed Call a physician or poison control center immediately. Rinse mouth thoroughly. Do not induce vomiting without advice from poison control center. If vomiting occurs, keep head los so that stomach content doesn't get into lungs. Do not use mouth to mouth method if victim ingested the substance. Most Important Symptoms and Effects Irritation of eyes and mucous membranes. Prolonged exposure may cause chronic ef f ects. Provide general supportive measures and treat symptomatically. Do not induce vomiting. Administer activated charcoal as a slurry. Perf orm gastric lavage. For protection of airways, place in Trendelenburg and lef t lateral decubitus position or by endotracheal intubation. Control any seizures f irst. Correct magnesium def icits. For seizures, administer intravenous diazepam or lorazapam. If seizures occur, give phenobarbital. Monitor f or hypotension, dysrhythmias, respiratory depression, and need f or endotracheal intubation. Evaluate f or hypoglycemia, electrolyte disturbances, and hypoxia. For hypertension and tachycardia, administer with benzodiazepines. For severe hypertension, nitroprusside is pref erred; labetalol, nitroglycerin, and phentolamine are alternatives. Dialysis will not ef f ectively remove this material. (Meditext) (USP DI). Section 5: Fire Fighting Measures Suitable Extinguishing Media Water spray, dry chemical, carbon dioxide, or f oam as appropriate f or surrounding f ire and materials. Special Hazards Arising From the Substance/Mixture No unusual f ire explosion hazards noted. Special PPE and/or Precautions for Firefighters Wear suitable protective equipment. As with all f ires, evacuate personnel to a saf e area. Firef ighters should use selfcontained breathing equipment and protective clothing. Cool containers exposed to f lames with water until well af ter the f ire is out. Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures 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 SDS. Wash spill site. 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. Wash spill site. Section 7: Handling and Storage Precautions for Safe Handling As a general rule, when handling chemicals, 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 a designated area is recommended f or handling or potent materials. Conditions for Safe Storage Store in tight container as def ined in the USP-NF. This material should be handled and stored per label instructions to ensure product integrity. Page 2 of 5 Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters Material Tacrolimus (CAS 109581-93-3) Type: TWA Value 0.2 micrograms/m3 Appropriate Engineering Controls Airborne exposures 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 dust-generating or aerosol-generating procedures. Use a laboratory f ume hood, vented enclosure, glovebox, or other ef f ective containment. PPE - Eye/Face Protection Saf ety glasses with side shields are recommended. Face shields or goggles may be required if splash potential exists or if corrosive materials are present. Approved eye protection 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. This material is extremely potent. 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 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. This material is extremely potent. 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. 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 take-home 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. Section 9: Physical and Chemical Properties Appearance Form: Powder Physical state: Solid Colour: White crystalline powder. Upper/Lower Flammability or Explosive Limits No data available Odor No data available 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 260.6 - 271.4 �F (127 - 133 �C) Solubility Solubility in water: Soluble 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 No reactivity hazards known. Chemical Stability Stable at normal conditions. Possibility of Hazardous Reactions No dangerous reaction known under conditions of normal use. Conditions to Avoid None under normal conditions. Incompatible Materials Strong oxidizing agents. Hazardous Decomposition Products NOx. 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 Oral Mouse 134 mg/kg (male) Acute Toxicity - Inhalation Due to lack of data the classif ication is not possible. Acute Toxicity - Dermal Due to lack of data the classif ication is not possible. Acute Toxicity - Eye Causes eye irritation. Skin Corrosion/Irritation Due to lack of data the classif ication is not possible. Serious Eye Damage/Irritation Causes eye irritation Respiratory or Skin Sensitazation Due to lack of data the classif ication is not possible. Germ Cell Mutagenicity Based on available data, the classif ication criteria are not met. Carcinogenicity IARC This product is not considered to be a carcinogen by IARC. Carcinogenicity ACGIH This product is not considered to be carcinogen by ACGIH. Carcinogenicity NTP This product is not considered to be carcinogen by NTP. Carcinogenicity OSHA This product in not considered to be carcinogen by OSHA. Reproductive Toxicity Based on available data, the classif ication criteria are not met. 0.32 - 1 mg/kg Reproductively test Result: Maternal toxicity observed; increased incidence of abortions. Species: Rabbit 1 - 3.2 mg/kg Reproductively test Result: Reduced pup weights. Species: Rat 3.2 mg/kg Reproductively test Result: Maternal toxicity observed; increase in late resorptions; decreased number of live births; decreased pup weight and viability 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 Causes damage to organs (Immune system) through prolonged or repeated exposure. 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 ingredients. 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 product, in its present state, when discarded or disposed of , its not a hazardous waste according to Federal regulations (40 CFR 261.4 (b) 94). Under RCRA, its it the responsibility of the user or 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 or liners may retain some product residues. This material and its container must be disposed of in a saf e manner (see Disposal instructions). Special Precautions Landfill or Incinerations 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. Other Information No data available Section 14: Transport Information UN Number UN Proper Shipping Name Transport Hazard Class(es) Packaging Group Environmental Hazards No Section 15: Regulatory Information CERCLA/SARA Hazardous Substances - Not applicable. All components are on the U.S EPA TSCA Inventory List. 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 hazard 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) 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. Issue Date 01/21/2008 Revision Date 12/07/2012. Page 4 of 5 Section 16: Other Information Additional Information N/A Prepared By Lisa Russell Revision Date 01/09/2019 16:23 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
