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Substance Name: Efinaconazole
Chemical Formula: C18H22F2N4O
Synonyms: Jublia
CAS Number: 164650-44-6
Recommended Use: Antifungal agent for topical treatment of onychomycosis
Manufacturer Name: Personal Care Pharmaceutical Producer
Emergency Phone: 24-Hour Response: Local Poison Control
Address: Manufacturer’s Facility, City, Postal Code, Country
Email: SafetyContact@producercompany.com
Classification: Hazardous substance under OSHA 29 CFR 1910.1200 (GHS classification)
Signal Word: Warning
Hazard Statements: May cause eye, skin, or respiratory tract irritation; Harmful if swallowed; Potential for allergic skin reaction
Precautionary Statements: Avoid breathing dust or vapor; Wash skin thoroughly after handling; Wear protective gloves/eye protection; Use only in a well-ventilated area
Key Routes of Exposure: Skin, eyes, inhalation, ingestion
Acute Effects: Redness, itching, watering eyes, sneezing, coughing
Chronic Effects: Dermatitis with extended or repeated use, allergies possible
Active Ingredient: Efinaconazole (Purity: 98%+)
Inert Components: Undisclosed, proprietary carrier solvents or excipients as permitted in registered formulation
Impurities: Not expected in significant levels; details available by request from manufacturer
Concentration: Pure API or formulated as <0.5% in topical products
Inhalation: Move affected person to fresh air, support breathing as needed, seek medical attention for breathing difficulty
Skin Contact: Remove contaminated clothing, wash exposed area with soap and water, consult a physician if irritation develops
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses, continue rinsing, seek medical advice if symptoms persist
Ingestion: Rinse mouth with water, never give anything by mouth to an unconscious person, call physician immediately
Suitable Extinguishing Media: Water spray, carbon dioxide, dry chemical powder, foam
Unsuitable Extinguishing Media: High-pressure water jet
Hazardous Combustion Products: Carbon monoxide, carbon dioxide, nitrogen oxides, halogenated compounds
Specific Firefighting Procedures: Evacuate area, use self-contained breathing apparatus and full protective gear, prevent runoff into drains
Special Protective Equipment: Firefighter turnout gear, gloves, eye protection
Personal Precautions: Avoid dust or vapor, use appropriate PPE (gloves, mask, goggles)
Environmental Precautions: Keep out of drains, surface waters, and soils
Cleanup Methods: Sweep up material carefully to avoid dusting, collect in suitable containers, clean area thoroughly with detergent and water, ventilate space
Waste Containment: Use sealed, labeled containers for disposal
Precautions for Safe Handling: Avoid contact with skin, eyes, and clothing, prevent dust or vapor accumulation, use local exhaust ventilation
Storage Conditions: Store in well-ventilated, dry, cool area away from direct sunlight, ignition sources, incompatible substances
Container Requirements: Tightly sealed, clearly labeled, chemical-resistant
Specific Use Considerations: Restrict access to trained personnel, maintain good hygiene practices
Exposure Limits: Not specifically established for Efinaconazole
Engineering Controls: Local exhaust ventilation, laboratory fume hood
Personal Protective Equipment: Safety glasses or goggles, protective gloves (nitrile), lab coat or protective clothing, NIOSH-approved respirator if dust or vapor risk
Hygiene Measures: Wash hands before eating or drinking, remove contaminated clothing promptly, clean work surface after handling
Appearance: White to pale yellow powder
Molecular Weight: 348.39 g/mol
Odor: Odorless or very faint chemical scent
Odor Threshold: Data not available
Melting Point: Around 110°C to 115°C
Boiling Point: Data not available
Flash Point: Not highly flammable
Solubility: Poor in water, soluble in organic solvents (ethanol, dimethyl sulfoxide)
pH: Data not available for solid
Vapor Pressure: Data not available
Partition Coefficient (log P): Approximately 3.5
Chemical Stability: Stable at room temperature in closed containers
Conditions to Avoid: Heat, humidity, direct sunlight, incompatible chemicals
Incompatible Materials: Strong oxidizing agents, acids, alkalis
Hazardous Decomposition Products: Carbon and nitrogen oxides, fluorinated compounds, toxic fumes
Polymerization: Does not occur under recommended conditions
Acute Toxicity: Oral LD50 in rats >2000 mg/kg (low toxicity)
Skin Corrosion/Irritation: Mild to moderate possible
Eye Damage/Irritation: Irritation possible, redness and tearing
Respiratory Sensitization: Not classified, may cause mild irritation
Skin Sensitization: Mild allergic reactions possible with chronic exposure
Mutagenicity: Not shown to be mutagenic in standard tests
Carcinogenicity: No evidence in animal or cell studies
Other Effects: Ingestion or misuse may cause nausea, vomiting, central nervous system effects at high doses
Environmental Toxicity: Toxic to aquatic organisms based on related triazoles
Persistence and Degradability: Expected to degrade slowly in the environment
Bioaccumulative Potential: Moderate based on partition coefficient
Mobility in Soil: Somewhat mobile in soil, risk for groundwater contamination if released
Other Adverse Effects: Prevent spill and rinsate from entering natural waterways
Disposal Methods: Dispose of in accordance with local, regional, and national regulations
Container Disposal: Triple rinse containers, puncture, dispose at permitted facility
Special Precautions: Avoid release to environment, collect and treat waste as hazardous, do not reuse empty containers for other purposes
UN Number: Not classified as dangerous goods for transport
Proper Shipping Name: Chemical, non-regulated
Transport Hazard Class: Non-hazardous
Packing Group: Not applicable
Labeling Requirements: No hazard label required
Other Transport Information: Protect from physical damage, avoid excessive heat and moisture during transit
OSHA Status: Hazardous under the criteria of the OSHA Hazard Communication Standard 29 CFR 1910.1200
TSCA Status: Not listed in TSCA inventory
REACH Registration: Covered for use in medicinal formulations; not intended for direct industrial release
Other Regulations: Subject to pharmaceutical and environmental regulations where marketed
California Proposition 65: Not listed
WHMIS (Canada): Classified as controlled product, consult SDS for local compliance
Other International Inventory Lists: Contact manufacturer for region-specific information
