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Material Safety Data Sheet (MSDS) for Efavirenz

Identification

Product Name: Efavirenz
Chemical Formula: C14H9ClF3NO2
Synonyms: Sustiva, Stocrin
Recommended Use: Antiretroviral agent for HIV treatment
Manufacturer: Contact details of supplier required for workplace MSDS compliance
Emergency Contact: Local poison control center, medical professional, or company hotline
CAS Number: 154598-52-4
UN Number: Not classified as dangerous for transport under current guidelines

Hazard Identification

Classification: Not listed as hazardous under GHS criteria, but animal testing indicates neurobehavioral effects
Potential Health Effects: May cause dizziness, drowsiness, headache, skin rash on contact; repeated exposure may result in nervous system effects
Signal Word: Warning
Hazard Statements: May cause skin irritation, eye irritation, respiratory irritation especially if dust is inhaled
Precautionary Statements: Avoid breathing dust, use proper protective clothing and eye protection, wash hands after use
Label Elements: Non-flammable solid, not toxic at low environmental concentration
Other Hazards: Chronic exposure could affect central nervous system based on animal studies

Composition / Information on Ingredients

Main Ingredient: Efavirenz 95% or greater purity
Inactive Components: Trace manufacturing residues, possible residual solvents under regulatory limits, no major excipients listed as hazardous
Impurities: Residual organic compounds well below accepted toxic thresholds
Molecular Weight: 315.68 g/mol

First Aid Measures

Inhalation: Move affected person to fresh air, seek medical attention if respiratory symptoms appear
Skin Contact: Remove contaminated clothing, wash exposed skin with soap and water, seek medical advice if rash or irritation persists
Eye Contact: Flush eyes gently but thoroughly with water for several minutes, consult a physician if irritation or discomfort continues
Ingestion: Rinse mouth, give water to rinse if person is conscious, seek immediate medical advice, do not induce vomiting unless advised
Note to Physicians: Treat symptoms, supportive care, monitor for central nervous system symptoms

Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, carbon dioxide, dry chemical or foam for surrounding fires
Unsuitable Media: Avoid water jets; may spread powder
Hazards from Combustion: May produce hazardous fumes such as carbon oxides, hydrogen chloride and toxic organic vapors
Protective Equipment: Firefighters should use self-contained breathing apparatus and full protective gear
Specific Hazards: Dust may become airborne and cause irritation if disturbed during fire
Additional Guidance: Contain extinguishing run-off to prevent environmental contamination

Accidental Release Measures

Personal Precautions: Use appropriate personal protective equipment including gloves, goggles, dust mask
Environmental Precautions: Prevent run-off to drains, soil, surface and groundwater
Containment: Avoid dust generation, sweep up or vacuum with HEPA device, place collected material in sealable chemical waste container
Cleaning Methods: Wash spill site thoroughly with mild detergent and water
Disposal: Dispose of residue and cleaning materials as hazardous medical waste according to local requirements

Handling and Storage

Handling: Avoid contact with skin, eyes, clothing; minimize dust creation; wear personal protective equipment
Hygiene Practices: Wash hands thoroughly after use, do not eat, drink, or smoke in areas where product is handled
Storage Conditions: Keep container tightly closed, store at controlled room temperature away from light and moisture
Compatibility: Store separate from food, beverages, incompatible materials such as strong oxidizers
Storage Life: Use within recommended shelf-life; observe expiration date for pharmaceutical use

Exposure Controls and Personal Protection

Occupational Exposure Limit: No established OSHA or ACGIH limit; handle as potentially hazardous pharmaceutical
Engineering Controls: Work in a well-ventilated area, use local exhaust if dust is generated
Personal Protective Equipment: Wear gloves made of nitrile, chemical splash goggles, lab coat or suitable body covering
Respiratory Protection: Use NIOSH-approved dust respirator if exposure to airborne dust is possible
Environmental Exposure Controls: Prevent contamination of water sources through control of run-off

Physical and Chemical Properties

Physical State: Solid crystalline powder
Color: White to off-white
Odor: Little to none
Melting Point: 138–141°C
Boiling Point: Not applicable (decomposes before boiling)
Solubility: Very slightly soluble in water, soluble in organic solvents such as ethanol and DMSO
Vapor Pressure: Not significant at room temperature
Partition Coefficient: log P (octanol/water) about 4.6
pH: Not applicable for solid
Flash Point: Not flammable under standard testing conditions
Molecular Structure: Aromatic fused ring with halogenated side chain

Stability and Reactivity

Chemical Stability: Stable under normal handling and storage conditions
Hazardous Reactions: No dangerous reactions known under recommended use; avoid contact with oxidizers
Conditions to Avoid: Elevated temperatures, moisture, direct sunlight
Incompatible Materials: Strong oxidizing agents, strong acids or bases
Hazardous Decomposition: Thermal decomposition can produce toxic fumes such as carbon oxides, hydrogen fluoride, nitrogen oxides

Toxicological Information

Acute Toxicity: LD50 (oral, rat) >2000 mg/kg, low acute toxicity
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Symptoms: Central nervous system effects (dizziness, confusion, abnormal dreams, hallucinations), minor skin or eye irritation possible
Chronic Toxicity: Long-term exposure can affect central nervous system, liver function (hepatic enzymes), psychiatric symptoms in sensitive individuals
Carcinogenicity: Not classified as carcinogenic to humans
Mutagenicity: Not mutagenic based on available studies
Reproductive Toxicity: Evidence of fetal risk in animal studies, contraindicated during pregnancy unless no alternatives
Sensitization: Skin and respiratory sensitization not observed at permitted workplace exposures

Ecological Information

Ecotoxicity: Low aquatic toxicity, but potential risk to aquatic environments through improper disposal
Persistence and Degradability: Not readily biodegradable, may persist in the environment
Bioaccumulative Potential: High partition coefficient suggests potential for bioaccumulation
Mobility in Soil: Limited, binds to organic material
Other Effects: No significant impact on sewage treatment at trace concentrations
Discharge Recommendations: Prevent release to environment; collect all wastes in closure container for safe disposal

Disposal Considerations

Waste Treatment Methods: Dispose via licensed hazardous waste contractor in accordance with local, regional, national regulations
Container Disposal: Remove labels, triple-rinse containers, incinerate if allowable or treat as hazardous chemical waste
Environmental Precautions: Do not allow to enter soil, water courses, or sewage systems
Contaminated Packaging: Treat empty packaging as hazardous, follow chemical-specific disposal guidance
Advice for Users: Store waste in labeled, sealed containers; avoid accidental spills or mixing with incompatible substances

Transport Information

UN Number: Not regulated under standard transport codes
Proper Shipping Name: Pharmaceutical substance, not otherwise specified
Transport Hazard Class: Not classified as hazardous for land, air or sea transport
Packing Group: No specific requirements
Special Precautions: Ensure packaging is secure, labeled, and protected from breakage, moisture, and extreme heat
Environmental Hazards: Not a marine pollutant under standard transport guidance

Regulatory Information

TSCA Status: Exempt as pharmaceutical ingredient
ECHA Reach: Registration not required for finished pharmaceutical products
WHMIS Classification: Not controlled
SARA Title III: Not listed
FDA Status: Prescription drug, approved for HIV therapy
Labeling: Follow national requirements for handling pharmaceuticals
Worker Protection: Comply with local occupational safety rules around medicines, particularly antiretrovirals
Other Regulations: Observe pharmaceutical disposal and storage rules by region