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Product Name: Vortioxetine Hydrobromide
Chemical Name: 1-[2-(2,4-Dimethylphenylsulfanyl)phenyl]piperazine hydrobromide
CAS Number: 960203-27-4
Recommended Use: Pharmaceutical ingredient
Manufacturer/Supplier: [Company Contact Information]
Emergency Phone: [Emergency Number]
GHS Classification: Acute Toxicity (Oral) Category 4, Eye Irritation Category 2A
Signal Word: Warning
Hazard Statements: Harmful if swallowed. Causes serious eye irritation.
Pictograms: Exclamation Mark
Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Precautionary Statements: Wash hands thoroughly after handling. Do not eat, drink or smoke when using this product.
Chemical Formula: C18H22N2S·HBr
Main Ingredient: Vortioxetine Hydrobromide — Purity >98%
Other Components: No significant non-active ingredients present
Impurities: Proprietary information available upon request
Concentration: 100% Active Pharmaceutical Ingredient
Inhalation: Remove to fresh air. Seek medical attention if symptoms appear.
Skin Contact: Wash thoroughly with soap and water. Remove contaminated clothing.
Eye Contact: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing.
Ingestion: Rinse mouth. Seek immediate medical attention.
Most Important Symptoms: Headache, dizziness, nausea, eye irritation.
Advice for Doctor: Treat symptomatically and provide supportive care as required.
Suitable Extinguishing Media: Water spray, dry chemical, carbon dioxide, foam
Unsuitable Extinguishing Media: Direct water jet
Specific Hazards: Emits toxic fumes under fire conditions (nitrogen oxides, sulfur oxides, hydrogen bromide).
Protective Equipment for Firefighters: Wear self-contained breathing apparatus and full protective clothing.
Special Procedures: Remain upwind and keep out of low areas. Avoid inhalation of fumes.
Personal Precautions: Evacuate unprotected personnel, wear suitable respiratory and skin protection, avoid dust formation.
Environmental Precautions: Prevent product from reaching drains, waterways, or soil.
Containment and Cleaning: Collect spilled material using inert absorbent, avoid generating dust, ventilate area, and dispose in suitable container.
Reference to Other Sections: See Sections 8 and 13 for exposure controls and disposal.
Handling: Use in well-ventilated areas, avoid inhalation, ingestion, and contact with skin, eyes, wear protective equipment.
Storage Conditions: Store in tightly closed containers, keep in cool, dry, and well-ventilated location, protect from light, moisture, and incompatible materials.
Storage Temperature: 2–8°C recommended
Incompatible Materials: Strong oxidizing agents, acids, bases.
Occupational Exposure Limit: No data available for this substance.
Engineering Controls: Use local exhaust ventilation or other engineering controls to minimize exposure.
Personal Protective Equipment:
Gloves (nitrile or similar), safety goggles, lab coats, and appropriate respiratory protection when dust or aerosols are present.
Hygiene Measures: Wash hands and face after handling, do not eat or drink while handling this material, avoid skin and eye contact.
Appearance: White to off-white crystalline powder
Odor: Odorless or mild odor
Odor Threshold: Not available
pH: 4-5 (1% solution)
Melting Point: 217–223°C
Boiling Point: Not applicable (decomposes upon heating)
Flash Point: Not applicable
Evaporation Rate: Not applicable
Flammability: Not flammable
Vapor Pressure: Not applicable
Vapor Density: Not applicable
Solubility: Soluble in water and DMSO, slightly soluble in ethanol
Partition Coefficient (log Pow): 1.3–1.6
Decomposition Temperature: Not available
Viscosity: Not applicable
Chemical Stability: Stable under recommended storage conditions.
Reactivity: Non-reactive under normal conditions.
Possibility of Hazardous Reactions: Will not occur under normal processing and handling.
Incompatible Materials: Strong oxidizers, acids, bases.
Hazardous Decomposition Products: Nitrogen oxides, sulfur oxides, hydrogen bromide, carbon monoxide, carbon dioxide.
Acute Toxicity: LD50 (oral, rat) >2000 mg/kg
Skin Corrosion/Irritation: Mild irritation possible on prolonged contact
Serious Eye Damage/Irritation: May cause significant irritation
Respiratory Sensitization: No data available
Skin Sensitization: Not expected
Carcinogenicity: No evidence found from animal test data
Reproductive Toxicity: Data limited, no known risk at therapeutic doses
Specific Target Organ Toxicity – Single Exposure: May cause central nervous system effects
Specific Target Organ Toxicity – Repeated Exposure: No evidence in animal studies
Information on Likely Routes of Exposure: Inhalation, ingestion, and skin or eye contact.
Ecotoxicity: Limited data, not expected to pose a significant hazard to aquatic environments at low concentrations.
Persistence and Degradability: Not readily biodegradable
Bioaccumulative Potential: Low bioaccumulation expected (log Pow 1.3–1.6)
Mobility in Soil: Moderate mobility, does not strongly adsorb to soil particles.
Other Adverse Effects: Data insufficient on chronic aquatic toxicity.
Waste Treatment Methods: Remove in accordance with local, regional, and federal regulations.
Contaminated Packaging: Dispose in compliance with official regulations.
Recommended Disposal: Incinerate in approved facility; do not discharge into drains, water courses, or onto the ground.
Special Precautions: Consider all waste potentially hazardous.
UN Number: Not regulated for transport.
Proper Shipping Name: Vortioxetine Hydrobromide
Transport Hazard Class: Not classified as hazardous for transport
Packing Group: Not applicable
Environmental Hazards: None identified
Special Precautions for User: Avoid release to the environment during transport.
Safety, Health, and Environmental Regulations: Covered under TSCA (Toxic Substances Control Act), not subject to SARA Title III.
OSHA Hazard Communication Status: Hazardous chemical under OSHA 29 CFR 1910.1200
EPA Status: Not listed as a hazardous waste.
WHMIS Classification (Canada): D2B (Toxic Material Causing Other Toxic Effects)
REACH Status (EU): Registered or exempted for pharmaceutical use
Labeling Requirements: GHS-compliant labeling with hazard pictograms, signal words, and statements.
