Substance Name: Zuclopenthixol
SYNONYMS: Clopenthixol, Zuclopenthixol dihydrochloride, Zuclopenthixol decanoate
CAS Number: 53772-83-1
Recommended Use: Antipsychotic medication used for the treatment of schizophrenia and other psychoses
Manufacturer: Lundbeck A/S and licensed pharmaceutical companies
Contact: Refer to local distributor or manufacturer's emergency contact number
Emergency Telephone: Chemtrec +1-800-424-9300 (international number varies by location)
Hazard Classification: Harmful if swallowed, toxic to aquatic life, irritant to eyes, skin, and respiratory tract
GHS Label Elements: Skull and crossbones, exclamation mark, aquatic toxicity symbol
Signal Word: Warning
Hazard Statements: May cause drowsiness or dizziness, may cause serious eye irritation, may cause organ damage through prolonged exposure, toxic to aquatic organisms with long lasting effects
Precautionary Statements: Wear gloves and protective eye protection, avoid breathing dust or vapors, do not eat drink or smoke when handling product, avoid release to the environment
Main Ingredient: Zuclopenthixol (active ingredient), 98% purity
Formulation Ingredients: Pharmaceutical excipients such as lactose monohydrate, magnesium stearate, sodium starch glycolate, may include decanoate or acetate salts for injectable forms
Impurities: Minimal, controlled under pharmaceutical GMP; consult certificate of analysis for trace impurity levels
CAS Numbers for Excipients: See manufacturer's specifications for specific batch ingredients and concentrations
Eye Contact: Rinse cautiously with water for at least 15 minutes, remove contact lenses if present, seek medical advice if irritation persists
Skin Contact: Wash thoroughly with soap and water, remove contaminated clothing, seek medical attention for persistent symptoms
Inhalation: Move person to fresh air, provide oxygen if breathing is difficult, seek medical advice
Ingestion: Rinse mouth with water, call for medical attention, do not induce vomiting unless directed by healthcare personnel
General Advice: Immediate medical attention is crucial for accidental high-dose exposure, always show this data sheet to healthcare professionals
Flammability: Not highly flammable in solid or tablet form
Extinguishing Media: Use carbon dioxide, dry chemical powder, or foam for small fires, water spray for larger fires
Specific Hazards: May emit toxic fumes such as nitrogen oxides, sulfur oxides, and hydrogen chloride in a fire
Protective Equipment: Firefighters should wear self-contained breathing apparatus and full protective clothing
Advice for Firefighters: Avoid inhaling combustion products, contain runoff to prevent environmental contamination
Personal Precautions: Wear gloves, goggles, disposable protective clothing to prevent skin and eye contact
Environmental Precautions: Prevent spillage from entering drains, sewers, or watercourses
Cleanup Methods: Sweep or shovel up spilled material carefully without creating dust, place in a suitable, labeled container for proper disposal
Decontamination: Wash contaminated surfaces with water and mild detergent, ventilate area thoroughly after cleanup
Disposal: Dispose of all contaminated waste in accordance with local regulations for pharmaceutical or chemical waste
Handling: Use with adequate ventilation, avoid breathing dust or vapors, do not eat, drink or smoke when using this product, practice good industrial hygiene
Storage: Store in original packaging, tightly closed, at controlled room temperature (15–30°C); protect from light, moisture and incompatible substances such as strong oxidizers
Special Precautions: Limit access to authorized personnel, ensure emergency washing facilities are available, keep away from food and drink
Engineering Controls: Use handling equipment with local exhaust ventilation, maintain dust levels below recommended occupational exposure limits
Personal Protective Equipment (PPE): Chemical-resistant gloves (nitrile or PVC), safety goggles, laboratory coat or disposable coveralls, NIOSH-approved dust mask or respirator where exposure risk exists
Hygiene Measures: Wash hands and face thoroughly after handling, launder contaminated clothing before reuse, do not reuse disposable protective gear
Appearance: White or off-white crystalline powder (raw form); tablets or injectables are commercial formulations
Odor: Odorless or mild pharmaceutical smell
pH: Not applicable in solid state; solutions depending on solvent (generally pH 5-7 in prepared injectable form)
Melting Point: 190-197°C (raw material)
Boiling Point: Not available
Solubility: Slightly soluble in water, more soluble in organic solvents (methanol, chloroform)
Partition Coefficient (log P): 4.7 (estimated)
Vapor Pressure: Not applicable
Density: Approximately 1.4 g/cm³
Stability: Stable under recommended storage conditions
Chemical Stability: Stable when stored properly away from heat, light, and moisture
Incompatible Materials: Strong oxidizing agents, strong acids
Hazardous Decomposition: May emit toxic gases (nitrogen oxides, sulfur oxides, hydrogen chloride) if heated to decomposition
Polymerization: Not expected to occur
Reactivity: Not known to react violently with water or common materials in pharmaceuticals
Acute Toxicity: LD50 (oral, rat): 98 mg/kg; can cause central nervous system depression, agitation, movement disorders, and potentially coma at high doses
Chronic Toxicity: May cause movement disorders (tardive dyskinesia), liver effects, metabolic changes with prolonged exposure
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Symptoms of Exposure: Sedation, drowsiness, extrapyramidal symptoms, hypotension, anticholinergic effects (dry mouth, blurred vision), allergic reactions
Carcinogenicity: Not classified as human carcinogen; long-term studies show no increase in tumor incidence
Mutagenicity: Not found to be mutagenic in standard tests
Reproductive Toxicity: Possible risk of fetal damage if administered during pregnancy
Toxicity to Aquatic Organisms: Harmful to fish, aquatic invertebrates, and algae (LC50/EC50 values in low mg/L range for some aquatic species)
Persistence and Degradability: Not readily biodegradable, may persist in the environment
Bioaccumulative Potential: Moderate potential for bioaccumulation in aquatic species
Mobility in Soil: Likely to bind to organic matter, minimize leaching
Other Adverse Effects: Avoid environmental release due to pharmaceutical activity in wildlife
Waste Treatment Methods: Dispose of unused product, contaminated packaging and materials at a licensed chemical or pharmaceutical waste facility
Contaminated Packaging: Triple rinse empty containers prior to disposal or recycling, manage as hazardous pharmaceutical waste
Handling of Waste: Incineration recommended at temperatures above 1200°C with proper gas scrubbing
Regulations: Follow local, state, and national hazardous waste regulations for pharmaceuticals
UN Number: Consult current regulations; Zuclopenthixol is not classified as a dangerous good under IATA or IMDG for small quantities in packaged medicinal forms
Proper Shipping Name: Zuclopenthixol-containing pharmaceutical product
Transport Hazard Class: Not regulated for road, rail, air, or sea under typical shipment, but bulk quantities may need assessment
Packing Group: Not applicable for finished dosage forms
Environmental Hazards: Marine pollutant in bulk; avoid spillage during transport
Special Precautions: Shipments should be protected from heat, moisture, and physical damage
International Inventory Status: Listed in major pharmaceutical regulatory inventories (US FDA, EMA, TGA, Health Canada)
Labeling Requirements: Comply with country-specific labeling rules for prescription pharmaceuticals
SARA Title III: Not subject to reporting requirements
OSHA Status: Not specifically regulated as a hazardous substance; observe all worker protection standards for handling drugs
Other Regulations: Controlled by prescription status in most jurisdictions, not scheduled as a narcotic or psychostimulant
