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Product Name: Miconazole Nitrate
Chemical Formula: C18H14Cl4N2O4·HNO3
Synonyms: 1-[2,4-Dichloro-β-(2,4-Dichlorobenzyl)oxylphenethyl]imidazole mononitrate
Manufacturer: Contact manufacturer for details
Recommended Use: Antifungal agent in pharmaceutical preparations
CAS Number: 22832-87-7
Emergency Contact Number: Refer to local supplier or regional poison control
GHS Classification: Eye irritation (Category 2A), Skin irritation (Category 2), Specific target organ toxicity – single exposure (Category 3)
Signal Word: Warning
Hazard Statements: Causes skin and eye irritation, May cause respiratory irritation
Precautionary Statements: Avoid breathing dust, Use in well-ventilated area, Wash hands thoroughly after handling, Wear protective gloves and eye protection
Pictograms: Exclamation Mark
Potential Health Effects: Irritates eyes, skin, and respiratory tract; prolonged or repeated exposure may cause allergic reaction in sensitive individuals
Chemical Name: Miconazole Nitrate
Percentage: ≥98% (by weight)
Impurities: Minor related substances (typically <2%)
Additives: No data on intentional additives present
Molecular Weight: 479.14 g/mol
Forms: Fine white or off-white crystalline powder
Inhalation: Move person into fresh air immediately, Seek medical attention if breathing becomes difficult
Skin Contact: Remove contaminated clothing, Rinse skin and hair with plenty of water for at least 15 minutes, Seek medical help if irritation persists
Eye Contact: Flush eyes with water for at least 15 minutes, Lift eyelids occasionally, Remove contact lenses if present and easy, Continue rinsing, Get prompt medical attention
Ingestion: Rinse mouth, Never give anything by mouth to an unconscious individual, Seek medical advice for large or symptomatic ingestion
Most Important Symptoms: Redness, itching, swelling, difficulty breathing if inhaled in large amounts
Keep Medical Staff Informed: Show the doctor this document or product label
Suitable Extinguishing Agents: Water spray, dry chemical powder, foam, carbon dioxide
Fire and Explosion Hazards: Fine dust may pose risk of dust explosion in confined areas, Not highly flammable but may emit toxic fumes if heated to decomposition (nitrogen oxides, chlorine compounds, carbon oxides)
Protective Equipment for Firefighters: Self-contained breathing apparatus, Full protective clothing
Special Procedures: Avoid inhalation of combustion products, Cool containers with water spray if exposed to fire
Evacuate Area: For large fires or when massive dust clouds are produced
Personal Precautions: Evacuate non-essential personnel, Use personal protection as listed in Exposure Controls
Environmental Precautions: Prevent further leakage or spillage if safe, Avoid dispersal to soil, drains, surface water, and sewers
Methods for Clean-Up: Sweep up carefully, Avoid creating dust, Place material in labeled waste containers, Ventilate area, Wash spill site after material pickup
Disposal: See Disposal Considerations below
Decontamination: Wash all surfaces and equipment with deluge of water, Collect washings for proper disposal
Handling: Minimize dust generation and accumulation, Use only in adequately ventilated areas, Avoid skin and eye contact, Wear appropriate personal protective equipment, Keep container tightly sealed when not in use
Storage: Store in cool, dry, well-ventilated place away from direct sunlight and incompatible materials such as strong oxidizers, acids, or bases, Keep containers tightly closed, Clearly label all containers
Special Requirements: Store separate from food and animal feed, Protect from moisture
Incompatibilities: Avoid contact with strong oxidizing agents, strong acids, strong bases
Occupational Exposure Limits: No established permissible exposure limit (PEL) but minimize exposure as a precaution
Engineering Controls: Local exhaust ventilation or general dilution ventilation to keep dust levels low
Eye Protection: Safety goggles or face shield
Skin Protection: Gloves (nitrile or neoprene), protective clothing
Respiratory Protection: Dust mask or NIOSH-approved respirator when handling powders or large volumes
Hygiene Measures: Wash hands before eating, smoking, drinking, and after handling the product, Remove contaminated clothing and launder before reuse
Monitoring: Routinely monitor airborne concentrations in workplaces handling large quantities
Appearance: White to off-white crystalline powder
Odor: Practically odorless
pH: Slightly acidic in aqueous solution
Boiling Point: Decomposes before boiling
Melting Point: 178–184°C
Solubility: Slightly soluble in water, freely soluble in ethanol and methanol, soluble in ether and chloroform
Vapor Pressure: Non-volatile at room temperature
Partition Coefficient: LogP 6.1 (octanol/water)
Decomposition Temperature: Not available
Other Properties: Non-flammable solid under normal conditions, forms airborne dust if handled as a powder
Chemical Stability: Stable under normal temperatures and pressures, Stable when stored as directed
Reactivity: Non-reactive with most common materials
Conditions to Avoid: Excessive heat, moisture, light, and incompatible chemicals mentioned in Handling and Storage
Incompatible Materials: Strong oxidizers, acids, bases
Hazardous Decomposition Products: Carbon oxides, nitrogen oxides, chlorine compounds on thermal decomposition
Polymerization: Does not undergo hazardous polymerization
Acute Toxicity: LD50 oral (rat): ~750 mg/kg, Signs of toxicity include gastrointestinal disturbance, CNS effects
Skin Corrosion: Can cause irritation with prolonged contact
Eye Damage: Can cause irritation and redness
Respiratory Sensitization: May irritate respiratory tract, especially as a fine powder
Carcinogenicity: No evidence from animal studies; Not classified as carcinogen by IARC, NTP, or OSHA
Mutagenicity: No data suggesting mutagenic effects in recommended applications
Reproductive Toxicity: No evidence in animal studies at normal exposure levels
Chronic Effects: Prolonged or repeated exposure may increase risk of allergic reactions and dermatitis
Ecotoxicity: Harmful to aquatic life with long lasting effects; EC50 (Daphnia magna, 48 hours): 4.4 mg/L
Persistence and Degradability: Not readily biodegradable, Persists in the environment
Bioaccumulation Potential: Moderate potential based on LogP
Mobility in Soil: Low solubility limits mobility, Risk of accumulation in sediment
Other Adverse Effects: Avoid contamination of watercourses; Do not allow significant quantities to reach ground water or water bodies
Disposal Methods: Dispose of in accordance with local, regional, and national regulations, Do not discharge into drains, soil, or water bodies
Contaminated Packaging: Empty containers must be triple-rinsed with water before disposal, Remove all product residues, Dispose through chemical waste incinerators with afterburner and scrubber
Waste Codes: Consult regional authorities for specific waste designation
Recycling: Not suitable for recycling in most regions
UN Number: Not classified as dangerous goods under UN regulations
Proper Shipping Name: Miconazole Nitrate
Transport Hazard Class: Not regulated
Packing Group: Not applicable
Marine Pollutant: Yes, may be harmful to aquatic species
Special Precautions: Secure containers to prevent accidental releases; Avoid direct sunlight and excessive heat during transport
TSCA Status: Listed on US TSCA inventory
REACH Registration: Registered or pre-registered in EU
US Federal Regulations: Not subject to SARA Title III reporting, Not on California Proposition 65 list
Labeling Requirements: Complies with US OSHA Hazard Communication Standard (29 CFR 1910.1200), EU Regulation (EC) No. 1272/2008
Workplace Labels: Clearly identify hazard class, pictograms, and first aid information
Other National Regulations: Consult specific regulations in your jurisdiction for any additional substance controls or requirements
