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Material Safety Data Sheet: Rivastigmine Tartrate

Identification

Product Name: Rivastigmine Tartrate
Chemical Name: 3-[(1S)-1-(Dimethylamino)ethyl]phenyl N-ethyl-N-methylcarbamate hydrogen tartrate
Synonyms: ENA 713, Exelon
CAS Number: 129101-54-8
Use: Pharmaceutical ingredient in treatment for dementia related to Alzheimer’s and Parkinson’s disease
Supplier: Pharmaceutical manufacturers and distributors
Contact for Emergency: Poison Control Center or local emergency services
Recommended Use: Research and pharmaceutical applications
Restrictions: For professional use under regulated handling

Hazard Identification

Classification: Acute toxicity (oral, dermal), Eye irritation, Skin irritation, Specific target organ toxicity
GHS Label Elements: Signal word: Warning; Pictograms include exclamation mark
Hazard Statements: Harmful if swallowed; Causes skin and eye irritation; May affect central and peripheral nervous system
Precautionary Statements: Avoid breathing dust; Wash hands thoroughly after handling; Use protective gloves and eye protection
Other Hazards: May aggravate existing medical conditions involving cholinergic system; Dust can cause respiratory tract irritation

Composition / Information on Ingredients

Chemical Entity: Rivastigmine tartrate
Chemical Formula: C14H22N2O2.C4H6O6
Concentration: 97-100% (pharmaceutical grade)
Impurities: Organic solvents, trace byproducts
EC Number: Not assigned
Molecular Weight: 400.43 g/mol

First Aid Measures

Inhalation: Remove person to fresh air; Provide artificial respiration if not breathing; Seek immediate medical attention
Skin Contact: Remove contaminated clothing; Rinse skin thoroughly with soap and water; Get medical attention if discomfort persists
Eye Contact: Rinse cautiously with water for several minutes; Remove contact lenses if present; Continue rinsing; Seek medical advice if irritation develops
Ingestion: Rinse mouth with water; Do not induce vomiting unless directed by medical personnel; Call a physician or Poison Control Center
Note for Physicians: Treat symptomatically and supportively; Monitor for cholinergic effects; Administer atropine as antidote for severe poisoning

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry chemical powder, carbon dioxide, foam
Unsuitable Media: Do not use a high-pressure water stream
Specific Hazards: May emit toxic vapors including nitrogen oxides and carbon oxides during combustion
Protective Equipment for Firefighters: Wear self-contained breathing apparatus and protective clothing
Advice in Fire: Move people away from area; Avoid breathing fumes; Cool containers exposed to fire with water spray

Accidental Release Measures

Personal Precautions: Wear gloves, lab coat, goggles, and NIOSH-approved respirator
Environmental Precautions: Prevent entry into drains, sewers, and waterways
Cleanup Methods: Sweep up material without creating dust; Place in suitable container for disposal; Ventilate area
Spill Management: Wash spill site with soap and water after clean-up; Dispose according to national and local regulations

Handling and Storage

Safe Handling: Ensure adequate ventilation; Minimize dust generation; Avoid contact with skin, eyes, and clothing; Practice good chemical hygiene
Storage Conditions: Store in airtight containers in a cool, dry, well-ventilated area; Keep away from incompatible substances such as strong oxidizers
Incompatibilities: Strong acids and bases, oxidizing agents
Other Advice: Keep containers tightly sealed and clearly labeled; Restrict access to authorized personnel only

Exposure Controls and Personal Protection

Engineering Controls: Work in a chemical fume hood or with local exhaust ventilation
Respiratory Protection: Use NIOSH-approved respirator if dust or aerosols are generated
Skin Protection: Wear chemical-resistant gloves and protective clothing
Eye Protection: Use safety goggles or face shield
Exposure Limits: No occupational exposure limits established; Minimize exposure due to potential neurotoxicity
Hygiene: Wash hands after handling; Remove contaminated clothing before entering eating areas

Physical and Chemical Properties

Appearance: White or off-white crystalline powder
Odor: No distinctive odor
Melting Point: 207-212°C (decomposition)
Solubility: Soluble in water, slightly soluble in ethanol
pH: 2.0-3.0 (1% aqueous solution)
Boiling Point: Not applicable (decomposes)
Vapor Pressure: Not available
Partition Coefficient (log Kow): 2.29 (estimated)
Density: Not available
Flash Point: Not applicable

Stability and Reactivity

Chemical Stability: Stable under recommended storage and handling conditions
Reactivity: Will not undergo hazardous polymerization
Conditions to Avoid: Heat, moisture, incompatible materials
Hazardous Decomposition: Carbon monoxide, carbon dioxide, nitrogen oxides
Incompatible Materials: Strong oxidizing agents, acids, bases
Other Hazards: Decomposition products may be harmful

Toxicological Information

Acute Toxicity (Oral LD50): Mouse: 5.6 mg/kg; Rat: 8.1 mg/kg (data varies by study)
Inhalation: Symptoms may include headache, dizziness, respiratory distress
Skin Contact: May cause irritation; Possibility of systemic absorption
Eye Contact: Causes moderate irritation
Chronic Effects: Possible neurological effects from repeated exposure; Symptoms can include tremors, confusion, and bradycardia
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, or OSHA
Other data: Can cross blood-brain barrier; Overdose may lead to cholinergic crisis; Risk higher for those with pre-existing conditions

Ecological Information

Ecotoxicity: Harmful to aquatic life; Toxicity data for fish and aquatic invertebrates limited
Persistence and Degradability: Not readily biodegradable; May persist in the environment
Bioaccumulation: Limited evidence of bioaccumulation potential
Mobility in Soil: May migrate through soil depending on conditions
Other Adverse Effects: Avoid release into environment; No known ozone depletion potential

Disposal Considerations

Waste Disposal Methods: Dispose through licensed chemical waste contractor; Incineration recommended for large quantities
Contaminated Packaging: Rinse thoroughly and treat as hazardous waste
Regulations: Follow national, regional, and local laws for pharmaceutical and hazardous waste disposal
Advice: Do not empty into drains; Do not mix with general waste streams

Transport Information

UN Number: Not assigned
UN Proper Shipping Name: Not regulated as a hazardous material for transport
Transport Hazard Class(es): Not classified
Packing Group: Not assigned
Sea (IMDG), Air (IATA), Road (ADR): Not subject to transport regulations for hazardous goods
Precautions for Transport: Keep container tightly closed, secure against physical damage; Avoid generating dust during transfer

Regulatory Information

International Inventories: Not listed on US TSCA, EU EINECS/ELINCS
OSHA Status: Not specifically regulated
SARA Title III: Not subject to reporting requirements
State Regulations: May vary by state; Pharmaceuticals regulated differently than industrial chemicals
Other Regulation: Prescription drug laws apply for clinical use; Workplace exposure guided by internal pharmaceutical safety programs