Product Name: Hydrocortisone-17-Butyrate
Synonyms: Hydrocortisone butyrate; 11β,17,21-Trihydroxypregn-4-ene-3,20-dione 17-butyrate
Use: Topical corticosteroid for inflammation and pruritus
Manufacturer: Refer to label information
Contact: Refer to product label for emergency numbers and supplier details
CAS Number: 13609-67-1
Recommended Restrictions: Professional use—hospital, pharmacy, research settings
Classification: Not classified as hazardous under GHS for typical pharmaceutical use. Bulk chemical may cause irritation to eyes and respiratory tract. Risk from prolonged or repeated occupational exposure.
Hazard Statements: May cause allergic skin reaction. Prolonged or repeated exposure may affect endocrine and immune systems.
Signal Word: Warning
Precautionary Statements: Avoid breathing dust; wear protective gloves and goggles; wash hands after handling.
Health Hazards: Possible skin, eye irritation, hormone effects with chronic exposure
Environmental Hazards: Avoid release into the environment, can impact aquatic organisms
Label Elements: Exclamation Mark – Skin Sensitization (Category 1)
Chemical Name: Hydrocortisone-17-butyrate
CAS Number: 13609-67-1
Concentration: 100% (active ingredient bulk), or variable (as formulated product)
Other Components: None in pure form; excipients may be present if in formulated product
Impurities: None significant for regulatory reporting
Inhalation: Move to fresh air. Seek medical attention for any respiratory symptoms.
Skin Contact: Remove contaminated clothing, wash affected area with soap and water. Seek medical attention for persistent irritation or allergic reaction.
Eye Contact: Rinse with plenty of water at least 15 minutes, keep eyelids open. Remove contact lenses if present and easy to do. Seek medical attention for ongoing symptoms.
Ingestion: Rinse mouth. Do not induce vomiting unless directed by medical personnel. Seek immediate medical advice for large exposures or if symptoms occur.
Symptoms and Effects: Irritation, redness, headache, dizziness, allergic reactions, disruption of endocrine function on repeated exposure
Suitable Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or foam.
Unsuitable Media: Strong jets of water may spread dust.
Specific Hazards: Product is combustible though does not sustain fire readily. May generate toxic fumes (carbon oxides, hydrogen fluoride) in fire conditions.
Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective gear.
Firefighting Instructions: Avoid inhalation of fumes. Keep containers cool with water spray if exposed to flames.
Personal Precautions: Avoid contact with skin and eyes; use PPE including gloves, goggles, and mask.
Environmental Precautions: Prevent entry into drains, surface, or groundwater.
Containment: Sweep up spill avoiding dust formation. Place in suitable container for disposal.
Clean-up Methods: Clean area with non-sparking tools. Wash surfaces with water once material collected.
Decontamination: Dispose of cleaning materials as hazardous waste. Ventilate area.
Handling: Handle under local exhaust ventilation. Wear protective clothing and gloves. Avoid creating dust. Do not eat, drink, or smoke during handling.
Storage Conditions: Store in original container, tightly closed, away from heat, moisture, and sunlight. Maintain at room temperature or as instructed by manufacturer.
Incompatibilities: Strong oxidizers, acids, bases may degrade compound.
Hygiene Practices: Wash hands thoroughly after use. Remove contaminated clothing.
Exposure Limits: No established occupational exposure limits for active ingredient; minimize exposure.
Controls: Local exhaust ventilation, containment hoods in processes liable to generate dust.
Personal Protection: Protective gloves (nitrile, latex), lab coat, safety goggles or face shield for splash risk, disposable mask or N95 for powder handling.
Other Protection: Eye wash and safety shower in work area.
General Measures: Avoid direct contact, follow established workplace safety protocols.
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not applicable
pH: Not applicable (insoluble in water)
Melting Point: 220-230°C
Boiling Point: Not available
Flash Point: Not readily flammable
Evaporation Rate: Not available
Flammability: Not highly flammable
Vapor Pressure: Negligible
Solubility: Practically insoluble in water; soluble in ethanol/chloroform
Partition Coefficient (log Kow): Not available
Auto-ignition Temperature: Not available
Decomposition Temperature: Not available
Viscosity: Not applicable
Chemical Stability: Stable under recommended storage conditions
Reactivity: Not reactive under normal conditions
Possibility of Hazardous Reactions: None under normal processing
Conditions to Avoid: Excess heat, open flame, direct sunlight, high moisture
Incompatible Materials: Strong oxidizers and acids
Hazardous Decomposition: Carbon oxides, perhaps corrosive fumes on combustion or thermal decomposition
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Acute Effects: May cause mild skin and eye irritation, respiratory discomfort with high airborne concentrations
Chronic Effects: Repeated exposure may disrupt adrenal, endocrine, or immune function. Risk of skin thinning, contact dermatitis, allergic reactions.
Sensitization: May cause allergic contact dermatitis in workplace settings.
Mutagenicity: Not classified as mutagenic according to current data
Carcinogenicity: Not listed with IARC, NTP, OSHA
Toxicity Data: LD50 (oral, rat) above 4000 mg/kg; significant effects unlikely at therapeutic doses, higher risk from occupational chronic exposure.
Ecotoxicity: Avoid release to natural waters. May affect aquatic organisms, especially at high concentrations.
Persistence and Degradability: Not rapidly biodegradable.
Bioaccumulative Potential: Some potential to bioaccumulate.
Mobility in Soil: Likely low; binds to organic matter.
Other Adverse Effects: Endocrine disrupting at high concentrations to wildlife, potential for chronic environmental effects from pharmaceutical residues.
Disposal Methods: Dispose of in accordance with local, regional, and national regulations for pharmaceuticals.
Contaminated Packaging: Dispose of as pharmaceutical waste if contaminated.
Precautions: Do not flush into surface water or drains. Use a licensed chemical disposal contractor for large quantities.
Hazardous Waste: Considered hazardous if bulk active ingredient or large volumes involved.
UN Number: Not regulated as dangerous goods under ADR, RID, ICAO, IMDG code for small quantities or formulated products.
Proper Shipping Name: Hydrocortisone-17-butyrate or “non-hazardous chemical for laboratory use”
Transport Hazard Class: Not applicable for non-bulk amounts
Packing Group: Not assigned
Environmental Hazards: Not a marine pollutant
Special Precautions: Protect from extreme temperatures, accidental damage during transport
US Regulations: Not listed under SARA Title III, not subject to TSCA. FDA regulated as prescription pharmaceutical.
EU Regulations: Not classified under CLP Regulation for typical use. Bundled within REACH exemption for medicinal products.
Canada: DSL/NDSL: Not listed
Other Regulations: Product subject to local and regional controls for prescription medicine, handling workplace safety requirements.
Labeling Requirements: Prescription only, warnings for occupational handlers where applicable.
Workplace Classification: Pharmaceuticals occupational exposure limits recommended.
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