TROMETHAMINE, USP 1KG by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name TROMETHAMINE 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) trometamol Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Not a hazardous substance or mixture. Signal Word None Hazard Statement(s) N/A Pictogram(s) N/A Precautionary Statement(s) N/A Hazards Not Otherwise Classified No data available Ingredient(s) with Unknown Toxicity No data available Section 3: Composition/Information on Ingredients Chemical Name Tris (hydroxymethyl)-aminomethane Common Name Tromethamine CAS Number 77-86-1 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice Notes to physician: No specif ic antidote. Treatment of exposure should be directed at the control of symptoms and the clinical condition of the patient. If Inhaled Move person into fresh air; If ef f ects occur, consult a physician. In Case of Skin Contact Wash of f with plenty of water. In Case of Eye Contact Flush eyes thoroughly with water f or several minutes. Remove contact lenses af ter the initial 1-2 minutes and continue f lushing f or several additional minutes. If ef f ects occur, consult a physician, pref erably and ophthalmologist. If Swallowed No emergency medical treatment necessary. Most Important Symptoms and Effects Aside from the inf ormation f ound under Description of f irst aid measures (above) and Indication of immediate medical attention and special treatment needed (see General Advice: notes to physician), any additional important symptoms and ef f ects are described in Section 11: Toxicology Inf ormation. Section 5: Fire Fighting Measures Suitable Extinguishing Media Water. Dry chemical f ire extinguishers. Carbon dioxide f ire extinguishers. Special Hazards Arising From the Substance/Mixture During a f ire, smoke may contain the original material in addition to combustion products of varying composition which may be toxic and/or irritating. Combustion products may include and are not limited to: Nitrogen oxides. Carbon monoxide. Carbon dioxide. Unusual Fire and Explosion Hazards: Container may rupture from gas generation in a f ire situation. Pneumatic conveying and other mechanical handling operations can generate combustible dust. To reduce the potential f or dust explosions, do not permit dust to accumulate. Special PPE and/or Precautions for Firefighters Fire Fighting Procedures: Keep people away. Isolate f ire and deny unnecessary entry. Soak thoroughly with water to cool and prevent re-ignition. Use water spray to cool f ire exposed containers and f ire af f ected zone until f ire is out and danger of reignition has passed. Fight f ire from protected location or saf e distance. Consider the use of unmanned hose holders or monitor nozzles. Immediately withdraw all personnel from the area in case of rising sound from venting saf ety device or discoloration of the container. Hand held dry chemical or carbon dioxide extinguishers may be used f or small f ires. Move container from f ire area if this is possible without hazard. Special protective equipment f or f iref ighters: Wear positive-pressure self-contained breathing apparatus (SCBA) and protective f ire f ighting clothing (includes f ire f ighting helmet, coat, trousers, boots, and gloves). If protective equipment is not available or not used, f ight f ire from a protected location or saf e distance. Page 1 of 4 Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Keep unnecessary and unprotected personnel from entering the area. Use appropriate saf ety equipment. For additional inf ormation, ref er to Section 8, Exposure Controls and Personal Protection. Methods and Materials Used for Containment Prevent from entering into soil, ditches, sewers, waterways and/or groundwater. See Section 12, Ecological Inf ormation. Cleanup Procedures Contain spilled material if possible. Use care to minimize generation of airborne dust. Collect in suitable and properly labeled containers. See Section 13, Disposal Considerations, f or additional inf ormation. Section 7: Handling and Storage Precautions for Safe Handling Avoid generating and breathing dust. Keep container closed. Good housekeeping and controlling of dusts are necessary f or saf e handling of product. See Section 8, EXPOSURE CONTROLS AND PERSONAL PROTECTION. Conditions for Safe Storage Store in a dry place. Do not store in: Zinc. Galvanized containers. Aluminum. Copper. Copper alloys. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters Exposure limits: None established. Appropriate Engineering Controls Use local exhaust ventilation, or other engineering controls to maintain airborne levels below exposure limit requirements or guidelines. If there are no applicable exposure limit requirements or guidelines, general ventilation should be suf f icient f or most operations. Local exhaust ventilation may be necessary f or some operations. PPE - Eye/Face Protection Use saf ety glasses (with side shields). PPE - Skin Protection Use gloves chemically resistant to this material when prolonged or frequently repeated contact could occur. Examples of pref erred glove barrier materials include: Neoprene. Nitrile/butadiene rubber ("nitrile" or "NBR"). Polyvinyl chloride ("PVC" or "vinyl"). NOTICE: The selection of a specif ic glove f or a particular application and duration of use in a workplace should also take into account all relevant workplace f actors such as, but not limited to: Other chemicals which may be handled, physical requirements (cut/puncture protection, dexterity, thermal protection), potential body reactions to glove materials, as well as the instructions/specif ications provided by the glove supplier. PPE - Body Protection Wear clean, body-covering clothing. PPE - Respiratory Protection Respiratory protection should be worn when there is a potential to exceed the exposure limit requirements or guidelines. If there are no applicable exposure limit requirements or guidelines, wear respiratory protection when adverse ef f ects, such as respiratory irritation or discomf ort have been experienced, or where indicated by your risk assessment process. In dusty or misty atmospheres, use an approved particulate respirator. The f ollowing should be ef f ective types of air-purif ying respirators: Particulate f ilter. Section 9: Physical and Chemical Properties Appearance White Crystals Upper/Lower Flammability or Explosive Limits No test data available Odor Odorless Vapor Pressure Literature Nil Odor Threshold No test data available Vapor Density No data available pH 10.4 Literature 1% aqueous solution. Relative Density No test data available Melting Point/Freezing Point 171-172°C (340-342°F) Literature Solubility Water solubility: Literature Soluble Initial Boiling Point and Boiling Range Not applicable Flash Point closed cup Not applicable Evaporation Rate No test data available Flammability (Solid, Gas) (solid, gas): No Partition Coefficient log Pow: -2.31 Measured Auto-Ignition Temperature No test data available Decomposition Temperature No test data available Viscosity Not applicable Page 2 of 4 Section 10: Stability and Reactivity Reactivity No dangerous reaction known under conditions of normal use. Chemical Stability Stable under recommended storage conditions. See Storage, Section 7. Hygroscopic. Possibility of Hazardous Reactions Polymerization will not occur. Conditions to Avoid Exposure to elevated temperatures can cause product to decompose. Generation of gas during decomposition can cause pressure in closed systems. Avoid moisture. Incompatible Materials Avoid contact with: Strong acids. Strong oxidizers. Avoid contact with metals such as: Aluminum. Zinc. Copper. Copper alloys. Galvanized metals. Avoid unintended contact with: Halogenated hydrocarbons. Hazardous Decomposition Products Decomposition products depend upon temperature, air supply and the presence of other materials. Section 11: Toxicological Information Acute Toxicity - LD50 Oral Very low toxicity if swallowed. Harmf ul ef f ects not anticipated from swallowing small amounts. LD50 Oral - rat - > 5,000 mg/kg. No deaths occurred at this concentration. Acute Toxicity - Inhalation Vapors are unlikely due to physical properties. Dust may cause irritation to upper respiratory tract (nose and throat). LC50 has not been determined. Acute Toxicity - Dermal Prolonged skin contact is unlikely to result in absorption of harmf ul amounts. LD50 Dermal - rat -male and f emale > 5,000 mg/kg OECD 402 or equivalent. No deaths occurred at this concentration. Acute Toxicity - Eye No data available. Skin Corrosion/Irritation Brief contact is essentially nonirritating to skin. Prolonged contact is essentially nonirritating to skin. Serious Eye Damage/Irritation May cause slight temporary eye irritation. Corneal injury is unlikely. Respiratory or Skin Sensitazation For skin sensitization: Did not cause allergic skin reactions when tested in guinea pigs. Respiratory sensitization: No relevant data f ound. Germ Cell Mutagenicity In vitro genetic toxicity studies were negative. Teratogenicity: For similar materials(s): Did not cause birth def ects or any other f etal ef f ects in laboratory animals. Carcinogenicity IARC No relevant data f ound. Carcinogenicity ACGIH No relevant data f ound. Carcinogenicity NTP No relevant data f ound. Carcinogenicity OSHA No relevant data f ound. Reproductive Toxicity In animal studies, did not interf ere with reproduction. Specific Target Organ Toxicity - Single Exposure Evaluation of available data suggests that this material is not an STOT-SE toxicant. Specific Target Organ Toxicity - Repeated Exposure Based on available data, repeated exposures are not anticipated to cause signif icant adverse ef f ects. Aspiration Hazard Product test data not available. Section 12: Ecological Information Toxicity Acute toxicity to f ish: Material is practically non-toxic to f ish on an acute basis (LC50>100 mg/L). For similar material(s): LC50, zebra f ish (Brachydanio rerio), 96 Hour, 460 mg/l. Acute toxicity to aquatic invertebrates: EC50, Daphnia magna (Water f lea), 48 Hour, 980 mg/l. Acute toxicity to algae/aquatic plants: ErC50, Pseudokirchneriella subcapitata (green algae), 72 Hour, Growth rate, 397 mg/l. Chronic aquatic toxicity. Chronic toxicity to aquatic invertebrates: For similar material(s): NOEC, water f lea Daphnia magna, 21 d, number of of f spring, 3.99 mg/l. Persistence and Degradability Material is readily biodegradable. Passes OECD test(s) f or ready biodegradability. 10-day Window: Pass. Biodegradation: 100%. Exposure time: 28 d. Method: OECD Test Guideline 301F or Equivalent. Bio-accumulative Potential Bioaccumulation: Bioconcentration potential is low (BCF < 100 or Log Pow < 3). Partition coef f icient: n-octanol/water (log Pow): -2.31 Measured. Mobility in Soil Potential f or mobility in soil is high (Koc between 50 and 150). Partition coef f icient (Koc): 75 Estimated. Other Adverse Effects No data available Section 13: Disposal Considerations Waste Treatment Methods Product DO NOT DUMP INTO ANY SEWERS, ON THE GROUND, OR INTO ANY BODY OF WATER. All disposal practices must be in compliance with all Federal, State/Provincial and local laws and regulations. Regulations may vary in dif f erent locations. Waste characterizations and compliance with applicable laws are the responsibility solely of the waste generator. Waste Treatment Methods Packaging FOR UNUSED & UNCONTAMINATED PRODUCT, the pref erred options include sending to a licensed, permitted: Landf ill. Incinerator or other thermal destruction device. Special Precautions Landfill or Incinerations No data available Other Information No data available Page 3 of 4 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 N/A Section 15: Regulatory Information OSHA Hazard Communication Standard: This product is not a "Hazardous Chemical" as def ined by the OSHA Hazard Communication Standard, 29 CFR 1910.1200. Superf und Amendments and Reauthorization Act of 1986 Title III (Emergency Planning and Community Right-to-Know Act of 1986) Sections 311 and 312: This product is not a hazardous chemical under 29CFR 1910.1200, and theref ore is not covered by Title III of SARA. Superf und Amendments and Reauthorization Act of 1986 Title III (Emergency Planning and Community Right-to-Know Act of 1986)Section 313: This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313. Calif ornia Proposition 65 (Saf e Drinking Water and Toxic Enf orcement Act of 1986): This product contains no listed substances known to the State of Calif ornia to cause cancer, birth def ects, or other reproductive harm, at levels which would require a warning under the statute. Pennsylvania Worker and Community Right-To-Know Act: To the best of our knowledge, this product does not contain chemicals at levels which require reporting under this statute. Unite States TSCA Inventory (TSCA): All components of this product are in compliance with the inventory listing requirements of the U.S. Toxic Substances Control Act (TSCA) Chemical Substance Inventory. Section 16: Other Information Additional Information Hazard Rating System, NFPA: Health-0, Fire-1, Reactivity-0 Prepared By Lisa Russell Revision Date 01/07/2019 17:11 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
