Material Safety Data Sheet (MSDS) for Halometasone

Identification

Product Name: Halometasone
Chemical Name: 9α-Fluoro-16β-methylprednisolone
Synonyms: Halomethasone; Halometasonum
Chemical Formula: C22H27ClF2O5
CAS Number: 50629-82-8
Intended Use: Topical corticosteroid for anti-inflammatory and immunosuppressive purposes
Manufacturer: Refer to packaging or supplier
Contact Information: Emergency numbers and technical support details provided by the original supplier
Recommended Restrictions: For external use only, recommended for professional healthcare or pharmaceutical settings

Hazard Identification

Classification: Skin and eye irritant; possible risk of reproductive toxicity; not classified as flammable; not labeled as a carcinogen under OSHA or IARC
Label Elements: Irritant symbol, health hazard pictogram
Signal Word: Warning
Hazard Statements: May cause skin irritation, eye irritation, and allergic reactions; avoid prolonged or repeated exposure
Precautionary Statements: Wear protective gloves and eye protection; avoid contact with skin and eyes; do not ingest; wash thoroughly after handling
Emergency Overview: Direct exposure could trigger local irritation and possible systemic adverse effects with chronic overuse

Composition / Information on Ingredients

Active Ingredient: Halometasone (concentration depends on formulation, often 0.05% in creams/ointments)
Inactive Ingredients: List varies by product and may include various emollients, stabilizers, and preservatives
Impurities: Trace solvents and byproducts from synthesis, if present, listed on batch record
Molecular Weight: 428.90 g/mol
Structure: Synthetic corticosteroid with fluoro, methyl, and chloro side groups to enhance potency and skin permeability

First Aid Measures

Inhalation: Remove individual to fresh air, provide respiratory support if breathing becomes labored, and seek medical advice for persistent symptoms
Skin Contact: Wash affected area with soap and water, remove contaminated clothing, monitor for irritation or allergic reaction
Eye Contact: Flush with plenty of water for at least 15 minutes, removing contact lenses if used, and obtain ophthalmological assessment for continued discomfort
Ingestion: Rinse mouth with water, do not induce vomiting, and seek immediate medical attention describing the product and exposure level
Notes for Physicians: Treat supportively based on signs and symptoms; manage systemic corticosteroid effects if significant exposure occurs

Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or foam extinguishers
Specific Hazards: Risk of toxic and irritating gas formation if burned; avoid inhalation of decomposition products
Protective Equipment: Firefighters must wear self-contained breathing apparatus and full protective clothing
Unusual Fire Hazards: Residue or contaminated packaging may fuel a fire; closed containers can rupture under extreme heat
Special Procedures: Move containers from fire area if possible without risk; dike runoff water for proper disposal

Accidental Release Measures

Personal Precautions: Isolate spill area, ventilate, and wear gloves, laboratory coat, and eye protection
Environmental Precautions: Prevent entry into drains, waterways, or soil; contain for collection and safe disposal
Cleanup Methods: Absorb liquid with inert material such as sand or earth, collect into labelled waste container, and clean spill area with detergent
Decontamination: Wash tools and equipment after handling; avoid using bleach or strong oxidizers on spill area
Reporting: Inform safety or environmental authorities if significant release occurs

Handling and Storage

Safe Handling: Use in a well-ventilated area, minimize dust or aerosol formation, avoid direct contact with skin, eyes, and clothing
Storage Conditions: Store tightly closed at 2–8°C (refrigeration recommended for active pharmaceutical forms), protected from light and moisture
Segregation: Keep separate from incompatible substances such as strong oxidizers, acids, and alkalis
Shelf Life: Follow manufacturer’s expiration date; monitor for color or texture changes that suggest instability
Packaging: Store in original container or pharmaceutical-grade, child-resistant packaging

Exposure Controls and Personal Protection

Exposure Limits: No official occupational exposure limit set, prudent to minimize exposure to lowest feasible level, especially in large-scale handling
Engineering Controls: Use of local exhaust ventilation, laboratory fume hood, and closed transfer systems
Personal Protection: Wear suitable gloves (nitrile or neoprene), laboratory coat, safety glasses or goggles, and a particulate mask when handling powders
Hygiene Measures: Wash hands and face after use, do not eat, drink, or smoke where material is handled, and avoid transfer of material outside controlled workspace
Environmental Controls: Implement containment methods to prevent emission of dust, vapors, or particles into the workplace and environment

Physical and Chemical Properties

Appearance: White to off-white crystalline powder (may be formulated as cream or ointment)
Odor: Odorless
Odor Threshold: Not applicable
pH: Not determined for powder; topical creams usually pH balanced to skin
Melting Point: 226–232°C (pure)
Boiling Point: Not applicable; decomposes on heating
Flash Point: Not available
Evaporation Rate: Not applicable
Flammability: Not considered combustible under normal conditions
Vapor Pressure: Negligible at room temperature
Solubility: Practically insoluble in water, soluble in organic solvents like ethanol and chloroform
Partition Coefficient (log P): Moderate lipophilicity, aiding skin penetration
Stability: Stable under normal storage conditions; moisture and light accelerate degradation

Stability and Reactivity

Chemical Stability: Maintains integrity if stored as recommended and protected from direct sunlight and moisture
Incompatibilities: Strong oxidizing agents, strong acids, bases, and reactive metals
Decomposition Products: Thermal decomposition can release corrosive and toxic fumes including hydrogen chloride, fluorine-containing gases, and carbon oxides
Hazardous Reactions: No dangerous reactions under recommended storage and handling, but chemical instability increases in high heat or with incompatible materials
Polymerization: Will not polymerize under normal conditions

Toxicological Information

Routes of Exposure: Skin contact (primary), inhalation of powder or dust, accidental ingestion, eye exposure
Acute Toxicity: Low systemic toxicity with proper topical use; oral LD50 in rodents >2,000 mg/kg indicates low acute hazard; prolonged or excessive exposure may increase risk of adrenal suppression
Skin and Eye Contact: May trigger localized irritation, dermatitis, and rarely allergic reactions; eye exposure causes irritation and inflammation
Chronic Effects: Repeated or extensive application increases risk of bruising, atrophy, adrenal suppression, immune suppression, and systemic corticosteroid effects
Mutagenicity and Carcinogenicity: No clear evidence for mutagenicity or carcinogenicity in standard models
Reproductive Toxicity: Animal models show possible teratogenic effects at high doses; not recommended in pregnancy without clear indication
Sensitization: Rare cases of allergic skin response documented

Ecological Information

Ecotoxicity: Classified as hazardous to aquatic life with long-term effects; bioaccumulation potential moderate due to fat solubility
Persistence and Degradability: Poorly biodegradable, persists in water and sediment environments
Mobility in Soil: Binds to organic material in soil, limited risk of groundwater contamination under normal use
Bioaccumulative Potential: Data suggest some potential for bioaccumulation in aquatic organisms
Other Adverse Effects: Discharge into the environment should be strictly limited; environmental release could disrupt endocrine systems of exposed organisms

Disposal Considerations

Waste Treatment Methods: Small bioactive waste must be incinerated or managed as hazardous chemical waste; do not dispose of product or residue down drains
Disposal Containers: Use appropriately labeled, fiberboard or plastic waste bins for solids, secure liquid waste in leak-proof containers
Regulatory Disposal Guidance: Follow local and national regulations for controlled pharmaceuticals and hazardous medical chemicals
Contaminated Packaging: Dispose of packaging and single-use implements as chemical waste, not with municipal refuse
Precautions: Never reuse packaging or containers for other materials after exposure to halometasone

Transport Information

UN No.: Not classified as dangerous goods for transport
DOT / IATA / IMDG Status: Not regulated as hazardous for shipping by ground, air, or sea under current guidelines for typical cream or ointment concentrations
Label Requirements: Ensure original labeling remains intact; use hazardous label for bulk active, especially powders
Packing Group: Not assigned
Special Transport Precautions: Protect from physical damage and extreme temperatures during transit; keep away from foodstuffs and incompatible chemical cargos

Regulatory Information

US Federal: Not listed as a controlled substance; check status under FDA and EPA, requires adherence to DEA schedules for bulk APIs
OSHA: Not specifically listed, classified as a hazardous chemical with risk of exposure
SARA Title III: Not listed as an extremely hazardous chemical
EU Regulations: Prescription-only pharmaceutical, subject to REACH exemptions for medicines
Other International Lists: Check relevant national, state, and municipal drug and chemical regulations for manufacture, handling, import/export, and disposal; Safety assessments must follow Good Manufacturing Practices (GMPs)