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Product Name: Lumefantrine
Chemical Name: (R)-2-(dibutylamino)-1-[(9Z)-2,7-dichloro-9-(4-chlorobenzylidene)-9H-fluoren-4-yl]ethanol
CAS Number: 82186-77-4
Molecular Formula: C30H32Cl3NO
Molecular Weight: 528.94 g/mol
Recommended Use: Antimalarial drug ingredient
Manufacturer Information: Pharmaceutical-grade chemical supplier, reference SDS available upon request
Emergency Contact Number: [Insert official emergency contact or poison control]
GHS Classification: Not classified as hazardous under GHS for most forms; dust exposure may cause irritation
Signal Word: Caution
Hazard Statements: May cause eye, skin, and respiratory tract irritation. Potential effects after prolonged or repeated exposure have not been fully characterized. Not expected to be acutely toxic in small pharmaceutical quantities.
Precautionary Statements: Avoid breathing dust. Wear protective gloves and eye protection. Wash exposed skin thoroughly after handling. Avoid release to the environment.
Chemical Identity: Lumefantrine
Purity: >98% by HPLC
Impurities: Trace related compounds and residual solvents less than 2% combined
Other Ingredients: None reported
Eye Contact: Rinse cautiously with water for several minutes. Remove contact lenses if present. Continue rinsing. Seek medical advice if irritation develops.
Skin Contact: Wash thoroughly with soap and water. Remove contaminated clothing and launder before reuse. If irritation occurs, seek medical attention.
Inhalation: Move the person to fresh air. If not breathing, provide artificial respiration as needed. Seek medical support if symptoms occur.
Ingestion: Rinse mouth with water. Never give anything by mouth to an unconscious person. Get appropriate medical advice in case of accidental ingestion or if feeling unwell.
Suitable Extinguishing Media: Use carbon dioxide, dry chemical, or foam for small fires. Use water spray for large fires.
Unsuitable Media: High-pressure water streams may spread powder.
Specific Hazards: May emit toxic fumes (carbon oxides, nitrogen oxides, hydrogen chloride, and other hazardous gases) under fire conditions.
Fire-Fighting Procedures: Firefighters should wear full protective equipment and self-contained breathing apparatus. Move containers away from fire area, if safe.
Explosion Hazard: Dust buildup may create combustible dust-air mixtures. Prevent dust accumulation.
Personal Precautions: Use personal protective equipment. Avoid dust formation. Ventilate area.
Environmental Precautions: Do not let product enter drains or environment uncontrollably.
Containment Methods: Sweep up or vacuum spill material using appropriate equipment. Avoid generating dust.
Cleanup Methods: Place collected material in suitable, closed containers for proper disposal.
Handling: Operate in well-ventilated conditions. Minimize formation and accumulation of dust. Avoid contact with eyes, skin, and clothing. Use appropriate personal protective equipment.
Storage: Store tightly closed in a dry, cool, well-ventilated area. Keep away from incompatible substances like acids, bases, and oxidizers. Protect from moisture, light, and direct heat.
Occupational Exposure Limits: No ACGIH, OSHA, or NIOSH exposure limits established. Recommend to limit exposure to the lowest feasible concentrations.
Engineering Controls: Use local exhaust or general ventilation.
Personal Protective Equipment: Safety goggles, laboratory gloves (nitrile or neoprene), disposable lab coats.
Respiratory Protection: Use particle respirator (N95 or better) if dust is generated.
Hygiene Measures: Do not eat, drink, or smoke in work areas. Wash hands after use.
Appearance: Yellow to orange crystalline powder
Odor: Odorless or faintly organic
Odor Threshold: Not determined
pH: Not applicable (insoluble in water)
Melting Point: 128–132°C
Boiling Point: Decomposes before boiling
Flash Point: Not determined
Evaporation Rate: Not determined
Flammability: Not considered flammable in solid form
Explosive Properties: Dust can form explosive mixtures in air
Vapor Pressure: Negligible at room temperature
Density: 1.22 g/cm³ (approximate)
Water Solubility: Practically insoluble
Partition Coefficient (log Kow): >5 (very high, indicative of bioaccumulation potential)
Auto-ignition Temperature: Not available
Chemical Stability: Stable under recommended storage conditions.
Hazardous Reactions: None known under normal use.
Decomposition Products: Under fire or heat, produces toxic gases (CO, NOx, HCl).
Incompatible Materials: Strong acids, strong bases, and oxidizing agents.
Polymerization: Will not occur.
Acute Toxicity: Low acute oral toxicity in animal models; specific LD50 not widely reported.
Inhalation: May cause mild respiratory irritation.
Skin Contact: Non-irritant or mild irritant for intact skin in most users.
Eye Contact: Dust or particulates may cause mechanical irritation.
Chronic Effects: Not fully studied; animal data suggest low risk at pharmaceutical exposures.
Carcinogenicity/Mutagenicity/Reproductive Toxicity: No evidence of genotoxicity or reproductive hazard in standard assays.
Ecotoxicity: Toxic to aquatic life with long-lasting effects. Significant log Kow suggests potential for bioaccumulation in aquatic organisms.
Persistence and Degradability: Likely persistent in soil and sediment due to high hydrophobicity.
Bioaccumulation Potential: High; log Kow over 5.
Mobility in Soil: Low mobility; binds to soil particles due to poor water solubility.
Other Adverse Effects: Proper disposal methods should prevent environmental contamination.
Waste Disposal: Dispose in accordance with local, regional, national, or international regulations. Incinerate or landfill at permitted facility, according to relevant environmental authorities.
Packaging Disposal: Treat containers as hazardous. All residues and containers are subject to regulations.
Do Not: Release powder into wastewater or normal garbage. Prevent environmental contamination at all stages.
UN Number: Not regulated under UN Orange Book.
Transport Hazard Class: Not classified as hazardous for transport.
Packing Group: Not assigned
Proper Shipping Name: Lumefantrine or pharmaceutical intermediate
Environmental Hazards: Not a marine pollutant under IMDG for limited quantities.
Special Precautions: Protect from breakage and keep packaging intact throughout transit.
International Inventories: May be listed in chemical inventories or exempt as pharmaceutical ingredient.
Labelling Requirements: In line with local health and safety legislation.
OSHA Status: Not specifically regulated.
WHMIS Classification: Not controlled in Canada.
EU Classification: Not a dangerous substance or preparation under EU regulations. Handle as pharmaceutical chemical.
Other Information: All chemical products to be used by qualified professionals in controlled conditions.
