TRANEXAMIC ACID USP 100GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name TRANEXAMIC ACID 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) trans-4-(Aminomethyl)cyclohexanecarboxylic acid Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Skin irritation (Category 2), Eye Irritation (Category 2), Specif ic Target Organ Toxicity - single exposure (Category 3) Signal Word Warning Hazard Statement(s) H315 Causes skin irritation H319 Causes serious eye irritation H335 May cause respiratory irritation Pictogram(s) Precautionary Statement(s) P261 Avoid breathing dust/f ume/gas/mist/vapours/spray. 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. Hazards Not Otherwise Classified None Ingredient(s) with Unknown Toxicity No data available Section 3: Composition/Information on Ingredients Chemical Name Tranexamic acid Common Name Tranexamic Acid CAS Number 1197-18-8 Additional Ingredient Information f ormula C8H15NO2, Molecular Weight: 157.21 g/mol Impurities and/or Stabilizing Additives cis-4-aminomethylcyclohexanecarboxylic acid, content below 0.2%; other impurities below 0.05% each and 0.2% in total. Section 4: First Aid Measures General Advice Consult a physician. Show this saf ety data sheet to the doctor in attendance. If Inhaled move the victim into fresh air. If not breathing, give artif icial respiration, If breathing is dif f icult, give oxygen. Consult a physician. In Case of Skin Contact remove contaminated clothing, wash of f with soap and plenty of water. In Case of Eye Contact Rinse thoroughly with plenty of water f or at least 15 minutes and consult a physician. If Swallowed Institute symptomatic and supportive measures. Administer activated charcoal via nasogastric tube to patients who are not f ully conscious or have impaired gag ref lex. Most Important Symptoms and Effects There are limited data on overdose of Tranexamic acid, symptoms may include dizziness, headache, nausea, vomiting, diarrhea, hypotension, or orthostatic hypotension. There is no known antidote f or Tranexamic acid overdose. Monitor vital signs to detect a possible hypertensive episode. In patients with severe vomiting or diarrhea, monitor f luid and electrolyte levels and administer intravenous f luids and replace electrolytes as necessary. Monitor urine output and maintain adequate diuresis. Because there is a risk of thrombosis in overly exposed individuals, monitor f or clinical evidence of thromboembolic complications (e.g., chest pain, shortness of breath, f lank pain, extremity pain). Anticoagulant therapy should be considered in these individuals. In symptomatic individuals, support cardiac and respiratory f unction, monitor blood count, renal f unction, pulse oximetry and/or blood gases and obtain a chest x-ray. Obtain an ECG and institute continuous cardiac monitoring. Page 1 of 4 Section 5: Fire Fighting Measures Suitable Extinguishing Media Suitable extinguishing media: water spray, carbon dioxide, dry chemical powder or appropriate f oam; Special Hazards Arising From the Substance/Mixture Carbon oxides, nitrogen oxides Special PPE and/or Precautions for Firefighters Use respiratory Protection apparatus and protective clothing to avoid contact with skin and eyes. Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures In case of spilled or leaked, use personal protective equipment. Avoid dust f ormation. Avoid breathing vapors, mist or gas. Ensure adequate ventilation. Evacuate personnel to saf e areas. Avoid breathing dust. Methods and Materials Used for Containment Do not let product enter drains. Cleanup Procedures Wear approved respirator, chemical saf ety goggles, rubber boots and rubber gloves. Take up dry, keep in suitable, closed containers f or disposal. Avoid generation of dust. Ensure supply of fresh air in enclosed rooms. Clean up af f ected area. Section 7: Handling and Storage Precautions for Safe Handling Avoid contact with skin and eyes. Avoid f ormation of dust and aerosols. Provide appropriate exhaust ventilation at places where dust is f ormed. Normal measures f or preventive f ire protection. Conditions for Safe Storage Keep container tightly closed in a dry and well-ventilated place. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters TWA 1.5 mg/m3. Biological limit values No biological exposure limits noted f or the ingredient(s). Appropriate Engineering Controls Handle in accordance with good industrial hygiene and saf ety practice. Wash hands bef ore breaks and at the end of workday. PPE - Eye/Face Protection Saf ety glasses with side-shields conf orming to EN166 Use equipment f or eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU). PPE - Skin Protection Handle with gloves to avoid skin contact with this product. Dispose of contaminated gloves af ter use in accordance with applicable laws and good laboratory practices. The selected protective gloves have to satisf y the specif ications of EU Directive 89/686/EEC and the standard EN 374 derived from it. PPE - Body Protection The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specif ic workplace. PPE - Respiratory Protection For nuisance exposures use type P95 (US) or type P1 (EU EN 143) particle respirator. For higher level protection use type OV/AG/P99 (US) or type ABEK-P2 (EU EN 143) respirator cartridges. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Page 2 of 4 Section 9: Physical and Chemical Properties Appearance White crystalline powder Upper/Lower Flammability or Explosive Limits No data available Odor Odorless Vapor Pressure No data available Odor Threshold No data available Vapor Density No data available pH 7.0-8.0 (2.5g/50ml) Relative Density No data available Melting Point/Freezing Point Melting point: >300�C Solubility Water solubility Easily 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 >300�C Viscosity N/A Section 10: Stability and Reactivity Reactivity No data available Chemical Stability Stable under recommended storage conditions Possibility of Hazardous Reactions No data available Conditions to Avoid No data available Incompatible Materials Strong oxidizing agents, acids and bases Hazardous Decomposition Products Other decomposition products - no data available Section 11: Toxicological Information Acute Toxicity - LD50 Oral LD50 Oral - mouse - > 10000 mg/kg Acute Toxicity - Inhalation No data available Acute Toxicity - Dermal No data available Acute Toxicity - Eye No data available Skin Corrosion/Irritation No data available Serious Eye Damage/Irritation No data available Respiratory or Skin Sensitazation No data available Germ Cell Mutagenicity No data available Carcinogenicity IARC No component of this product present at levels greater than or equal to 0.1% is identif ied as probable, possible or conf irmed human carcinogen by IARC. Carcinogenicity ACGIH No data available Carcinogenicity NTP No data available Carcinogenicity OSHA No data available Reproductive Toxicity Ef f ects on Fertility: Female f ertility index (e.g., # f emales pregnant per # sperm positive f emales; # f emales pregnant per # f emales mated ). Reproductive toxicity - mouse - Oral Ef f ects on Newborn: Weaning or lactation index (e.g., # alive at weaning per # alive at day 4). Developmental Toxicity - rat - Oral Ef f ects on Embryo or Fetus: Fetotoxicity (except death, e.g., stunted f etus). Specific Target Organ Toxicity - Single Exposure Inhalation - May cause respiratory irritation Specific Target Organ Toxicity - Repeated Exposure No data available Aspiration Hazard No data available Page 3 of 4 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 Of f er surplus and non-recyclable solutions to a licensed disposal company. Contact a licensed prof essional waste disposal service to dispose of this material. Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an af terburner and scrubber. Waste Treatment Methods Packaging Dispose of as unused product. 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 Section 15: Regulatory Information This saf ety datasheet complies with the requirements of Regulation (EC) No. 1907/2006. Saf ety, health and environmental regulations/legislation specif ic f or the substance or mixture. No data available Chemical Saf ety Assessment Section 16: Other Information Additional Information N/A Prepared By Lisa Russell Revision Date 01/03/2019 14:44 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
