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Product Name: Tenofovir Disoproxil Fumarate
Synonyms: Tenofovir DF, Viread, Tenofovir disoproxil, TDF
Chemical Family: Nucleotide analog antiviral
Recommended Uses: Antiviral medication, treatment of HIV-1 and chronic hepatitis B
Manufacturer: Major pharmaceutical companies producing antiviral agents
Emergency Contact: Refer to local poison control center or manufacturer's safety line for acute exposures
CAS Number: 202138-50-9
UN Number: Not classified as dangerous goods for transport regulatory information
Classification: Not regarded as hazardous under GHS criteria, but care required for occupational exposure
Physical State: Solid, crystalline powder
Signal Word: Warning for fine or bulk powder handling
Hazard Statements: May cause respiratory irritation, mild skin or eye irritation possible, potentially hazardous by inhalation in manufacturing settings
Precautionary Statements: Avoid generating dust, avoid skin and eye contact, use personal protective equipment
Target Organs: Kidneys and bone marrow (as observed in long-term administration)
Other Hazards: Not suspected to be carcinogenic, non-flammable, non-explosive under standard conditions
Active Ingredient: Tenofovir Disoproxil Fumarate
Purity: Pharmaceutical grade, over 98% as Tenofovir DF
Impurities: Synthesis-related impurities typically less than 0.5%, controlled by GMP standards
Other Components: Tablets may contain excipients such as lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, but the safety sheet focuses on active ingredient
Molecular Formula: C19H30N5O10P·C4H4O4
Molecular Weight: 635.5 g/mol
Inhalation: Move person to fresh air, seek medical attention for persistent symptoms
Skin Contact: Wash with soap and water for at least 15 minutes
Eye Contact: Rinse immediately with plenty of water for at least 15 minutes, remove contact lenses if possible
Ingestion: Rinse mouth with water, never give anything by mouth to an unconscious person, consult a physician
Acute Symptoms: Respiratory tract irritation, mild gastrointestinal disturbance, no reported acute life-threatening effects from single exposure at workplace concentrations
Note to Physician: Treat supportively based on symptoms, consider prolonged elimination due to renal excretion
Suitable Extinguishing Media: Use carbon dioxide, dry chemical powder, water spray, or foam
Specific Hazards: Combustion may generate toxic fumes including carbon monoxide, oxides of phosphorus, nitrogen oxides
Protective Equipment: Firefighters should use self-contained breathing apparatus, full protective clothing
Special Procedures: Avoid breathing dust or fumes from burning material, withdraw personnel to safe area
Explosion Sensitivity: Not considered to present an explosion hazard
Personal Precautions: Evacuate unnecessary personnel, ventilate area, avoid contact with skin/eyes, wear respiratory protection for powder
Environmental Precautions: Prevent entry into water sources, drains, or soil, carry out procedures to limit dust
Clean Up Methods: Use HEPA vacuum or wet sweeping for dust, collect in suitable closed containers for disposal, avoid dry sweeping
Decontamination: Wash spill area with detergent and water, dispose of cleaning residues per local, state, and national laws
Handling: Minimize dust generation, avoid breathing powder, use closed systems or local exhaust ventilation, keep containers tightly closed
Storage Conditions: Store at controlled room temperature (20–25°C), away from direct sunlight and heat sources
Storage Containers: Use original container or equivalent with secure closure
Incompatibilities: Separate from strong oxidizing agents, acids, and bases
Hygiene: Wash hands after handling and before eating or drinking, remove contaminated clothing promptly
Exposure Limits: Occupational exposure limits for active pharmaceutical ingredients not established but evidence supports minimizing to as low as reasonably achievable
Engineering Controls: Local exhaust ventilation recommended, process enclosures for dusty operations
Respiratory Protection: NIOSH-approved respirators for scenarios with airborne dust
Gloves: Chemical-resistant gloves such as nitrile or neoprene
Eye Protection: Safety glasses with side shields
Skin Protection: Laboratory coat or chemical-resistant clothing
Other Controls: Eyewash station and safety shower should be available in area of use
Appearance: White to off-white crystalline solid
Odor: Odorless
pH: Not applicable (solid at room temperature)
Solubility: Slightly soluble in water, more soluble in organic solvents like methanol and ethanol
Melting Point: About 110–115°C (decomposes before melting completely)
Boiling Point: Not determined (decomposition)
Density: Approximately 1.4 g/cm³
Partition Coefficient (log P): -0.4 (predicted for parent molecule, low potential for bioaccumulation)
Vapor Pressure: Negligible
Flash Point: Not applicable
Flammability: Not flammable
Explosive Properties: No explosive properties identified
Stability: Stable under normal laboratory conditions when stored as recommended
Hazardous Reactions: No dangerous reactions known under standard conditions
Materials to Avoid: Strong oxidizing agents
Hazardous Decomposition Products: Carbon oxides, phosphorus oxides, nitrogen oxides on combustion
Polymerization: Does not occur
Acute Toxicity: Oral LD50 (rat) estimated above 2000 mg/kg (low acute toxicity)
Inhalation: Dust may irritate respiratory system, higher risk with bulk drug manufacturing
Skin/Eye Contact: May cause mild irritation
Chronic Effects: At therapeutic doses in humans, can cause renal toxicity, reduced bone mineral density, lactic acidosis in rare cases, increased liver enzymes; animal studies indicate no relevant carcinogenic or mutagenic risk
Sensitization: Not a known skin sensitizer
Reproductive Toxicity: No evidence for teratogenicity at recommended human doses
Aquatic Toxicity: No acute harmful effects at environmentally relevant concentrations, chronic effects at higher doses in aquatic species possible
Persistence and Degradability: Expected to be partially biodegradable, resistant to hydrolysis, breakdown may be slow in soil or water; parent drug can persist in wastewater
Bioaccumulation Potential: Low, based on predicted low log P
Mobility in Soil: Likely mobile due to hydrophilic nature, potential for movement to groundwater not excluded
Other Effects: Evidence supports monitoring concentrations near pharmaceutical manufacturing and wastewater treatment facilities
Waste Disposal: Incineration recommended at authorized facilities, do not dispose with household garbage, avoid release to environment
Packaging Disposal: Triple rinse or otherwise decontaminate signature packaging, follow national and local regulations
Precautions: Handle waste with appropriate PPE, prepare waste manifest where required, incinerate as pharmaceutical waste
UN Number: Not regulated as hazardous for transport
Transport Hazard Class: Non-dangerous goods not assigned a transport class
Packing Group: Not applicable
Labeling Requirements: No special labels required for road, air, or sea transport under standard conditions
Special Precautions: Protect from extreme temperatures and moisture during shipment
Regulation: Listed as prescription drug substance in US FDA, EMA, WHO, and other major national drug regulatory authorities
Safety Assessment: Occupational exposure banding by NIOSH and EMA places in low-to-moderate hazard band
Labeling Requirements: Pharmaceutical workplace regulations require hazard communication for bulk handling, no specific GHS pictograms
Inventory Status: Registered with national inventories relevant to pharmaceuticals, including REACH exemption for medicinal products
Workplace Standards: OSHA, WHMIS, EU CLP not classified as hazardous for supplied tablet form; extra precautions in raw/active ingredient manufacturing
