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Product Name: Gefitinib
Chemical Name: 4-Quinazolinamine, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy]-
CAS Number: 184475-35-2
Synonyms: Iressa
Recommended Use: Pharmaceutical ingredient used in the treatment of cancer, mainly non-small cell lung cancer.
Manufacturer’s Name and Address: Refer to pharmaceutical supplier’s packaging.
Emergency Contact: Seek local poison control or emergency medical services.
GHS Classification: Acute Toxicity (Oral) Category 4, Eye Irritation Category 2A, Specific Target Organ Toxicity (Single Exposure) Category 3
Signal Word: Warning
Hazard Statements: Harmful if swallowed; Causes serious eye irritation; May cause respiratory irritation
Pictograms: Exclamation mark
Precautionary Statements: Avoid breathing dust; Wash thoroughly after handling; Do not eat, drink or smoke when using.
Other Hazards: May cause skin irritation on repeated exposure and allergic reactions in sensitive individuals.
Chemical Name: Gefitinib
Concentration: >97% (pharmaceutical grade)
Impurities: Trace synthetic intermediates, solvents (below reporting thresholds based on manufacturing process)
Molecular Formula: C22H24ClFN4O3
Molecular Weight: 446.90 g/mol
Inhalation: Move affected person to fresh air as fast as possible. If breathing difficulties persist, seek medical help.
Skin Contact: Rinse skin immediately with plenty of water for fifteen minutes and remove contaminated clothing.
Eye Contact: Flush eyes with water for at least fifteen minutes, keeping eyelids open. If discomfort continues, get medical attention.
Ingestion: Rinse mouth with water, do not induce vomiting, and seek urgent medical attention.
Medical Advice: Symptomatic treatment and support of vital functions.
Suitable Extinguishing Media: Water spray, dry powder, foam, carbon dioxide
Special Hazards: Emits toxic fumes of nitrogen oxides, hydrogen chloride and hydrogen fluoride in a fire
Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective clothing.
Specific Methods: Prevent fire-fighting runoff from entering drains or watercourses.
Personal Precautions: Wear protective gloves, goggles, and a dust mask.
Environmental Precautions: Avoid discharge into drains, surface and groundwater.
Cleanup Methods: Sweep up spilled product without raising dust, collect in appropriate container. Wash area with water and ventilate.
Disposal: Transport collected material for destruction according to local regulations.
Handling: Use engineering controls such as fume hoods, work with proper skin and eye protection. Avoid dust formation.
Storage: Store in a tightly closed, labeled container, away from incompatible materials like acids and oxidizers. Maintain storage in a cool, dry, well-ventilated place.
Hygiene: Wash hands and face thoroughly after use. Do not eat, drink, or smoke during handling.
Engineering Controls: Use local exhaust ventilation or other controls to minimize exposure.
Occupational Exposure Limits: No specific occupational exposure limits established for Gefitinib.
Respiratory Protection: Wear suitable dust mask or respirator if dust exposure risk exists.
Eye Protection: Use tightly sealed goggles.
Hand Protection: Nitrile or latex gloves are a practical barrier.
Body Protection: Wear lab coat or coveralls.
Other Protective Equipment: Use eyewash station and safety shower.
Appearance: White to off-white crystalline powder
Odor: Odorless
Odor Threshold: Not determined
pH: Not applicable
Melting Point: 136–140°C
Boiling Point: Decomposes before boiling
Flash Point: Not determined
Evaporation Rate: Not available
Flammability: Not flammable under standard conditions
Vapor Pressure: Negligible at room temperature
Solubility: Slightly soluble in water, more soluble in DMSO and methanol
Partition Coefficient (log Kow): Estimated 2.2
Auto-ignition Temperature: Not determined
Decomposition Temperature: Above 140°C
Viscosity: Not applicable
Reactivity: No specific reactivity under normal use and storage
Chemical Stability: Stable under normal storage and handling conditions
Possibility of Hazardous Reactions: No hazardous polymerization expected
Incompatible Materials: Strong acids, strong oxidizers
Hazardous Decomposition Products: Nitrogen oxides, hydrogen chloride, hydrogen fluoride
Conditions to Avoid: Excessive heat, direct sunlight, uncontrolled humidity
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Acute Toxicity: LD50 (oral, rat): >2000 mg/kg
Skin Corrosion/Irritation: Mild irritant
Serious Eye Damage/Irritation: Irritant
Respiratory Sensitization: May irritate respiratory system
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, OSHA
Reproductive Toxicity: Studies point to possible effects on embryo-fetal development at high doses
Other Information: Clinical reports document skin rash, diarrhea, elevation of liver enzymes in therapeutic use.
Ecotoxicity: Data limited; hazard to aquatic life not fully determined, but structurally related compounds affect aquatic species at low concentrations
Persistence/Degradability: Likely to persist due to low biodegradability
Bioaccumulative Potential: May bioaccumulate based on physical and chemical properties
Mobility in Soil: Moderate mobility predicted due to solubility profile
Other Adverse Effects: Dispose responsibly to avoid environmental contamination
Product Disposal: Incinerate or send to approved hazardous waste facility according to local, state, and federal regulations
Container Disposal: Empty packaging should be handled with care; triple rinse and render non-reusable before disposal
Precautions: Do not allow product or runoff to enter watercourses, drains, or sewers. Consult with licensed professional waste disposal service.
UN Number: Not regulated as hazardous for transport
UN Proper Shipping Name: Not applicable
Transport Hazard Class: Not classified
Packing Group: Not applicable
Environmental Hazards: Not a marine pollutant
Transport Precautions: Ship in a tightly sealed container, away from incompatible chemicals and foodstuffs.
OSHA Status: Not specifically listed; handle using relevant general controls for hazardous pharmaceuticals
SARA Title III: Not listed under Sections 302, 304, 313
TSCA: Gefitinib not listed
IARC/NTP/OSHA Carcinogen: Not classified as carcinogen
FDA: Approved active pharmaceutical ingredient for specific indications
EU Regulation: Subject to controls for medicinal products; not classified as dangerous under Regulation (EC) No 1272/2008
Other Regulations: Observe all applicable local, regional, national, and international legislation regarding pharmaceutical handling and disposal.
