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An ISO 9001:2000 Certified Company Material Safety Data Sheet 3-[(Dimethylamino) Methyl] -1,2,3,9-Tetrahydro-9- Methyl-4h-Carbazol-4-One HCL Synonym: Ondansetron Mannich Base HCL; Ondansetron Mannich Base Cas No. 119812-29-2 Section 1 - Chemical Product and Company Identification Cas No. 119812-29-2 Contact Information: Synonym: Ondansetron Mannich Base HCL; Ondansetron Chemical Name: 3-[(Dimethylamino) Methyl] -1,2,3,9- Tetrahydro-9-Methyl-4h-Carbazol-4-One HCL 303, 3rd Floor, Royale Manor, Chemical Formula: C16H22N2O. HCL Law Garden, Ellisbridge, Ahmedabad - 380006, Molecular Weight: 294.86 Material Use: Intermediate of Ondansetron For emergencies, call: Tel: + 91 79 26463395, 65123395 Fax: + 91 79 26463395 Email: [email protected] [email protected] Section 2: Composition/information on Ingredients 96.0%-101.0% w/w 3-[(Dimethylamino) Methyl] -1,2,3,9-Tetrahydro-9-Methyl-4h-Carbazol-4-One HCL 119812-29-2 Synonym: Ondansetron Mannich Base HCL; Ondansetron Mannich Base Section3. Hazards identification, including emergency overview Appearance : An off white colored powder Caution! May cause eye, skin, and respiratory tract irritation. The toxicological properties of this material have not been fully investigated. Target Organs: No data found. Potential Health Effects Eye: May cause eye irritation. Skin: May cause skin irritation. Ingestion: May cause irritation of the digestive tract. The toxicological properties of this substance have not been fully investigated. Inhalation: May cause respiratory tract irritation. The toxicological properties of this substance have not been fully investigated. Tel: + 91 79 65123395, 26463395 303, 3rd Floor, Royale Manor, Law Garden, Fax: +91 79 26463395 Ellisbridge, Ahmedabad – 380006, Website: www.manusaktteva.in An ISO 9001:2000 Certified Company Potential Chronic Health Effects: CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available. DEVELOPMENTAL TOXICITY: Not available. The substance is toxic to the nervous system. Repeated or prolonged exposure to the substance can produce target organs damage. Section4. First aid measures No information is available about the potential of thi s p od u ct to produce adverse environmental effects. Ingestion: Never attempt to induce vomiting. Do not attempt to give any solid or liquid by mouth if the exposed subject is unconscious or semi-conscious. Wash out the mouth with water. If the exposed subject is fully conscious, give plenty of water to drink. Obtain medical attention. Inhalation : Remove from exposure and move to fresh air immediately. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical aid. Skin Contact : Using appropriate personal protective equipment, remove contaminated clothing and flush exposed area with large amounts of water. Obtain medical attention if skin reaction occurs, which may be immediate or delayed. Eye Contact: Wash immediately with clean and gently flowing water. Continue for at least 15 minutes. Obtain medical attention. NOTES TO HEALTH PROFESSIONALS: Medical Treatment Treat according to locally accepted protocols. For additional guidance, refer to the current prescribing information or to the local poison control information centre. Medical treatment in cases of overexposure should be treated as an overdose and the target organs being nerves, treat it under expert medical advice and supervision. Section 5. Fire fighting measures Flammability of the Product: This product is non flammable. Flash Point: Not applicable. Auto ignition Temperature: Not applicable. Explosion Limits, Lower: Not available. Upper: Not available. General Information: As in any fire, wear a self-contained breathing apparatus in pressure-demand, MSHA/NIOSH (approved or equivalent), and full protective gear. During a fire, irritating and highly toxic gases may be generated by thermal decomposition or combustion. Extinguishing Media: In case of fire, use water, dry chemical, chemical foam, or alcohol-resistant foam. Section 6. Accidental release measures Small Spill: Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements. Large Spill: Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate through the sanitary system. Tel: + 91 79 65123395, 26463395 303, 3rd Floor, Royale Manor, Law Garden, Fax: +91 79 26463395 Ellisbridge, Ahmedabad – 380006, Website: www.manusaktteva.in An ISO 9001:2000 Certified Company Section 7. Handling and storage No special control measures required for the normal handling of this product. Normal r oom ventilation is expected to be adequate for routine handling of this product. Wash thoroughly after handling. Remove contaminated clothing and wash before reuse. Avoid contact with eyes, skin, and clothing. Avoid ingestion and inhalation. Store in a cool, dry well ventilated area away from incompatible substances. Keep container tightly closed when not in use. Store at 25 o C excursion permitted to 15-35 o C. Avoid exposure to excessively warm temperatures and moisture. Section 8. Exposure controls/personal protection 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, fume or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit. Personal Protective Equipment: Eyes: Wear safety glasses and chemical goggles if splashing is possible. Skin: Wear appropriate protective gloves and clothing to prevent skin exposure. Clothing: Wear appropriate protective clothing to minimize contact with skin. Respirators: Wear a NIOSH/MSHA or European Standard EN 149 approved full-face piece airline respirator in the positive pressure mode with emergency escape provisions. Exposure Limits: Not available. Section 9. Physical and chemical properties Physical state and appearance: Solid Appearance: A white or Brownish white crystalline powder Chemical Formula: C16H22N2O. HCL Molecular Weight: 294.86 pH (1% solution/water): Not available. Boiling Point: Not applicable. Freezing/Melting Point: 180 o C -200 o C Specific Gravity: Not applicable. Solubility: Soluble in methanol Auto ignition Temperature: Not available. Flash Point: Not available. Section 10. Stability and reactivity Chemical Stability: Stable under normal temperatures and pressures. Stable at room temperature in closed containers under normal storage and handling conditions. Conditions to Avoid: Incompatible materials, strong oxidants and dust generation. Incompatibilities with Other Materials: Avoid contact with strong oxidizing agents and excessive heat Hazardous Decomposition Products: Nitrogen oxides, carbon monoxide, irritating and toxic fumes and gases, carbon dioxide, Nitrogen. Hazardous Polymerization: Has not been reported. Corrosivity: Non-corrosive. Tel: + 91 79 65123395, 26463395 303, 3rd Floor, Royale Manor, Law Garden, Fax: +91 79 26463395 Ellisbridge, Ahmedabad – 380006, Website: www.manusaktteva.in An ISO 9001:2000 Certified Company Section 11. Toxicological information Routes of Entry: Ingestion. Toxicity to Animals: LD50: Not available. LC50: Not available. Chronic Effects on Humans: Causes damage to the following organs: the nervous system. Other Toxic Effects on Humans: Hazardous in case of ingestion. Slightly hazardous in case of inhalation. Special Remarks on Toxicity to Animals: Not available. Special Remarks on Chronic Effects on Humans: Not available. Special Remarks on other Toxic Effects on Humans: N o t a va ilable. RTECS#: CAS# 119812-29-2unlisted. Carcinogenicity: CAS# 119812-29-2: Not listed by ACGIH, IARC, NTP, or CA Prop 65. Effects of Acute Exposure: Data not available Effects of Chronic Exposure: Data not available Irritancy of Product: Data not available Skin Sensitization: Data not available Respiratory Sensitization: Data not available Carcinogenicity-IARC : Data not available Carcinogenicity – ACGIH: Data not available Reproductive Toxicity: Data not available Teratogenicity: Data not available Embryotoxicity: Data not available Mutagenicity: Data not available Name of Synergistic Products / Effects: Data not available 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 of Biodegradation: The products of degradation are more toxic. Special Remarks on the Products of Biodegradation: Not available. Section 13. Disposal considerations Disposal Recommendations Dispose of in a manner consistent with federal, state, and local regulations. Collect for recycling or recovery if possible. The disposal method for rejected products/returned goods must ensure that they cannot be re-sold or re-used. Chemical waste generators must determine whether a discarded chemical is classified as a hazardous waste. US EPA guidelines for the classification determination are listed in 40 CFR Parts 261.3. Additionally, waste generators must consult state and local hazardous waste regulations to ensure complete and accurate classification. RCRA P-Series: None listed. RCRA U-Series: None listed. Tel: + 91 79 65123395, 26463395 303, 3rd Floor, Royale Manor, Law Garden, Fax: +91 79 26463395 Ellisbridge, Ahmedabad – 380006, Website: www.manusaktteva.in An ISO 9001:2000 Certified Company Section 14. Transport information DOT Classification: Not a D OT controlled material (United States). Identification: Not applicable. Special Provisions for Transport: Not applicable. IATA : NOT REGULATED BY IATA as dangerous goods. RID/ADR : NOT CONTROLLED UNDER ADR EUROPE. Transport Information: Transportation and shipping of this product is not restricted. It has no known, significant hazards requiring special packaging or labeling for air, maritime, US or European ground transport purposes Section 15. Regulatory information European/International Regulations European Labeling in Accordance with EC Directives Hazard Symbols: Not available Risk Phrases: R 22,36,37 Harmful if swallowed, Irritating to eyes, respiratory system Safety Phrases:36 Wear suitable protective clothing, S 24/25 Avoid contact with skin and eyes. S 37 Wear suitable gloves, S 45 In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). S 28A after contact with skin wash immediately with plenty of water United Kingdom Occupational Exposure Limits , United Kingdom Maximum Exposure Limits CAS# 119812-29-2 is listed on EINECS Master Inventory list Exposure Limits US FEDERAL TSCA CAS# 119812-29-2 is not noticed by us on TSCA list. CAS# 119812-29-2 is listed on EINECS Master Inventory list Section 16. Other information The information above is believed to be accurate and represents the best information currently available to us. However, MANUS AKTTEVA make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for their particular purposes. In no way shall MANUS AKTTEVA be liable for any claims, losses, or damages of any third party or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if the company has been advised of the possibility of such damages. MSDS creation date: May 2008, Revision Date: None. Tel: + 91 79 65123395, 26463395 303, 3rd Floor, Royale Manor, Law Garden, Fax: +91 79 26463395 Ellisbridge, Ahmedabad – 380006, Website: www.manusaktteva.in

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