SIGMA-ALDRICH Material Safety Data Sheet Date Printed: 08/OCT/2003 Date Updated: 15/APR/2002 Version 1.0 According to 91/155/EEC 1 - Product and Company Information Product Name DICLOFENAC SODIUM SALT Product Number D174 Company Sigma-Aldrich Chemie GmbH Riedstrasse 2 89555 Steinheim Germany Technical Phone # 49-89-6513(0)-1444 Fax 49-7329-97-2319 Emergency Phone # 49 7329 97 2323 2 - Composition/Information on Ingredients Product Name CAS # EC no DICLOFENAC SODIUM 15307-79-6 239-346-4 Formula C14H10Cl2NNaO2 Molecular Weight 318.1 AMU Synonyms Benzeneacetic acid, 2-((2, 6-dichlorophenyl)amino)-, monosodium salt,(o-(2, 6-Dichloroanilino)phenyl)acetic acid monosodium s alt,(o-(2, 6-Dichloroanilino)phenyl)acetic acid sodium salt, 2-((2, 6-Dichlorophenyl)amino)benzeneacetic acid monosod ium salt,Dichronic,Diclofenac sodium, Diclophenac sodium,GP 45840,Huma-Difenac,Kriplex, Neriodin,Orthophen,Ortofen,Prophenatin, Sodium (o-(2,6-dichloroanilino)phenyl)acetate, Sodium (o-((2, 6-dichlorophenyl)amino)phenyl)acetate, Sodium diclofenac,Tsudohmin,Valetan,Voltaren, Voltarol 3 - Hazards Identification SPECIAL INDICATION OF HAZARDS TO HUMANS AND THE ENVIRONMENT Toxic if swallowed. 4 - First Aid Measures AFTER INHALATION If inhaled, remove to fresh air. If not breathing give artificial respiration. If breathing is difficult, give oxygen. AFTER SKIN CONTACT In case of skin contact, flush with copious amounts of water for at least 15 minutes. Remove contaminated clothing and shoes. Call a physician. AFTER EYE CONTACT In case of contact with eyes, flush with copious amounts of water for at least 15 minutes. Assure adequate flushing by separating the eyelids with fingers. Call a physician. AFTER INGESTION If swallowed, wash out mouth with water provided person is conscious. Call a physician immediately. 5 - Fire Fighting Measures EXTINGUISHING MEDIA Suitable: Water spray. Carbon dioxide, dry chemical powder, or appropriate foam. SPECIAL RISKS Specific Hazard(s): Emits toxic fumes under fire conditions. SPECIAL PROTECTIVE EQUIPMENT FOR FIREFIGHTERS Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes. 6 - Accidental Release Measures PERSONAL PRECAUTION PROCEDURES TO BE FOLLOWED IN CASE OF LEAK OR SPILL Evacuate area. PROCEDURE(S) OF PERSONAL PRECAUTION(S) Wear self-contained breathing apparatus, rubber boots, and heavy rubber gloves. METHODS FOR CLEANING UP Sweep up, place in a bag and hold for waste disposal. Avoid raising dust. Ventilate area and wash spill site after material pickup is complete. 7 - Handling and Storage HANDLING Directions for Safe Handling: Do not breathe dust. Do not get in eyes, on skin, on clothing. Avoid prolonged or repeated exposure. STORAGE Conditions of Storage: Keep tightly closed. 8 - Exposure Controls / Personal Protection ENGINEERING CONTROLS Use only in a chemical fume hood. Safety shower and eye bath. GENERAL HYGIENE MEASURES Wash contaminated clothing before reuse. Wash thoroughly after handling. PERSONAL PROTECTIVE EQUIPMENT Respiratory Protection: Government approved respirator. Hand Protection: Compatible chemical-resistant gloves. Eye Protection: Chemical safety goggles. 9 - Physical and Chemical Properties Appearance Physical State: Solid SIGMA - D174 www.sigma-aldrich.com Page 2 Color: White Property Value At Temperature or Pressure pH N/A BP/BP Range N/A MP/MP Range 275 - 277 °C Flash Point N/A Flammability N/A Autoignition Temp N/A Oxidizing Properties N/A Explosive Properties N/A Explosion Limits N/A Vapor Pressure N/A Partition Coefficient N/A Viscosity N/A Vapor Density N/A Saturated Vapor Conc. N/A Evaporation Rate N/A Bulk Density N/A Decomposition Temp. N/A Solvent Content N/A Water Content N/A Surface Tension N/A Conductivity N/A Miscellaneous Data N/A Solubility N/A 10 - Stability and Reactivity STABILITY Stable: Stable. Materials to Avoid: Strong oxidizing agents. HAZARDOUS DECOMPOSITION PRODUCTS Hazardous Decomposition Products: Carbon monoxide, Carbon dioxide, Nitrogen oxides, Hydrogen chloride gas. HAZARDOUS POLYMERIZATION Hazardous Polymerization: Will not occur 11 - Toxicological Information RTECS NUMBER: AG6330000 ACUTE TOXICITY LD50 Oral Rat 53 mg/kg Remarks: Behavioral:Altered sleep time (including change in righting reflex). Behavioral:Ataxia. Lungs, Thorax, or Respiration:Respiratory stimulation. LD50 Intraperitoneal Rat 25 MG/KG LD50 Subcutaneous SIGMA - D174 www.sigma-aldrich.com Page 3 Rat 83 MG/KG LD50 Intravenous Rat 117 MG/KG LD50 Rectal Rat 85400 UG/KG LD50 Oral Mouse 95 mg/kg LD50 Intraperitoneal Mouse 74 MG/KG LD50 Subcutaneous Mouse 390 MG/KG LD50 Intravenous Mouse 116 MG/KG LD50 Oral Dog 59 mg/kg LD50 Intravenous Dog 42 MG/KG LD50 Oral Rabbit 157 mg/kg LD50 Intravenous Rabbit >100 MG/KG SIGNS AND SYMPTOMS OF EXPOSURE Exposure can cause: Gastrointestinal disturbances. Nausea, dizziness, and headache. To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated. ROUTE OF EXPOSURE Skin Contact: May cause skin irritation. Skin Absorption: May be harmful if absorbed through the skin. SIGMA - D174 www.sigma-aldrich.com Page 4 Eye Contact: May cause eye irritation. Inhalation: Material may be irritating to mucous membranes and upper respiratory tract. May be harmful if inhaled. Ingestion: Toxic if swallowed. TARGET ORGAN INFORMATION Kidneys. Liver. G.I. System. CHRONIC EXPOSURE - TERATOGEN Species: Rat Dose: 1 MG/KG Route of Application: Oral Exposure Time: (21D PREG) Result: Specific Developmental Abnormalities: Cardiovascular (circulatory) system. Species: Rat Dose: 6 MG/KG Route of Application: Oral Exposure Time: (9-14D PREG) Result: Effects on Embryo or Fetus: Fetotoxicity (except death, e.g., stunted fetus). CHRONIC EXPOSURE - REPRODUCTIVE HAZARD Result: Overexposure may cause reproductive disorder(s) based on tests with laboratory animals. Species: Woman Dose: 20 MG/KG Route of Application: Oral Exposure Time: (34-25W PREG) Result: Effects on Newborn: Apgar score (human only). Effects on Newborn: Physical. Species: Rat Dose: 24 MG/KG Route of Application: Oral Exposure Time: (9-14D PREG) Result: Effects on Newborn: Growth statistics (e.g., reduced weight gain). Species: Rat Dose: 15 MG/KG Route of Application: Intramuscular Exposure Time: (5-19D PREG) Result: Effects on Newborn: Biochemical and metabolic. Species: Mouse Dose: 24 MG/KG Route of Application: Oral Exposure Time: (7-12D PREG) Result: Maternal Effects: Other effects. Effects on Embryo or Fetus: Fetotoxicity (except death, e.g., stunted fetus). Effects on Newborn: Growth statistics (e.g., reduced weight gain). Species: Rabbit Dose: 10 MG/KG Route of Application: Oral Exposure Time: (1D PRE) Result: Effects on Fertility: Other measures of fertility SIGMA - D174 www.sigma-aldrich.com Page 5 12 - Ecological Information No data available. 13 - Disposal Considerations SUBSTANCE DISPOSAL Contact a licensed professional waste disposal service to dispose of this material. Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber. Observe all federal, state, and local environmental regulations. 14 - Transport Information RID/ADR UN#: 2811 Class: 6.1 PG: III Proper Shipping Name: Toxic solid, organic, n.o.s. IMDG UN#: 2811 Class: 6.1 PG: III EmS Number: 6.1-04 MFAG Number: 999 Proper Shipping Name: Toxic solid, organic, n.o.s. Marine Pollutant: No Severe Marine Pollutant: No Technical Name: X IATA UN#: 2811 Class: 6.1 PG: III Proper Shipping Name: Toxic solid, organic, n.o.s. Inhalation Packing Group I: No Technical Name: X 15 - Regulatory Information CLASSIFICATION AND LABELING ACCORDING TO EU DIRECTIVES INDICATION OF DANGER: T Toxic. R-PHRASES: 25 Toxic if swallowed. S-PHRASES: 22 36/37 45 Do not breathe dust. Wear suitable protective clothing and gloves. In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). 16 - Other Information WARRANTY The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. Sigma-Aldrich Inc., shall not be held liable for any damage resulting from handling or from contact with the above product. See reverse side of invoice or packing slip for additional terms and conditions of sale. Copyright 2003 Sigma-Aldrich Co. License granted to make unlimited paper copies for internal use only. SIGMA - D174 www.sigma-aldrich.com Page 6 DISCLAIMER For R&D use only. Not for drug, household or other uses. 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