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Product Name: Pirfenidone
Synonyms: 5-methyl-1-phenyl-2-(1H)-pyridone
Chemical Formula: C12H11NO
CAS Number: 53179-13-8
Manufacturer: Specified by supplier
Recommended Use: Pharmaceutical ingredient (used in the treatment of idiopathic pulmonary fibrosis)
Emergency Contact: Listed by distributor/supplier according to locality requirements
GHS Classification: Acute Toxicity (Oral), Skin Irritation, Eye Irritation, Specific Target Organ Toxicity (Repeated Exposure)
Signal Word: Warning
Hazard Statements: Harmful if swallowed, causes skin irritation, causes serious eye irritation, may cause damage to organs through prolonged or repeated exposure, dust may cause respiratory irritation
Pictogram: Exclamation mark symbol
Precautionary Statements: Avoid breathing dust, wear protective gloves/eye protection/face protection, wash hands and exposed skin thoroughly after handling, do not eat/drink/smoke while using material
Main Ingredient: Pirfenidone
Concentration: 98-100% by weight
Impurities: Proprietary impurities below notification limits, as given by batch analysis
Other Additives: None expected for API-grade product
Inhalation: Move to fresh air, keep at rest, seek medical advice if irritation or symptoms persist
Skin Contact: Remove contaminated clothing, rinse skin with plenty of running water and mild soap, get medical attention if symptoms appear, launder clothing before reuse
Eye Contact: Rinse immediately with gentle running water for at least 15 minutes, remove contact lenses if present and easy to do, seek medical advice
Ingestion: Rinse mouth with water, do not induce vomiting unless told to by medical authority, get medical advice or attention
Most Significant Symptoms/Effects: Irritation, possible allergic reaction, nausea, dizziness, headache, respiratory tract irritation
Suitable Extinguishing Media: Dry chemical, CO₂, foam, water spray
Fire and Explosion Hazards: Product may emit hazardous fumes of nitrogen oxides, carbon monoxide, carbon dioxide
Special Protective Equipment for Firefighters: Wear self-contained breathing apparatus and protective clothing
Specific Methods: Keep containers cool with water spray, avoid inhalation of combustion products
Personal Precautions: Ventilate area, avoid breathing dust, use personal protective equipment—gloves, goggles, mask
Environmental Precautions: Prevent entry into watercourses, sewers, or confined areas
Cleanup Methods: Scoop up material without creating dust, place in suitable closed container, wash spill site with water and detergent, dispose as hazardous waste
Handling: Avoid contact with eyes, skin, and clothing, avoid inhalation of dust or fumes, work in well-ventilated area, use appropriate personal protective equipment
Hygiene Practices: Wash hands thoroughly after handling, do not eat, drink, or smoke when using this chemical, keep away from food and drink
Storage: Store tightly closed, in original container, in a cool, dry, and well-ventilated place, protect from light and moisture, keep away from incompatible substances and unauthorized personnel
Exposure Limits: No established occupational exposure limits for Pirfenidone; use pharma industry controls
Engineering Controls: Use local exhaust or process enclosure to minimize airborne dust
Personal Protection: Wear chemical resistant gloves (nitrile or latex), safety goggles or face shield, laboratory coat, dust mask or NIOSH-approved respirator if exposure potential exists, emergency eye wash stations and showers recommended
Environmental Controls: Avoid release to environment, use spill containment if necessary
Appearance: White to pale yellow crystalline powder
Odor: Odorless or faint characteristic
pH: Not applicable (insoluble in water)
Melting Point: 109–111°C
Boiling Point: Not available
Flash Point: >100°C (closed cup, estimated)
Solubility: Slightly soluble in water, more soluble in methanol, ethanol, DMSO
Vapor Pressure: Not determined
Partition Coefficient (log Kow): 1.66 (reported)
Density: 1.213 g/cm³
Other Properties: Stable under recommended storage conditions
Chemical Stability: Stable under normal handling and storage conditions
Reactivity: Not reactive under normal use
Materials to Avoid: Strong acids, strong oxidizing agents, strong bases
Hazardous Decomposition Products: Nitrogen oxides, carbon oxides, possible toxic fumes in case of fire
Polymerization: Not expected to occur
Routes of Exposure: Inhalation, ingestion, skin contact, eye contact
Acute Toxicity: Harmful if swallowed; LD₅₀ (oral, rat) 1,450 mg/kg (literature)
Chronic Toxicity: May cause organ effects with repeated exposure, observed in animal studies, humans experience photosensitivity and GI discomfort
Skin and Eye Contact: Causes irritation, redness, possible allergic reaction
Carcinogenicity: Not listed as carcinogen by IARC, NTP, OSHA
Other Information: Not mutagenic in standard tests, not expected to pose significant reproductive risk under normal conditions
Eco-Toxicity: Not fully evaluated, low expected hazard due to slow release from facilities, may cause damage to aquatic organisms with acute or chronic exposure
Persistence/Degradability: Limited data, not considered readily biodegradable, monitoring recommended
Bioaccumulation: Not expected to bioaccumulate significantly based on structure and low log Kow
Mobility in Soil: Likely to have limited mobility due to poor water solubility
Other Adverse Effects: Prevent uncontrolled release to environment to reduce risk of contamination
Waste Disposal Methods: Dispose of as hazardous pharmaceutical waste by incineration or controlled landfilling, coordinate disposal through licensed contractor, never discharge to drain or natural water bodies
Container Disposal: Triple rinse containers before disposal, render unusable, follow local and state/national protocols
Precautions: Wear proper protective equipment during handling and disposal operations
UN Number: Not classified as dangerous goods under UN transport regulations
Proper Shipping Name: Not regulated
Hazard Class: Not classified
Packing Group: Not applicable
Environmental Hazards: Not a marine pollutant (per IMDG), avoid bulk uncontrolled release
Transport Precautions: Ship in tightly sealed containers, away from food and feedstuffs
Labeling: Label as hazardous if supplied as pure substance, provide clear hazard statements
EC Number: 258-956-6
Inventory Status: Listed in national and international inventories where required (e.g., TSCA, REACH, AICS)
Risk Phrases: R22 (harmful if swallowed), R36/37/38 (irritating to eyes, respiratory system and skin)
Safety Phrases: S36/37/39 (wear suitable protective clothing, gloves, and eye/face protection)
Other Regulations: Use, storage, and disposal governed by local, regional, and national guidelines; not regulated as a controlled substance
