SUCRALFATE, USP 1KG by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name SUCRALFATE 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) Aluminum, hexadeca-mu-hydroxytetracosahydroxy(mu(sup 8)-(1,3,4,6-tetra-O-sulf o-beta-D-fructof uranosyl-alpha-Dglucopyranoside tetrakis(hydrogen sulf ato)(8-)))hexadecaRelevant 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 Aluminum, hexadeca-mu-hydroxytetracosahydroxy(mu(sup 8)-(1,3,4,6-tetra-O-sulf o-beta-D-fructof uranosyl-alpha-Dglucopyranoside tetrakis(hydrogen sulf ato)(8-)))hexadecaCommon Name Sucralf ate CAS Number 54182-58-0 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice No data available If Inhaled Remove to open air. If the subject stops breathing, administer artif icial respiration. Get medical advice/attention immediately. In Case of Skin Contact Remove contaminated clothing. Rinse skin with a shower immediately. Get medical advice/attention immediately. Wash contaminated clothing bef ore using it again. In Case of Eye Contact Remove contact lenses, if present Wash immediately with plenty of water f or at least 15 minutes, opening the eyelids f ully. If problem persists, seek medical advice If Swallowed Get medical advice/attention immediately. Do not induce vomiting. Do not administer anything not explicitly authorised by a doctor. Most Important Symptoms and Effects For symptoms and ef f ects caused by the contained substances, see chap. 11. Section 5: Fire Fighting Measures Suitable Extinguishing Media The extinguishing equipment should be of the conventional kind: carbon dioxide, f oam, powder and water spray. Special Hazards Arising From the Substance/Mixture Do not breathe combustion products.The product is combustible and, when the powder is released into the air in suf f icient concentrations and in the presence of a source of ignition, it can create explosive mixtures with air. Fires may start or get worse by leakage of the solid product from the container, when it reaches high temperatures or through contact with sources of ignition. Special PPE and/or Precautions for Firefighters GENERAL INFORMATION Use jets of water to cool the containers to prevent product decomposition and the development of substances potentially hazardous f or health. Always wear f ull f ire prevention gear. Collect extinguishing water to prevent it from draining into the sewer system. Dispose of contaminated water used f or extinction and the remains of the f ire according to applicable regulations. SPECIAL PROTECTIVE EQUIPMENT FOR FIRE-FIGHTERSNormal f ire f ighting clothing i.e. f ire kit (BS EN 469), gloves (BS EN 659) and boots (HO specif ication A29 and A30) in combination with self-contained open circuit positive pressure compressed air breathing apparatus (BS EN 137). Page 1 of 4 Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Use breathing equipment if f umes or powders are released into the air. These indications apply f or both processing staf f and those involved in emergency procedures. Methods and Materials Used for Containment The product must not penetrate into the sewer system or come into contact with surf ace water or ground water. Cleanup Procedures Conf ine using earth or inert material. Collect as much material as possible and eliminate the rest using jets of water. Contaminated material should be disposed of in compliance with the provisions set f orth in point 13. Section 7: Handling and Storage Precautions for Safe Handling Keep away from heat, sparks and naked f lames; do not smoke or use matches or lighters. Without adequate ventilation, vapours may accumulate at ground level and, if ignited, catch f ire even at a distance, with the danger of backf ire. Avoid bunching of electrostatic charges. Do not eat, drink or smoke during use. Remove any contaminated clothes and personal protective equipment bef ore entering places in which people eat. Avoid leakage of the product into the environment. Conditions for Safe Storage Store only in the original container. Store in a well ventilated place, keep f ar away from sources of heat, naked f lames and sparks and other sources of ignition. Keep containers away from any incompatible materials, see section 10 f or details. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters Inf ormation not available. OEL SUGGESTED BY EUTICALS : 1 mg/mc OEL-KOREA: TWA 2 mg(Al)/m3, 2006 OEL-NEW ZEALAND: TWA 2 mg(Al)/m3, JAN2002 OEL-RUSSIA: STEL 2 mg/m3, JUN2003 (RTECS Database : last update : 10.2012). Appropriate Engineering Controls Work with adequate localised aspiration systems. Use of adequate technical measures should always take priority over personal protective equipment. Respect general rules of hygiene such as: storing work overalls separately from normal clothes; not smoking, eating and/or drinking outside the designated areas; washing hands bef ore eating or smoking. PPE - Eye/Face Protection Wear airtight goggles, in compliance with applicable EN standards. PPE - Skin Protection Wear chemical protection overalls, in compliance with applicable EN standards. Wear chemical protection gloves, in compliance with applicable EN standards. PPE - Body Protection Wear chemical protection overalls, in compliance with applicable EN standards. Wear chemical protection gloves, in compliance with applicable EN standards. PPE - Respiratory Protection Wear f acemask with P3 dust f ilter, in compliance with applicable EN standards. Section 9: Physical and Chemical Properties Appearance Appearance: powder. Colour: white or almost white. Upper/Lower Flammability or Explosive Limits No data available Odor Odorless Vapor Pressure Not available Odor Threshold Not available Vapor Density Not available pH Not available Relative Density Not available Melting Point/Freezing Point Not available Solubility insoluble in water Initial Boiling Point and Boiling Range Not available Flash Point Not available Evaporation Rate Not available Flammability (Solid, Gas) Not available Partition Coefficient Not available Auto-Ignition Temperature Not available Decomposition Temperature Not available Viscosity Not available Page 2 of 4 Section 10: Stability and Reactivity Reactivity There are no particular risks of reaction with other substances in normal conditions of use. Chemical Stability The product is stable in normal conditions of use and storage. Possibility of Hazardous Reactions No hazardous reactions are f oreseeable in normal conditions of use and storage. Conditions to Avoid None in particular. However the usual precautions used f or chemical products should be respected Incompatible Materials Inf ormation not available. Hazardous Decomposition Products Inf ormation not available. Section 11: Toxicological Information Acute Toxicity - LD50 Oral LD50 (Oral). > 12000 mg rat 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 data available Carcinogenicity ACGIH No data available Carcinogenicity NTP No data available Carcinogenicity OSHA No data available Reproductive Toxicity No data available Specific Target Organ Toxicity - Single Exposure No data available Specific Target Organ Toxicity - Repeated Exposure No data available Aspiration Hazard No data available Section 12: Ecological Information Toxicity Inf ormation not available. Persistence and Degradability Inf ormation not available. Bio-accumulative Potential Inf ormation not available. Mobility in Soil Inf ormation not available. Other Adverse Effects Inf ormation not available. Section 13: Disposal Considerations Waste Treatment Methods Product Reuse, when possible. Neat product residues should be considered special non-hazardous waste. Disposal must be perf ormed through an authorised waste management f irm, in compliance with national and local regulations. Avoid littering. Do not contaminate soil, sewers and waterways. Solid residues may be suitable f or disposal in an authorised landf ill site. Waste Treatment Methods Packaging Contaminated packaging must be recovered or disposed of in compliance with national waste management regulations. 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 3 of 4 Section 15: Regulatory Information Seveso category. None. Restrictions relating to the product or contained substances pursuant to Annex XVII to EC Regulation 1907/2006. None. Substances in Candidate List (Art. 59 REACH). None. Substances subject to authorisarion (Annex XIV REACH). None. Substances subject to exportation reporting pursuant to (EC) Reg. 689/2008: None. Substances subject to the Rotterdam Convention: None. Substances subject to the Stockholm Convention: None. Healthcare controls. Inf ormation not available. Chemical saf ety assessment. No chemical saf ety assessment has been processed f or the mixture and the substances it contains. Section 16: Other Information Additional Information Molecular weight. 2086,82 Explosion class 0 (*) Explosion pressure 0 pMax (*) Pressure grade 0 dP/dt (*) Kst (bar*m/s) 0 (*) Minimum ignition temperature (MI) > 500 �?° C (*) Minimum ignition energy (MIE) (mjoules) Estimated : > 1000 mJ (*) (*) Redox snc (Italy) - RP.075/13 No GxP . Prepared By Lisa Russell Revision Date 01/08/2019 13:17 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
