Material Safety Data Sheet - 16A-Hydroxyprednisolone-21Acetate

Identification

Product Name: 16A-Hydroxyprednisolone-21Acetate
Chemical Formula: C23H30O6
Synonyms: 16α-Hydroxy-prednisolone 21-acetate
CAS Number: 10030-73-2
Manufacturer: Refer to sourcing pharmaceutical supplier
Recommended Use: Research and laboratory use only
Restrictions: Not for drug, household, or veterinary uses

Hazard Identification

GHS Classification: Not classified as hazardous under GHS standards
Health Hazards: May cause skin, eye, or respiratory irritation with prolonged exposure; immunosuppressive effects possible
Environmental Hazards: Not expected to pose an acute environmental risk in small laboratory quantities, though pharmaceutical steroids can disrupt endocrine systems in water bodies
Signal Word: None required under standard GHS
Pictograms: None designated for this compound
Precautionary Statements: Avoid inhalation, ingestion, and contact with skin and eyes; use in well-ventilated area

Composition / Information on Ingredients

Chemical Name: 16A-Hydroxyprednisolone-21Acetate
Concentration: ≥ 99% pure
Impurities: Trace related steroids & acetates (total ≤ 1%)
Additives: None
Molecular Weight: 402.48 g/mol

First Aid Measures

Inhalation: Move person to fresh air; monitor for irritation or any signs of respiratory distress; consult physician if symptoms occur
Skin Contact: Remove contaminated clothing; wash thoroughly with soap and water; seek medical attention for persistent irritation
Eye Contact: Rinse immediately with water for at least 15 minutes, ensuring eyelids are held open; remove contact lenses if present and easy; seek ophthalmological evaluation if irritation develops
Ingestion: Rinse mouth thoroughly with water; do not induce vomiting; obtain medical advice if accidentally swallowed or symptoms develop
Important Symptoms/Effects: Immune suppression, hormonal effects possible with repeated exposure; limited acute toxicity in short-term, but clinical monitoring advised

Fire-Fighting Measures

Suitable Extinguishing Media: Dry chemical powder, carbon dioxide, foam, water spray
Unsuitable Extinguishing Media: High volume water jet for small spills can cause spread
Specific Hazards: Emits toxic fumes of carbon oxides on combustion
Protective Equipment for Firefighters: Full firefighting turn-out gear; self-contained breathing apparatus recommended
Other Advice: Avoid breathing combustion products and run-off; contain fire water to avoid environmental release

Accidental Release Measures

Personal Precautions: Use personal protective equipment; avoid inhalation or contact with skin and eyes
Environmental Precautions: Prevent further leakage or spillage if safe; do not let material enter drains or surface water; prevent from reaching soil
Methods for Clean-up: Soak up with inert absorbent material (sand, earth, or vermiculite) and place in a chemical waste container; ventilate area; wipe surfaces clean after removal

Handling and Storage

Handling: Use in a certified chemical fume hood; wear protective lab coat, gloves, and safety glasses; avoid unnecessary contact; avoid aerosol or dust generation
Storage Conditions: Keep tightly closed in original container; store in a dry, cool, and well-ventilated area; keep away from heat, moisture, and sources of ignition
Incompatibilities: Strong oxidizers; bases; acids can hydrolyze the acetate group
Specific Storage Requirements: Store at 2-8°C for stability; protect from direct sunlight

Exposure Controls and Personal Protection

Engineering Controls: Use local exhaust ventilation or chemical fume hood; maintain low airborne concentrations
Eyes Protection: Chemical safety goggles
Skin Protection: Nitrile or rubber gloves; lab coat or apron
Respiratory Protection: Use dust mask or respirator (NIOSH-approved) if airborne particulates are present
Exposure Limits: No occupational exposure limit established; minimize exposure by best lab practices

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless or faint steroid-like
Melting Point: Approx. 225-230°C
Boiling Point: Decomposes before boiling
Solubility: Insoluble in water; soluble in ethanol, DMSO, and chloroform
pH: Not applicable as solid
Vapor Pressure: Negligible at room temperature
Partition Coefficient (log Kow): Estimated 2.4-2.8
Flash Point: Not determined (organic solid)
Autoignition Temperature: Not available

Stability and Reactivity

Chemical Stability: Stable at recommended storage conditions
Conditions to Avoid: Moisture, high temperatures, prolonged exposure to light
Incompatible Materials: Strong acids, strong bases, oxidizing agents
Hazardous Decomposition Products: Carbon oxides, possible acetic acid, and steroid fragments on thermal decomposition
Polymerization: Not known to occur

Toxicological Information

Acute Toxicity: Not acutely toxic by oral, dermal, or inhalation routes at low laboratory doses; long-term systemic exposure may cause typical glucocorticoid side effects
Skin and Eye Irritation: Possible mild irritant in sensitive individuals
Inhalation: May irritate airway in powder form
Chronic Effects: Prolonged low-level exposure may disrupt endocrine and immune function
Mutagenicity/Carcinogenicity: No germ cell mutagenicity data; long-term impact unknown
Reproductive Effects: Possible endocrine disruption at repeated systemic doses
Target Organs: Endocrine system, immune system, liver with repeated exposure

Ecological Information

Ecotoxicity: Not well studied; steroid hormones may affect aquatic vertebrates at very low concentrations
Persistence and Degradability: Expected to be slowly biodegradable; may persist in sediment
Bioaccumulation: May bioaccumulate due to lipophilicity
Mobility in Soil: Low water solubility suggests limited mobility; adsorbs to particulate matter
Effect on Sewage Plants: Can disrupt microbial activity at elevated concentrations
Addition to Water Bodies: Prevent runoff or discharge into surface and groundwater

Disposal Considerations

Waste Disposal: Treat as hazardous pharmaceutical waste; use incineration or authorized contractor facilities
Container Disposal: Deface labels, triple rinse if possible, dispose with licensed chemical waste handler
Contaminated Materials: Decontaminate with detergent; collect cleaning materials for hazardous disposal

Transport Information

UN Number: Not assigned
Proper Shipping Name: Not regulated for transport under typical international guidelines
Hazard Class: Not listed
Packing Group: Not applicable
Special Precautions: Package securely to avoid leaks; label as laboratory chemical, not for human or veterinary use
Environmental Hazards: Avoid releases during transport; ensure any spillage is contained and remediated promptly

Regulatory Information

US TSCA: Not listed for commercial manufacture
OSHA Hazard Communication Standard: Not regulated as hazardous
EU REACH: Not registered; research quantities exempt
Canada WHMIS: Not classified
SARA/Title III: Not subject to reporting
State Regulations: Follow state and local guidelines for handling small-scale pharmaceutical chemicals
International Inventory: Registrations or import permits required in some countries for steroidal substances
Other Regulations: Handle as controlled substance precursor in jurisdictions regulating steroid synthesis