Product Name: Clobetasone Butyrate
Chemical Family: Corticosteroid
CAS Number: 25122-57-0
Molecular Formula: C26H32ClFO6
Molecular Weight: 510.98 g/mol
Synonyms: 17-Butyryl-9alpha-fluoro-11beta-hydroxy-21-chloro-16alpha-methylpregna-1,4-diene-3,20-dione
Recommended Use: Topical anti-inflammatory product for dermatological applications
Supplier: Chemical distributors, pharmaceutical manufacturers, hospital supply channels
Emergency Contact: Refer to site-specific emergency plan or poison control center information
Classification: Not classified as hazardous according to OSHA (29 CFR 1910.1200) for occupational exposures, though risk of eye, skin, or respiratory irritation occurs.
Label Elements: Not required under current US regulations; handle as a drug substance and avoid direct exposure.
Potential Health Effects: Prolonged exposure may cause skin irritation, allergic reactions, corticosteroid-induced side effects (Cushingoid features, delayed wound healing, atrophy).
Physicochemical Hazards: Combustible as an organic compound; avoid dust formation due to potential respiratory irritation.
Environmental Hazards: Compound may be toxic to aquatic life on chronic exposure.
Chemical Name: Clobetasone Butyrate
Purity: Pharmaceutical grade, typically >99%
Impurities: Trace precursors, organic solvents (<0.5%) from manufacturing process
Ingredient Compliance: Complies with pharmacopeia standards (USP, EP, JP) in most formulations, with ingredients strictly monitored during synthesis
Inhalation: Move individual to fresh air, keep comfortable, seek medical attention if respiratory symptoms develop.
Skin Contact: Wash thoroughly with soap and water, remove contaminated clothing, monitor for persistent irritation; seek care if reaction develops.
Eye Contact: Rinse with plenty of water for at least 15 minutes, remove contact lenses, and consult a healthcare provider immediately.
Ingestion: Rinse mouth, do not induce vomiting, monitor for symptoms, urgent medical review required.
Acute Symptoms: Redness, irritation, corticosteroid systemic effects on overexposure (rare in acute settings)
Suitable Extinguishing Media: Use water spray, foam, dry chemical, or carbon dioxide for controlling fire.
Unsuitable Media: Direct water jet may spread powder.
Special Firefighting Procedures: Wear full protective gear, self-contained breathing apparatus; prevent chemical runoff into water sources.
Hazardous Combustion Products: Releases toxic fumes of hydrochloric acid, carbon monoxide, carbon dioxide, fluorine-containing gases on burning.
Unusual Fire Hazards: Fine dust dispersed in air can create an explosion hazard with strong ignition sources.
Flash Point: Data unavailable, but expected to be above 100°C based on structure
Personal Precautions: Avoid breathing dust, ventilate area, wear appropriate PPE including gloves, goggles, and an N95 mask or higher protection.
Spill Cleanup Methods: Collect spilled powder using a HEPA filtered vacuum or by wet-wiping; do not sweep dry.
Environmental Precautions: Prevent release to drains and surface water.
Waste Treatment: Dispose of as pharmaceutical or hazardous waste per institutional protocols.
Decontamination: Wash spill site with detergent and water following removal of bulk solid; avoid spreading powder during cleanup
Handling: Avoid creating dust, always use in well-ventilated spaces or under fume hoods, wear gloves and lab coat, keep away from food and drinks.
Storage Conditions: Store in a tightly closed, light-resistant container at 15–25°C (room temperature), away from incompatible substances such as strong oxidizers.
Safe Transfer: Minimize transfer amounts, avoid spillage, ensure transfer equipment is electrically grounded.
Special Requirements: Secure from unauthorized personnel, do not store with flammable goods or open flames, maintain inventory control and access logs for pharmaceutical-grade substances
Exposure Limits: No specific TLV/PEL established; pharmaceutical workers should use consistent good industrial hygiene practice.
Engineering Controls: Use chemical fume hoods, powder containment booths if handling bulk quantities.
Personal Protection Equipment: Nitrile gloves, safety goggles, disposable lab coat, and particulate respirator for dust.
Hygiene Measures: Wash hands after use, do not eat, drink, or smoke in handling area.
Environmental Controls: Local exhaust ventilation, regular surface cleaning, periodic environmental sampling in production sites
Appearance: White to off-white crystalline powder
Odor: Odorless
pH: Not applicable (insoluble in water)
Melting Point: 202–210°C
Boiling Point: Decomposes before boiling
Solubility: Poorly soluble in water, soluble in ethanol, chloroform, and acetone
Vapor Pressure: Negligible at room temperature
Partition Coefficient (log P): High partition coefficient, significant tissue penetration
Stability: Stable under recommended storage conditions, sensitive to light and heat
Appearance Under UV Light: May fluoresce due to conjugated steroid nucleus
Thermal Stability: Stable at room temperature, decomposes on heating; avoid temperatures above 50°C.
Chemical Stability: Sensitive to strong acids, bases, oxidizing agents.
Hazardous Decomposition Products: Produces CO, CO2, HCl, HF upon combustion.
Reactions to Avoid: Strong oxidizers, alkali metals may initiate hazardous reactions.
Polymerization: Not expected to undergo hazardous polymerization.
Acute Toxicity: LD50 (oral, rat) >2000 mg/kg; low acute toxicity by dermal or inhalation routes.
Chronic Toxicity: Long-term overuse may lead to adrenal suppression, skin thinning, immune effects, in line with other corticosteroids.
Irritation: May cause irritation to eyes and mucous membranes, rare allergic skin reactions reported.
Sensitization: Low incidence, but possible upon repeated exposure.
Carcinogenic / Mutagenic Effects: No evidence for carcinogenicity or mutagenicity in humans; follow established pharmaceutical guidelines.
Other Effects: Chronic misuse may lead to systemic corticoid effects (Cushing's syndrome, glucose intolerance, osteoporosis).
Aquatic Toxicity: Toxic to aquatic organisms in long-term exposures; low water solubility may limit mobility.
Persistence and Degradability: Relatively persistent, resists breakdown in standard wastewater treatment.
Bioaccumulation: High potential due to lipid solubility, likely to accumulate in aquatic organisms.
Mobility in Soil: Low mobility; binds to soil particles, risk of leaching is low.
Other Ecotoxic Effects: Potential for adverse effects on aquatic endocrine systems if present in high environmental concentrations.
Disposal Methods: Manage as hazardous or pharmaceutical waste; incinerate at high temperature in certified facility.
Do Not Discharge: Avoid flushing into sewer, water courses, or soil.
Packaging Disposal: Decontaminate or incinerate contaminated packaging based on facility guidance.
Regulatory Requirements: Follow federal, state, and local regulations governing pharmaceutical substance destruction.
UN Number: Not regulated for ground, air, or sea transport in most jurisdictions
Shipping Name: Clobetasone Butyrate (non-hazardous) or Pharmaceutical Product, NOS
Hazard Class: Not assigned
Packing Group: Not assigned
Special Transport Precautions: Protect against physical damage, moisture, and high temperatures.
Label Requirements: No hazard label required, though certain export destinations may require declaration as medicament or controlled substance.
US Federal Regulations: Not specifically listed by EPA, CERCLA, SARA Title III; FDA regulated as prescription therapeutic.
OSHA Hazard: Treat as non-hazardous under 29 CFR 1910, yet observe safe lab and manufacturing practices.
EU Classification: Not hazardous per Regulation (EC) No 1272/2008 (CLP); subject to medicinal product controls.
Other Regulations: Listed as a prescription pharmaceutical; record-keeping and storage controls enforced.
Workplace Controls: Regular training, risk assessments, safe use protocols for healthcare and laboratory staff.
Environmental Release: Subject to local discharge limits for pharmaceuticals and controls on wastewater effluent from manufacturing.
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