Microsoft word - topiramate msds.doc

Manufacturer/Supplier: Upsher-Smith Laboratories, Inc. Address: 6701 Evenstad Drive, Maple Grove, MN 55369 Skin Corrosion: Category 3 Eye Corrosion: Category 2B Skin Sensitization: Not available Carcinogenicity: N/A Reproductive/Developmental: 2 Target Organ Toxicity (Repeated): Liver & Central Nervous System GHS Label: Symbols: Do not eat or drink in areas where Topiramate or a solution containing Topiramate is handled, processed, Overexposure may cause convulsions, drowsiness, speech disturbance, blurred vision, diplopia, mentation impaired, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness and depression. Overdose has also resulted in severe metabolic acidosis. 3. Composition / Information on Ingredients In case of eye contact, flush with copious amounts of water for at least 15 minutes. Hold eyelids away from eyeball to ensure thorough rinsing. Seek medical attention immediately. If redness, dryness or other signs of irritation develop, wash the affected area with plenty of warm water and soap. If irritation persists, seek medical attention immediately. In the final form not a likely route of exposure. However, in case of inhalation, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult administer oxygen. Seek medical attention immediately. In case of accidental ingestion, give the victim several glasses of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Do not force an unconscious or convulsing person to drink liquids or to vomit. Seek medical attention immediately. Use an appropriate media including water spray, dry powder, Extinguishing Media: foam, carbon dioxide. Wear self-contained breathing apparatus and personal protective equipment to prevent contact with skin and eyes. Combustion Products When heated to decomposition it emits toxic gases (such as carbon monoxide) and fumes may be released in a fire involving Topiramate. Spill Response Instructions: The following spill response instructions only apply to bulk quantities of the material. Report emergency situations immediately. Non-essential personnel should be evacuated from the affected area. Spills should be cleaned up in a manner that minimizes exposure to personnel. Personnel involved in the clean up of spills should wear the appropriate respiratory protection, gloves, eye protection, and protective coveralls. Remove all sources of heat and ignition. Cover spill with absorbent material and collect for disposal. Ventilate the area and clean spill area thoroughly with soap and water. Collect wash with absorbent material and transfer all waste to a labeled container for disposal. Observe all applicable regulations when disposing of this substance. General Handling In a manufacturing setting or other situation where exposure to aerosols may occur appropriate personal protective equipment, including respiratory protection, must be worn. Use good personal hygiene – wash hands and exposed skin thoroughly with soap and water after use. Remove any contaminated clothing and clean before reuse. Destroy contaminated belts and shoes and other items that cannot be decontaminated. Keep away from heat and flame. Keep operating temperatures below ignition temperatures at all times. Use non-sparking tools. Storage When not in use, store in a cool, dry, well-ventilated area, in tightly sealed containers that are labeled in accordance with OSHA’s Hazard Communication Standard [29 CFR 1910.1200]. Keep away from ignition sources including electrostatic charge, heat, sparks, open flame, and strong oxidizers. In case of insufficient ventilation, wear suitable respiratory protection. Keep this drug out of the reach of children. Protect from physical damage. Do not cut, grind, or weld on or near containers unless precautions are taken against these hazards. 8. Exposure Controls / Personal Protection Engineering Controls: In a manufacturing setting, local exhaust ventilation may be necessary to control air contaminants to their exposure limits. The use of local ventilation is recommended to control emissions near the source. Provide mechanical ventilation for confined spaces. Personal Protective Equipment (PPE) In a manufacturing setting, the following personal protective equipment requirements apply: Eye Protection: Wear appropriate chemical safety goggles, safety glasses or face shield as described by OSHA’s eye and face protection regulations in 29 CFR 1910.133. Have eyewash stations available where eye contact can occur. Skin Protection: Avoid skin contact. Wear gloves impervious to conditions of use. Additional protection may be necessary to prevent skin contact including the use of an apron, face shield, boots, or full body protection. A safety shower should be located in the work area. Respiratory Protection: If exposure limits are exceeded, approved respiratory protection should be worn. Seek professional assistance for proper selection of respiratory protection. Octanol/Water Partition Coefficient: N/A Stability/Incompatibility: The mixture is stable under normal conditions of use. Signs and Symptoms of Overexposure: In its final form overexposure is unlikely. Signs and symptoms of reported overexposures include convulsions, drowsiness, speech disturbance, blurred vision, diplopia, mentation impaired, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness and depression. Overdose has also resulted in severe metabolic acidosis. Eye Contact: May cause slight irritation. Avoid contact with eyes. Skin Contact: May cause slight irritation. Avoid contact with skin. Inhalation: In the final form, not a likely route of exposure. However, in case of inhalation, respiratory tract irritation may occur. Ingestion: May result in slight irritation of the mouth and throat and abdominal pain. Target Organ Effects: Reproductive, Liver, and Central Nervous System. Chronic Effects: Topiramate is a suspected human teratogen. It has been shown to cause terotogenic effects and embryo fetal toxicity in rabbits, rats, and mice. FDA Pregnancy Category D Acute Toxicity Values: LD50 (rat oral) = >1500 mg/kg (for Topiramate) Ecological impact data has not been determined for this mixture. Disposal Procedure: Must dispose of in accordance with all local, state, and federal U. S. Department of Transportation (DOT) Proper Shipping Name: N/A Hazard Class: N/A UN/NA Number: N/A Packing Group: N/A Labels Required: N/A International Maritime Organization (MDG) Proper Shipping Name: N/A Hazard Class: N/A UN/NA: N/A Packing Group: N/A Labels Required: N/A U. S. Federal Regulations Not regulated. Toxic Substance Control Act (TSCA): Magnesium Stearate is included on the TSCA inventory. Clean Water Act (CWA): There are no ingredients in this mixture listed in the Clean Water Act. Clean Air Act (CAA): There are no ingredients in this mixture listed under the Clean Air Act. Superfund Amendments and Reauthorization Act (SARA) Title III Information: There are no ingredients in this mixture listed under SARA. State Regulations California: This product contains chemical(s) known to the State of California to cause cancer, birth defects or reproductive harm, which would require a warning under the statute: Magnesium Stearate, Sodium Starch Glycolate (heavy metals) Canadian Environmental Protection Act: Lactose Monohydrate, Sodium Starch Glycolate and Magnesium Stearate are listed on the Canadian Domestic Substances list (DSL). Canadian Workplace Hazardous Materials Information System (WHMIS): Lactose Monohydrate and Magnesium Stearate are controlled by the WHMIS. European Inventory of Existing Chemicals (EINECS): Two components contained in this product (Lactose Monohydrate and Magnesium Stearate) are included on the European Inventory of Existing Commercial Chemical Substances. EU Classification: European labeling in accordance with EC directives. EU Risk (R) and Safety (S) Phrases: R36/37/38: Irritating to eyes, respiratory system and skin. R22: Harmful if swallowed. R61: May cause harm to the unborn child. S26: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36: Wear suitable protective clothing. National Fire Protection Association (NFPA) Warnings Health: 1 Upsher-Smith Laboratories, Inc. believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it is without warranty of any kind, express or implied. The information contained herein is designated only as guidance for safe handling and storage of the substance and is not a specification nor does it guarantee any specific properties. Only competent personnel, within a controlled environment, should handle all chemicals. Upsher-Smith Laboratories, Inc. shall not be held liable for any loss, injury or damage from contact with the product.

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