Product Name: Deflazacort
Chemical Name: (11β,17β)-21-(acetyloxy)-11-hydroxy-2'-methyl-5β-pregna-1,4-dieno(17,16-d)-oxazolone-3,20-dione
CAS Number: 14484-47-0
Synonyms: Calcort, Emflaza
Recommended Use: Pharmaceutical corticosteroid for anti-inflammatory and immunosuppressant therapy
Supplier Details: Refer to packaging or pharmacy for specifics
Emergency Telephone: Refer to local poison control center
Hazard Classification: Not classified as hazardous under GHS for pharmaceutical use, but can cause health effects upon improper handling
Physical Hazards: Not classified as a flammable or explosive substance, though fine particulate from large spills may present dust hazards
Health Hazards: Possible eye, skin, and respiratory irritation; immunosuppression and endocrine disruption if absorbed in significant amounts
Environmental Hazards: Low toxicity to aquatic life under normal use; improper disposal may introduce persistent pharmaceutical compounds to water systems
Signal Word: Caution
Pictograms: None required for dilute forms; laboratory and manufacturing concentrations may need health hazard pictograms
Chemical Ingredient: Deflazacort
Concentration: Typically 100%, depending on formulation
Impurities: Not anticipated in regulated pharmaceutical products
Additives: None in pure active material; refer to specific drug formulation for excipients or fillers
Molecular Formula: C25H31NO6
Molecular Weight: 441.52 g/mol
Inhalation: Move affected individual to fresh air; seek medical attention if symptoms like coughing, difficulty breathing, or throat irritation persist
Skin Contact: Wash thoroughly with plenty of water and mild soap; remove contaminated clothing
Eye Contact: Rinse cautiously for several minutes with water; remove contact lenses if present; continue rinsing and seek medical attention for persistent discomfort
Ingestion: Rinse mouth with water; never give anything by mouth to an unconscious person; seek medical advice promptly
Note to Physician: Treat supportively based on symptoms; monitor for effects related to corticosteroid exposure
Suitable Extinguishing Media: Carbon dioxide, dry chemical powder, alcohol-resistant foam, water spray
Unsuitable Extinguishing Media: Direct stream of water may spread powder
Specific Hazards: Product not expected to be flammable, but thermal decomposition can produce irritating smoke, carbon oxides, nitrogen oxides
Protective Equipment: Firefighters wear self-contained breathing apparatus and protective clothing
Advice for Firefighters: Contain run-off; treat any smoke or fumes as potentially hazardous
Personal Precautions: Ensure adequate ventilation; avoid inhaling dust; avoid contact with skin and eyes; wear suitable PPE such as gloves, goggles, and a mask
Environmental Precautions: Prevent spillage from entering drains, surface water, or soil
Methods for Containment: Collect powder by dampening lightly to avoid airborne dust; sweep into suitable, closed container for disposal
Cleanup Procedures: Decontaminate surface area with detergent and water after removal; dispose of cleaning materials safely
Handling: Handle in well-ventilated areas; minimize dust formation and accumulation; wash hands thoroughly after handling
Storage: Store in a cool, dry location away from direct sunlight; keep container tightly closed until use; segregate from incompatible materials such as strong oxidizers
Special Requirements: Limit access to storage areas to trained staff; follow all local regulations for controlled substances
Occupational Exposure Limits: No established workplace exposure limits; minimize exposure though practice of good hygiene
Engineering Controls: Use local exhaust ventilation or work inside a chemical fume hood in bulk handling or compounding
Personal Protection: Wear lab coats or gowns, gloves made of nitrile or latex, protective goggles, and a suitable dust respirator if powder generation is likely
Environmental Controls: Avoid release to environment; follow all regulatory guidelines for workplace and pharmaceutical waste
Appearance: White or off-white crystalline powder
Odor: Odorless or faint characteristic smell
Odor Threshold: Not applicable
pH: Not determined
Melting Point/Freezing Point: Approximately 244–246°C
Boiling Point: Decomposes before boiling
Flash Point: Not applicable
Evaporation Rate: Not applicable
Flammability: Not classified as flammable
Vapor Pressure: Not determined
Vapor Density: Not determined
Solubility: Sparingly soluble in water; soluble in methanol, chloroform, ethyl acetate
Partition Coefficient (n-octanol/water): Not available
Decomposition Temperature: Above 230°C
Viscosity: Not applicable
Density: Not determined
Chemical Stability: Stable under normal temperatures and pressures if kept dry and out of light
Reactivity: Not reactive under expected conditions of use and storage
Incompatible Materials: Strong oxidizing agents, strong acids
Hazardous Decomposition Products: Can yield toxic fumes of carbon monoxide, carbon dioxide, nitrogen oxides, and other unknown compounds in fire
Conditions to Avoid: Prolonged exposure to heat, moisture, or light
Routes of Exposure: Inhalation, ingestion, dermal, ocular
Acute Toxicity: Not fully characterized in humans; overdose may lead to corticosteroid toxicity
Local Effects: Irritation to eyes, skin, and mucous membranes
Systemic Effects: Immunosuppression, endocrine and metabolic disturbances at pharmacological doses
Chronic Exposure: Can cause Cushingoid features, osteoporosis, muscle wasting, glucose intolerance
Carcinogenicity: Not listed as a carcinogen by IARC, OSHA, or NTP
Reproductive Toxicity: Not adequately studied in humans; potential for fetal harm at high doses
Mutagenicity: No evidence in standard tests
Ecotoxicity: Data for aquatic and terrestrial organisms limited, but structurally related corticosteroids have shown persistence and low acute toxicity to aquatic life at environmental levels
Persistence and Degradability: Degrades slowly; long-term accumulation possible
Bioaccumulation Potential: Unlikely due to rapid metabolism in vertebrates, though waterborne pharmaceutical waste remains a concern
Mobility in Soil: Expected to be immobile in normal use; wastewater risk remains
Other Adverse Effects: Uncontrolled disposal may impact microorganism communities and aquatic ecosystems
Waste Disposal Method: Disposal through incineration at a licensed pharmaceutical waste facility; discharge to sewer or landfill not recommended
Contaminated Packaging: Triple rinse and render unusable prior to safe disposal
Special Precautions: Follow local, regional, and national regulations for pharmaceutical and cytotoxic waste; do not allow entry into environment
UN Number: No UN number assigned for pharmaceutical products in clinical or commercial use
UN Proper Shipping Name: Not regulated as a hazardous material for ground, air, or sea transport
Transport Hazard Class: Not classified
Packing Group: Not applicable
Special Precautions: Protect from physical damage or moisture during transport
Environmental Hazards: Not classified as a marine pollutant; bulk transport may require consideration of pharmaceutical regulations
TSCA Inventory: Not listed as a bulk chemical
OSHA: No specific regulatory requirements for deflazacort; follow universal precautions for pharmaceuticals
EU REACH: Not registered for non-pharmaceutical uses
SARA Title III: Not listed
California Proposition 65: Not listed
Other Regulations: Prescription-only medicine; subject to regulatory controls by FDA, EMA, and national health authorities
Workplace Labelling: Label containers with product identity, hazard classification, and appropriate handling instructions