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Product Name: Vismodegib
Chemical Name: 2-Chloro-N-(4-chloro-3-pyridyl)-4-(methylsulfonyl)benzamide
CAS Number: 879085-55-9
Recommended Use: Pharmaceutical agent used in oncology
Manufacturer: Genentech, Inc.
Emergency Contact: CHEMTREC, 1-800-424-9300 (US); +1-703-527-3887 (international)
GHS Classification: Acute toxicity (oral, dermal, inhalation, category 4), specific target organ toxicity (single exposure, category 2), reproductive toxicity (category 2)
Label Elements: Signal Word: Warning; Hazard Statements: H302 - Harmful if swallowed, H332 - Harmful if inhaled, H361 - Suspected of damaging fertility or the unborn child
Physical Hazards: Not classified as flammable or explosive
Health Hazards: May cause organ damage, reproductive effects, skin and eye irritation; can cause gastrointestinal symptoms if ingested
Environmental Hazards: Harmful to aquatic organisms, may cause long-term adverse effects in aquatic environments
Chemical Name: Vismodegib
Synonyms: GDC-0449
CAS Number: 879085-55-9
Concentration: >98% (Active Pharmaceutical Ingredient)
Impurities: Trace process-related byproducts, each typically <0.1%
Additives: None significant at API level
Inhalation: Remove victim to fresh air, keep at rest, seek medical attention for persistent symptoms such as cough, dizziness, or shortness of breath.
Skin Contact: Wash with plenty of water and soap, remove contaminated clothing, get medical attention if irritation persists.
Eye Contact: Immediately flush eyes with large amounts of water, seek prompt medical advice.
Ingestion: Rinse mouth, never give anything by mouth to an unconscious person, seek immediate medical help for symptoms such as vomiting, abdominal pain, or drowsiness.
Note to Physician: Provide symptomatic and supportive treatment, monitor for signs of toxicity to gastrointestinal and nervous systems.
Suitable Extinguishing Media: Water spray, dry chemical powder, foam, carbon dioxide.
Unsuitable Extinguishing Media: Direct water jet may spread the materials.
Combustion Hazards: Emits toxic fumes including oxides of nitrogen, sulfur, carbon, hydrogen chloride, and hydrochloric acid.
Protective Equipment: Self-contained breathing apparatus, full protective clothing.
Special Fire-Fighting Procedures: Evacuate area, prevent runoff into drains, use standard fire-fighting procedures for chemical fires.
Personal Precautions: Use proper personal protective equipment including gloves, goggles, and respirator.
Environmental Precautions: Prevent spillage from reaching drainage systems, soil, or surface waters.
Cleanup Procedures: Use damp, disposable cloths or absorbent materials, avoid raising dust, scoop debris into suitable container for disposal.
Decontamination: Wash affected area with soap and water after removal, ventilate area before reuse.
Reporting: Notify authorities if significant release occurs.
Handling: Wear protective equipment, avoid contact with skin, eyes, and clothing, do not breathe dust, work in well-ventilated areas, avoid generating airborne dust.
Storage Conditions: Store in tightly closed containers in a cool, dry, well-ventilated place, protect from heat, moisture, and direct sunlight.
Incompatibilities: Keep away from strong oxidizers, acids, and bases.
Packing Materials: Use original or approved containers resistant to chemical action.
Precautions: Protect from physical damage, restrict access to authorized personnel who understand safety measures for antineoplastic drugs.
Occupational Exposure Limits: No occupational exposure limit established for vismodegib; use pharmaceutical exposure control banding based on hazard assessment.
Engineering Controls: Handle in biosafety cabinet or chemical fume hood, use local exhaust ventilation.
Personal Protective Equipment: Nitrile gloves, safety goggles, lab coat, and, if risk of inhalation exists, use NIOSH-approved respirator.
Hygiene Measures: Wash hands after handling, do not eat, drink, or smoke in processing area, remove contaminated clothing before leaving workspace.
Environmental Controls: Avoid release to sewer or environment, employ HEPA-filtered vacuum for cleanup.
Form: Solid powder
Color: White to off-white
Odor: Odorless
Melting Point: Approximately 188°C
Boiling Point: Not applicable (decomposes)
Solubility: Insoluble in water, soluble in DMSO, methanol, ethanol
pH: Not applicable
Partition Coefficient (log P): Approximately 2.7
Vapor Pressure: Not volatile
Other Properties: Stable under standard conditions, forms dust easily if handled aggressively
Chemical Stability: Stable under recommended storage conditions, degrades slowly when exposed to light or moisture.
Incompatible Materials: Strong acids, strong bases, oxidizing agents.
Decomposition: May form hazardous gases including nitrogen oxides, sulfur oxides, hydrogen chloride, carbon monoxide and dioxide at high temperatures.
Hazardous Reactions: No known dangerous polymerization or reactions under normal use.
Conditions to Avoid: Excessive heat, open flames, sunlight, moisture.
Acute Toxicity (Oral): LD50 (rat): approximately 200–2000 mg/kg (harmful if swallowed)
Inhalation: Can cause respiratory tract irritation, harmful if inhaled in significant quantities
Skin/Irritation: Mild skin irritation in laboratory animals
Eye Irritation: Causes eye irritation
Chronic Effects: Animal studies showed possible liver, kidney, and blood toxicity at high doses; risk of teratogenicity and reproductive toxicity
Carcinogenicity: Not classified as carcinogenic based on available data
Mutagenicity: No evidence of mutagenic potential in standard tests
Other Effects: Possible developmental toxicity; limited data in humans due to restricted therapeutic use
Ecotoxicity: Harmful to aquatic life with long lasting effects, no data on specific LC50 or EC50 values for aquatic organisms
Persistence and Degradability: Not readily biodegradable, may persist in soil and water for extended periods
Bioaccumulation: Low potential based on physical properties, but no experimental data supporting accumulation in aquatic organisms
Mobility in Soil: Likely low mobility due to low water solubility
Other Adverse Effects: Avoid contamination of water sources, wastewater, and soil
Waste Disposal: Treat as hazardous pharmaceutical waste, consult local and national regulations
Incineration: Use high temperature incinerator with flue gas scrubber for complete destruction
Packaging Disposal: Dispose of empty containers and contaminated protective clothing as hazardous waste
Precautions: Avoid landfill disposal, never pour into waterways or sewer systems
Special Instructions: Use qualified and authorized contractors for on-site incineration or chemical disposal
UN Number: Not regulated for transport under international regulations
Transport Hazard Class: Not classified as dangerous goods by ADR, IATA, DOT, or IMDG
Packing Group: Not assigned
Proper Shipping Name: Pharmaceuticals, n.o.s. (not otherwise specified)
Special Precautions: Protect package from physical damage, temperature extremes, and moisture during transit
US Regulations (TSCA, OSHA, SARA): Not listed on TSCA; not considered an OSHA hazardous chemical as a finished dosage pharmaceutical; SARA Title III Sections 302, 304, 311, 312, 313 not applicable
EU Regulation (REACH): Exempt as a pharmaceutical active substance under Article 2(5)
GHS: Compliant with labelling and hazard communication for pharmaceuticals
WHMIS (Canada): Exempt from hazardous products classification under Drugs and Health Products Regulations
Other Global Regulations: Subject to country-specific pharmaceutical safety, transport, and environmental legislation
Restriction of Use: Handling restricted to qualified personnel, prescription-only medicine in all developed markets
