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Product Name: Fluconazole
Chemical Name: 2-(2,4-Difluorophenyl)-1,3-Bis(1H-1,2,4-Triazol-1-Yl)-2-Propanol
CAS Number: 86386-73-4
Molecular Formula: C13H12F2N6O
Manufacturer/Supplier: Provided by invoice record
Use of Substance: Pharmaceutical antifungal agent used to manage and treat fungal infections
Emergency Contact: Standard facility emergency numbers or local poison control centers
Recommended Restrictions: For industrial or laboratory use only; not intended for direct human or veterinary use without prescription and proper instruction
GHS Classification: Acute toxicity, oral (Category 4); Skin irritation (Category 3); Eye irritation (Category 2B)
Signal Word: Warning
Hazard Statements: Harmful if swallowed. May cause mild skin and eye irritation. Suspected of causing genetic defects in animal studies. Potential for liver toxicity in repeated exposures.
Precautionary Statements: Avoid breathing dust. Wash thoroughly after handling. Do not eat, drink or smoke while using this product.
Emergency Overview: White crystalline powder, moderate health hazard on ingestion or inhalation, may cause acute symptoms, potential target organ effect is liver
Chemical Substance: Fluconazole
Common Synonyms: Diflucan, Fluconazolum
Concentration: Pure substance (approximately 100%)
Impurities: Residual solvents, process-related impurities less than 0.1% (as per pharmaceutical quality standards)
Other Ingredients: None intentionally added
Inhalation: Remove affected person to fresh air. Monitor for respiratory difficulty. Seek medical attention if symptoms persist or worsen.
Skin Contact: Remove contaminated clothing. Immediately wash skin with soap and water. Seek medical attention if irritation occurs or persists.
Eye Contact: Rinse thoroughly with plenty of water for 15 minutes, keeping eyelids open. Remove contact lenses if present and easy to do. Continue rinsing. Seek medical attention if irritation persists.
Ingestion: Rinse mouth thoroughly. Do not induce vomiting unless directed by medical personnel. Seek immediate medical help, especially if large amounts ingested or symptoms develop.
Most Important Symptoms and Effects, Acute and Delayed: Abdominal discomfort, headache, dizziness, nausea, skin or eye irritation, potential liver dysfunction on high or prolonged exposure
Suitable Extinguishing Media: Use water spray, dry chemical, carbon dioxide or foam for fires involving this material.
Special Hazards Arising from the Chemical: Thermal decomposition releases toxic fumes such as nitrogen oxides, hydrogen fluoride, carbon monoxide, and carbon dioxide.
Advice for Firefighters: Wear self-contained breathing apparatus and full protective gear. Avoid inhalation of combustion gases.
Firefighting Procedures: Move containers from danger zone if safe, douse surrounding area with water to cool containers, prevent runoff into drains or watercourses.
Explosion Data: Sensitivity to mechanical impact or static discharge not anticipated at typical handling conditions
Personal Precautions: Evacuate unnecessary personnel. Wear recommended personal protective equipment including gloves, goggles and lab coat. Avoid dust formation, avoid breathing dust.
Environmental Precautions: Prevent further spillage or leakage if safe to do so. Prevent entry into drains, surface waters or soil.
Containment and Cleanup: Sweep up avoiding dust generation, transfer to suitable container for disposal following local authority guidance. Wash contaminated area with plenty of water after initial cleanup. Dispose of waste in accordance with regulations.
Methods for Disposal: Follow hazardous waste disposal guidelines; do not flush to surface water or sewage system
Precautions for Safe Handling: Use in well-ventilated areas. Avoid generation of dusts. Minimize contact with skin and eyes. Wear personal protective equipment including gloves, protective clothing and eye protection.
Hygiene Measures: Wash hands thoroughly after handling. No eating, drinking, or smoking in work area. Remove contaminated clothing and wash before reuse.
Conditions for Safe Storage: Store in cool, dry, well-ventilated area away from incompatible substances. Keep containers tightly closed. Protect from light, moisture, and sources of ignition.
Storage Requirements: Segregate from food and feedstuffs. Label container clearly. Keep away from children and unauthorized personnel.
Incompatible Materials: Strong acids, strong bases, strong oxidizing agents
Control Parameters: No established occupational exposure limits for Fluconazole. Handle in accordance with good industrial hygiene and safety practices.
Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to minimize dust exposure.
Personal Protective Equipment: Protective gloves (nitrile recommended), safety goggles, lab coat, dust respirator if airborne dust is generated.
Environmental Controls: Avoid release to the environment. Implement containment if possible.
Protective Measures: Maintain eyewash stations and safety showers in work areas.
Appearance: White to off-white crystalline powder
Odor: Negligible or odorless
Odor Threshold: Not determined
pH: 7.6 (1% solution in water)
Melting Point/Freezing Point: 137-141 °C
Boiling Point/Range: Not applicable (decomposes before boiling)
Solubility: Soluble in water, methanol, dimethylformamide
Partition Coefficient (n-octanol/water): Log P = 0.5-0.8
Vapor Pressure: Not determined (nonvolatile)
Density: 1.4 g/cm³
Viscosity: Solid at room temperature
Flash Point: Not applicable
Explosive Properties: No data
Oxidizing Properties: Not oxidizing
Decomposition Temperature: > 140 °C, releases toxic fumes at higher temperatures
Chemical Stability: Stable under standard storage and handling conditions. Sensitive to moisture and intense heat.
Possibility of Hazardous Reactions: No hazardous polymerization expected under normal conditions.
Conditions to Avoid: Excess moisture, high temperatures, open flames, strong oxidizers.
Incompatible Materials: Strong acids, strong bases, oxidizing agents.
Hazardous Decomposition Products: Nitrogen oxides, hydrogen fluoride, carbon oxides; toxic fumes possible on burning or decomposition
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Acute Toxicity: Oral LD50 (rat): ~1270 mg/kg; low acute toxicity in humans at therapeutic doses
Chronic Toxicity: Potential for liver enzyme elevations, rare hepatic dysfunction in prolonged exposure or high-dose cases reported in pharmaceutical literature.
Irritation/Corrosivity: Mild skin and eye irritant; dust may be irritating to mucous membranes.
Sensitization: No clear evidence of skin sensitization.
Germ Cell Mutagenicity: Some positive findings in animal genotoxicity assays, but clinical relevance is unclear.
Carcinogenicity: No adequate evidence of carcinogenicity in humans.
Reproductive Toxicity: Some evidence of potential risk in animal studies, limited data from clinical exposure.
Target Organ Effects: Liver is primary target for toxicity.
Other Effects: High doses or hypersensitivity may provoke allergic-like symptoms: rash, hives, rare anaphylaxis
Ecotoxicity: Harmful to aquatic organisms with potential for long-term adverse effects. LC50 (fish, 96 h): >100 mg/L; EC50 (daphnia, 48 h): 80 mg/L.
Persistence and Degradability: Moderate persistence in the environment. Partially biodegradable.
Bioaccumulative Potential: Low potential, log Kow below 1.
Mobility in Soil: Moderately mobile in soil; risk of leaching into groundwater.
Other Adverse Effects: Pharmaceutical residues may contribute to development of resistance in environmental fungi or bacteria if released continuously
Waste Disposal: Collect for chemical waste disposal. Dispose of in accordance with local, regional, national, and international regulations. Do not discharge to surface water, groundwater or drains.
Container Disposal: Rinse containers, remove labels, recycle or incinerate in approved facility as hazardous waste.
Recommended Disposal Method: High temperature incineration or treatment by licensed contractor to destroy active compound.
Special Precautions: Contaminated packaging should receive same treatment as product residue to prevent environmental release
UN Number: Not classified as a dangerous good for transport by road, sea, or air under most regulations
Proper Shipping Name: Not regulated
Transport Hazards Class: Non-hazardous in transport
Packing Group: Not applicable
Special Precautions: Keep container tightly closed and in upright position during transport. Avoid mechanical stress and exposure to extreme conditions.
Transport Label: No special label required under standard transport law
Safety, Health and Environmental Regulations/Legislation Specific for the Substance: Subject to national chemical safety laws. Not listed as a controlled substance. Monitored under pharmaceutical product guidelines and environmental regulations for pharmaceutical manufacturing waste.
Regulatory Status: Not classified as a carcinogen or mutagen by major international agencies such as IARC, NTP, ACGIH, OSHA.
Inventory Information: Registered in major chemical substance inventories (EINECS, TSCA, DSL, etc.) where applicable.
Additional Regulations: Pharmaceutical site handling may require environmental permits for air and water discharge. Export and import may be regulated in some jurisdictions.
Workplace Labelling: Label with hazard statements, precautionary statements and product identification as per CLP (GHS) requirements
