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Material Safety Data Sheet for Nimesulide

Identification

Product Name: Nimesulide
Chemical Name: N-(4-Nitro-2-phenoxyphenyl)methanesulfonamide
CAS Number: 51803-78-2
Synonyms: Aulin, Mesulid
Molecular Formula: C13H12N2O5S
Molecular Weight: 308.31 g/mol
Intended Use: Nonsteroidal anti-inflammatory drug (NSAID) for pain and fever relief
Supplier Information: Manufacturers and distributors of pharmaceutical chemicals
Emergency Contact: Local poison control or regulatory health officials

Hazard Identification

Hazard Classification: May cause reproductive and developmental toxicity, possible hepatotoxicity, irritation to skin, eyes, and respiratory tract
Label Elements: GHS warning symbol, hazard statements on serious health risks, precautionary information
Signal Word: Warning
Hazard Statements: Harmful if swallowed, may cause liver damage, irritating to eyes and skin, harmful to aquatic life
Precautionary Statements: Avoid inhalation, ingestion, prolonged or repeated contact with skin, use personal protective equipment, avoid contamination of water sources

Composition / Information on Ingredients

Component: Nimesulide
Concentration: >98% (as active pharmaceutical ingredient)
Impurities: Minor process-related impurities, water, trace solvents
Other Ingredients: Typically none in raw pharmaceutical form

First Aid Measures

Inhalation: Move person to fresh air, keep at rest in a position comfortable for breathing, seek medical advice for respiratory symptoms, provide rescue breathing if needed
Skin Contact: Wash thoroughly with soap and water, remove contaminated clothing, seek medical attention if irritation develops
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present and easy to do, continue rinsing, consult healthcare provider
Ingestion: Rinse mouth with water, do not induce vomiting, seek immediate medical attention, show the label or packaging if possible
Most Important Symptoms: Nausea, vomiting, allergic reactions, possible damage to liver

Fire-Fighting Measures

Flash Point: Data not available, expected to be above common combustible limits
Extinguishing Media: Use water spray, dry chemical, foam, or carbon dioxide, avoid high-pressure water jets
Special Hazards: Fumes may contain oxides of nitrogen, sulfur, and other toxic substances
Protective Equipment: Firefighters should use self-contained breathing apparatus and standard protective gear
Advice for Firefighters: Move containers from area, cool with spraying water, avoid run-off from entering drains or water courses

Accidental Release Measures

Personal Precautions: Wear protective clothing, chemical-resistant gloves, safety goggles, avoid dust formation
Environmental Precautions: Prevent further leakage or spillage if safe, do not let product enter drains, surface water, or soil
Methods for Cleanup: Sweep up and shovel material without creating dust, store in suitable closed containers for disposal, ventilate area and wash spill site
Decontamination Procedures: Use suitable absorbent material, wash contaminated surfaces with water and mild detergent, dispose of clean-up material according to regulations

Handling and Storage

Safe Handling: Handle in a controlled environment, avoid inhaling dust, avoid contact with skin and eyes, wash thoroughly after use, keep away from incompatible materials
Storage Requirements: Store in tightly closed original container, protected from light and moisture, temperature not to exceed product recommendations (usually below 25°C)
Incompatible Materials: Strong oxidizers, strong acids, strong bases
Storage Area: Designated area for pharmaceutical chemicals, keep out of reach of unauthorized personnel
Storage Conditions: Dry, well-ventilated area, segregate from foodstuffs and similar consumables

Exposure Controls and Personal Protection

Occupational Exposure Limits: No established limits in most jurisdictions, minimize exposure as best practice
Engineering Controls: Use local exhaust ventilation or process enclosures to control airborne dust
Personal Protective Equipment: Safety glasses or goggles, lab coat or chemical-resistant coveralls, suitable gloves (nitrile recommended), respirator if dust or mist exposure risk exists
Hygiene Measures: Wash hands, arms, and face after handling, do not eat, drink, or smoke while handling, remove contaminated clothing
Environmental Controls: Prevent contamination of air, soils, and water streams during use or disposal

Physical and Chemical Properties

Appearance: Yellowish crystalline powder
Odor: Faint chemical odor
pH: Slightly acidic (in suspension)
Melting Point: 140-146°C
Boiling Point: Not applicable as product decomposes
Solubility: Insoluble in water, freely soluble in dimethylformamide and dimethylsulfoxide
Vapor Pressure: Not significant at room temperature
Density: ~1.4 g/cm³
Partition Coefficient (Log P): ~2.1

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions, sensitive to prolonged exposure to light and moisture
Reactivity: No known hazardous reactivity under normal usage
Hazardous Reactions: May react with strong oxidizing agents to yield toxic gases
Decomposition Products: Emits oxides of nitrogen, sulfur, and carbon when heated to decomposition
Incompatible Materials: Strong acids, strong bases, oxidizing agents, sources of ignition

Toxicological Information

Acute Toxicity: Low LD50 in rodents (oral LD50 rat ~770 mg/kg)
Chronic Effects: Repeated or high dosing increases risk of severe hepatic injury, renal impairment, blood disorders
Skin/Eye Irritation: Moderately irritating to eyes and skin
Sensitization: Potential for allergic reactions, especially in sensitive individuals
Carcinogenicity: No conclusive human data, animal studies limited
Reproductive Toxicity: Studies report risk of fetal toxicity and developmental issues in rats at high doses
Target Organs: Liver, kidneys, hematopoietic system

Ecological Information

Toxicity to Aquatic Organisms: Harmful to aquatic species, especially fish and invertebrates
Persistence and Degradability: Moderately persistent in environment, may not rapidly degrade
Bioaccumulation: Low to moderate potential based on log P value and limited studies
Mobility in Soil: Tends to remain bound to sediments, low mobility in soil
Other Adverse Effects: Can contribute to pharmaceutical contamination in waterways, disrupt aquatic ecosystems

Disposal Considerations

Waste Treatment Methods: Dispose of via authorized chemical waste contractor, follow all local and national guidelines
Incineration: Preferred method under strictly controlled conditions
Product/Container Disposal: Rinse containers thoroughly, dispose safely according to pharmaceutical waste rules
Do Not: Dispose of in household garbage or sewer systems, avoid release to environment
Special Precautions: Clearly label all waste, use sealed packaging, complete documentation for tracking

Transport Information

UN Number: Not classified as a dangerous good in most jurisdictions
Transport Hazard Class: No specific hazard class, may be regulated as pharmaceutical shipment
Packing Group: Not assigned
Shipping Name: Nimesulide, bulk or raw material
Environmental Hazards: Avoid accidental release, protect from moisture and extreme temperatures
Special Precautions for Transport: Handle within tightly closed packaging, traceability through documentation

Regulatory Information

Safety, Health, and Environmental Regulations: Covered under global pharmaceutical handling and workplace safety laws such as OSHA, WHMIS, REACH, and local equivalents
Labelling Requirements: GHS hazard symbols and warnings, specific risk and safety phrases
International Inventories: Substance or formulations may appear on inventories such as EINECS/ELINCS in Europe, TSCA in the US
Restrictions and Bans: Some countries restrict or prohibit Nimesulide for certain uses due to safety concerns
Other Regulatory Comments: Monitor updates by World Health Organization and regional health agencies for any changes in classification or use restrictions