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Material Safety Data Sheet: Maprotiline Hydrochloride

1. Identification

Product Name: Maprotiline Hydrochloride
Chemical Formula: C20H23N•HCl
Molecular Weight: 313.87 g/mol
Synonyms: Ludiomil, 2-(3-methyl-10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)ethylamine hydrochloride
Uses: Pharmaceutical ingredient, antidepressant agent
Manufacturer: Refer to container or label
Emergency Contact: Refer to local poison control and emergency services

2. Hazard Identification

Classification: Acute Toxicity (Oral) Category 3, Eye Irritant Category 2A
GHS Signal Word: Danger
Hazard Statements: Toxic if swallowed, causes serious eye irritation
Precautionary Statements: Avoid breathing dust, wash hands thoroughly after handling, do not eat, drink, or smoke when using this product
Potential Health Effects: May cause central nervous system depression, respiratory distress, and gastrointestinal irritation
Routes of Exposure: Inhalation, oral, dermal, ocular contact
Symptoms: Drowsiness, dry mouth, blurred vision, cardiac arrhythmia, respiratory depression

3. Composition / Information on Ingredients

Chemical Name: Maprotiline Hydrochloride
CAS Number: 10347-81-6
Concentration: >98% (by weight)
Impurities: Residual solvents, trace synthetic intermediates (quantities <1%)
Additives: None
Mixture: Not a mixture, single component substance

4. First Aid Measures

Inhalation: Move to fresh air, monitor breathing, administer artificial respiration if needed, seek immediate medical care
Eye Contact: Rinse cautiously with water for at least 15 minutes, remove contact lenses if present and easy to do, seek medical advice
Skin Contact: Wash with plenty of soap and water, remove contaminated clothing, seek medical help for persistent irritation
Ingestion: Do not induce vomiting, rinse mouth with water, call poison control, provide material information to responders
Symptoms Requiring Urgent Care: Convulsions, severe drowsiness, loss of consciousness, difficulty in breathing, cardiac symptoms

5. Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry powder, carbon dioxide, foam
Unsuitable Extinguishing Media: Avoid strong water jet
Specific Hazards: Toxic and irritating fumes (nitrogen oxides, hydrochloric acid, carbon monoxide)
Special Protective Equipment: Self-contained breathing apparatus, protective fire gear
Precautions: Prevent runoff from contaminating waterways, evacuate area if necessary

6. Accidental Release Measures

Personal Precautions: Wear suitable respiratory protection, gloves, eye protection
Environmental Precautions: Prevent product from entering drains, surface waters, and soil
Containment and Cleaning Up: Use inert absorbent material for spills, sweep carefully to avoid dust, place in a suitable closed container
Decontamination: Dispose cleaning materials as hazardous waste, ventilate area thoroughly after removal of material

7. Handling and Storage

Handling Precautions: Handle in chemical fume hood, avoid creating dust, keep container tightly closed and labeled
Storage Conditions: Store in cool, dry, well-ventilated area, away from incompatible materials (strong oxidizers, acids), protect from moisture and light
Safe Transfer: Transfer only in fume hood or well-controlled areas, use appropriate containers
Incompatibilities: Store separate from food, drinking water, pharmaceuticals for immediate use

8. Exposure Controls and Personal Protection

Engineering Controls: Local exhaust ventilation, enclosed processing systems, HEPA filtration for airborne dust
Exposure Limits: No established occupational exposure limits from OSHA, NIOSH, or ACGIH; control dust below nuisance levels
Personal Protective Equipment (PPE): Nitrile or neoprene gloves, lab coat, safety goggles, approved respirator for dust
Hygiene Measures: No eating or drinking in work area, thorough hand washing after handling, remove contaminated clothing after exposure
Environmental Controls: Contain process emissions, maintain negative pressure in work area, monitor for potential leaks or dust release

9. Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless or very faint amine scent
pH (1% solution): 4.0–5.0
Melting Point: 220–225°C (decomposes)
Boiling Point: Not applicable (decomposes before boiling)
Flash Point: Not determined (non-volatile solid)
Solubility: Soluble in water, sparingly soluble in alcohol, insoluble in chloroform and ether
Vapor Pressure: Negligible at room temperature
Partition Coefficient (log Kow): Estimated 1.8–2.5
Bulk Density: 0.6–0.8 g/cm³ (tap density variable with batch)

10. Stability and Reactivity

Chemical Stability: Stable under recommended storage, sensitive to light, heat, and humidity
Conditions to Avoid: Moisture, prolonged UV exposure, elevated temperature
Incompatible Materials: Strong oxidizing agents, acids, bases
Hazardous Decomposition Products: Nitrogen oxides, carbon dioxide, carbon monoxide, hydrochloric acid gases
Polymerization: Not expected under normal conditions

11. Toxicological Information

Acute Toxicity: Oral LD50 (rat) approx. 200 mg/kg
Exposure Symptoms: Nausea, vomiting, agitation, drowsiness, ataxia, hypotension, arrhythmias, seizures after large ingestion
Chronic Effects: Liver enzyme changes in prolonged exposure, possible hepatotoxicity, no evidence for carcinogenicity
Eye Effects: Moderate to severe irritation with direct contact
Skin Effects: Possible mild irritation, dermatitis with repeated exposure, no absorption through intact skin
Sensitization: Not reported in published literature

12. Ecological Information

Ecotoxicity: Limited data; expected fish LC50 (acute) >100 mg/L
Persistence and Degradability: Not readily biodegradable in water, partially mineralized in soil over weeks to months
Bioaccumulation: Not significant (low octanol-water partition coefficient), not expected to biomagnify
Mobility in Soil: Moderately mobile, potential to reach groundwater in large spills
Hazard to Sewage Microorganisms: May impair activated sludge function at high concentrations

13. Disposal Considerations

Disposal of Product: As hazardous pharmaceutical waste, incineration in licensed facility, do not flush to sewer or mix with general refuse
Contaminated Packaging: Treat as hazardous, triple rinse then incinerate or dispose according to local regulations
Special Precautions: Wear PPE during disposal, record batch and volume, keep records for regulatory reporting

14. Transport Information

UN Number: Not assigned for this substance
Proper Shipping Name: Pharmaceutical product, solid (Maprotiline Hydrochloride)
Transport Hazard Class: Not classified as dangerous for transport under ADR, RID, DOT, IMDG, or IATA
Packing Group: Not regulated
Special Precautions for User: Avoid damage to packaging, keep separate from food and feedstuffs, transport with compatible substances only
Environmental Hazards: Not marine pollutant, in bulk avoid draining into sewers or open water

15. Regulatory Information

Inventory Listings: Listed on major chemical inventories (EU REACH, US TSCA, Canada DSL/NDSL) as pharmaceutical API
Product Labeling: Complies with FDA labeling for active pharmaceutical ingredients, not intended for general consumer use
SARA 313: Not listed
California Proposition 65: Not known to be listed
Other Local/Regional Laws: Specific for pharmaceutical use, facility must follow national and state hazardous materials rules
Worker Safety: OSHA Hazard Communication Standard applies, employee training required for handling controlled substances