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Product Name: Terfenadine
Synonyms: Seldane, Teldane, Triludan
Chemical Formula: C32H41NO2
CAS Number: 50679-08-8
Recommended Use: Pharmaceutical antihistamine
Manufacturer: Indicate responsible pharmaceutical company
Emergency Contact: Refer to local poison control center and emergency hotlines
Use Restrictions: Intended only for professional and laboratory purposes
Classification: Non-flammable solid, hazardous to health if ingested
Signal Word: Warning
Potential Health Effects: Risk of cardiotoxicity, especially QT prolongation; arrhythmia; dry mouth; drowsiness; rare risk for severe allergic reactions
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Symptoms: Palpitations, dizziness, nausea, tremor, rash, headache
Environmental Impact: Moderate; can harm aquatic species
Chemical Name: Terfenadine
Concentration: 98-100%
Impurities: Trace residual solvents, byproducts from synthesis
Additives: None typically present in raw material
Molecular Weight: 471.67 g/mol
Inhalation: Move person to fresh air; monitor respiratory function
Skin Contact: Wash area thoroughly with soap and water
Eye Contact: Rinse gently with plenty of water for at least 10 minutes; seek medical advice if irritation persists
Ingestion: Rinse mouth; seek immediate medical attention; do not induce vomiting
Physician Notes: Monitor ECG for cardiac arrhythmias, especially QT prolongation; provide supportive care
Suitable Extinguishing Media: Dry chemical, CO2, water spray (small fires), foam
Unusual Hazards: Emits toxic fumes under combustion including nitrogen oxides, carbon monoxide, carbon dioxide
Protective Equipment: Firefighters should use self-contained breathing apparatus and protective clothing
Fire Fighting Instructions: Keep containers cool using water spray to prevent pressure build-up and potential container rupture
Personal Precautions: Wear gloves, goggles, lab coat; avoid dust generation
Environmental Precautions: Prevent substance from reaching drains and waterways
Methods for Cleaning Up: Sweep up with minimum dust; place in labeled, sealed container for disposal; ventilate area after cleanup
Disposal: Refer to disposal considerations below for local or national regulations
Handling: Use only in well-ventilated areas; avoid contact with skin, eyes, and clothing. People who handle this material should receive suitable training and understand emergencies. Wash hands and exposed skin after use.
Storage Conditions: Store tightly sealed in a cool, dry, well-ventilated space out of direct sunlight. Protect from moisture and incompatible materials, such as strong oxidizers or acids. Dedicated pharmaceutical stores minimize misuse.
Incompatible Materials: Strong oxidizing agents, acids, bases, and direct sources of heat
Engineering Controls: Employ fume hood, local exhaust, and good general ventilation.
Personal Protective Equipment: Lab-grade gloves (nitrile or latex), goggles, lab coat; use NIOSH-approved respirator for dusty environments
Exposure Limits: No established occupational exposure limit for terfenadine; general nuisance dust limits can serve as guidelines
Hygiene Measures: Remove contaminated clothing and wash before reuse; do not eat, drink, or smoke in handling areas
Physical State: Solid
Appearance: White to off-white crystalline powder
Odor: Odorless or faint characteristic
Melting Point: Approximately 158–160°C
Boiling Point: Data not available
Solubility: Practically insoluble in water; soluble in chloroform, methanol, ethanol
Density: 1.13 g/cm3 (approximate)
pH: Not determined (substance is nearly insoluble in water)
Partition Coefficient (log P): About 6.8
Chemical Stability: Stable under recommended storage and handling; slow degradation in light
Hazardous Reactions: Reacts with strong oxidizers or acids, risk increases for hazardous gases under fire
Decomposition Products: Nitrogen oxides, carbon oxides, possibly toxic organic fragments
Unsafe Conditions: Moisture, heating above decomposition temperature, prolonged exposure to sunlight
Acute Toxicity: Data for animals show oral LD50 (rat) > 1000 mg/kg
Chronic Effects: Prolonged use or high doses lead to cardiac arrhythmia, especially in those with liver impairment or concurrent CYP3A4 inhibitors
Sensitization: Low frequency of skin or respiratory sensitization
Target Organs: Heart, liver
Carcinogenic Status: No established link with cancer in humans
Mutagenicity: Not found mutagenic in common in vitro and in vivo test systems
Reproductive Toxicity: Animal data do not show direct harm; insufficient human data at therapeutic doses
Ecotoxicity: Can produce moderate toxicity to aquatic life in high concentrations; stable in the environment
Bioaccumulation Potential: Log P of almost 7 suggests bioaccumulation is possible in aquatic organisms
Mobility in Soil: Poor solubility means low leaching through soil
Degradability: Slowly degradable under environmental conditions; not considered readily biodegradable
Other Harm: Pharmaceuticals like terfenadine, detected in traces in surface water, can disrupt aquatic systems
Waste Disposal Method: Incinerate in a chemical waste incinerator equipped with afterburner and scrubber; do not discharge to drains
Container Disposal: Triple rinse empty containers, puncture, and dispose of as hazardous waste according to local regulations
Contaminated Packaging: Treat as hazardous, manage using licensed waste management contractors
Precautions: Keep away from foodstuffs and animal feed; never landfill pharmaceutical residues
UN Number: Not regulated for transport under ADR, IATA, IMDG
Transport Hazard Class: Not assigned
Packing Group: Not regulated as dangerous goods
Special Transport Precautions: Prevent spillage and release to environment en route; assure secure and labeled packaging
Shipping Description: Pharmaceutical chemical, non-hazardous for transport under usual global rules
Safety Standards: Complies with OSHA Hazard Communication Standard; not listed as a carcinogen by IARC, NTP, OSHA
TSCA Status: Checked for compliance; research or pharmaceutical use only
WHMIS Classification (Canada): D2A (very toxic materials causing other toxic effects)
Other Regulations: Restricted by many regulatory agencies due to safety profile; refer to FDA and EMA guidance
REACH Status (EU): Not registered for broad industrial use
Labeling Required: Toxicity and environmental risk symbols must appear on packaging
