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Product Name: Trimebutine Maleate
Chemical Name: 2-(Dimethylamino)-2-phenylbutyl 3,4,5-trimethoxybenzoate hydrogen maleate
CAS Number: 34140-59-5
Recommended Use: Pharmaceutical intermediate, active pharmaceutical ingredient
Supplier and Emergency Contact: Manufacturer’s name, address, and phone number, including 24-hour emergency line
Synonyms: Trimebutine hydrogen maleate, 2-phenyl-2-(N,N-dimethylaminomethyl)butyl 3,4,5-trimethoxybenzoate maleate
Classification: Hazardous according to OSHA Hazard Communication Standard
Physical Hazards: No significant physical hazard identified under normal handling
Health Hazards: May cause eye and skin irritation, respiratory tract irritation, possible allergic reactions, central nervous system effects in case of exposure, can be harmful if ingested or inhaled
Environmental Hazards: Limited data for environmental impact, suspected toxic to aquatic organisms if released in significant quantities
Label Elements: Signal word: Warning; Hazard statements: H302 Harmful if swallowed, H315 Causes skin irritation, H319 Causes serious eye irritation; Precautionary statements: P264 Wash hands thoroughly after handling, P273 Avoid release to environment
Chemical Identity: Trimebutine Maleate
Percentage: Pure substance, usually between 98%-100% active ingredient
Impurities: Residual solvents or related compounds under validated threshold set by pharmacopeias, less than 1% typically
Molecular Formula: C22H29NO5·C4H4O4
Molecular Weight: Approximately 499.54 g/mol
Inhalation: Move victim to fresh air, provide oxygen if breathing is difficult, seek medical attention for discomfort or irritation
Skin Contact: Remove contaminated clothing, thoroughly wash affected area with soap and water, seek medical help if irritation or redness persists
Eye Contact: Rinse cautiously with water for several minutes, remove contact lenses if present and easy to do, continue rinsing, call physician for ongoing pain or discomfort
Ingestion: Rinse mouth thoroughly with water, do not induce vomiting, seek immediate medical advice, give water to drink only if person is conscious
Most Important Symptoms: May see redness, itching, respiratory symptoms, dizziness or drowsiness with overexposure
Special Instructions for Physician: Treat based on symptoms and clinical condition, monitor for allergic reactions or systemic toxicity
Suitable Extinguishing Media: Water spray, carbon dioxide, dry powder, or foam, avoid high-pressure water jets
Specific Hazards: May produce toxic fumes of carbon monoxide, nitrogen oxides, and other decomposition products under combustion
Protective Equipment: Wear self-contained breathing apparatus and full protective clothing
Special Precautions for Firefighters: Evacuate area, fight fire from safe distance, prevent contamination of water sources, use extreme caution for toxic gases
Explosive Properties: No data for explosive hazard under normal conditions
Personal Precautions: Wear appropriate personal protective equipment including gloves, goggles, and dust mask
Environmental Precautions: Prevent dispersion into drains, waterways, or soil, contain spillage using suitable absorbent material
Methods for Cleanup: Scoop up material carefully, place in designated disposal container, avoid creating dust, ventilate area, wash spill site after clean-up
Emergency Procedures: Restrict access to area, notify responsible personnel as necessary for large releases
Handling Practices: Avoid inhalation, ingesting, or skin/eye contact, keep container tightly closed, handle in well-ventilated area, use local exhaust as needed, minimize dust generation
Storage Conditions: Store at room temperature or as indicated on product label, keep out of direct sunlight and away from incompatible materials like oxidizers or strong acids, keep in original container, secure storage area to prevent unauthorized access
Packaging Materials: Use high-density polyethylene or glass containers with secure lids
Incompatible Materials: Strong acids, bases, strong oxidizing agents
Control Parameters: No occupational exposure limits established by OSHA, NIOSH, or ACGIH, implement internal company-specific guidelines where available
Engineering Controls: Employ local exhaust ventilation, closed system operation, or fume hoods to keep air levels low
Personal Protective Equipment: Lab coat, safety glasses or chemical goggles, nitrile gloves, dust mask or respirator if dust is present
General Hygiene Measures: Wash hands after handling, do not eat or drink in work area, remove contaminated clothing promptly
Appearance: White or off-white crystalline powder
Odor: Odorless or faint characteristic smell
Odor Threshold: Not available
pH: Not applicable for solid
Melting Point/Freezing Point: 135-140°C typically
Boiling Point: Decomposes before boiling
Flash Point: Not established
Evaporation Rate: Not applicable
Lower/Upper Explosion Limits: Not determined
Vapor Pressure: Negligible
Vapor Density: No data
Solubility: Slightly soluble in water, soluble in methanol, ethanol, chloroform
Partition Coefficient (log Pow): Estimated in range of 1-3
Autoignition Temperature: No data
Decomposition Temperature: Above 140°C
Viscosity: Not applicable
Chemical Stability: Stable under recommended conditions of storage and handling, sensitive to prolonged exposure to high temperature, light, or moisture
Reactivity: Not expected to react violently under normal conditions
Hazardous Reactions: Avoid contact with strong acids/oxidizers which can lead to decomposition or hazardous gases
Hazardous Decomposition Products: May generate carbon monoxide, carbon dioxide, nitrogen oxides and other toxic vapors on decomposition
Conditions to Avoid: Excess heat, open flame, incompatible materials, high humidity
Acute Toxicity: Oral LD50 in rats >200 mg/kg, not highly acutely toxic but can cause gastrointestinal and neurological symptoms
Skin Corrosion/Irritation: May cause mild to moderate irritation based on similar compounds
Serious Eye Damage/Irritation: Possible mild eye irritation
Respiratory Sensitization: Not reported widely but avoid inhalation as a precaution
Carcinogenicity: No classification as a carcinogen by IARC, NTP, or OSHA
Reproductive Toxicity: No evidence in animal studies at pharmaceutical doses; effects at high exposures unknown
Other Information: May cause drowsiness, headaches, dizziness if significant exposure occurs, aggravates preexisting medical conditions in rare cases
Ecotoxicity: No comprehensive data; possible toxicity to aquatic life; restrict large-scale environmental release
Mobility: Low due to low water solubility and high molecular weight
Persistence and Degradability: Likely to persist in soil and water; slow biodegradation
Bioaccumulation: Potential for bioaccumulation considered low to moderate based on chemical structure
Other Adverse Effects: Avoid uncontrolled disposal, as impact on sewage treatment and water bodies is uncertain
Waste Disposal Methods: Dispose per local, regional, and national regulations; incinerate in chemical waste-approved facility or landfill according to hazardous waste rules
Contaminated Packaging: Remove chemical residues, triple rinse, dispose as hazardous chemical waste
Precautions: Do not pour down drains; do not contaminate ground or surface water
UN Number: Not classified as a dangerous good under international transport standards
Transport Hazard Class: Not regulated
Packing Group: Not applicable
Marine Pollutant: Not designated marine pollutant
Special Transport Precautions: Ship in original containers, secure against shifting, protect from moisture and physical damage, follow site-to-site transfer procedures for APIs
US Regulations: Not listed on SARA Title III Section 302/313 lists, subject to requirements under OSHA Hazard Communication
EU Regulations: Not classified as hazardous under CLP Regulation EC No 1272/2008 for standard laboratory use
Other International Regulations: No restrictions under Canadian WHMIS, not listed by AICS, DSL, or ENCS
Chemical Inventory Status: May not appear on some country-specific chemical inventories due to pharmaceutical use; require appropriate documentation for import/export
Labeling Requirements: Provide safety information on containers, use hazard pictograms as required by GHS standards for laboratory chemicals
