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Product Name: Doxepin Hydrochloride
Chemical Name: 3-dibenz(b,e)oxepin-11(6H)-ylidene-N,N-dimethyl-1-propanamine hydrochloride
Synonyms: Doxepin HCl, Adapin, Sinequan
CAS Number: 1229-29-4
Molecular Formula: C19H21NO·HCl
Manufacturer: Refer to supplier or distributor details on packaging
Emergency Phone: Refer to local poison control centers
GHS Classification: Acute Toxicity Oral Category 4, Eye Irritation Category 2A, Skin Irritation Category 2, Reproductive Toxicity Category 2, Acute Aquatic Toxicity Category 3
Pictograms: Exclamation mark, Health hazard
Signal Word: Warning
Hazard Statements: Harmful if swallowed, Causes serious eye irritation, Causes skin irritation, Suspected of causing genetic defects, May cause respiratory irritation
Precautionary Statements: Avoid breathing dust, wash thoroughly after handling, use only outdoors or in a well-ventilated area, wear protective gloves, clothing, eye, face protection
Chemical: Doxepin Hydrochloride
CAS Number: 1229-29-4
Concentration: 100% pure substance
Impurities: May contain traces of related organic compounds
Additives: No intentional additives in pure active pharmaceutical ingredient (API)
Inhalation: Move exposed individual to fresh air; monitor breathing and seek medical attention if symptoms like coughing, difficulty breathing, or dizziness occur.
Skin Contact: Remove contaminated clothing, wash affected skin with plenty of soap and water for at least 15 minutes. Seek medical advice if irritation develops.
Eye Contact: Flush eyes gently with plenty of water for 15 minutes, lifting eyelids to ensure thorough rinsing, and obtain medical attention right away.
Ingestion: Rinse mouth; do not induce vomiting. Seek immediate medical care or call poison control. Watch for symptoms such as confusion, drowsiness, or agitation.
Notes to Physician: Monitor for respiratory distress, altered mental state, or arrhythmias.
Suitable Extinguishing Media: Water spray, dry chemical powder, carbon dioxide, foam; select agents based on surrounding material.
Special Hazards: Gives off toxic fumes like nitrogen oxides, carbon monoxide, hydrochloric acid in fire.
Protective Equipment: Firefighters should wear self-contained breathing apparatus (SCBA) and full protective clothing. Avoid inhaling decomposition products.
Advice: Prevent runoff from entering drains or watercourses.
Personal Precautions: Avoid creating dust; ventilate the area; wear protective gloves, mask, goggles, and appropriate laboratory clothing.
Environmental Precautions: Prevent entry to waterways, drains, sewers.
Methods for Cleanup: Sweep or vacuum up material, avoiding dust generation, and place in a suitable closed, labeled container for disposal according to local regulations. Wash area with water after collection.
Reference to Other Sections: Refer to handling, disposal, and exposure guidelines in other sections.
Handling: Handle in a fume hood or well-ventilated area; avoid contact with skin, eyes, or clothing; do not inhale dust; wear appropriate PPE.
Hygiene Practices: Wash hands after handling and before eating, drinking, or smoking; keep work area clean.
Storage Conditions: Store in tightly closed container in a cool, dry, well-ventilated area away from incompatible materials like oxidizers.
Special Requirements: Avoid excess heat, protect from moisture; keep away from foodstuffs and animal feed.
Occupational Exposure Limits: No set limits in most jurisdictions; minimize exposure.
Engineering Controls: Use local exhaust ventilation or laboratory hood to control exposure.
Personal Protective Equipment: Wear gloves (nitrile preferred), eye protection (safety goggles), protective laboratory coat, and dust mask or respirator if dust is generated.
Environmental Controls: Effluent and waste disposal processes should prevent release to the environment.
Monitoring: Regular monitoring for airborne levels in processing/compounding sites.
Appearance: White or off-white crystalline powder
Odor: None or faint amine odor
Melting Point: Approximately 204-208°C
Boiling Point: Not applicable (decomposes before boiling)
Solubility: Soluble in water, ethanol, chloroform
pH Value: Slightly acidic aqueous solution
Partition Coefficient: logP ~3.4 (for doxepin base)
Vapor Pressure: Not volatile
Flash Point: Not applicable
Stability: Stable under recommended storage conditions
Reactivity: Not reactive under normal conditions.
Chemical Stability: Stable under normal temperatures and pressures if kept dry.
Possible Hazardous Reactions: None noted under standard laboratory use.
Conditions to Avoid: Excess heat, moisture, exposure to strong oxidizers.
Hazardous Decomposition Products: May produce toxic gases like nitrogen oxides and hydrochloric acid on thermal decomposition.
Incompatible Materials: Powerful oxidizing agents, acids, bases.
Acute Toxicity: Oral LD50 (rat): ~372 mg/kg for doxepin hydrochloride; symptoms may include drowsiness, anticholinergic effects, and CNS depression.
Chronic Effects: Prolonged exposure can affect nervous system, cardiovascular function, and hepatic enzyme levels.
Skin and Eye Exposure: Irritation, redness, local inflammation.
Respiratory Exposure: May irritate mucous membranes; inhalation can cause coughing, respiratory discomfort.
Mutagenicity/Carcinogenicity: Animal studies show no clear evidence of carcinogenicity, but compound has not been classified by IARC.
Reproductive Toxicity: Some animal studies suggest potential hazard; not enough evidence for humans.
Target Organs: Central nervous system, cardiovascular system, liver, eyes.
Ecotoxicity: Toxicity data on aquatic organisms is limited; may cause harmful effects on fish and aquatic invertebrates if large quantities released.
Persistence and Degradability: Not rapidly biodegradable; may persist and accumulate in the environment.
Bioaccumulative Potential: Potential for bioaccumulation in aquatic life; logP value suggests moderate uptake.
Mobility in Soil: May bind to organic matter in soil; limited mobility.
Other Adverse Effects: Avoid unintentional disposal to natural waters; pharmaceutical contamination can disrupt aquatic systems.
Waste Disposal Methods: Dispose of unused material as hazardous pharmaceutical waste; incinerate in an approved facility if possible.
Contaminated Packaging: Dispose of containers as hazardous waste; do not reuse.
Environmental Precautions: Do not discharge to sewers or surface waters; follow local, regional, national, and international regulations for hazardous waste disposal.
Special Considerations: Keep records of quantities disposed, ensure personnel handling disposal are properly trained.
UN Number: Not assigned for Doxepin Hydrochloride.
Proper Shipping Name: Not regulated as a hazardous material for ground, air, or sea transport under most shipping agencies (IATA, IMDG, DOT); check with specific carrier.
Transport Hazard Class: Not classified.
Packing Group: Not applicable.
Environmental Hazards: Not a marine pollutant.
Special Precautions for User: Store and handle containers securely; avoid packaging damage and dust release during transport.
TSCA Status: Not listed under U.S. Toxic Substances Control Act for bulk pharma; for research and pharmaceutical use only.
SARA Title III: Not classified as a hazardous chemical under Emergency Planning and Community Right-to-Know Act.
EU Regulation: Covered by REACH regulations for pharmaceuticals.
OSHA Hazard Communication: Considered hazardous, requires training and labeling.
DEA Schedule: Not a controlled substance in most jurisdictions.
Other Regulations: Subject to pharmaceutical and environmental regulations in manufacturing, research, and healthcare settings; disposal and use must follow local policies.
