IDENTIFICATION AND USE: Simethicone is a gray, translucent, viscous liquid. Simethicone is used in the production of anti-gas tablets; lubrication and bubble free application of topical preparations; anti-whitening properties in acne and other dermatological ointments, creams and lotions; as an antifoaming agent in the manufacture of drug products made by microbial fermentations; it is used in cosmetic and toiletry products. HUMAN EXPOSURE AND TOXICITY: Unrelated case reports have been documented where simethicone was administered in conjunction with another drug as part of a prescribed treatment and an adverse event occurred. The incidences of pulmonary aspiration of gastric contents and apnea did not indicate that simethicone alone was the cause of the adverse event. The two cases of overdose were not intentional but due to incorrect dosing instructions or unknown drug interaction. ANIMAL STUDIES: In studies on the treatment of irritable bowel syndrome with rats, simethicone reduced stress-induced increase of colonic permeability and hypersensitivity to distension. In developmental toxicity study it was found that oral administration of food grade simethicone during organogenesis produced no developmental effects including teratogenicity in rabbits at dietary levels up to 2.5%.
参考文献：M Chen, V Vijay, Q Shi, Z Liu, H Fang, W Tong. 美国食品药品监督管理局批准的药物标签用于研究药物诱导的肝损伤，《药物发现今日》，16(15-16):697-703, 2011. PMID:21624500 DOI:10.1016/j.drudis.2011.05.007
M Chen, A Suzuki, S Thakkar, K Yu, C Hu, W Tong. DILIrank：按人类发展药物诱导肝损伤风险排名的最大参考药物清单。《药物发现今日》2016, 21(4): 648-653. PMID:26948801 DOI:10.1016/j.drudis.2016.02.015
References:M Chen, V Vijay, Q Shi, Z Liu, H Fang, W Tong. FDA-Approved Drug Labeling for the Study of Drug-Induced Liver Injury, Drug Discovery Today, 16(15-16):697-703, 2011. PMID:21624500 DOI:10.1016/j.drudis.2011.05.007
M Chen, A Suzuki, S Thakkar, K Yu, C Hu, W Tong. DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans. Drug Discov Today 2016, 21(4): 648-653. PMID:26948801 DOI:10.1016/j.drudis.2016.02.015
Simethicone is physiologically inert; it does not appear to be absorbed from the GI tract or to interfere with gastric secretion or absorption of nutrients. Following oral administration, the drug is excreted unchanged in feces.
Section 1. Chemical Product and Company Identification Simethicone Common Name/ Trade Name Manufacturer Commercial Name(s) Synonym Chemical Name Chemical Family Simethicone Section 4. First Aid Measures Eye Contact Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Get medical attention if irritation occurs. Skin Contact Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops. Serious Skin Contact Not available. Inhalation If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention. Serious Inhalation Not available. Ingestion Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. If large quantities of this material are swallowed, call a physician immediately. Loosen tight clothing such as a collar, tie, belt or waistband. Serious Ingestion Not available. Section 5. Fire and Explosion Data Flammability of the Product May be combustible at high temperature. Auto-Ignition Temperature Not available. Flash Points CLOSED CUP: 196°C (384.8°F). Flammable Limits Not available. Products of Combustion Not available. Fire Hazards in Presence of Slightly flammable to flammable in presence of open flames and sparks, of heat. Various Substances Explosion Hazards in Presence Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product in presence of static discharge: Not available. of Various Substances SMALL FIRE: Use DRY chemical powder. Fire Fighting Media and Instructions LARGE FIRE: Use water spray, fog or foam. Do not use water jet. Not available. Special Remarks on Fire Hazards Special Remarks on Explosion Not available. Hazards Section 6. Accidental Release Measures Small Spill Absorb with an inert material and put the spilled material in an appropriate waste disposal. Large Spill Absorb with an inert material and put the spilled material in an appropriate waste disposal. Finish cleaning by spreading water on the contaminated surface and allow to evacuate through the sanitary system. Simethicone Section 7. Handling and Storage Precautions Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not breathe gas/fumes/ vapor/spray. Keep away from incompatibles such as oxidizing agents. Storage Keep container tightly closed. Keep container in a cool, well-ventilated area. Section 8. Exposure Controls/Personal Protection Engineering Controls Provide exhaust ventilation or other engineering controls to keep the airborne concentrations of vapors below their respective threshold limit value. Ensure that eyewash stations and safety showers are proximal to the work-station location. Personal Protection Safety glasses. Lab coat. Personal Protection in Case of Splash goggles. Full suit. Boots. Gloves. Suggested protective clothing might not be sufficient; consult a a Large Spill specialist BEFORE handling this product. Exposure Limits Not available. Section 9. Physical and Chemical Properties Physical state and appearance Liquid. (viscous, translucent, oil-like) Bland. Mild. Odor Taste Not available. Molecular Weight Not available. Color Light Gray or white pH (1% soln/water) Not applicable. Boiling Point >150°C (302°F) Melting Point <-50°C (-58°F) Critical Temperature Not available. 0.995 @ 25 C.(Water = 1) (from Vendor MSDS) Specific Gravity 0.980 (Aldrich; Handbook of Fine Chemicals and Laboratory Equipment, 2000-2001) <0.1 kPa (@ 20°C) Vapor Pressure Vapor Density >1 (Air = 1) Volatility Not available. Odor Threshold Not available. Water/Oil Dist. Coeff. Not available. Not available. Ionicity (in Water) Dispersion Properties Not available. Solubility Insoluble in cold water, hot water. Insoluble in alcohol. Section 10. Stability and Reactivity Data Stability The product is stable. Not available. Instability Temperature Conditions of Instability Heat, incompatible materials Incompatibility with various Reactive with oxidizing agents. substances Corrosivity Not available. Simethicone Not available. Special Remarks on Reactivity Not available. Special Remarks on Corrosivity Polymerization Will not occur. Section 11. Toxicological Information Routes of Entry Skin. Eye contact. Toxicity to Animals LD50: Not available. LC50: Not available. Chronic Effects on Humans May cause damage to the following organs: skin, eyes. Other Toxic Effects on Slightly hazardous in case of skin contact (irritant), of ingestion, of inhalation. Humans Special Remarks on Not available. Toxicity to Animals Special Remarks on Not available. Chronic Effects on Humans Special Remarks on other Acute Potential Health Effects: Toxic Effects on Humans Skin: May cause skin irritation. No evidence of harmful effects from available information Eyes: May cause eye irritation. No evidence of harmful effects from available information. Inhalation: Low hazard. Short-term harmful effects are not expected from vapor generated at ambient temperature. Ingestion: Low hazard. It is not absorbed from the gastrointestinal tract. It is not expected to have any major toxic effects. It may cause stomach upset, bloating, constipatioin, diarrhea, gas, heartburn. No evidence of harmful effects from availble information. Section 12. Ecological Information Ecotoxicity Not available. BOD5 and COD Not available. Products of Biodegradation Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise. Toxicity of the Products Not available. of Biodegradation Special Remarks on the Not available. Products of Biodegradation Section 13. Disposal Considerations Waste Disposal Waste must be disposed of in accordance with federal, state and local environmental control regulations. Section 14. Transport Information DOT Classification Not a DOT controlled material (United States). Not applicable. Identification Not applicable. Special Provisions for Transport Simethicone DOT (Pictograms) Section 15. Other Regulatory Information and Pictograms No products were found. Federal and State Regulations California California prop. 65: This product contains the following ingredients for which the State of California has found to cause cancer which would require a warning under the statute: No products were found. Proposition 65 Warnings California prop. 65: This product contains the following ingredients for which the State of California has found to cause birth defects which would require a warning under the statute: No products were found. Other Regulations OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). WHMIS (Canada) Not controlled under WHMIS (Canada). Other Classifications DSCL (EEC) This product is not classified according Not applicable. to the EU regulations. Health Hazard HMIS (U.S.A.) 1 National Fire Protection 1 Flammability 1 Association (U.S.A.) Fire Hazard 1 0 Reactivity Health Reactivity 0 Specific hazard Personal Protection a WHMIS (Canada) (Pictograms) DSCL (Europe) (Pictograms) TDG (Canada) (Pictograms) ADR (Europe) (Pictograms) Protective Equipment Not applicable. Lab coat. Not applicable. Safety glasses.
