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Material Safety Data Sheet for Indomethacin

Identification

Product Name: Indomethacin
Chemical Name: 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid
Synonyms: Indocin, Indometacin
CAS Number: 53-86-1
Recommended Use: Anti-inflammatory drug
Supplier: Pharmaceutical manufacturers, medical suppliers
Contact Information: Refer to direct manufacturer or distributor for emergency or product information
Emergency Phone Number: Refer to supplier documentation

Hazard Identification

Hazard Class: Not classified as a hazardous substance or mixture by OSHA (29 CFR 1910.1200)
Routes of Exposure: Inhalation, ingestion, skin absorption, eye contact
Potential Health Effects: May cause irritation to eyes, skin, and respiratory system; may affect liver, kidneys, and central nervous system on prolonged or repeated exposure; can produce gastrointestinal discomfort, headache, dizziness, or rash
Carcinogenic Status: Not listed by IARC, NTP, or OSHA
Specific Hazards: Slight risk of allergic skin reaction; dust may cause irritation to upper respiratory tract
Label Elements: Not a GHS-classified hazardous material; still, prudent precautions advised due to potential pharmaceutical effects

Composition / Information on Ingredients

Chemical Identity: Indomethacin
Concentration: 98% and above in pure forms; variable in formulations
Impurities/Additives: None of significant concern in pharmaceutical grade material
Molecular Formula: C19H16ClNO4
Molecular Weight: 357.8 g/mol

First Aid Measures

Inhalation: Move to fresh air, support breathing as needed. Seek medical attention if symptoms persist.
Skin Contact: Remove contaminated clothing, rinse skin with water and soap. Seek medical attention for persistent irritation.
Eye Contact: Flush eyes gently for at least 15 minutes with water, lifting eyelids. Get medical help if irritation develops.
Ingestion: Rinse mouth, do not induce vomiting, seek immediate medical assistance and provide the product information if available.
Advice for Doctor: Symptomatic treatment and supportive care based on clinical judgment

Fire-Fighting Measures

Suitable Extinguishing Media: Use foam, dry chemical powder, carbon dioxide, or water spray
Specific Hazards During Fire: Decomposition releases toxic gases including carbon monoxide, carbon dioxide, hydrogen chloride, and nitrogen oxides
Protective Equipment: Firefighters wear full protective clothing including self-contained breathing apparatus
Special Procedures: Avoid breathing fumes, prevent runoff from entering drains or waterways, remove containers from fire area if safe

Accidental Release Measures

Personal Precautions: Wear gloves, goggles, and protective clothing; avoid inhaling dust and contact with skin or eyes
Environmental Precautions: Prevent entry to sewers, surface water, or soil
Cleanup Methods: Scoop or sweep up without raising dust; gather residue into labeled, sealed containers for disposal; ventilate area and wash contaminated surface with water and detergent; use approved vacuum or wet methods to minimize airborne particles

Handling and Storage

Precautions for Safe Handling: Handle in areas with adequate ventilation, avoid dust generation, prevent ingestion and contact with eyes or skin, do not consume food or drink while handling product, wash hands following use
Conditions for Safe Storage: Store in sealed containers at room temperature away from direct sunlight, moisture, and incompatible materials such as strong oxidizing agents; keep container tightly closed and in a secure location to prevent unauthorized access

Exposure Controls and Personal Protection

Exposure Limits: No OSHA PEL or ACGIH TLV established specifically for Indomethacin
Engineering Controls: Use local exhaust or general room ventilation to minimize airborne levels; work in laboratory fume hood if available
Personal Protective Equipment: Lab coat or gown, chemical-resistant gloves (nitrile or equivalent), safety goggles or face shield for eye protection, use an NIOSH-approved respirator if dust or aerosol is generated

Physical and Chemical Properties

Appearance: Pale yellow to yellow crystalline powder
Odor: Slight, weak odor
Odor Threshold: Not available
pH: Not applicable (insoluble in water)
Melting Point: 160–165°C
Boiling Point: Decomposes before boiling
Flash Point: Approximately 240°C (closed cup)
Flammability: Not highly flammable, but may burn at elevated temperature
Vapor Pressure: Negligible at room temperature
Solubility: Poorly soluble in water, soluble in ethanol, methanol, acetone, chloroform, and other organic solvents
Partition Coefficient (log Kow): Approx. 4.3
Decomposition Temperature: Above 200°C
Viscosity: Not applicable
Evaporation Rate: Not determined

Stability and Reactivity

Chemical Stability: Stable under recommended storage and handling conditions
Reactivity: Not reactive with most common substances under normal use
Hazardous Reactions: May react with strong oxidizing agents
Decomposition Products: Decomposes on strong heating, producing carbon monoxide, carbon dioxide, hydrogen chloride, nitrogen oxides
Conditions to Avoid: Elevated temperatures, moisture, open flames, and sources of ignition

Toxicological Information

Likely Routes of Exposure: Oral, inhalation, skin and eye contact
Acutely Toxic Dose (LD50 oral rat): About 50 mg/kg
Possible Health Effects: Can cause gastrointestinal irritation, blood in stools, vomiting, central nervous system effects like dizziness and headache, allergic skin reactions in sensitive individuals
Chronic Effects: Prolonged exposure linked to kidney and liver damage in animal studies, potential risk for gastrointestinal ulceration, rare blood dyscrasias
Mutagenicity: Not proven mutagenic in standard assays
Carcinogenicity: Long-term animal data do not show carcinogenicity
Reproductive Toxicity: Possible risk of fetal effects when used during pregnancy; avoid use especially during third trimester

Ecological Information

Ecotoxicity: Toxic to some aquatic species even at low concentrations, possible disruption of fish development and plankton populations
Persistence and Degradability: Slightly persistent in aquatic environments, may not degrade readily and could bioaccumulate
Bioaccumulation Potential: Moderate log Kow points to some risk of bioaccumulation in aquatic organisms
Mobility in Soil: Low mobility due to poor water solubility
Other Adverse Effects: Limit large-scale pharmaceutical releases into environment to protect water quality and ecosystem balance

Disposal Considerations

Waste Handling: Treat as pharmaceutical waste; incinerate at licensed facility with pollution control; avoid disposal to drains and natural waters
Container Disposal: Triple-rinse, perforate, and send empty containers to approved landfill or incinerator as per local and national regulations
Regulatory Compliance: Follow all federal, state, and local environmental control regulations on chemical waste

Transport Information

UN Number: Not classified as hazardous for transport
UN Proper Shipping Name: Indomethacin
Transport Hazard Class: Non-regulated material
Packing Group: Not assigned
Marine Pollutant: Not classified as a marine pollutant in packaged form
Special Precautions: Avoid damage to containers and prevent release of powder during storage and transit

Regulatory Information

OSHA Status: Not specifically regulated by OSHA as hazardous
TSCA: Listed on the TSCA Inventory
SARA Title III: No SARA 302 or SARA 313 chemicals present at significant levels
California Proposition 65: Not listed as a chemical known to cause cancer or reproductive harm
European Union CLP Regulation: Not classified as a hazardous substance
Other National Regulations: Subject to pharmaceutical control in many jurisdictions — usage, storage, and disposal might come with specific requirements outside chemical hazard frameworks