Product Name: Pizotifen Malate
Chemical Name: 4-(1-methyl-4-piperidylidene)-9,10-dihydro-4H-benzo[4,5]cyclohepta[1,2-b]thiophene hydrogen malate
Synonyms: Pizotyline Malate, Sandomigran
CAS Number: 15583-40-5
Molecular Formula: C23H27NO4S
Molecular Weight: 413.54 g/mol
Recommended Use: Pharmaceutical chemical; preventative treatment for migraine.
Manufacturer: See associated documentation for supplier information.
Emergency Telephone: Refer to regional poison control or local emergency services.
GHS Classification: Acute toxicity (oral, category 4), Skin and eye irritant
GHS Label Elements: Exclamation mark, health hazard symbol
Signal Word: Warning
Hazard Statements: Harmful if swallowed, may cause skin and eye irritation, can induce drowsiness, headache, and anticholinergic effects.
Precautionary Statements: Wash exposed skin thoroughly, use in well-ventilated area, avoid inhalation and contact with eyes, seek medical attention if symptoms occur.
Chemical Identity: Pizotifen Malate
Purity: Not less than 98%
CAS Number: 15583-40-5
Impurities: Residual solvents and process-related impurities, generally at trace levels.
Additives: None specified
Formulation Type: Crystalline powder, typically in bulk for pharmaceutical manufacturing
Inhalation: Move person to fresh air. Seek medical attention if symptoms like dizziness or difficulty breathing develop.
Skin Contact: Wash area with plenty of soap and water for at least 15 minutes. Remove contaminated clothing.
Eye Contact: Immediately rinse eyes with clean water for at least 15 minutes, holding the eyelids apart. Seek professional medical evaluation.
Ingestion: Rinse mouth, do not induce vomiting except if advised by medical personnel. Provide symptomatic care and seek immediate medical assistance.
Symptoms and Effects: May include dry mouth, visual disturbances, drowsiness, anticholinergic symptoms, and gastrointestinal discomfort.
Advice for Medical Personnel: Treat symptomatically; supportive therapy recommended for severe exposure.
Suitable Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or foam.
Unsuitable Extinguishing Media: Strong water jets may disperse the chemical.
Specific Hazards from Fire: Generates hazardous fumes including carbon monoxide, carbon dioxide, nitrogen oxides, and sulfur oxides during combustion.
Protective Equipment: Firefighters should wear self-contained breathing apparatus and standard protective clothing.
Advice for Firefighters: Move exposed containers from area if it is safe, use water to cool nearby containers, avoid breathing dust or fumes, keep run-off water out of sewers and water sources.
Personal Precautions: Restrict access to the area, wear appropriate PPE, avoid generating dust.
Environmental Precautions: Prevent contamination of water bodies, drains, or soil.
Method for Clean-up: Sweep up and place in labeled, tightly closed containers for disposal, ventilate the area, wash spill site after material pickup is complete, decontaminate clothing and equipment.
Reference to Other Sections: For disposal see relevant section below.
Safe Handling: Handle in well-ventilated space, minimize dust creation, avoid inhalation and skin/eye contact, use local exhaust if available, use with caution and avoid eating, drinking, or smoking.
Storage Conditions: Store in tightly closed, clearly labeled container, in cool, dry, and well-ventilated area, away from direct sunlight, heat sources, incompatible chemicals (strong oxidizers), and moisture.
Incompatible Materials: Strong oxidizing agents, avoid contact with strong acids or alkalis.
Special Precautions: Ensure proper labeling, restrict access to trained personnel.
Occupational Exposure Limits: No ACGIH, OSHA, or NIOSH exposure limits established for this substance.
Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels low.
Personal Protective Equipment: Wear protective gloves (nitrile or neoprene), chemical safety goggles, laboratory coat.
Respiratory Protection: Wear NIOSH-approved dust respirator if dust generation unavoidable.
Hygiene Measures: Wash hands before breaks and after work, avoid eating or drinking in work area.
Appearance: White or almost white crystalline powder
Odor: Odorless or faint odor
Odor Threshold: Not established
pH: Slightly acidic to neutral in solution
Melting Point: 205°C – 210°C
Boiling Point: Not available
Solubility: Slightly soluble in water, soluble in methanol
Partition Coefficient (Log Pow): Not determined
Vapor Pressure: Negligible at room temperature
Relative Density: Not established
Decomposition Temperature: >210°C
Viscosity: Not applicable
Evaporation Rate: Not applicable
Flammability: Non-flammable solid
Chemical Stability: Stable under recommended conditions, moisture and light sensitive.
Reactivity: Avoid strong oxidizers, acids, bases.
Hazardous Reactions: No known hazardous polymerization.
Conditions to Avoid: Excessive heat, light, moisture.
Hazardous Decomposition Products: Emits toxic fumes including NOx, SOx, CO, and CO2 upon decomposition.
Acute Toxicity: Oral LD50 (rat): 500-2000 mg/kg
Skin Corrosion/Irritation: May cause mild irritation on prolonged or repeated contact.
Eye Damage/Irritation: Can cause redness, watering, irritation.
Respiratory Sensitization: May provoke mild symptoms like cough or sore throat at high concentrations.
Germ Cell Mutagenicity: Not classified
Carcinogenicity: Not listed by IARC, NTP, or OSHA
Reproductive Toxicity: Limited data suggest possible effects at high doses.
STOT - Single Exposure: Central nervous system effects, drowsiness, dry mouth.
STOT - Repeated Exposure: Potential for liver and renal effects at repeated high doses.
Aspiration Hazard: Not expected.
Ecotoxicity: Not extensively studied; likely low risk due to low solubility.
Aquatic Toxicity: No data on LC50, but avoid direct release to water sources.
Persistence and Degradability: Degradation in environment expected to be slow.
Bioaccumulative Potential: No significant bioaccumulation anticipated.
Mobility in Soil: Expected to be low due to low water solubility.
Other Adverse Effects: Prevent further leakage or spillage if safe to do so.
Disposal Methods: Dispose of contents and container according to local, regional, national, and international regulations.
Contaminated Packaging: Empty containers should be handled with care. Rinse and discard following official guidance.
Relevant Waste Codes: Follow pharmaceutical or chemical waste guidelines for incineration.
Precautions: Minimize release to environment.
UN Number: Not classified as hazardous for transport.
UN Proper Shipping Name: Not regulated.
Transport Hazard Class: Not applicable.
Packing Group: Not regulated.
Labels: None required.
Special Precautions for User: Use securely sealed and labeled containers, protect from moisture, avoid freezing and direct sunlight, keep away from food and feedstuffs during transit.
U.S. Regulations: Not listed as a controlled substance. Not subject to SARA, CERCLA, or TSCA reporting.
EU Regulations: Not classified as a hazardous substance under EC Regulation 1272/2008.
Japanese Regulation: Not subject to class notification under the Chemical Substances Control Law.
Canadian Regulation: DSL/NDSL: Not listed.
Workplace Labeling: Requires hazard communication in accordance with OSHA, WHMIS, or relevant jurisdictional guidelines.
Other Regulation: Ensure compliance with local, state, and federal regulations for pharmaceutical ingredients and chemicals.
