Product Name: Halobetasol Propionate Chemical Name: 21-chloro-6α,9-difluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate Synonyms: Ulobetasol Propionate CAS Number: 66852-54-8 Recommended Use: Active pharmaceutical ingredient for topical corticosteroid formulations Manufacturer Information: Stated on packaging Emergency Contact: Listed on shipment documentation Molecular Formula: C25H31ClF2O5 Molecular Weight: 484.96 g/mol
GHS Classification: Eye irritation Category 2A, Skin sensitizer Category 1, Reproductive toxicity Category 2 Hazard Pictogram: Exclamation mark, Health hazard Signal Word: Warning Hazard Statements: Causes serious eye irritation, May cause allergic skin reactions, Suspected of damaging fertility or the unborn child Precautionary Statements: Wash thoroughly after handling, Wear protective gloves and eye protection, Avoid release to the environment Routes of Exposure: Skin, eyes, inhalation, ingestion
Active Ingredient: Halobetasol Propionate Concentration: >99% (pure form), Variable in formulated products Impurities: Trace related corticosteroid compounds Other Components: Formulated products may contain excipients such as petrolatum, propylene glycol, mineral oil (not present in pure API powder)
Inhalation: Move to fresh air; seek medical support if symptoms develop Skin Contact: Rinse with water, remove contaminated clothing, seek healthcare if irritation persists Eye Contact: Rinse thoroughly with water for several minutes; remove contact lenses; seek medical advice for persistent irritation Ingestion: Rinse mouth with water; do not induce vomiting; consult physician Important Symptoms: Eye redness, skin irritation, burning sensation Special Notes for Providers: Show label and/or safety sheet to medical staff
Suitable Extinguishing Media: Carbon dioxide, dry powder, foam, water spray Unsuitable Extinguishing Media: Direct water stream may spread powder Specific Hazards: Combustion may create hazardous fumes including hydrogen chloride, fluorine compounds, carbon oxides Firefighter Protection: Self-contained breathing apparatus, full protective gear Thermal Decomposition Products: HCl gas, HF, CO, CO₂
Personal Precautions: Avoid direct contact, ensure ventilation, wear gloves and goggles Protective Equipment: Chemical-resistant gloves, lab coat, safety goggles, particulate respirator Containment: Avoid dust formation, use vacuum or wet method for collection Cleanup: Sweep up carefully, avoid raising dust, place in labeled container for disposal Environmental Precautions: Prevent product from entering drains, waterways, soil
Safe Handling: Work in well-ventilated space, minimize dust, avoid skin and eye contact Hygiene Practices: Wash hands after handling, do not eat or drink during handling Storage Conditions: Store in tightly closed original container in cool, dry place, away from sunlight Incompatibilities: Strong oxidizers, acids, alkalis Shelf Life: Refer to batch documentation
Engineering Controls: Local exhaust ventilation, containment if possible Personal Protective Equipment: Disposable gloves, safety goggles, lab coat, suitable respiratory protection for powders Hygiene Measures: No smoking, eating, or drinking in work area; wash hands thoroughly Exposure Limit: No established occupational exposure limit, practice pharmaceutical control banding Environmental Controls: Prevent occupational release, filtered fumehood use preferred
Physical State: White to almost white powder Odor: Odorless Solubility: Insoluble in water, soluble in ethanol, methanol, chloroform Melting Point: 238 - 240 °C Boiling Point: Data not available pH (1% solution): Not applicable Vapor Pressure: Negligible at room temperature Partition Coefficient (logP): Approx. 3.57 Density: Approx. 1.3 g/cm³ Flash Point: Not flammable in solid form Appearance: Crystalline powder
Chemical Stability: Stable under recommended storage conditions Possible Hazardous Reactions: Not known under normal conditions Incompatible Materials: Strong oxidizers, reducing agents, acids, alkalis Conditions to Avoid: Moisture, extreme temperatures, direct sunlight Hazard Decomposition Products: Hydrogen chloride, hydrogen fluoride, carbon oxides on combustion
Routes of Exposure: Skin, eyes, inhalation, ingestion Acute Toxicity: Data from animal studies: LD50 (rat, oral) > 2000 mg/kg (estimated low acute toxicity in pure form) Chronic Effects: May cause dermal atrophy, suppression of hypothalamic-pituitary-adrenal axis, potential reproductive toxicity Potential Health Effects: Skin: Irritation, possible allergic reaction; Eyes: Irritation, redness; Inhalation: Respiratory tract irritation; Ingestion: GI tract effects Carcinogenicity: Not listed by IARC, NTP, OSHA Mutagenicity: Not shown in standard assays Reproductive Toxicity: Evidence in animal studies at high doses
Ecotoxicity: No acute aquatic toxicity data available; corticosteroid active pharmaceutical ingredients can impact aquatic life at low concentrations Persistence and Degradability: Not readily biodegradable; may persist in environment Bioaccumulative Potential: Moderate, predicted logP >3 Mobility in Soil: Immobile due to low water solubility Other Adverse Effects: Pharmaceutical pollutants entering water systems have downstream biological impacts; precaution urged in waste management
Disposal Methods: Collect as hazardous pharmaceutical waste, incinerate at licensed facility Contaminated Packaging: Dispose of containers as hazardous waste Precautions: Avoid release to environment, prevent contact with watercourses Regulatory Compliance: Follow local and national hazardous waste guidelines
UN Number: Not regulated as dangerous for transport according to ADR, IATA, IMDG codes Proper Shipping Name: Halobetasol Propionate Hazard Class: Not dangerous for transport Packing Group: Not assigned Special Precautions: Keep in original container, tightly closed, protect from physical damage and moisture
US Federal Regulations: Not listed specifically as hazardous by OSHA, SARA, CERCLA Europe: Complies with REACH registration, not classified as PBT/vPvB WHMIS Classification (Canada): Controlled, prescription ingredient Other National Regulations: Pharmaceutical handling and waste management law applies Label Requirements: Name, chemical identifier, hazard, and safety instructions must be clearly marked Workplace Control: Use in licensed pharmaceutical manufacturing or compounding operations; safety sheet must be accessible
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