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Product Name: Fenofibrate
Chemical Name: 2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropanoic acid, 1-methylethyl ester
Synonyms: Tricor, Lipidil
CAS Number: 49562-28-9
Recommended Use: Pharmaceutical intermediate, medication for cholesterol management
Manufacturer Contact: Emergency numbers and addresses available from the pharmaceutical supplier
Restrictions: For professional or industrial use only, not for direct human consumption without prescription
Hazard Classification: No classification for physical or acute health hazards under OSHA GHS. Chronic health impacts include mild irritancy and possible organ effects on prolonged exposure.
Signal Word: Warning
Hazard Statements: May cause mild irritation of eyes, skin, and respiratory tract on contact; not acutely toxic by oral, dermal, or inhalation exposure; chronic exposure may lead to mild liver effects in studies
Precautionary Statements: Avoid contact with eyes and prolonged skin exposure; do not inhale dust or fine particles; wash thoroughly after handling; use only with adequate ventilation
Symptoms of Exposure: Redness, itching, or discomfort at contact site; coughing or sneezing if inhaled; headache or dizziness in poorly ventilated settings
Target Organs: Liver, possibly kidneys on long-term exposure at high levels based on animal data
Ingredient: Fenofibrate
Chemical Formula: C20H21ClO4
Concentration: >98% pure pharmaceutical grade
Impurities: Trace solvent residues as per USP monograph, non-specific minor degradants below 1%
Other Additives: None for raw API; finished tablets may contain excipients including microcrystalline cellulose, lactose, or others depending on manufacturer
Inhalation: Move to fresh air, encourage slow deep breathing if person feels unwell, seek medical help for breathing difficulty or persistent symptoms
Skin Contact: Remove contaminated clothing, wash skin thoroughly with soap and water for several minutes, use moisturizing cream if irritation persists
Eye Contact: Rinse cautiously with water for at least 15 minutes, lift upper and lower lids occasionally, avoid rubbing, seek medical attention if symptoms remain
Ingestion: Do not induce vomiting, rinse mouth with water, seek medical advice; show product label or safety sheet to the healthcare provider
General Advice: Provide the responder with product details, follow standard first aid protocols, keep at rest, and observe for delayed symptoms
Suitable Extinguishing Media: Carbon dioxide, dry chemical powder, alcohol-resistant foam, or water spray
Unsuitable Extinguishing Media: Do not use high-pressure water jets, which may spread fine powder
Specific Hazards: Burning may produce toxic fumes including hydrogen chloride, carbon monoxide, and carbon dioxide
Firefighting Precautions: Firefighters should wear approved self-contained breathing apparatus and full protective clothing to prevent contact with skin or inhalation
Further Information: Avoid runoff entering drains or watercourses; cool exposed containers with water spray from a safe distance
Personal Precautions: Evacuate unnecessary personnel from the area, wear protective equipment (gloves, goggles, mask)
Environmental Precautions: Prevent entry into drains, sewers, groundwater, or open water systems; contain with suitable barriers
Clean-Up Methods: Sweep up or vacuum spillage into suitable labeled containers for disposal, avoid generating airborne dust, ventilate area
Decontamination: Wash the area thoroughly with water and detergent, dispose of cleaning solutions appropriately
Handling: Use in a well-ventilated space, avoid creating or inhaling dust, use local exhaust where needed; wash hands before breaks or eating; do not mix with incompatible substances
Storage Conditions: Store in tightly closed containers, away from heat, moisture, and sources of ignition; recommended temperature between 15°C and 30°C (59°F–86°F); keep out of reach of unauthorized personnel
Incompatible Materials: Strong oxidizers, strong acids, and alkalis may react or degrade the compound
Storage Segregation: Do not store with food, beverages, or personal items; store away from pharmaceuticals for human use unless as finished product
Exposure Limits: No occupational exposure limit value established for fenofibrate; follow general pharmaceutical dust guidelines (e.g., NIOSH REL for nuisance dust: 10 mg/m³ total, 3 mg/m³ respirable)
Engineering Controls: Local exhaust ventilation, HEPA-filtered fume hoods, physical containment where feasible
Personal Protective Equipment: Nitrile or latex gloves, chemical goggles or safety glasses, lab coat or protective gown, N95 or P3 respirator when handling outside control areas
Hygiene Measures: No eating, drinking, or smoking in areas of use; wash hands and face after handling
Appearance: White to off-white crystalline powder
Odor: Practically odorless
Odor Threshold: Not determined
pH: Not applicable (insoluble in water)
Melting Point: 79–82°C
Boiling Point: Not available (decomposes before boiling)
Flash Point: Not readily flammable
Evaporation Rate: Not applicable
Explosion Limits: Not defined for this substance
Vapor Pressure: Negligible at room temperature
Solubility: Practically insoluble in water; soluble in ethanol, methanol, and acetone
Partition Coefficient (log Kow): 5.24 (estimated)
Decomposition Temperature: Above 250°C
Viscosity: Not relevant (solid)
Density: 1.21 g/cm³ (estimated)
Chemical Stability: Stable under standard conditions, sensitive to strong oxidizers and acids
Reactivity: No dangerous reactions in normal use or storage; decomposes at high temperatures
Hazardous Reactions: Decomposition above 250°C produces toxic fumes (chlorinated and carbonaceous gases)
Conditions to Avoid: Excess heat, strong ultraviolet light, moisture, and strong oxidants
Incompatible Materials: Oxidizing materials, strong acids, and bases
Hazardous Decomposition Products: Hydrogen chloride, carbon monoxide, carbon dioxide, possibly unidentified organic compounds
Acute Toxicity: Oral LD50 (rat) >6000 mg/kg, indicating low acute oral toxicity
Skin/Eye Irritation: Slight and reversible irritation in animal studies
Respiratory Sensitization: Not classified as a respiratory sensitizer
Skin Sensitization: No evidence of skin sensitization in tested subjects
Repeated Dose Toxicity: Long-term administration in animal models caused reversible hepatic weight increase and minor enzyme changes; no significant adverse effects below therapeutic exposure levels
Mutagenicity/Carcinogenicity: Not mutagenic in standard in vitro tests; no human carcinogenicity observed in epidemiological studies
Reproductive Toxicity: No established risk in humans when prescribed appropriately; high doses in some animal models affected fetal parameters
Target Organs: Liver, kidneys at high doses
Symptoms of Overexposure: Nausea, vomiting, abdominal pain, fatigue in animal or accidental human exposures
Ecotoxicity: Data limited; high log Kow suggests potential for bioaccumulation, though low expected concentrations in aquatic environments from typical handling
Aquatic Toxicity: Not acutely harmful to fish at environmental concentrations; chronic data unavailable
Persistence/Degradability: Slow biodegradation in standard water/sediment studies; not readily biodegradable
Bioaccumulation: Potential bioaccumulative behavior due to high partitioning coefficient
Soil Mobility: Low mobility in soil due to poor water solubility
Other Ecological Effects: Avoid release in bulk quantities to the environment; pharmaceuticals disposed with care to prevent water course contamination
Disposal Methods: Dispose of content and container in accordance with local and national regulations
Recommended Disposal: Incineration in approved high-temperature chemical incinerator, do not place in municipal waste streams
Contaminated Packaging: Triple rinse and treat as hazardous pharmaceutical waste; dispose of at licensed facility
Precautions: Do not allow entry into surface waters, drains, or uncontrolled landfills
UN Number: Not regulated as a dangerous good for road, sea, or air transport
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Labels Required: None for transport under usual commerce
Special Precautions: Avoid container rupture during transit, protect from moisture, handle sealed in original container
Bulk Shipment: Follow guidelines for pharmaceutical actives; secure and label cargo
OSHA Status: Not specifically listed as hazardous; recommended precautions for particulates and pharmaceutical actives
EPA Status: Not on the EPCRA Section 313 or CERCLA hazardous substances lists
TSCA: Listed for research and development only; not for general unrestricted use
Other Designations: Registered pharmaceutical ingredient, subject to specific FDA, EU, and local controls
Workplace Labelling: Must include chemical identification, hazard signal word, and handling advice
Health Surveillance: Required for long-term occupational exposure
International Controls: Subject to prescription medicine rules in most jurisdictions; comply with ICH, EMA, and WHO handling standards
