HYDROXYZINE PAMOATE, USP 100GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name HYDROXYZINE PAMOATE 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) ethanol, 2-(2-(4-((4-chlorophenyl)phenylmeethyl)-1-piperazinyl)ethoxy)-, compd. with 4-4'methylenebis (3-hydroxy-2- naphtalenecarboxylic acid) (1:1) Relevant Use(s) of Product Manuf acture or Compounding of Substances Section 2: Hazards Identification Classification of Substance or Mixture Acute toxicity, Oral (Category 4) Signal Word Warning Hazard Statement(s) H302 Harmf ul if swallowed Pictogram(s) Precautionary Statement(s) P264 Wash hands thoroughly af ter handling. P270 Do not eat, drink or smoke when using this product. P301+P312 IF SWALLOWED Call a POISON CENTER or doctor/physician if you f eel unwell. P330 Rinse mouth. 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 4-[(3-carboxy-2-hydroxynaphthalen-1-yl)methyl]-3-hydroxynaphthalene-2-carboxylic acid; 2-[2-[4-[(4-chlorophenyl)- phenylmethyl]piperazin-1-yl]ethoxy]ethanol Common Name Hydroxyzine Pamoate CAS Number 10246-75-0 Impurities and/or Stabilizing Additives No data available Section 4: First Aid Measures General Advice Consult a physician. Show this saf ety data sheet to the doctor in attendance. Move out of dangerous area. If Inhaled Avoid breathing aerosols and dusts that may be generated from handling the product. Move the person from the exposed area to fresh air immediately. Get medical advice if adverse symptoms will appear or if the exposure was signif icantly long or intense. In Case of Skin Contact Remove contaminated clothes and shoes immediately. Wash af f ected area with soap or mild detergent and large amount of water until no evidence of substance remains (15-20 minutes). Get medical advice and show the label to the doctor. In Case of Eye Contact Wash thoroughly with water or saline. Keep the eyelids open during f lushing. Consult your doctor and show the label in case of adverse ef f ects. If Swallowed If swallowed, rinse mouth thoroughly with water if the person is conscious. Get immediately medical advice and show the label to the doctor. Most Important Symptoms and Effects Acute ef f ects: Ingestion: harmf ul if swallowed. Exposure through inhalation: may cause irritation. Skin Contact: may cause irritation. Eye contact: may cause irritation. Delayed ef f ects: There are no symptoms and delayed ef f ects attributable to this substance. Indication of any immediate medical attention and special treatment needed: Medical monitoring: Not required on the basis of the classif ication of the substance. Antidotes, if known: There are no known antidotes. Contraindications: There are not contraindications. Immediate treatment at workplace: Not Required. Page 1 of 4 Section 5: Fire Fighting Measures Suitable Extinguishing Media Suitable: Water spray, CO2, dry powder. Unsuitable: None Special Hazards Arising From the Substance/Mixture May produce toxic f umes of COx, NOx, HCL Special PPE and/or Precautions for Firefighters Do not attempt to extinguish the f ire without the use of self-contained breathing apparatus (SCBA) and appropriate protective clothing. Wear boots, gloves, eye and f ace protection, respirators, comply with relevant standards UNI f or Italy and EN f or Europe. Use the recommended devices in the best conditions of care based on the inf ormation reported in the previous subsection. Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures For non-emergency personnel: Eye: Wear appropriate protective equipment (see section 8). Skin: Wear f ull body protection clothing. Inhalation: In case of f ire and explosion avoid breathing f umes and vapors. Use a self-contained breathing apparatus (SCBA) and appropriate protective clothing. the f umes can be eliminated by spraying with water. See also section 8. In case of accidental spilling (non in normal condition of use) the use of Personal Protection Equipment is always recommended. This PPE must be in accordance with EN criteria. Methods and Materials Used for Containment In case of accidental release in the environment avoid that the substance can reach drains, surf ace water and ground water. Limit leakages with earth or sand. Collect the product and send it to the incinerator. If necessary absorb it with inert material. Af ter collection, rinse area and materials involved with water. Cleanup Procedures In case of accidental release in the environment avoid that the substance can reach drains, surf ace water and ground water. Limit leakages with earth or sand. Collect the product and send it to the incinerator. If necessary absorb it with inert material. Af ter collection, rinse area and materials involved with water. Section 7: Handling and Storage Precautions for Safe Handling Handle away from sparks and f lames -sources of ignition. Handle in a well ventilated place. Avoid contact with incompatible materials. Wear suitable personal protective equipment (see section 8). Keep the mixture away from drains, surf ace or ground waters. Do not eat, drink, and smoke in the working areas. Wash hands af ter handling mixture. Remove contaminated clothing and protective equipment bef ore entering eating areas. Conditions for Safe Storage Do not expose to temperatures exceeding 40�???�??�?°C, it could cause swelling of the container due to the development of gas. No containment procedure estimated. Store at room temperature (15-30�???�??�?°C). Below 40�???�??�?°C. Do not expose to direct sunlight. Do not store in humid environment. No containment procedure estimated. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters Not present in the consulted databases. The measurements of the substance/s) in the workplace must be carried out in accordance with standardized methods described by EN guidances. Appropriate Engineering Controls The adoption of the most appropriate engineering controls is also based on the local Risk Assessment done by the employer in its workplace conditions (use of mixture), particularly when a standardized exposure scenario is not available (ingredients in the mixture are not yet REACH registered). PPE - Eye/Face Protection Saf ety goggles as f or EN 166; f acial shield PPE - Skin Protection Wear protective gloves f or non classif ied substances. Gloves resistant to chemical agents as f or the EN 374, parts 1, 2, e 3 and the European Directive 89/89/CEE f or classif ied substances. The gloves material must be waterproof and stable against the mixture content. Select the glove material on the basis of the type of the material, typical or minimal breakdown times, permeability ranges, thickness. PPE - Body Protection Select the suitable protective equipment based on the activity of use and possible exposure. Wear gauntlets, boots, bodysuit and other devices in accordance with EN 14605 in case of sketches or EN 13982 in case of powders. PPE - Respiratory Protection When the risk evaluation f oresees the need to use respirator devices with assisted ventilation, use a powder f ilter like P1, P2, and P3. Use only devices approved by the Competent Authorities such as NIOSH (USA) and CEN (EU). Page 2 of 4 Section 9: Physical and Chemical Properties Appearance Yellow powder. Upper/Lower Flammability or Explosive Limits Lower: 90 mg/L Odor Odorless Vapor Pressure Not present in the consulted databases Odor Threshold Not present in the consulted databases Vapor Density Not present in the consulted databases pH Not present in the consulted databases Relative Density Not present in the consulted databases Melting Point/Freezing Point >250°C Solubility Water solubility: Insoluble. Organic solvent solubility: Soluble in dimethylf ormamide. Initial Boiling Point and Boiling Range Not present in the consulted databases Flash Point Not present in the consulted databases Evaporation Rate Not present in the consulted databases Flammability (Solid, Gas) Not present in the consulted databases Partition Coefficient Not present in the consulted databases Auto-Ignition Temperature 420°C Decomposition Temperature Not present in the consulted databases Viscosity Not present in the consulted databases Section 10: Stability and Reactivity Reactivity Under normal operating conditions the substance is not considered reactive. Chemical Stability The substance is stable at the normal condition of temperature and pressure and if stored in closed containers in well ventilated and cool place. Possibility of Hazardous Reactions Possibility of an exothermic reaction: No. Possibility of a reaction re leasing excessive pressure: No. Possible degradation with instable product f ormation: No Conditions to Avoid Do not expose to heat sources. Keep away from temperature above 40�???�??�?°C. Incompatible Materials Avoid contact with alkalis. Hazardous Decomposition Products If heated at high temperatures, decomposes re leasing f umes and toxic gases of COx, NOx, HCL. Section 11: Toxicological Information Acute Toxicity - LD50 Oral LD50 rat: 1740 mg/kg Acute Toxicity - Inhalation None present in the consulted databases Acute Toxicity - Dermal None present in the consulted databases Acute Toxicity - Eye No data available Skin Corrosion/Irritation None present in the consulted databases. Serious Eye Damage/Irritation Severe ocular lesion: None expected. Respiratory or Skin Sensitazation None present in the consulted databases Germ Cell Mutagenicity None present in the consulted databases. Negative in the Ames test. Carcinogenicity IARC Not available studies. Not present in the NTP, IARC and OSHA lists. Carcinogenicity ACGIH Not available studies. Not present in the NTP, IARC and OSHA lists. Carcinogenicity NTP Not available studies. Not present in the NTP, IARC and OSHA lists. Carcinogenicity OSHA Not available studies. Not present in the NTP, IARC and OSHA lists. Reproductive Toxicity Studies in rats have shown that it causes f etal abnormalities at doses substantially above the human therapeutic range. RTECS number: QL2200000 Specific Target Organ Toxicity - Single Exposure Not present in the consulted databases. Specific Target Organ Toxicity - Repeated Exposure Not present in the consulted databases. Aspiration Hazard Not present in the consulted databases. Page 3 of 4 Section 12: Ecological Information Toxicity No data available Persistence and Degradability Not present in the consulted databases. Bio-accumulative Potential Not present in the consulted databases. Log Pow (pred.) idrossizine: 2.82 Mobility in Soil Not present in the consulted databases Other Adverse Effects Not present in the consulted databases Section 13: Disposal Considerations Waste Treatment Methods Product Mixture wastes: Incineration. Contaminated packaging: Incineration. Recover if possible. Send to authorized disposal plants or f or incineration under controlled conditions. Operate in compliance with local and national regulations. Waste Treatment Methods Packaging Mixture wastes: Incineration. Contaminated packaging: Incineration. Recover if possible. Send to authorized disposal plants or f or incineration under controlled conditions. Operate in compliance with local and national 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 N/A Section 15: Regulatory Information Saf ety, Health and Environmental regulation/legislation specif ic f or the mixture of its ingredients: Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the saf ety and health of workers at work (Of f iical Journal L 183, 29/06/1989 P. 0001-0008) and f ollowing amendment and national reinf orcements. Council Directive 89/686 /EEC of 21 December 1989 on the approximation of the laws of the Member States relating to the personal protective equipment. Council Directive 98/24/EC of 7 April 1998 on the protection of the health and saf ety of workers from the risks related to chemical agents at work (f ourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) Of f icial Journal L 131, 05/05/1998 P. 0011-0023. Section 16: Other Information Additional Information N/A Prepared By Lisa Russell Revision Date 01/11/2019 13:52 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
