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Product Name: Sorafenib
Synonyms: Nexavar, BAY 43-9006
Chemical Formula: C21H16ClF3N4O3
CAS Number: 284461-73-0
Intended Use: Pharmaceutical for cancer therapy
Manufacturer: Unlike agricultural chemicals, major international pharmaceutical companies manufacture and distribute approved Sorafenib formulations.
Emergency Contact: Dedicated medical team or local poison control center
Address: Local distributor locations or hospital pharmacies following prescription requirements
Recommended Restrictions: Only use under direct supervision of qualified medical professionals
Classification: Acute toxicity (Oral, Dermal), Eye irritation, Carcinogenicity (based on therapeutic classification), Reproductive toxicity
Hazard Statements: Harmful if swallowed, may cause skin and eye irritation, possible risk of reproductive toxicity, suspected of causing cancer with prolonged occupational exposure
Pictogram: Skull and crossbones, exclamation mark, health hazard
Precautionary Statements: Avoid breathing dust, wash any contacted skin thoroughly, do not eat or drink near material, avoid direct contact during handling, proper medical supervision required
Signal Word: Danger
Active Ingredient: Sorafenib Tosylate 100% (by weight or volume, depends on specific formulation)
Chemical Abstracts Number: 284461-73-0
Molecular Weight: 464.8 (Tosylate form)
Formulation Additives: Pharmaceutical versions contain excipients such as microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, iron oxide pigments for tablet coatings
Impurities: Levels tightly controlled under GMP, residual solvents and unreacted intermediates typically below 0.1%
Eye Contact: Rinse eyes with water for at least 15 minutes, remove contact lenses if present, seek medical advice right away
Skin Contact: Remove contaminated clothing, wash skin with plenty of soap and water, consult a physician if symptoms persist or irritation develops
Ingestion: Do not induce vomiting, rinse mouth with water if person is conscious, call a poison control center or physician immediately
Inhalation: Move affected person into fresh air, closely observe for respiratory distress, medical assessment essential
Note to Physicians: Treat symptoms, monitor vital signs, provide supportive care, for large exposures, consider possible systemic toxicity including liver, kidney, and GI effects
Suitable Extinguishing Media: Powder, carbon dioxide, dry chemical, foam; avoid straight water jets
Specific Hazards: Can produce toxic fumes such as oxides of carbon, nitrogen, sulfur, chlorine upon decomposition
Protective Equipment: Firefighters must wear self-contained breathing apparatus and protective clothing
Special Precautions: Use caution to prevent water runoff from entering drains or sewers
Thermal Hazards: Heating or burning causes emission of irritating vapors, avoid inhalation
Personal Precautions: Wear gloves, safety goggles, and mask; avoid dust formation; ventilate the area
Environmental Precautions: Prevent entry into soil, sewers, and groundwater using physical barriers, use absorbent materials for liquid spills
Methods for Clean-Up: Sweep up powder carefully or use HEPA-filtered vacuum, collect in suitable closed containers for disposal, wash affected area with water and detergent after cleanup
Handling: Use local exhaust ventilation to minimize exposure to airborne particles; employ protective gear including gloves, lab coats, and eye protection; wash hands after handling even in trace amounts
Storage: Store in original tight-sealed container, away from incompatible substances like oxidizing agents, acids, and bases; keep in cool, dry location, protected from sunlight and direct heat sources
Special Considerations: Limit access to authorized trained personnel, monitor inventories closely, follow legal disposal regulations
Engineering Controls: Fume hood or biological safety cabinet for handling powders, negative pressure laboratory rooms for scale-up operations
Respiratory Protection: NIOSH-approved particulate respirator or half-mask with appropriate filters when handling outside of containment
Eye/Face Protection: Chemical splash goggles and face shields
Skin Protection: Nitrile gloves, long-sleeved lab coats, and closed shoes, change gloves frequently
Exposure Limits: No established OSHA or ACGIH limits, but adopt occupational exposure band guidance (low nanogram to microgram range for hazardous pharmaceuticals)
Hygiene Measures: Do not eat or drink in handling area, wash thoroughly after use, launder clothing routinely
Appearance: Pale yellow crystalline powder
Odor: Odorless or faintly medicinal
Melting Point: About 200-210°C
Boiling Point: Not readily volatilized, decomposes before boiling
Solubility: Very slightly soluble in water, more soluble in DMSO and methanol
pH: Not applicable for solid form; DMSO solutions show weak acidity
Vapor Pressure: Negligible at room temperature
Partition Coefficient: High logP (approx. 3.8), indicating lipophilicity
Stability: Stable under normal temperature and pressure, decomposes on strong heating
Flash Point: Exceeds 100°C, non-flammable under standard storage and handling
Chemical Stability: Stable under recommended storage conditions; light, moisture, or strong oxidizers can cause breakdown
Hazardous Reactions: Avoid contact with strong acids, alkalis, or oxidizing materials that may trigger degradation
Decomposition Products: Combustion or hydrolytic breakdown produces toxic gases including HCl, HF, NOx, SOx
Possibility of Hazardous Polymerization: Will not polymerize under normal conditions
Conditions to Avoid: Heat, open flames, incompatible chemicals, prolonged exposure to air and moisture
Acute Toxicity: LD50 in animals ranges between 200-300 mg/kg (oral, rats & mice)
Chronic Toxicity: Repeated or prolonged exposure in animal studies causes liver, kidney, and gastrointestinal effects; risk of carcinogenesis in long-term studies
Mutagenic Effects: Evidence from in vitro and in vivo studies suggests possible mutagenic activity
Carcinogenicity: Evaluated in animal testing with increased tumor incidence at very high exposures
Reproductive Toxicity: Animal studies indicate risk of fetal toxicity and impaired fertility; category warning for women of childbearing age
Irritation: Moderate skin and severe eye irritant effects in animal models
Sensitization: Potential for allergic or hypersensitivity reactions in some exposed workers
Ecotoxicity: Highly toxic to aquatic organisms (acute and chronic tests with Daphnia, fish, algae); may produce long-term adverse effects in aquatic environment
Persistence and Degradability: Not readily biodegradable, stable in environmental matrices, slow breakdown in water or soil
Bioaccumulative Potential: High potential to bioaccumulate in aquatic species due to high partition coefficient
Mobility in Soil: Binds to organic matter, low mobility in most soils, possible leaching in sandy or low-organic soils
Other Adverse Effects: Significant risk of contamination to downstream water bodies, proper containment essential at every use and disposal point
Waste Disposal Methods: Treat as hazardous pharmaceutical waste, incinerate under controlled conditions in licensed facilities
Container Disposal: Do not reuse containers, rinse triple with compatible solvent, send for hazardous waste destruction or return to supplier
Special Precautions: Never dispose to municipal sewage, ensure all disposal follows local, state, and national regulations
Spill Cleanup Residue: Treat as bulk drug waste, handle with PPE and appropriate documentation
UN Number: Not assigned for finished pharmaceutical products; may fall under “Medicines, solid, toxic, n.o.s.” for bulk shipments
UN Proper Shipping Name: Sorafenib or related substances
Transport Hazard Class: Class 6.1 (Toxic substances) for bulk chemical
Packing Group: III (Moderate hazard)
Transport Label Requirements: Skull and crossbones for bulk, standard labeling for pharmaceutical use under prescription
Special Precautions for User: Secure packaging, clear labeling, notification of hazardous contents as per carrier and regulatory requirements
OSHA Status: Considered hazardous by OSHA Hazard Communication Standard in laboratory or workplace
TSCA Status: Pharmaceutical versions exempt from TSCA, chemical subject to reporting in manufacturing
EPA Regulations: Not specifically listed as hazardous waste, but must follow pharmaceutical hazardous waste protocols
FDA Status: Prescription-only medication, approval for specific cancer indications, restricted distribution
International Regulations: Included in WHO Model List of Essential Medicines, subject to local drug safety laws and workplace exposure limits
Other Regulatory References: National and international drug control laws, waste management acts, chemical safety directives for handling, storage, and destruction
