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MSDS for Trimethoprim Lactate

Identification

Product Name: Trimethoprim Lactate
Synonyms: 2,4-Diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine lactate salt
CAS Number: 23256-42-0
Recommended Use: Antibacterial pharmaceutical agent
Manufacturer: [Insert manufacturer name and contact information]
Emergency Contact: [Insert emergency phone number, accessible 24 hours]

Hazard Identification

Hazard Classification: Not classified as hazardous under GHS criteria
Signal Word: None
Hazard Statements: May cause eye irritation. Dust may cause slight respiratory irritation. Potential for skin sensitization through prolonged contact.
Pictogram: None required
Precautionary Statements: Avoid breathing dust. Use personal protective equipment as required. Wash thoroughly after handling.
Health Effects: Inhalation may cause coughing or discomfort. Skin contact can cause dryness or mild irritation. Eye contact might result in redness or watering. Ingestion can cause nausea.

Composition / Information on Ingredients

Chemical Name: Trimethoprim Lactate
Concentration: ≥98% by weight
CAS Number: 23256-42-0
Additives or Impurities: None known at anticipated concentration
Molecular Formula: C14H18N4O3·C3H6O3
Molecular Weight: 354.4 g/mol (Trimethoprim base)
Relevant Impurities: None identified as significant at relevant quantities

First Aid Measures

Inhalation: Remove person to fresh air. Provide oxygen or artificial respiration if needed. Seek medical attention for symptoms such as shortness of breath, dizziness or severe coughing.
Skin Contact: Wash affected area thoroughly with soap and water. Remove contaminated clothing and wash before re-use. Seek medical attention if irritation persists.
Eye Contact: Flush eyes generously with water for at least 15 minutes, lifting upper and lower lids occasionally. Remove contact lenses if possible. Seek medical help for continued discomfort, redness, or pain.
Ingestion: Rinse mouth with water. Do not induce vomiting unless directed by a medical professional. Give water to drink. Medical attention recommended for significant ingestion amount or symptoms.

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, foam, dry chemical, and CO2 extinguishers can be used.
Specific Hazards: Powder can become airborne and ignite in presence of strong ignition sources. Decomposition can produce carbon monoxide, carbon dioxide, nitrogen oxides.
Protective Equipment: Firefighters should use self-contained breathing apparatus and wear full protective gear to avoid inhalation of combustion gases.
Advice for Firefighters: Move containers away from fire area if safe to do so. Dike fire-control water to prevent environmental contamination.

Accidental Release Measures

Personal Precautions: Wear appropriate personal protective equipment including gloves, safety goggles, lab coat, and dust mask to avoid inhaling powder.
Environmental Precautions: Prevent further leakage or spillage if safe. Do not allow product to reach drains, water courses, or soil.
Methods for Clean Up: Scoop or vacuum spilled material using tools and equipment that won’t create dust clouds. Dampen powder if necessary. Place material in a suitable, labeled waste container. Ventilate area and wash spill site after material pickup is complete.

Handling and Storage

Safe Handling: Avoid creating dust or aerosol. Use only in well-ventilated areas. Prevent contact with skin, eyes, and clothing. Wash hands thoroughly after handling.
Storage Conditions: Store in a tightly closed container, away from incompatible substances like strong acids and oxidizers. Keep in a cool, dry, well-ventilated place. Maintain temperature below 30°C (86°F) and avoid excessive heat or moisture.
Special Considerations: Store away from direct sunlight and foodstuffs. Only allow trained personnel access to storage and handling areas.

Exposure Controls and Personal Protection

Workplace Exposure Limits: No specific ventilation or airborne limits published for trimethoprim lactate; minimize inhalation.
Engineering Controls: Use local exhaust ventilation to minimize airborne concentrations. Enclosed processes preferred.
Personal Protective Equipment (PPE): Wear safety glasses with side shields, lightweight chemical-resistant gloves (nitrile or neoprene), lab coat or other protective clothing. Use appropriate dust mask or respirator if handling powders in unventilated areas.
Hygiene Controls: Wash hands and face before eating, drinking, or smoking. Remove contaminated clothing and wash before reuse. Avoid touching face or eyes until hands are clean.

Physical and Chemical Properties

Physical State: Solid powder
Color: Off-white to light yellow
Odor: Odorless
Melting Point: 200–210°C
pH (1% solution): 5.0–6.5
Solubility: Slight in water, more soluble in methanol and DMSO
Boiling Point: Not applicable (decomposes)
Flash Point: Not determined
Density: ~1.25 g/cm3
Vapor Pressure: Negligible
Partition Coefficient (log P): 0.9 (estimated for trimethoprim base)
Evaporation Rate: Non-volatile

Stability and Reactivity

Chemical Stability: Stable under normal temperatures and recommended storage conditions.
Reactivity: No hazardous reactivity under normal conditions.
Conditions to Avoid: High heat, open flame, exposure to moisture.
Incompatible Materials: Strong acids, bases, and strong oxidizing agents.
Hazardous Decomposition Products: Smoke, carbon monoxide, carbon dioxide, nitrogen oxides when heated to decomposition.
Polymerization: No data indicating risk of hazardous polymerization.

Toxicological Information

Acute Toxicity: Oral LD50 (rat): >5000 mg/kg for trimethoprim base. Lactate component considered of low toxicity.
Inhalation: Dust can cause mild respiratory tract irritation.
Skin Contact: Not expected to be toxic, but prolonged exposure may cause mild irritation or sensitization.
Eye Contact: Dust can cause minor conjunctival irritation.
Chronic Effects: Chronic exposure to high levels may cause hypersensitivity reactions.
Mutagenicity: No evidence in standard assays.
Carcinogenicity: Not listed by IARC, NTP, or OSHA as a carcinogen.
Reproductive Effects: Animal data suggest no substantial evidence for reproductive toxicity at therapeutic exposures.
Notes: Always handle with care, especially if immunologically sensitive or with prior history of drug allergies.

Ecological Information

Environmental Fate: Limited data for trimethoprim lactate, but antibiotic compounds can persist in the environment and impact microbial ecosystems.
Aquatic Toxicity: EC50 (Daphnia magna): 10-100 mg/L (estimated based on structural analogs); potentially harmful to aquatic life on prolonged exposure.
Soil Mobility: Low to moderate mobility expected; possibility for groundwater contamination if disposed improperly.
Bioaccumulation: Not expected to bioaccumulate significantly.
Degradation: Slowly biodegradable; may persist under certain conditions.
Special Precautions: Avoid release to the environment. Prevent contamination of surface waters and soil.

Disposal Considerations

Product Disposal: Collect and seal in labeled containers for incineration in accordance with local, regional, and national regulations.
Container Disposal: Triple rinse and dispose of containers through licensed chemical disposal firms.
Regulatory Compliance: Do not dispose of via sewage, drains, or natural water bodies. Contact local waste authority for further guidance.
Precautions: Wear PPE during disposal. Ensure all spill cleanup materials are treated as pharmaceutical waste.

Transport Information

UN Number: Not assigned
Proper Shipping Name: Not regulated as dangerous goods for transport by air, sea, or road
Transport Hazard Class: None
Packing Group: None
Special Precautions for User: Avoid generating dust during transport and handling. Transport in tightly closed containers. Prevent exposure to strong sunlight, excessive heat or humidity during transit.
Environmental Hazards: Not a marine pollutant
Bulk Transport: Not applicable

Regulatory Information

TSCA Listing: Exempt (pharmaceutical use)
REACH Status: Registration not required for medicinal products
OSHA Hazards: Not considered hazardous under OSHA’s Hazard Communication Standard
WHMIS Classification (Canada): Not controlled
SARA 313: Not subject to reporting requirements
California Proposition 65: Not listed
Other Regulations: Use and distribution subject to national and local pharmaceutical and environmental legislation. Follow workplace safety standards for handling active pharmaceutical ingredients.
Inventory Status: Not listed on major international chemical inventories due to pharmaceutical use exemption.