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Substance Name: Amorolfine Hydrochloride
Chemical Structure: Synthetic morpholine derivative
Primary Use: Antifungal treatment for topical application, mainly prescribed for nail infections
Molecular Formula: C21H35NO·HCl
Appearance: White or almost white crystalline powder
Odor: Almost odorless
Solubility: Freely soluble in methanol and ethanol, slightly soluble in water
CAS Number: 78613-35-1
Health Hazards: Prolonged skin contact may cause mild to moderate irritation. Eyes become easily irritated on exposure. Inhalation of powder may irritate respiratory tract.
Environmental Hazards: Toxic to aquatic organisms, risk of long-term adverse effects in the aquatic environment.
Fire and Explosion Risk: Not highly flammable, though dust can fuel small fires.
GHS Classification: Not classified as hazardous for skin contact under normal handling conditions, but care should guide routine use.
Active Ingredient: Amorolfine Hydrochloride
Concentration: Varies with formulation; as pure substance, 100% amorolfine hydrochloride
Impurities: May include minimal trace amounts left over from synthesis, but pure samples do not list significant contaminants.
Inhalation: Remove to fresh air promptly, keep at rest, and seek medical advice if coughing or breathing difficulty persists.
Skin Contact: Wash affected area gently with soap and plenty of water. Remove contaminated clothing.
Eye Contact: Rinse with plenty of clean, lukewarm water for at least 15 minutes and get medical attention if discomfort continues.
Ingestion: Rinse mouth thoroughly, avoid inducing vomiting, and consult a healthcare professional.
Suitable Extinguishing Media: Use water spray, carbon dioxide, dry chemical powder, or foam.
Combustion Hazards: Emits toxic fumes, including nitrogen oxides and carbon oxides.
Special Equipment: Firefighters should wear full protective gear, including self-contained breathing apparatus.
Personal Protection: Wear gloves, goggles, and protective clothing to avoid direct exposure.
Environmental Protection: Avoid releasing dust or powder into drains, waterways, or soil.
Cleanup Methods: Collect spilled material using a vacuum with HEPA filter or sweep gently into a suitable container for disposal.
Handling Practices: Always use in a well-ventilated area. Avoid generating dust; handle with care using appropriate personal protection to reduce skin and eye exposure.
Storage Conditions: Keep container tightly closed in a dry, cool place, protected from direct sunlight and away from incompatible substances like strong oxidizing agents.
Incompatible Materials: Strong acids, bases, and oxidizers can degrade the chemical.
Occupational Exposure Controls: Engineering controls such as fume hoods or local exhaust ventilation reduce dust exposure.
Personal Protective Equipment: Use gloves, goggles, and a lab coat. For large quantities or dusty environments, respiratory protection like a dust mask or full respirator may be necessary.
Hygiene Practices: Wash hands thoroughly after handling, and avoid eating, drinking, or smoking in the work area.
Physical State: Solid, crystalline powder
Color: White to off-white
Odor: Essentially odorless
Boiling Point: Not applicable
Melting Point: Around 150–160°C
Solubility: Freely soluble in common organic solvents, slightly soluble in water
Flash Point: No substantial risk under normal ambient conditions.
Chemical Stability: Stable under recommended storage and handling, but prolonged exposure to moisture, heat, and light can degrade potency.
Reactivity: Non-reactive under normal use conditions; reacts with strong oxidizers and acids.
Decomposition Products: May produce hazardous fumes like nitrogen oxides and carbon monoxide if exposed to extreme heat or fire.
Acute Effects: Ingestion or inhalation in large quantities causes gastrointestinal upset, respiratory irritation, and minor central nervous system effects. Regular occupational exposure does not typically lead to systemic toxicity.
Skin and Eye Contact: Localized irritation, redness, or allergic reaction occurs in some sensitive individuals.
Chronic Effects: Evidence does not point to severe chronic toxicity, but as with many pharmaceuticals, regular contact should be minimized.
Sensitization: Low potential for allergic sensitization based on current clinical data.
Aquatic Toxicity: Harmful to fish and other aquatic life at significant concentrations.
Degradability: Breaks down slowly in the environment. Persistent residues may linger, so waste management becomes especially important.
Environmental Mobility: Not very mobile in soil; binds to sediments and organic material.
Product Disposal: Incinerate or dispose of in accordance with local regulations on pharmaceutical waste. Do not dump in drains or natural water bodies.
Contaminated Packaging: Rinse containers and dispose of with usual industrial waste streams or as hazardous waste if required by local guidance.
Special Instructions: Prevent contamination of surface waters, soil, and sewage systems during disposal.
UN Number: Not classified as dangerous for road, rail, sea, or air transport under standard regulatory frameworks.
Transport Precautions: Secure containers tightly and protect from physical damage or exposure to moisture.
Labeling: Not considered a dangerous good, so no special transport labeling is required, though clear identification on packaging remains good practice.
Pharmaceutical Regulation: Approved for sale and use in many regions for antifungal treatment. Local regulations and standards dictate distribution and occupational exposure.
Chemical Regulation: Not listed specifically as hazardous under major international chemical regulations but subject to general pharmaceutical and workplace safety laws.
Occupational Guidelines: Best practice standards recommended for minimizing occupational contact and limiting environmental impact.
