SILDENAFIL CITRATE 25GM by Letco Medical Safety Data Sheet Section 1: Identification Common Name/Trade Name Sildenaf il Citrate 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) 1-[4-Ethoxy-3-(6, 7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl) phenylsulf onyl]-4- methylpiperazine citrate. 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, Skin corrosion/Irritation, Category 2, Serious eye damage/Eye irritation, Category 2, Target organ systemic toxicity (single exposure), Category 3, Aquatic toxicity (Chronic), Category 3 Signal Word Warning Hazard Statement(s) H302 Harmf ul if swallowed H315 Causes skin irritation H319 Causes serious eye irritation H334 May cause allergy or asthma symptoms or breathing dif f iculties if inhaled H335 May cause respiratory irritation H412 Harmf ul to aquatic lif e with long lasting ef f ects Pictogram(s) Precautionary Statement(s) P261 Avoid breathing dust/f ume/gas/mist/vapours/spray. P264 Wash hands thoroughly af ter handling. P273 Avoid release to the environment. P280 Wear protective gloves/protective clothing/eye protection/f ace protection. P301+P312 IF SWALLOWED Call a POISON CENTER or doctor/physician if you f eel unwell. P302+P352 IF ON SKIN Wash with soap and water. P330 Rinse mouth. P332+P313 If skin irritation occurs Get medical advice/attention. P337+P313 If eye irritation persists Get medical advice/attention. P362 Take of f contaminated clothing and wash bef ore reuse. Hazards Not Otherwise Classified No data available Ingredient(s) with Unknown Toxicity No data available Section 3: Composition/Information on Ingredients Chemical Name 5-[2-ethoxy-5(4-methylpiperazinylsulf onyl)phenyl]-1-methyl-3-n-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7- one.; citrate Common Name Sildenaf il Citrate CAS Number 171599-83-0 Impurities and/or Stabilizing Additives N/A Section 4: First Aid Measures General Advice Not available If Inhaled Remove to fresh air. If not breathing give artif icial respiration. If breathing is dif f icult, give oxygen. Seek medical attention. In Case of Skin Contact Immediately wash skin with soap and copious amounts of water f or at least 15 minutes. If irritation persists, seek medical attention. In Case of Eye Contact Immediately f lush eyes with copious amounts of water f or at least 15 minutes. Seek medical advice. If Swallowed If swallowed, wash out mouth with water, provided person is conscious. Seek medical advice. Most Important Symptoms and Effects Adverse Ef f ects: Adverse ef f ects most commonly reported in clinical use include dif f icult digestion (dyspepsia), nose bleed, headache, f lushing, insomnia, abnormal redness of skin (erythema), dif f iculty breathing, muscle pain, f ever, gastroentestinal irritation, tingling/itching (paresthesia), transient changes in light perception and color vision, ef f ects on hearing, and ef f ects on vision. Page 1 of 5 Section 5: Fire Fighting Measures Suitable Extinguishing Media Use carbon dioxide, dry chemical, or water spray. Unsuitable extinguishing agents: Formation of toxic gases is possible during heating or f ire. Special Hazards Arising From the Substance/Mixture This material is assumed to be combustible. As with all dry powders it is advisable to ground mechanical equipment in contact with dry material to dissipate the potential buildup of static electricity. Fine particles (such as dust and mists) may f uel f ires/explosions. Special PPE and/or Precautions for Firefighters During all f iref ighting activities, wear appropriate protective equipment, including self-contained breathing apparatus. Section 6: Accidental Release Measures Personal Precautions, Protective Equipment and Emergency Procedures Ensuring personal saf ety, mark out contaminated area with signs and prevent unauthorized access. Turn leaking containers up to prevent f urther Evacuate area. Wear self-contained breathing apparatus, rubber boots & heavy rubber gloves. Sweep up/absorb in suitable material, place in a container and hold f or disposal. Avoid raising dust. Ventilate area and wash spill site af ter pick-up complete. Methods and Materials Used for Containment Prevent entry into waterways, sewers, surf ace drainage systems and poorly ventilated areas. Cleanup Procedures Small Spill: Contain the source of spill if it is saf e to do so. Collect spilled material by a method that controls dust generation. A damp cloth or a f iltered vacuum should be used to clean spills of dry solids. Clean spill area thoroughly. Large Spill: Non-essential personnel should be evacuated from af f ected area. Report emergency situations immediately. Clean up operations should only be undertaken by trained personnel. Section 7: Handling and Storage Precautions for Safe Handling Sildenaf il citrate is slightly-hygroscopic substances at normal conditions of temperature and relative humidity. While handle the material avoid all contact and inhalation of dust, and or vapors associated with this material. Wash thoroughly af ter handling. Conditions for Safe Storage Preserve in air-tight, containers. Store below 30�????�???�??�?°C. This material should be handled and stored per label instructions to ensure product integrity. Section 8: Exposure Controls/Personal Protection Components with Workplace Control Parameters Exposure limits: Industry: 8-minute *OEL: 350 micrograms/m3 Appropriate Engineering Controls Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, f ume or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit. Airborne exposure 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. Local exhuast ventilation such as a laboratory f ume hood or other vented enclosure is recommended, particularly f or grinding, crushing, weighing, or other dust-generating procedures. General protective and hygienic measures: The usual precautionary measures are to be adhered to when handling chemicals. Do not drink, eat and smoke while working. Avoid contact with the eye and skin. Keep away from f ood stuf f s, f eed and beverages. 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 are. PPE - Skin Protection Protective coveralls should be worn. The sleeves should either be taped or have gloves worn over them to prevent material from contacting the skin. PPE - Body Protection .Protective coveralls should be worn. The sleeves should either be taped or have gloves worn over them to prevent material from contacting the skin. PPE - Respiratory Protection Respiratory protection is not required. Where protection from nuisance levels of dusts are desired, use type N95(US) or type P1 (EN 143) dust masks. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Page 2 of 5 Section 9: Physical and Chemical Properties Appearance White or almost white crystalline powder. Upper/Lower Flammability or Explosive Limits Not f ound. Odor Odorless Vapor Pressure 00 mgHg at 25�?°C Odor Threshold No data available Vapor Density No data available pH Not f ound Relative Density Not f ound Melting Point/Freezing Point Not f ound Solubility Slightly soluble in water and in methanol. Initial Boiling Point and Boiling Range No data available Flash Point 376.372�?°C Evaporation Rate No data available Flammability (Solid, Gas) Not f ound Partition Coefficient Not f ound Auto-Ignition Temperature Not f ound Decomposition Temperature Between 185.0 and 195.0 with decomposition Viscosity No data available Section 10: Stability and Reactivity Reactivity No data available Chemical Stability Stable under normal conditions of use. Possibility of Hazardous Reactions Avoid excessive heat (Temperatures above 70C may result in exothermic decomposition) Conditions to Avoid Avoid direct sunlight, conditions that might generate heat and sources of ignition. Incompatible Materials As a precautionary measure, keep away from strong oxidizers. Hazardous Decomposition Products This material is combustible. When heated to de-composition, material emits toxic f umes of sox, nox, and Hcl. Emits toxic f umes under f ire conditions. Page 3 of 5 Section 11: Toxicological Information Acute Toxicity - LD50 Oral Rat Oral LDmin. 300-500 mg/kg. Mouse Oral LDmin. 500-1000 mg/kg. Rat Dermal LD50>2000 mg/kg. Acute Toxicity - Inhalation No data available Acute Toxicity - Dermal No data available. Harmf ul if absorbed through skin. May cause skin irritation. Acute Toxicity - Eye No data available. May cause eye irritation. Skin Corrosion/Irritation Skin Irritation Rabbit Non-irritating Serious Eye Damage/Irritation Eye Irritation Rabbit Moderate Respiratory or Skin Sensitazation Skin Sensitization Guinea Pig Negative Germ Cell Mutagenicity In Vitro Bacterial Mutagenicity (Ames) Salmonella Negative. In Vitro Cytogenetics Human Lymphocytes Negative. In Vivo Micronucleus Chromosome Aberration Mouse Bone Marrow Negative. Carcinogenicity IARC None of the components present in this material at concentrations equal to or greater than 0.1% are listed by IARC, NTP, OSHA, or ACGIH as a carcinogen. Carcinogenicity ACGIH None of the components present in this material at concentrations equal to or greater than 0.1% are listed by IARC, NTP, OSHA, or ACGIH as a carcinogen. Carcinogenicity NTP None of the components present in this material at concentrations equal to or greater than 0.1% are listed by IARC, NTP, OSHA, or ACGIH as a carcinogen. Carcinogenicity OSHA None of the components present in this material at concentrations equal to or greater than 0.1% are listed by IARC, NTP, OSHA, or ACGIH as a carcinogen. Reproductive Toxicity Reproductive & Fertility - Rat Oral 60mg/kg/day NOEL No ef f ects at maximum dose. Embryo/Fetal Development - Rat Oral 50 mg/kg/day NOEL Maternal Toxicity, Not Teratogenic. Embryo/Fetal Development - Rabbit ORal 50 mg/kg/day NOEL Maternal Toxicity, Not Teratogenic. 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 Section 12: Ecological Information Toxicity Aquatic Toxicity: Sildenaf il Ctirate: Daphnia Magna TAD EC50 48 Hours 14 mg/L. Oncorhynchus mykiss (Rainbow Trout) OECD LC50 96 Hours > 9.5 mg/L. Pseudokirchneriella subcapitata (Green Alga) OECD EC50 72 Hours 20 mg/L. Persistence and Degradability This material contains an active pharmaceutical ingredient with octanol/water partition coef f icient data that suggests that f or environmental f ate predictions the active pharmaceutical ingredient will not have the tendency to distribnute into f ats. Bio-accumulative Potential The active ingredient in this f ormulation has low potential to bioaccumulation and Long-term adverse ef f ects to aquatic organisms are not expected. Mobility in Soil This material contains an active pharmaceutical ingredient that is likely to absorb to soil or Sediment. It may persist in soil or sediment if released directly to the environment. Other Adverse Effects This material contains an active pharmaceutical ingredient that will not readily enter into the air from Hard surf aces or from a container of the pure substance. Section 13: Disposal Considerations Waste Treatment Methods Product Dispose of waste in accordance with all applicable laws and regulations. Member State specif ic and Community specif ic provisions must be considered. Considering the relevant Known environmental and human health hazards of the material review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure and environmental release. It is recommended that waste minimization be practiced. The best available technology should be utilized to prevent environmental releases. This may include destructive techniques f or waste and waste water. Waste Treatment Methods Packaging No data available 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 Page 4 of 5 Section 15: Regulatory Information DSCL (EEC): Unlisted. HMIS (USA): Unlisted. NFPA: Health 0, Flammability 1, Instability 0. Section 16: Other Information Additional Information N/A Prepared By Lisa Russell Revision Date 01/03/2019 15:28 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
