Material Safety Data Sheet: Prednisolone Acetate

Identification

Product Name: Prednisolone Acetate
Chemical Name: 21-Acetoxy-11β,17α-dihydroxypregna-1,4-diene-3,20-dione
Synonyms: 11β,17α,21-Trihydroxypregna-1,4-diene-3,20-dione 21-acetate
CAS Number: 52-21-1
Recommended Use: Pharmaceutical corticosteroid primarily for anti-inflammatory and immunosuppressive effects
Supplier Information: Manufacturer or distributor contact info is listed on packaging
Emergency Contact: Refer to local poison control or company’s emergency response team

Hazard Identification

Physical State: White to off-white crystalline powder
Hazard Classification: Not considered hazardous under normal laboratory use
Label Elements: Not classified as dangerous under GHS ; occupational exposure may cause allergic reactions or steroid side effects in sensitive individuals
Routes of Exposure: Inhalation, ingestion, skin or eye contact
Potential Health Effects: Prolonged contact may result in respiratory irritation, changes in skin atrophy, or aggravation of infections
Chronic Effects: Risks from long-term or repeated exposure may include immunosuppression, adrenal suppression in sensitive individuals

Composition / Information on Ingredients

Chemical: Prednisolone Acetate
CAS Number: 52-21-1
Concentration: Typically over 95% pure; pharmaceutical preparations contain less, mixed with excipients
Impurities: Minimal, levels monitored in accordance with pharmacopeial standards
Formulation Ingredients: Suspensions may include vehicle agents, preservatives, and stabilizing agents; always review formulation-specific data

First Aid Measures

General Advice: Remove individual from exposure and seek medical attention if symptoms appear
Inhalation: Move to fresh air; get medical help if respiratory symptoms develop
Skin Contact: Remove contaminated clothing; wash affected skin with soap and plenty of water
Eye Contact: Immediately flush with plenty of water for at least 15 minutes; seek medical care
Ingestion: Rinse mouth with water; do not induce vomiting unless directed by medical personnel
Symptoms Requiring Emergency Care: Severe allergic reaction (rash, swelling, trouble breathing), persistent irritation

Fire-Fighting Measures

Suitable Extinguishing Media: Use carbon dioxide, dry chemical powder, foam, or water spray
Hazardous Combustion Products: Emits toxic fumes under fire conditions (carbon monoxide, carbon dioxide)
Specific Hazards: Product itself not highly flammable, but packaging or excipients might burn
Firefighters’ Protection: Use self-contained breathing apparatus and full protective gear
Precautions: Avoid breathing smoke, fumes, or vapors; evacuate area if necessary

Accidental Release Measures

Personal Precautions: Use appropriate personal protective equipment; avoid dust formation and breathing vapor
Environmental Precautions: Prevent release into sewers or waterways; collect spillage and dispose in accordance with regulations
Spill Response: Gather powder with damp disposable cloth or HEPA-filter vacuum; avoid dry sweeping
Decontamination: Clean site thoroughly with water after removal
Reporting: Notify safety officers of significant spills or exposure incidents

Handling and Storage

Handling: Minimize dust generation; ventilate work area; wear protective clothing; avoid prolonged contact with skin and eyes
Storage Conditions: Store in tightly closed original container at room temperature; avoid exposure to light, moisture, and incompatible substances
Special Storage Notes: Store away from oxidizers; keep out of reach of unauthorized personnel
Hygiene Measures: Do not eat, drink, or smoke near product; wash hands after handling

Exposure Controls and Personal Protection

Occupational Exposure Limits: No established exposure limits specifically for prednisolone acetate; use industry control practices for corticosteroids
Engineering Controls: Employ local exhaust ventilation; consider containment for bulk handling
Personal Protective Equipment:
— Respiratory Protection: Use NIOSH-approved respirator if exposure to powder/dust is possible
— Eye Protection: Wear safety goggles or face shield
— Skin Protection: Disposable gloves; laboratory coat or coveralls
Environmental Controls: Prevent workplace dust build-up; limit access to trained employees

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Practically odorless
Molecular Formula: C23H30O6
Molecular Weight: 402.48 g/mol
Melting Point: 240–245°C (decomposes)
Solubility: Practically insoluble in water; soluble in chloroform, acetone, and methanol
Partition Coefficient (log P): 1.6
pH: Neutral in aqueous suspension
Vapor Pressure: Negligible at ambient temperature
Density: 1.29 g/cm³
Stability: Stable under recommended conditions

Stability and Reactivity

Chemical Stability: Product remains stable under normal storage and handling conditions
Reactivity: Low chemical reactivity in typical pharmaceutical environments
Incompatible Materials: Strong oxidizing agents; acids and bases in concentrated form
Decomposition Products: Thermal breakdown releases irritating and toxic fumes; including carbon oxides
Hazardous Polymerization: Has not been reported

Toxicological Information

Acute Toxicity: Prednisolone acetate carries a moderate hazard for acute toxicity, reflecting effects noted in corticosteroids. LD50 (oral, rat): >3000 mg/kg
Skin Contact: May provoke dermatitis after chronic exposure
Eye Contact: Irritation possible if dust contacts eyes
Inhalation: Excessive airborne exposure may irritate respiratory tract
Chronic Effects: Long-term exposure risks mirror those of systemic corticosteroids: immunosuppression, hormonal disturbance, Cushingoid features
Mutagenicity, Carcinogenicity, Reproductive Risks: Not classified as carcinogenic by NTP, IARC, or OSHA; standard use and monitoring minimize any theoretical risks

Ecological Information

Ecotoxicity: Limited data available on acute aquatic or terrestrial toxicity; corticosteroids may exhibit environmental persistence and harm to aquatic life in large concentrations
Persistence and Degradability: Not readily biodegradable; degradation depends on microbial activity, temperature, and light
Bioaccumulation Potential: Low; the compound’s physical properties limit significant accumulation in organisms
Mobility in Soil: Moderately adsorbed to soils; run-off risk increases after uncontrolled release
Other Adverse Effects: Environmental hazards mainly from bulk manufacturing waste; prudent practice limits impact

Disposal Considerations

Disposal Methods: Incinerate in approved facility or dispose as hazardous or pharmaceutical waste following local, regional, and national regulations
Do Not: Discharge to sewers, soil, or natural waterways
Packing Waste: Dispose of contaminated packing as regulated waste; avoid reuse
Additional Notes: For large quantities, licensed hazardous waste contractor should manage removal

Transport Information

UN Number: Not regulated for transport as hazardous material
Proper Shipping Name: Prednisolone Acetate, Pharmaceutical Compound
Transport Hazard Class: Not applicable
Packing Group: Not regulated
Special Precautions: Protect from physical damage and water; keep in original container
Transport Regulations: Comply with applicable state, federal, and international standards and documentation requirements

Regulatory Information

Safety, Health and Environmental Regulations: Prednisolone acetate is subject to pharmaceutical and chemical safety regulations; not listed as a controlled substance
OSHA Classification: Not classified as hazardous by OSHA
SARA (Title III) Status: No chemical subject to reporting
TSCA Inventory: Not listed for non-pharmaceutical use; regulated under FDA guidelines
EU REACH: Substance exempted for medicinal use
Other National Listings: Handled as prescription-only medicine; subject to Good Manufacturing Practice (GMP) and worker safety standards