Material Safety Data Sheet: Rivastigmine Tartrate

Identification

Product Name: Rivastigmine Tartrate
Chemical Name: (S)-N-Ethyl-3-[(1-dimethylamino)ethyl]-N-methylphenyl-carbamate hydrogen tartrate
CAS Number: 129101-54-8
Synonyms: ENA 713 tartrate, Exelon tartrate
Recommended Use: Research, pharmaceutical formulation, active pharmaceutical ingredient
Manufacturer: Refer to supplier datasheet for contact and emergency numbers
Emergency Telephone: Refer to supplier's details for accurate contact information

Hazard Identification

GHS Classification: Acute Toxicity Oral (Category 3), Skin Sensitizer (Category 1), Eye Irritation (Category 2A)
Hazard Statements: Toxic if swallowed, may cause an allergic skin reaction, causes serious eye irritation
Signal Word: Danger
Pictograms: Skull and crossbones, exclamation mark
Precautionary Statements: Avoid breathing dust, wear protective gloves, wash skin thoroughly after handling, do not eat or drink when using this material
Symptoms of Exposure: Nausea, vomiting, muscle weakness, skin irritation, eye discomfort, dizziness

Composition / Information on Ingredients

Chemical Identity: Rivastigmine Tartrate
Percentage: ≥98% pure
CAS Number: 129101-54-8
Additional Ingredients: No known impurities at hazardous concentrations

First Aid Measures

Inhalation: Move person to fresh air, keep at rest, provide oxygen if not breathing normally, seek immediate medical attention
Skin Contact: Remove contaminated clothing, wash skin with plenty of water and soap for at least 15 minutes, seek medical evaluation if symptoms persist
Eye Contact: Rinse thoroughly with plenty of water for at least 15 minutes, remove contact lenses if present, keep eyelids open, get prompt ophthalmological care
Ingestion: Do not induce vomiting, rinse mouth with water, never give anything by mouth to an unconscious person, seek urgent medical help
Most Important Symptoms: Vomiting, sweating, bradycardia, tremors, muscle weakness, miosis
Notes to Physician: Symptomatic and supportive treatment, consider administration of atropine if cholinergic symptoms occur

Fire-Fighting Measures

Suitable Extinguishing Media: Use water spray, alcohol-resistant foam, dry chemical powder, or carbon dioxide
Unsuitable Extinguishing Media: High volume water jet
Specific Hazards: Combustion releases toxic fumes of nitrogen oxides, carbon oxides
Protective Equipment: Self-contained breathing apparatus, full protective clothing
Recommendations for Firefighters: Wear positive pressure apparatus, remove containers from fire area if safe, keep cool with water spray

Accidental Release Measures

Personal Precautions: Evacuate unprotected personnel, ventilate area, use personal protective equipment including gloves, goggles, dust mask
Environmental Precautions: Prevent release into drains, sewers, or water sources, contain spill using absorbent materials
Methods for Cleanup: Pick up in a manner that minimizes dust formation, sweep or scoop into suitable labeled containers for disposal, wash spill area with detergent and water
Disposal: Dispose contaminated materials as hazardous waste according to regulations

Handling and Storage

Handling: Handle in a chemical fume hood or well-ventilated area, avoid contact with skin, eyes, and clothing, avoid inhaling dust, wash hands thoroughly after handling, keep containers tightly closed
Storage: Keep in original, labeled container, store in a cool, dry, and well-ventilated place, avoid exposure to sunlight or heat, separate from incompatible substances such as oxidizers
Special Considerations: Restrict access to trained personnel, maintain inventory, store away from acids and bases

Exposure Controls and Personal Protection

Occupational Exposure Limits: No established ACGIH or OSHA limits, minimize exposure
Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels low
Personal Protective Equipment:

  • Eyes: Chemical safety goggles
  • Skin: Gloves resistant to chemicals, lab coat or coverall
  • Respiratory: Dust mask or respirator for higher concentrations
  • Hygienic Practices: Do not eat or smoke in work area, wash thoroughly before breaks and at end of shift

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Practically odorless
Molecular Formula: C14H22N2O2.C4H6O6
Molecular Weight: 400.43 g/mol
Melting Point: 128 – 132 °C
Solubility: Freely soluble in water, slightly soluble in methanol and ethanol
pH (1% solution): 2.0 - 3.0
Boiling Point: Not applicable (decomposes before boiling)
Vapor Pressure: Not significant at room temperature
Partition Coefficient (log Pow): Not readily available
Flash Point: No data available

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions
Conditions to Avoid: Excessive heat, moisture, direct sunlight
Incompatible Materials: Strong oxidizers, strong acids, alkalis
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, toxic fumes
Hazardous Reactions: No dangerous reactions known under normal conditions

Toxicological Information

Acute Toxicity: Oral LD50 (rat): ~2 mg/kg, highly toxic by ingestion
Skin Corrosion/Irritation: May cause mild irritation in sensitive individuals
Serious Eye Damage/Irritation: Causes eye irritation
Respiratory or Skin Sensitization: May cause allergic reaction on skin contact
Germ Cell Mutagenicity: No data from long-term studies
Carcinogenicity: Not classified as carcinogen by IARC, NTP, or OSHA
Reproductive Toxicity: Animal studies: no adverse effect on pregnancy
Specific Target Organ Toxicity: May interfere with neuromuscular and parasympathetic functions
Symptoms: Headache, bradycardia, tremors, miosis, respiratory depression possible in overdose

Ecological Information

Ecotoxicity: Toxic to aquatic life based on structure and pharmacological activity
Persistence and Degradability: Limited biodegradability, may persist in the environment
Bioaccumulative Potential: Low potential due to low log Pow
Mobility in Soil: Highly water soluble, potential for leaching
Other Adverse Effects: No known ozone depletion, do not release to environment or wastewater without proper treatment

Disposal Considerations

Waste Disposal Methods: Incinerate in a chemical incinerator equipped with afterburner and scrubber, comply with all federal, state, and local regulations
Container Disposal: Rinse discarded containers, puncture and triple rinse before disposal, treat as hazardous waste
Special Precautions for Landfill or Incineration: Avoid release to sewers, surface waters, or soil

Transport Information

UN Number: Not assigned as hazardous for transport under most regulations
UN Proper Shipping Name: Not regulated for transport
Transport Hazard Class: Not classified
Packing Group: Not required
Environmental Hazards: Avoid transport with food and animal feedstuffs
Special Precautions: Protect from physical damage, keep containers sealed and dry

Regulatory Information

TSCA Status: Not listed as of latest update
DSL/NDSL (Canada): Not listed
EU Regulations: Not classified according to EC Regulation No 1272/2008
SARA 311/312 Hazards: Acute health hazard
California Proposition 65: Not listed as a chemical known to cause cancer or reproductive toxicity
Workplace Regulations: Use in accordance with local occupational health regulations, provide safety training and access to datasheet for all workers handling