Product Name: Prednisolone-21-Acetate
Chemical Name: 11β,17α,21-Trihydroxypregna-1,4-diene-3,20-dione 21-acetate
Synonyms: Prednisolone acetate
CAS Number: 125-02-0
EC Number: 204-722-3
Recommended Use: Pharmaceutical corticosteroid, anti-inflammatory agent
Supplier Information: Pharmaceutical and laboratory chemical suppliers typically handle storage, safety, and handling queries
Emergency Contact: Refer to organization's safety officer or poison control; local emergency services
Classification: Eye irritation (Category 2), Skin sensitization (Category 1), Reproductive toxicity (Category 2), Specific target organ toxicity (Category 2)
Label Elements: Warning pictograms for skin, eye, and reproductive toxicity
Signal Word: Warning
Hazard Statements: H319 – Causes serious eye irritation; H317 – May cause an allergic skin reaction; H361 – Suspected of damaging fertility or the unborn child; H373 – May cause damage to organs through prolonged or repeated exposure
Precautionary Statements: P280 – Wear protective gloves and eye protection; P264 – Wash hands thoroughly after handling; P305+P351+P338 – If in eyes, rinse cautiously with water
Routes of Exposure: Inhalation, ingestion, dermal, ocular
Most Immediate Hazards: Eye irritation and allergic skin reaction
Chemical Identity: Prednisolone-21-Acetate
CAS Number: 125-02-0
Purity: More than 98% active pharmaceutical ingredient
Molecular Formula: C23H30O6
Molecular Weight: 402.48 g/mol
Relevant Impurities: Trace synthesis residues (less than 1%)
Other Components: Negligible amounts of formulation excipients when present
General Advice: Move exposed person to fresh air and seek medical advice for all significant exposures
Inhalation: Remove from exposure; provide fresh air; obtain medical attention for persistent symptoms
Skin Contact: Rinse thoroughly with soap and water; remove contaminated clothing; monitor for skin reactions
Eye Contact: Rinse eyes immediately and thoroughly with water for at least 15 minutes, lifting eyelids; obtain medical advice
Ingestion: Rinse mouth with water; do not induce vomiting; seek immediate medical help
Symptoms and Effects: Sensitization, irritation of eyes or skin, symptoms of steroid overdose if swallowed
Suitable Extinguishing Media: Foam, dry powder, carbon dioxide, water spray
Unsuitable Extinguishing Media: Avoid water jets with full force
Hazardous Combustion Products: Carbon monoxide, carbon dioxide, irritating fumes
Specific Hazards: Dust can form explosive mixtures with air
Advice for Firefighters: Wear self-contained breathing apparatus and full protective gear
Thermal Decomposition: Can release hazardous vapors in a fire situation
Personal Precautions: Avoid contact with skin, eyes, and clothing; use personal protective equipment
Environmental Precautions: Prevent further leakage or spillage; do not let product enter drains, surface water, or groundwater
Cleanup Procedures: Ventilate area; use HEPA-filter vacuum or wet-mop method to avoid dust generation; properly collect in closed, labeled containers for disposal
Emergency Procedures: Evacuate area if needed for large spills; minimize personnel in affected zone
Reference to Other Sections: See handling, exposure controls, and disposal notes below
Safe Handling Advice: Avoid dust formation; handle with tools to minimize hand contact; prevent inhalation; carry out all procedures in accordance with local regulatory guidelines
Protective Practices: Use appropriate personal protection; handle in well-ventilated areas or fume hoods
Storage Conditions: Keep container tightly closed in a dry, cool, and well-ventilated place; protect from light and moisture; segregate from food and incompatible materials
Storage Class: Pharmaceuticals and hormone class compounds; separate from strong oxidizers, acids, and bases
Further Information: Retain in labeled, sealed containers; access restricted to trained personnel
Occupational Exposure Limits: No occupational exposure limits set; general threshold values to minimize corticosteroid exposure
Engineering Controls: Use local exhaust ventilation or effective laboratory hoods
Personal Protective Equipment: Chemical-resistant gloves (nitrile or latex); goggles; lab coats; dust masks or respirators for powder handling
Hygiene Measures: Wash hands after handling; do not eat, drink, or smoke near work area; avoid hand-to-mouth, hand-to-eye contact
Environmental Exposure Controls: Avoid release to the environment; use containment to prevent spills
Appearance: White to off-white crystalline powder
Odor: Odorless or faintly characteristic
pH: Not applicable; compound not soluble in water
Melting Point: 244 to 246°C
Boiling Point: Not established; decomposes before boiling
Flash Point: Non-flammable solid
Solubility: Practically insoluble in water; soluble in ethanol, acetone, and chloroform
Partition Coefficient (Log Kow): Approximately 1.6 (estimate)
Density: About 1.25 g/cm³
Vapor Pressure: Negligible at ambient conditions
Other Data: Stable under recommended storage; sensitive to light and heat
Chemical Stability: Stable under recommended storage and handling conditions
Reactivity: No specific reactivity hazards known under normal conditions
Possibility of Hazardous Reactions: Polymerization will not occur
Conditions to Avoid: Prolonged exposure to heat, light, moisture
Incompatible Materials: Strong oxidizers, acids, alkalis
Hazardous Decomposition: May release toxic fumes of carbon oxides on combustion or thermal breakdown
Acute Toxicity: Low acute toxicity by oral, dermal, or inhalation exposure
Skin Sensitization: Repeated contact may cause allergic skin reactions
Eye Effects: May cause irritation, tearing, redness
Carcinogenicity: Not classified as a carcinogen by IARC, NTP, or OSHA
Mutagenicity: Data does not show clear evidence of genetic toxicity
Reproductive Effects: Steroidal drugs can cause adverse reproductive and developmental effects
Chronic Exposure: Systemic effects possible with repeated exposure, including immunosuppression, endocrine disruption, or skin thinning
Other Risks: Possible hypersensitivity reactions in susceptible individuals
Aquatic Toxicity: No specific data for prednisolone-21-acetate, but corticosteroids can disrupt aquatic hormonal balance at low concentrations
Persistence and Degradability: Expected to be persistent due to steroid core stability; slow biodegradation seen in environmental studies
Bioaccumulative Potential: Moderate potential due to lipid solubility
Mobility in Soil: Low water solubility suggests limited mobility; binds to sediments
Other Adverse Effects: Chronic pharmaceutical exposure to wildlife may affect reproductive or immune function
Disposal Recommendations: Avoid environmental release whenever handling or disposing
Waste Treatment Methods: Use chemical or pharmaceutical waste collection; do not discharge to sewer systems
Product Disposal: Incinerate in approved facility; follow local, regional, and national regulations
Contaminated Packaging: Rinse and dispose of empty containers as hazardous waste
Special Precautions: Handle all disposal in accordance with official guidelines for pharmaceutical residues to avoid environmental release
UN Number: Not classified as a dangerous good for transport
UN Proper Shipping Name: Not regulated
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Environmental Hazards: Avoid accidental release into water or sewers during transport
Special Precautions for User: Safely sealed, labeled containers are recommended; transport according to general pharmaceutical standards
Safety, Health, and Environmental Regulations: Subject to regulation as a pharmaceutical ingredient and as a hazardous chemical in many jurisdictions
OSHA: Can be regulated under Hazard Communication Standard as a hazardous chemical
TSCA Status: Not listed for commercial distribution in the United States
EU Classification: Controlled as a prescription hormone; subject to environmental health regulations
WHMIS (Canada): Classified for skin, eye, and reproductive toxicity
Other International Regulations: Handled under pharmaceutical regulatory controls and strict occupational safety standards
Restrictions: Use only by trained professionals in controlled settings; consult regional authorities for exact guidelines
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