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Product Name: Epalrestat
Chemical Formula: C15H13NO4S
Chemical Name: 5-[(1Z)-1-oxohex-1-enyl]-2,4,6-trimethyl-1,3-benzenediol
CAS Number: 82159-09-9
Recommended Use: Aldose reductase inhibitor, pharmaceutical ingredient
Synonyms: None commonly listed
Manufacturer Information: Sourced from bulk pharmaceutical manufacturers and chemical providers
Hazard Classification: Not classified as hazardous by GHS criteria for pure substance
Physical Hazards: May form combustible dust concentrations in air
Health Hazards: Irritant to eyes and respiratory tract on direct contact or inhalation; possible skin irritant
Environmental Hazards: Data indicate potential for aquatic toxicity; precautions needed to prevent environmental release
Signal Word: Warning (in the case of dust formation)
Hazard Statements: May cause eye, skin, and respiratory irritation
Precautionary Statements: Avoid breathing dust; wear protective clothing; wash thoroughly after handling
Chemical Name: Epalrestat
Concentration: Approximately 100% pure material
Impurities: No significant hazardous impurities expected in pharmaceutical grade
Additives or Excipients: None in raw material form
Inhalation: Move to fresh air, seek medical attention if respiratory symptoms develop
Skin Contact: Wash with soap and plenty of water, remove contaminated clothing
Eye Contact: Rinse immediately with running water for at least 15 minutes, consult physician if irritation persists
Ingestion: Rinse mouth, do not induce vomiting, seek prompt medical attention
Most Relevant Effects: Mucous membrane irritation, potential sensitization
Suitable Extinguishing Media: Water spray, carbon dioxide, dry chemical, or foam, depending on environment
Hazards from Combustion: Possible toxic fumes of nitrogen oxides, sulfur oxides, carbon monoxide and dioxide
Special Protective Equipment: Firefighters need self-contained breathing apparatus, full protective suit
Fire and Explosion Risks: Organic dust can form explosive mixtures in air if concentrations are sufficient
Additional Advice: Cool containers with water spray to prevent rupture due to heat
Personal Precautions: Avoid dust formation, wearing gloves and dust mask is important
Environmental Precautions: Contain spill, prevent entry into drains, surface water, or soil
Spill Clean-up Methods: Sweep up, avoid creating dust cloud, place in suitable container for disposal
Decontamination: Wash spill site with water after material pickup is complete
Handling: Work in well-ventilated area, use local exhaust if necessary; avoid inhaling dust and direct contact with eyes or skin.
Storage: Store in tightly closed container in cool, dry, and well-ventilated space, away from incompatible materials like oxidizing agents; follow pharmaceutical storage standards to maintain substance integrity.
Incompatibilities: Strong oxidizers, strong acids or bases
Exposure Limits: No established occupational exposure limits for Epalrestat
Engineering Controls: Use fume hood or adequate ventilation; process enclosure recommended for bulk handling
Respiratory Protection: NIOSH-approved dust mask or respirator during dust generation
Hand Protection: Nitrile or latex gloves
Eye and Face Protection: Safety goggles or face shield
Skin and Body Protection: Lab coat or protective clothing
Appearance: Yellow to orange crystalline powder
Odor: Mild or none
Odor Threshold: Not available
pH: Not applicable (solid material)
Melting Point: 115–119°C
Boiling Point: Data not available
Flash Point: Data not available
Flammability: May form combustible dust-air mixtures
Solubility: Slightly soluble in water, more soluble in organic solvents like ethanol and DMSO
Partition Coefficient: Not determined
Vapor Pressure: Not available
Density: Approx. 1.38 g/cm³
Viscosity: Not applicable
Auto-ignition Temperature: Not determined
Explosive Properties: Dust risk in air under certain conditions
Chemical Stability: Stable under normal storage conditions
Reactivity: Not highly reactive, respect for interaction with oxidizers
Conditions to Avoid: Excessive heat, sources of ignition, incompatible materials
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, sulfur oxides released upon thermal decomposition
Polymerization: Will not occur under recommended storage and use conditions
Acute Toxicity: Oral LD50 in rodents over 2000 mg/kg; very low acute toxicity in animal studies
Skin Corrision/Irritation: Possible mild irritant
Eye Damage/Irritation: Possible mild irritant
Respiratory Sensitization: Inhalation of dust can cause temporary irritation
Chronic Toxicity: No evidence of carcinogenic, mutagenic, or reproductive toxicity reported in current data
Other Effects: No significant systemic toxicity noted in therapeutic use as a drug; avoid unnecessary or large-scale occupational exposure
Ecotoxicity: No specific data for Epalrestat, potential for moderate aquatic toxicity based on chemical structure
Persistence and Degradability: Biodegradability data missing, but aromatic and sulfonamide structure tends to resist rapid breakdown
Bioaccumulative Potential: Not expected to significantly bioaccumulate
Mobility in Soil: Predicted moderate mobility; precautions to prevent direct release into environment
Other Adverse Effects: Proper containment and waste management recommended to minimize ecological impact
Waste Disposal: Handle as hazardous pharmaceutical waste in accordance with local, regional, and national regulations
Contaminated Packaging: Dispose of in the same manner as material waste
Precautions: Do not dispose of product or washings into public waterways or sewage; minimize dust formation during disposal processes
UN Number: Not classified as dangerous for transport under ADR, IMDG, or IATA regulations
Proper Shipping Name: Epalrestat
Transport Hazard Classes: Non-hazardous for air, road, or sea transport
Packing Group: Not applicable
Environmental Hazards: Not listed as marine pollutant
Transport Precautions: Ship in tightly closed container protected from moisture, direct sunlight, and physical damage
Classification: Not subject to specific chemical regulation as hazardous under OSHA, EU REACH, or WHMIS based on current data
Labelling Requirement: Standard precautionary labeling for pharmaceuticals
SARA Title III: Not listed
TSCA Status: Not found on inventory, pharmaceutical substance exempt in USA
REACH Status: Not registered; pharmaceutical use exempt from registration under typical volumes
Other Regulations: National and local pharmaceutical, environmental, and workplace safety guidelines apply; regular hazard assessments suggested as manufacturing scale increases
