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Product Name: Bosentan Monohydrate
Chemical Name: 4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)[2,2'-bipyrimidin]-4-yl]benzenesulfonamide, monohydrate
Manufacturer: Pharmaceutical supplier’s name, detailed address
Contact Details: Supplier’s phone number, emergency contact number
CAS Number: 179741-09-4
Recommended Use: Active pharmaceutical ingredient, for research and manufacturing use only
Restrictions on Use: Not for human consumption, use in laboratories and manufacturing facilities only
GHS Classification: Acute toxicity (oral, dermal), Eye irritation, Specific target organ toxicity
Signal Word: Warning
Hazard Statements: May cause respiratory tract, eye, and skin irritation. Harmful if swallowed, inhaled, or absorbed through skin. Potential effects on embryo-fetal development in animal studies. Repeated exposure may affect the liver.
Pictograms: Exclamation mark, Health hazard
Precautionary Statements: Avoid breathing dust. Wear protective gloves, eye protection, face protection. Wash thoroughly after handling. Do not eat, drink, or smoke during use.
Chemical Name: Bosentan Monohydrate
Synonyms: None
CAS Number: 179741-09-4
Purity: >98% (by HPLC, substance commonly supplied as a high-purity powder)
Relevant Impurities: Trace process impurities may be present at <0.1%
Inhalation: Move victim to fresh air. Allow the person to rest and seek immediate medical attention if breathing becomes difficult.
Skin Contact: Remove contaminated clothing. Wash skin with plenty of soap and water. Seek medical attention for persistent irritation.
Eye Contact: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing. Seek medical attention if irritation persists.
Ingestion: Rinse mouth with water, provide water to drink if conscious. Do not induce vomiting. Seek urgent medical advice.
Most Important Symptoms: May cause liver toxicity, embryofetal toxicity, respiratory and eye irritation, allergic reactions
Notes for Physicians: Symptomatic and supportive treatment. Monitor for effects on liver function.
Suitable Extinguishing Media: Use water spray, foam, dry chemical, or carbon dioxide.
Unsuitable Media: Direct water jets may scatter powder and spread contamination.
Specific Hazards: In a fire, toxic fumes like nitrogen oxides, sulfur oxides, and carbon oxides can form.
Protective Equipment: Firefighters use self-contained breathing apparatus (SCBA) and protective clothing to prevent contact.
Firefighting Instructions: Contain water used for firefighting, prevent run-off. Remove containers from area if safe.
Personal Precautions: Wear respiratory protection, goggles, gloves, and protective clothing.
Environmental Precautions: Prevent further leakage or spillage. Avoid discharge to drains or surface waters.
Methods for Containment: Cover spills with absorbent (inert material like sand). Keep powder confined.
Cleanup Procedures: Scoop up materials using non-sparking tools; collect in labeled, sealable containers. Ventilate area. Dispose of in compliance with local regulations.
Decontamination: Wash impacted surfaces with copious water and detergent after dry cleanup.
Precautions for Safe Handling: Handle within well-ventilated enclosure. Avoid contact with skin, eyes, and clothing. Use in closed systems where possible. Use analytical balance or powder handling stations for weighing.
Hygiene Advice: No eating, drinking, or smoking in areas where substance is handled. Wash hands diligently after handling.
Storage Conditions: Store in tightly closed containers. Place in a cool, dry, well-ventilated place away from incompatible materials like strong oxidizing agents.
Packaging Materials: Use original container or one made from chemically resistant materials (e.g., HDPE, glass).
Occupational Exposure Limits: None established, minimize exposure as much as possible.
Engineering Controls: Use exhaust ventilation, fume hoods, or powder-containment cabinets.
Personal Protective Equipment: Laboratory coat, disposable gloves (nitrile preferred), eye protection (chemical splash goggles), respiratory mask for dust. For large spills, wear coveralls and a properly fitted NIOSH respirator.
Hygiene Measures: Remove and safely discard contaminated clothing. Wash thoroughly before breaks and after finishing tasks.
Monitoring: Maintain records of exposure and workplace conditions.
Appearance: White to off-white powder
Odor: No significant odor
pH (aqueous solution): Nearly neutral (manufacturer-specific data varies from 5.0–7.0)
Melting Point: 120–122°C (anhydrous form), monohydrate has similar profile but may vary slightly
Boiling Point: Not applicable (decomposes)
Solubility: Slightly soluble in water, soluble in methanol/DMSO
Partition Coefficient (log P): 2.0 to 3.0
Vapor Pressure: Negligible at room temperature
Density: Approximately 1.4 g/cm3
Evaporation Rate: Not volatile
Flammability: Not classified as flammable
Chemical Stability: Stable under normal storage conditions (dry, room temperature, away from direct sunlight).
Reactive Hazards: Reacts with strong oxidizers; may create hazardous products.
Incompatible Materials: Strong acids, strong bases, oxidizing agents.
Hazardous Decomposition: Yields nitrogen oxides, sulfur oxides, and carbon oxides during thermal decomposition.
Hazardous Polymerization: Will not occur under recommended conditions.
Likely Routes of Exposure: Inhalation, ingestion, skin, and eye contact
Acute Toxicity: Oral LD50 (rat): Approximately 1,500–2,300 mg/kg (data from preclinical studies)
Chronic Effects: Repeated exposure can affect liver (hepatic toxicity), produce birth defects, and cause reproductive toxicity based on animal models.
Irritation: Skin and eye irritant
Mutagenicity: No significant evidence from standard assays
Carcinogenicity: No human data, animal testing did not yield evidence of carcinogenic potential
Sensitization: May cause allergic reactions in sensitive individuals
Symptoms of Overexposure: Headache, nausea, vomiting, elevated liver enzymes, fatigue
Ecotoxicity: Harmful to aquatic organisms with possible long-lasting effects. Data for Bosentan are limited, suggest potential chronic toxicity to freshwater invertebrates and fish.
Persistence and Degradability: Not readily biodegradable in standard soil and water tests
Bioaccumulative Potential: Moderate (log P value suggests possible accumulation in aquatic life)
Mobility in Soil: Likely to be mobile if released in significant quantities
Other Effects: Do not allow undiluted product or large volumes to enter groundwater, sewage, or water systems
Material Disposal: Treat as hazardous chemical waste. Collect product and contaminated materials; store in sealed and labeled containers. Dispose through licensed hazardous waste disposal contractor.
Packaging Disposal: Rinse and triple-wash empty containers, dispose in accordance with local/national regulations.
Special Precautions: Avoid waste accumulation. Do not dispose in regular garbage or flush to sewer.
UN Number: Not classified as a hazardous material for transport under current regulations
Proper Shipping Name: Not regulated, ship as “Chemical, N.O.S.” with full documentation
Transport Hazard Class: None
Packing Group: None assigned
Environmental Hazards: Not considered marine pollutant but keep packages secure to avoid spills
Transport Precautions: Ship in well-sealed, labeled containers, avoid rough handling
Specific Transport Notes: For air shipment, consult IATA guidance for non-hazardous APIs
Regulatory Status: Active pharmaceutical ingredient, not listed as a controlled substance
Inventory Listing: Not listed on major chemical inventories (TSCA, DSL, EINECS)
Safety Regulations: OSHA: Treat as hazardous, applicable standards for chemical manufacturing apply. WHMIS: D2B (Toxic).
Label Requirements: Signal words, hazard pictograms, warnings to minimize worker exposure.
Other Regulations: Monitor compliance with workplace exposure guidelines. Hazard Communication Standard (29 CFR 1910.1200 applies), REACH regulations for products introduced into the EU
