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Product Name: Doxofylline
Chemical Name: 7-(1,3-Dioxolan-2-ylmethyl)theophylline
SYNONYMS: 1,3-Dimethyl-7-(2,2-dioxo-1,3-dioxolan-4-yl)methylxanthine
CAS Number: 69975-86-6
Recommended Use: Pharmaceutical ingredient, bronchodilator
Supplier: Manufacturer, distributor or importer contact information should be referenced from the container label
Emergency Contact: Reach out to local emergency response services for urgent matters involving exposure or accidents related to this chemical
Classification: Harmful if swallowed, causes eye and skin irritation, respiratory sensitizer; acute toxicity, oral; eye irritation; specific target organ toxicity, single exposure
Hazard Statements: May cause irritation to eyes, respiratory system, and skin. Prolonged or repeated exposure can cause headaches, nausea, gastrointestinal discomfort.
Pictograms: Exclamation mark symbol for acute toxicity and irritation
Signal Word: Warning
Precautionary Statements: Avoid contact with eyes, skin, and clothing. Do not breathe dust. Wash hands thoroughly after handling. Use only outdoors or in a well-ventilated area.
Substance: Doxofylline
Chemical Formula: C11H14N4O4
Content: Pure active pharmaceutical ingredient, >98%
Impurities: Minor levels of residual solvents or process impurities may be detected, generally far less than 1% by weight
Inhalation: Remove exposed person to fresh air immediately. If breathing becomes difficult, ensure plenty of air circulation and seek medical attention if symptoms persist.
Skin Contact: Wash thoroughly with soap and water for at least 15 minutes. Remove contaminated clothing and wash before reuse.
Eye Contact: Flush immediately with plenty of water for at least 15 minutes while holding eyelids open. Contact physician if irritation or pain develops.
Ingestion: Rinse mouth with water. Never induce vomiting unless told to do so by medical personnel. Seek medical help promptly, especially if symptoms like vomiting, confusion, or weakness show up.
Most Important Symptoms and Effects: Nausea, vomiting, headaches, and mild to moderate irritation
Recommendations to First Responders: Wear personal protective equipment to avoid direct exposure
Suitable Extinguishing Media: Use foam, dry chemical powder, or carbon dioxide. Avoid water spray as it may spread powder.
Specific Hazards: Fine dust may form explosive mixtures with air; thermal decomposition releases hazardous gases (nitrogen oxides, carbon monoxide, carbon dioxide).
Protective Equipment for Firefighters: Wear self-contained breathing apparatus and full protective gear to minimize inhalation of fumes and contact with skin and eyes.
Advice for Firefighters: Move containers away from fire area if possible; avoid inhaling decomposition products and control run-off water
Personal Precautions: Ensure adequate ventilation, avoid creating dust, and use personal protective equipment—gloves, goggles, dust mask.
Environmental Precautions: Prevent further leakage or spillage into drains and surface waters; avoid soil contamination.
Methods for Containment and Cleanup: Scoop up spilled material carefully to minimize dusting and place in a well-marked container for proper disposal. Clean spill area thoroughly using damp cleaning methods to avoid dust formation.
Reference to Other Sections: For disposal details, consult relevant regulatory and safety instructions outlined below
Precautions for Safe Handling: Minimize airborne dust generation, wash hands before breaks and after handling, avoid contact with eyes, skin, and clothing, and use good laboratory practices.
Conditions for Safe Storage: Store in tightly closed containers, away from sources of ignition, heat, and moisture. Ensure the storage area is cool, dry, adequately ventilated, and protected from physical damage.
Incompatible Materials: Strong oxidizing agents, acids, and bases should be kept away to prevent hazardous reactions
Engineering Controls: Local exhaust ventilation or containment systems help control airborne concentrations; ensure eyewash stations and safety showers are available in working areas.
Occupational Exposure Limits: No established exposure limits for doxofylline; general dust limits apply (10 mg/m³ total dust, 5 mg/m³ respirable particles).
Personal Protective Equipment (PPE): Eye protection using chemical safety goggles, suitable gloves (nitrile preferred), laboratory coats or coveralls, and respiratory protection if dust forms in excessive concentrations.
Hygiene Measures: Do not eat, drink, or smoke during handling; wash hands after handling, and handle in accordance with good chemical hygiene practices
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not available
pH: Not available
Melting Point: Approximately 115 to 120°C
Boiling Point: Not applicable (decomposes before boiling)
Flash Point: Not relevant for powders
Decomposition Temperature: >180°C (liberates irritating or toxic fumes if overheated)
Vapor Pressure: Negligible at room temperature
Solubility: Soluble in water, methanol, and ethanol
Density: About 1.4 g/cm³
Partition Coefficient (log Pow): Not established; estimated to fall within range common to xanthine derivatives
Evaporation Rate: Not applicable for a solid
Chemical Stability: Stable under normal storage and handling conditions. Sensitive to strong oxidizers and excessive heat.
Reactivity: Dust may present explosive hazard in presence of ignition source.
Possibility of Hazardous Reactions: Not expected under recommended storage and handling practices; avoid strong oxidizers or alkalis.
Conditions to Avoid: Excessive heat, sparks, open flame, formation of airborne dust.
Incompatible Materials: Strong acids, strong alkalis, strong oxidizing agents.
Hazardous Decomposition Products: Under fire or decomposition conditions, carbon oxides, nitrogen oxides may form
Likely Routes of Exposure: Inhalation, ingestion, skin contact, eye contact
Acute Toxicity: LD50 (oral, rat): estimated 950-1200 mg/kg
Chronic Toxicity: No significant chronic risk identified in humans at therapeutic doses; animals exposed to high doses experience symptoms similar to other xanthine-based bronchodilators
Skin and Eye Irritation: May cause mild to moderate irritation
Sensitization: Dust exposure may trigger respiratory or skin sensitization in susceptible individuals
Other Effects: In large doses, can cause agitation, gastrointestinal disturbances, palpitations, or convulsions
Aquatic Toxicity: Limited data; xanthine derivatives can be toxic at high concentrations to aquatic invertebrates
Persistence and Degradability: Expected to degrade slowly in soil and water; hydrolysis and photo-oxidation help break down compound over weeks or months
Bioaccumulation Potential: Not expected to bioaccumulate due to physicochemical properties
Mobility in Soil: Moderate mobility, soluble in water, may leach through soil if uncontrolled release occurs
Other Adverse Effects: Uncontrolled release into the environment may affect aquatic organisms; avoid direct disposal to waterways or drains
Disposal Methods: Chemical must be managed in accordance with local, state, and federal regulations. Handle as hazardous chemical waste; incinerate or send to licensed treatment facility.
Contaminated Packaging: Empty containers should be triple-rinsed and disposed according to guidelines for contaminated chemical containers; do not reuse for other purposes.
Precautions: Prevent material from contaminating soil, drains, or water courses. Collect and transport following all applicable regulations
UN Number: Not classified as hazardous for transport
Proper Shipping Name: Doxofylline, not restricted
Transport Hazard Class: Non-hazardous
Packing Group: None required
Special Precautions: Ensure packaging prevents the release of dust and is clearly labeled. Use secondary containment during transport to prevent accidental spillage
Safety, Health, and Environmental Regulations: Not specifically listed under major regulations such as OSHA, TSCA, EU REACH, or GHS as a restricted substance, but general workplace safety legislation applies. Pharmaceutically active; manufacture and sale require regulatory marketing approval in most jurisdictions.
Label Requirements: Standard chemical hazard labels (irritant, harmful, avoid inhalation) needed.
Other Requirements: Companies handling doxofylline must provide proper employee training, maintain safety documentation, and ensure compliance with workplace and environmental safety directives
