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Chemical Name: Ivacaftor
Synonyms: VX-770, Kalydeco
CAS Number: 873054-44-5
Product Use: Pharmaceutical active ingredient for cystic fibrosis therapy
Manufacturer: Vertex Pharmaceuticals Incorporated
Contact: Emergency phone: Refer to local company data, usually available in safety protocols.
Formula: C24H28N2O3
Molecular Weight: 392.49 g/mol
GHS Classification: Not classified as hazardous under GHS for general handling, but occupational settings and accidental exposure require special precautions.
Health Hazards: Eye and respiratory tract irritation, possible skin irritant. High exposure could involve nervous system effects, similar to class-related adverse reactions.
Environmental Hazards: Persistence in aquatic environments, potential bioaccumulation risk.
Physical Hazards: Dust may form explosive mixtures when dispersed in air under rare scenarios.
Label Elements: Signal word: Warning, Hazard pictograms: Exclamation mark symbol.
Exposure Symptoms: Cough, shortness of breath, irritation, possible mild headache.
Precautionary Statements: Avoid breathing dust or powder, wash hands thoroughly after handling, use in well-ventilated area.
Main Ingredient: Ivacaftor (CAS 873054-44-5), >99% purity
Impurities: Generally pharmaceutical grade includes unspecified trace process impurities below threshold for GHS classification.
Other Components: No additional hazardous ingredients reported in standard pharmaceutical material.
Eye Contact: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Seek medical attention if irritation persists.
Skin Contact: Wash with plenty of soap and water. Remove contaminated clothing. Get medical advice if irritation develops.
Inhalation: Move affected person to fresh air, keep at rest. Seek medical attention if symptoms appear.
Ingestion: Rinse mouth. Do not induce vomiting. Seek medical attention if feeling unwell.
Medical Advice: Treat symptomatically. Show MSDS to attending physician.
Suitable Extinguishing Media: Water spray, foam, dry chemical, carbon dioxide.
Special Hazards: Burning may produce hazardous fumes such as nitrogen oxides, carbon monoxide, carbon dioxide.
Protective Equipment: Firefighters need self-contained breathing apparatus, full protective gear. Do not allow run-off from fire to enter drains or watercourses.
Specific Methods: Cool containers with water spray to prevent heat damage.
Combustion Products: Toxic and irritating gases, especially in confined or poorly ventilated fires.
Personal Precautions: Use personal protective equipment: approved respirator, gloves, goggles, lab coat or protective suit.
Environmental Precautions: Prevent further leakage or spillage if safe. Do not let product enter drains. Avoid soil or water contamination.
Containment and Clean-Up: Collect spillage with non-combustible absorbent material, such as sand or inert powder. Sweep up and place in suitable, closed containers for disposal.
Decontamination: Wash area with water after material removal. Ensure adequate ventilation.
Disposal: Send to authorized hazardous waste disposal contractors.
Precautions for Safe Handling: Handle with comprehensive industrial hygiene, avoid inhalation or skin contact, avoid generation of dust. Use in designated areas, do not eat, drink, or smoke during use.
Storage Conditions: Store in a closed, dry, cool, well-ventilated place. Keep container tightly sealed and clearly labelled. Protect from direct sunlight and incompatible chemicals.
Incompatible Materials: Strong oxidizers, reducing agents, acids, alkalis.
Storage Temperature: Typically 2–8°C (refrigerated), as drug substance stability data recommend.
Package Materials: Preferably in amber glass or polyethylene containers.
Engineering Controls: Work in ventilated fume hood, use local exhaust where dust is generated. Maintain minimum dust accumulation.
Personal Protective Equipment (PPE): Gloves (nitrile or neoprene), splash-proof goggles, protective clothing, dust mask or approved respirator (P2 or N95 equivalent).
Hygiene Measures: Wash hands and face after handling. Remove contaminated clothing and clean before reuse.
Exposure Limits: Not established for Ivacaftor, standard pharmaceutical facilities use occupational exposure banding systems to guide controls.
Monitoring Procedures: Routine surface and air monitoring recommended for production areas, healthcare settings.
Appearance: White to off-white powder
Odor: Odorless
Odor Threshold: Not determined
Melting Point: 131–134°C
Boiling Point: Not established (decomposes)
Flash Point: Not available
Evaporation Rate: Not applicable
Flammability: Not classifiable as flammable but combustible as organic material
Vapor Pressure: Negligible
Vapor Density: Not applicable
Solubility: Practically insoluble in water, higher solubility in dimethyl sulfoxide and methanol
Partition Coefficient (log Pow): 5.1 (highly lipophilic)
Explosive Properties: Not explosive
Density: Approximately 1.215 g/cm³
pH: Not applicable (solid)
Chemical Stability: Stable under normal storage and handling conditions.
Reactivity: No known dangerous reactions under normal use.
Hazardous Reactions: Contact with strong oxidizing or reducing agents may cause hazardous decomposition.
Decomposition Products: Carbon oxides, nitrogen oxides on combustion. Potential for toxic fumes if thermally decomposed.
Conditions to Avoid: Prolonged exposure to light and heat, direct sunlight, open flames or sources of ignition.
Acute Toxicity: Oral LD50 (rat) > 2000 mg/kg. Single exposure unlikely to cause severe symptoms.
Chronic Effects: Target organs: liver, based on preclinical/clinical data. Repeated occupational exposure may affect hepatic system.
Irritation: May cause mild to moderate eye and skin irritation.
Sensitization: Not known to cause skin sensitization in standard tests.
Muta-/Carcinogenicity: Not classifiable as carcinogen, no genotoxicity in animal studies.
Reproductive Toxicity: No effects in animal studies up to limit dose; precautionary principles in workplace.
Further Information: Overexposure in therapeutic use correlates with headaches, upper respiratory symptoms, mild liver enzyme changes.
Acute Toxicity (Aquatic): LC50, EC50 values not readily available, environmental data limited. Ivacaftor bioaccumulates, moderate persistence seen in sediment and water-screening studies.
Mobility in Soil: Moderately mobile, higher potential for sediment binding due to lipophilicity.
Persistence: Not readily biodegradable. Potential for long-term presence in environment.
Bioaccumulation: High potential due to partition coefficient (log Pow 5.1).
Other Adverse Effects: No evidence for direct toxicity at predicted environmental concentrations, but exposure minimization advised.
Waste Disposal Methods: Collect and dispose of residual product as hazardous pharmaceutical waste in accord with local, national, regional regulations.
Contaminated Packaging: Triple rinse and treat containers as hazardous waste.
Incineration: Authorized chemical incinerator with afterburner and scrubber is preferred.
Disposal Precautions: Do not allow to enter waterways, soil, municipal drains.
Recommended Agencies: Professional skilled and licensed waste handlers required.
UN Number: Not classified as dangerous goods for transport
Proper Shipping Name: Not regulated
Transport Hazard Class: Not applicable
Packing Group: Not assigned
Special Precautions: Prevent container damage, ship under cool conditions advised for bulk shipment.
ADR/RID, IMDG, IATA: Not regulated under these codes for standard laboratory quantities.
Labeling: Caution labels for pharmaceutical materials, not legally hazardous for global transport, but workplace labelling applies.
Inventory Status: Listed on pharmaceutical ingredient inventories where approved
Compliance: OSHA Hazard Communication Standard, EPA Pharmaceutical Waste Rules, EU REACH exemption for finished pharmaceutical.
Controlled Substance: Not controlled.
Worker Protection: Covered under occupational health guidelines for potent chemical exposure (e.g., OEB 3/4 banding occupational exposure limits).
International Regulations: Conforms to ICH and EMA guidance for new active substances. Notified to environmental authorities during market approval for lifecycle management.
