Material Safety Data Sheet (MSDS): Deflazacort

1. Identification

Product Name: Deflazacort
Chemical Name: Deflazacort
Common Synonyms: CAS 13649-88-2, Calcort
Recommended Use: Pharmaceutical corticosteroid for inflammatory and autoimmune conditions
Manufacturer: [Manufacturer Name]
Emergency Contact: [Emergency Contact Number]
Address: [Manufacturer Address]
Email: [Contact Email]

2. Hazard Identification

GHS Classification: Not classified as hazardous under GHS
Acute Health Hazards: May cause irritation to eyes, skin, or respiratory tract if handled incorrectly
Chronic Health Hazards: Possible suppression of immune system on prolonged exposure or misuse
Signal Word: None required under normal use
Pictograms: None required
Precautionary Statements: Avoid contact with eyes, skin, and clothing; prevent inhalation of dust
Risk Phrases: R36/37/38: Irritating to eyes, respiratory system and skin
Target Organs: Immune system, eyes, skin
Potential Environmental Effects: Not expected to be hazardous to the environment under normal conditions

3. Composition / Information on Ingredients

Chemical Name: Deflazacort
CAS Number: 13649-88-2
EC Number: 237-157-6
Concentration: 98-100%
Molecular Formula: C25H31NO6
Impurities: Minor byproducts from synthesis under GMP levels; typically < 1% total impurities

4. First Aid Measures

Eye Contact: Rinse thoroughly with water for several minutes; remove contact lenses if present and easy to do; seek medical attention for persistent irritation
Skin Contact: Wash with soap and water after removing contaminated clothing; seek medical help if symptoms develop
Inhalation: Move to fresh air; if symptoms like cough or shortness of breath develop, consult a physician
Ingestion: Rinse mouth with water; seek immediate medical attention; do not induce vomiting unless advised by medical personnel
Note for Healthcare Providers: Treat symptomatically as corticosteroids can alter immune responses

5. Fire-Fighting Measures

Suitable Extinguishing Media: Dry chemical, foam, CO2, or water spray
Hazards from Combustion: Produces toxic fumes including carbon monoxide, carbon dioxide, and oxides of nitrogen
Special Protective Equipment: Firefighters should use self-contained breathing apparatus and full protective gear
Specific Fire Hazards: May emit irritating or toxic fumes if involved in a fire; keep containers cool with water spray
Advice for Firefighters: Avoid inhalation of combustion products, maintain safe distance during fire-fighting

6. Accidental Release Measures

Personal Precautions: Use appropriate PPE: gloves, goggles, protective clothing, dust mask
Environmental Precautions: Prevent substance entering sewers or waterways
Spill Cleanup Methods: Sweep up or vacuum material without generating dust and place in suitable labeled containers for disposal
Disposal: Dispose of collected material according to federal, state, and local regulations
Decontamination: Wash spill area thoroughly with soap and water after material removal

7. Handling and Storage

Handling: Handle with care to avoid dust generation; use in well-ventilated area; avoid contact with skin and eyes; wash hands thoroughly after handling
Special Handling Advice: Maintenance of good industrial hygiene practices is required for safe use
Storage: Store in original tightly closed container, in a cool, dry, well-ventilated area away from sunlight and incompatible substances
Incompatibles: Strong oxidizing agents, acids

8. Exposure Controls and Personal Protection

Occupational Exposure Limits: No occupational exposure limits established; minimize exposure by control methods
Engineering Controls: Use local exhaust ventilation or other engineering controls to reduce airborne concentrations
Respiratory Protection: Use NIOSH-approved dust mask if dust generation likely
Skin Protection: Wear chemical-resistant gloves; laboratory coats
Eye/Face Protection: Use safety goggles to prevent eye contact
Hygiene: Avoid eating, drinking, or smoking during use; wash hands after handling

9. Physical and Chemical Properties

Appearance: White to off-white powder
Odor: Odorless
Odor Threshold: Not available
pH: Not available
Melting Point: 245-250 °C
Boiling Point: Not available (decomposes)
Flash Point: Not determined
Flammability: Not flammable
Vapor Pressure: Negligible at room temperature
Solubility: Practically insoluble in water; soluble in methanol, ethanol, chloroform
Partition Coefficient (log Pow): 2.1-2.9 (estimated)
Bulk Density: Not determined
Evaporation Rate: Not applicable

10. Stability and Reactivity

Chemical Stability: Stable under normal temperatures and pressures
Reactivity: No hazardous reactions expected under standard use
Conditions to Avoid: Excessive moisture, heat, open flames
Incompatible Materials: Strong oxidizing agents, acids
Hazardous Decomposition Products: Carbon dioxide, carbon monoxide, nitrogen oxides
Polymerization: Will not occur

11. Toxicological Information

Routes of Exposure: Eyes, skin, ingestion, inhalation
Acute Toxicity: LD50 (oral, rat): >4000 mg/kg (extrapolation from data)
Chronic Effects: Prolonged or repeated exposure may affect endocrine and immune systems
Skin Contact: Can cause irritation
Eye Contact: Can cause irritation and redness
Inhalation: Irritation to mucous membranes possible
Sensitization: Not expected to cause skin sensitization
Mutagenicity/Carcinogenicity: Not classified as mutagenic or carcinogenic under available data, but corticosteroids linked to immune suppression
Reproductive Toxicity: Deflazacort alters hormone regulation; animal studies point to possible reproductive effects at high doses

12. Ecological Information

Ecotoxicity: No significant data on aquatic or terrestrial toxicity; not expected to bioaccumulate
Persistence and Degradability: Likely biodegradable but environmental exposure should be minimized
Bioaccumulation Potential: Low potential for bioaccumulation
Mobility in Soil: Limited by low solubility in water
Other Adverse Effects: Avoid release in large quantities to prevent pharmaceutical contamination of water systems

13. Disposal Considerations

Disposal Methods: Dispose through licensed hazardous waste contractor; incineration recommended
Container Disposal: Triple-rinse containers before discarding in accordance with local, regional, and national regulations
Precautions: Do not allow material or rinsate to enter drains, sewers, or water bodies

14. Transport Information

UN Number: Not regulated for transport
UN Proper Shipping Name: Not regulated
Transport Hazard Class: Not applicable
Packing Group: Not classified
Special Precautions: Keep containers tightly sealed and upright during transport; avoid mechanical shocks
Environmental Hazards: None identified

15. Regulatory Information

TSCA Status: Listed on US Toxic Substances Control Act (TSCA) inventory
REACH Status: Registered under EU Regulation (EC) No 1907/2006
OSHA Hazards: Not considered hazardous under OSHA regulations
DSL/NDSL (Canada): Listed/Compliant
SARA Title III: Not subject to reporting
WHMIS Classification: Not controlled under Canadian WHMIS
Other Regulations: Meets pharmaceutical standards for use under prescription in regulated markets