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Substance name: Miltefosine
Chemical family: Alkylphosphocholines
Appearance: White to off-white crystalline powder or solid
Intended use: Originally developed as an anticancer agent; widely known as an oral medication for leishmaniasis
Chemical Formula: C21H46NO4P
Synonyms: Hexadecylphosphocholine
Health hazards: Can cause serious eye irritation, skin irritation, and organ toxicity through prolonged exposure. Swallowing may lead to gastrointestinal issues such as nausea, vomiting, and diarrhea. Animal studies show reproductive toxicity and possible embryotoxicity.
Routes of exposure: Skin contact, eye contact, inhalation of dust, accidental ingestion
Environmental impact: Toxic to aquatic organisms; possible long-term effects in the aquatic environment
Signal words: Warning—potential toxic effects require respect and care
Risk symbols: GHS07 (exclamation mark), GHS08 (health hazard)
Active component: Miltefosine (C21H46NO4P)
Purity: Typically above 98% in pharmaceutical-grade samples
Impurities: Minor process-related impurities, not generally hazardous in regulated manufacturing conditions
Formulation: Bulk solid or encapsulated in pharmaceutical products, with inert excipients
Inhalation: Move to fresh air at once. If breathing feels difficult, medical attention becomes necessary.
Skin contact: Wash thoroughly with soap and water. Remove contaminated clothing.
Eye contact: Rinse gently with plenty of water for at least 10 minutes. Avoid rubbing the eye.
Ingestion: Do not induce vomiting. Rinse mouth with water if the victim is conscious. Seek immediate medical attention.
General guidance: Rescue measures only by trained personnel. Medical observation needed in all cases of significant exposure.
Suitable extinguishing media: Use carbon dioxide, foam, or dry chemical powder. Water spray can help cool, but avoid direct streams on powder fires.
Special fire hazards: Combustion can release phosphorus oxides, nitrogen oxides, and carbon oxides.
Precautions for firefighters: Wear self-contained breathing apparatus and chemical protective clothing.
No unusual reactivity: Product does not support combustion significantly but keeps firefighters aware of hazardous decomposition byproducts.
Personal precautions: Wear gloves, goggles, and lab coat. Respiratory protection advised for dusty situations.
Cleanup procedures: Sweep up powder with minimum dust generation. Place in labelled, sealed containers for disposal. Wash contaminated surfaces with water and mild detergent.
Avoid runoff: Keep out of drains and water sources, as residues could harm aquatic environments.
Emergency considerations: Limit area access until cleanup is complete. Do not attempt cleanup without training.
Storage environment: Cool, dry, and well-ventilated. Container should remain tightly closed and protected from light.
Handling steps: Use local exhaust ventilation and minimize dust. Always wash hands after handling.
Incompatible materials: Strong oxidizing agents. Store away from food, beverages, and animal feeds.
General hygiene: No eating, drinking, or smoking in handling area.
Engineering controls: Use fume hood or local exhaust. Safety shower and eyewash stations recommended.
Protective clothing: Lab coat, chemical-resistant gloves (nitrile preferred), and safety goggles.
Respiratory protection: Mask or respirator if airborne dust is significant.
Environmental controls: Prevent access to water systems. Regular inspection and cleaning of workspace is important.
Special populations: Pregnant workers need to avoid exposure due to possible reproductive toxicity.
Physical state: Solid
Appearance: White to off-white crystalline solid
Odor: Odorless
pH (1% aqueous): Slightly basic
Melting point: Approximately 85°C
Boiling point: Decomposes before boiling
Solubility: Slightly soluble in water; freely soluble in alcohols and chloroform
Vapor pressure: Not volatile at ambient conditions
Stability: Stable in ordinary environmental conditions but degrades slowly in light and air
Chemical stability: Stable in light-protected, airtight containers at room temperature.
Conditions to avoid: Direct sunlight, excessive heat, and moisture.
Incompatible substances: Strong oxidizing agents and acids.
Hazardous products of decomposition: Phosphorus oxides, nitrogen oxides, and carbon monoxide may form if strongly heated.
No dangerous polymerization: Does not undergo polymerization under normal conditions.
Acute toxicity: Causes moderate irritation to eyes, skin, and respiratory tract. Ingesting toxic doses may provoke severe gastrointestinal symptoms and systemic toxicity.
Chronic toxicity: Animal studies show possible reproductive and developmental toxicity. High doses can harm kidneys, liver, and blood-forming organs.
Carcinogenicity: No strong evidence of cancer risk in humans, but long-term animal studies have not fully assessed this risk.
Sensitization: No evidence for strong sensitizing potential, though data in humans is limited.
No known antidote: Supportive medical care is critical in case of overdose.
Aquatic toxicity: Harmful to aquatic organisms. Persisting residues could impair aquatic ecosystems.
Persistence and degradability: Degrades slowly; not rapidly biodegradable.
Bioaccumulation potential: Risk of bioaccumulation in aquatic species remains, so strict containment is needed.
Soil mobility: Tends to bind to soil, limiting groundwater transport but not eliminating local risks.
Waste handling: Treat as hazardous pharmaceutical waste. Dispose of in accordance with local and national regulations.
Container disposal: Triple-rinse containers and render unusable before discarding.
Environmental precautions: Do not release into waterways or sewers. Incineration in permitted facilities is preferred.
Transport regulations: Subject to hazardous material transport and pharmaceutical handling rules, especially in bulk.
Proper shipping name: Miltefosine, solid, toxic, n.o.s.
Packaging requirements: Leak-proof and clearly labelled, with secure closures, especially in the case of commercial transport.
Transport category: Health hazard—special precautions for transit accidents.
Pharmaceutical regulations: Controlled as a prescription-only medicine in most countries.
Workplace safety rules: Subject to chemical hazard communication standards and exposure control regulations in laboratory and manufacturing settings.
Environmental laws: Listed as a hazardous chemical for wastewater and waste facility reporting.
Training requirements: Only trained personnel handle the substance.
Global status: Registration required in every jurisdiction that approves its medical use, with periodic review of manufacturing sites and environmental safety.
