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Product Name: Afatinib
Chemical Name: N-(4-((3-chloro-4-fluorophenyl)amino)-7-(((3S)-tetrahydrofuran-3-yloxy)-6-quinazolinyl))-4-(dimethylamino)-2-butenamide
Synonyms: BIBW 2992, Giotrif
CAS Number: 439081-18-2
Intended Use: Pharmaceutical ingredient, cancer therapy
Supplier Details: Refer to manufacturer label
Emergency Contact: Local poison control center or company safety officer for rapid advice
Classification: Acute toxicity (oral, dermal, inhalation), specific target organ toxicity, environmental hazard
Signal Word: Warning
Hazard Statements: Harmful if swallowed, irritant to eyes and skin, may cause respiratory irritation, may cause harm to aquatic life
Pictograms: Exclamation mark, Health hazard, Aquatic toxicity
Precautionary Statements: Avoid inhalation, wear gloves and protective eyewear, keep away from watercourses, wash hands thoroughly after handling
Chemical Formula: C24H23ClFN5O3
Molecular Weight: 485.9 g/mol
Main Component: Afatinib (≥98%)
Impurities: Process-related and degradation impurities, notification per batch analysis
No Additives: No stabilizers or excipients in raw substance
Inhalation: Move person to fresh air, keep them at rest, seek medical attention if breathing problems develop
Skin Contact: Remove contaminated clothing, flush skin with plenty of water and soap, seek advice if irritation continues
Eye Contact: Rinse eyes gently with water for at least 15 minutes, seek eye specialist if irritation persists
Ingestion: Rinse mouth, do not induce vomiting, immediately call for medical help, monitor for symptoms
Note to Physician: Provide symptomatic and supportive care, monitor for delayed symptoms related to antineoplastic toxicity
Suitable Extinguishing Media: Water spray, foam, dry chemical, carbon dioxide
Unsuitable Extinguishing Media: Direct water jet
Hazards from Combustion: May release toxic fumes of nitrogen oxides, hydrogen chloride, hydrogen fluoride, carbon monoxide, carbon dioxide
Protective Equipment: Wear full protective gear and self-contained breathing apparatus
Specific Tactics: Contain run-off, prevent entry into sewers and water streams
Personal Precautions: Wear gloves, mask, goggles, avoid dust formation
Environmental Precautions: Prevent from entering drains, surface water, soil
Containment: Use spill control materials, cover spill with absorbent material
Cleanup Procedures: Collect for disposal in sealable containers, ventilate area, wash surfaces thoroughly after cleanup, avoid raising dust
Handling: Use in well-ventilated space, wear appropriate safety gear, minimize generation of dust or aerosols, avoid contact with eyes, skin, and clothing
Hygiene Measures: Wash hands and face after handling, do not eat, drink, or smoke in work area
Storage Conditions: Store in tightly closed container, away from light, moisture, incompatible substances (strong oxidizers, acids), keep in a cool, dry place
Specific Storage Design: Use locked storage for pharmaceuticals, restrict access to trained personnel, have spill control response materials nearby
Exposure Limits: No official occupational exposure limits; guidelines based on internal risk assessment (keep dust below 0.1 mg/m³)
Engineering Controls: Local exhaust ventilation, closed handling systems preferred
Respiratory Protection: Respirator or mask with particulate filter (P3 or N100) in case of dust generation
Skin Protection: Wear chemical-resistant gloves (nitrile or similar), lab coat, long sleeves
Eye/Face Protection: Safety goggles or face shield
Additional Protective Measures: Emergency eyewash stations and safety showers available in work area
Appearance: White to off-white powder
Odor: Odorless
pH: Not applicable (insoluble in water)
Melting Point: 237–240°C
Boiling Point: Not available
Solubility: Soluble in DMSO, sparingly soluble in ethanol, practically insoluble in water
Vapor Pressure: Not determined
Density: Approximately 1.4 g/cm³
Partition Coefficient (log P): 3.9
Flash Point: Not flammable under normal use
Auto-ignition Temp: Not available
Explosion Limits: Not applicable
Chemical Stability: Stable under normal storage and working conditions
Incompatible Materials: Strong acids, bases, oxidative agents, reducing agents
Decomposition Products: Nitrogen oxides, hydrogen chloride, fluorine compounds, carbon oxides on thermal decomposition
Hazardous Polymerization: Will not occur
Conditions to Avoid: Heat, moisture, light, open sources of ignition, prolonged exposure to air
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Acute Toxicity: Harmful by ingestion (LD50 oral rat >500 mg/kg)
Chronic Toxicity: Target organ effects on gastrointestinal tract, liver, kidneys, eyes; potential for irritation, possible carcinogenicity
Symptoms: Coughing, shortness of breath, skin and eye redness, gastrointestinal discomfort
Sensitization: Possible skin sensitizer; handle with care
Mutagenicity/Carcinogenicity: Long-term studies not fully conclusive, some evidence of risk in animals
Other Data: Antineoplastic may cause reproductive toxicity, handle as hazardous drug
Ecotoxicity: Toxic to aquatic organisms (fish, invertebrates, algae), may cause long-term adverse effects in aquatic environments
Persistence and Degradability: Moderately persistent, incomplete degradation in environment
Bioaccumulation Potential: Possible, given lipophilicity (log P 3.9)
Mobility in Soil: Low water solubility limits mobility, stays mostly in upper soil layers
Other Adverse Effects: Avoid contamination of water bodies and soil
Waste Treatment: Collect and contain in sealed containers clearly labeled
Disposal Method: Incinerate in approved chemical incinerator with afterburner and scrubber, do not dispose via regular garbage or drains
Contaminated Packaging: Triple rinse containers, puncture and dispose according to hazardous waste protocols
Special Instructions: Follow all local, regional, and national hazardous waste disposal regulations
UN Number: Not assigned; not classified as dangerous for transport in most regions, but must ship as hazardous drug according to company/local rules
Proper Shipping Name: Afatinib, pharmaceutical substance
Transport Hazard Classes: None specified
Packing Group: Not applicable
Environmental Hazards: Prevent release in case of leak, package to prevent spillage
Precautions for User: Handle sealed containers with gloves, transport in secondary containment, emergency spill instructions included with package
US TSCA: Not listed for consumer use, for research and pharmaceutical manufacture only
EU REACH: Exempt as medicinal product, risk management duties apply for occupational handling
DEA/Controlled Substance: Not scheduled
OSHA: Handle as hazardous drug, apply workplace safety standards
WHMIS/Canada: Controlled product, handle with care, follow safety documentation
Other: For workplace use only, training required on safe use and potential risks, waste must be tracked and reported according to regulations
