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Product Name: Erdosteine
Chemical Name: N-(2-mercaptoacetyl)-L-homoserine lactone
CAS Number: 84611-23-4
Synonyms: 2-(2-oxotetrahydrothien-3-yl)acetamidoacetic acid
Use: Mucolytic agent in pharmaceutical products
Manufacturer: [Insert Manufacturer’s Details]
Contact for Emergency: [Emergency Contact Details]
Hazard Classification: Not classified as hazardous according to GHS for routine handling
Signal Word: None
Hazard Statements: May cause mild eye and skin irritation, mild respiratory irritation possible with high dust levels
Precautionary Statements: Avoid breathing dust, use in well-ventilated areas
NFPA Ratings: Health: 1, Flammability: 0, Reactivity: 0
Potential Health Effects: Eye contact: slight irritation
Skin contact: mild irritation possible
Inhalation: prolonged exposure to high concentrations can irritate mucous membranes
Ingestion: may cause mild gastrointestinal upset
Chemical: Erdosteine
CAS No.: 84611-23-4
Content: >98% purity (bulk drug substance)
Impurities: Residual solvents, unreacted starting materials (<2%)
Form: Powder or crystalline solid, intended for formulation as oral drugs
General: Ensure safety of person rendering aid
Inhalation: Remove to fresh air, seek medical attention if cough or breathing difficulty develops
Skin Contact: Remove contaminated clothing, wash skin with soap and plenty of water, medical attention if rash persists
Eye Contact: Flush eyes with running water for at least 15 minutes, consult physician
Ingestion: Rinse mouth, give water, seek medical attention if symptoms occur
Note to Physician: Symptomatic treatment only, no specific antidote
Flammability: Not easily ignitable, low fire hazard
Suitable Extinguishing Media: Water spray, foam, dry chemical, carbon dioxide
Hazardous Combustion Products: Sulfur oxides, carbon oxides
Special Protective Equipment: Firefighters require self-contained breathing apparatus, full protective gear
Unsuitable Media: No specific restrictions
Explosion Hazard: Dust in sufficient quantity can form explosive mixtures with air; proper controls needed during transfer
Personal Precautions: Wear appropriate protective gear including gloves, eye protection, and dust mask
Environmental Precautions: Prevent spillage reaching waterways, sewers, or drains
Cleanup Methods: Avoid dust generation, sweep up and place in approved container for disposal, wash spill area with plenty of water
Disposal: See Disposal Considerations
Decontamination: Clean area thoroughly after collection; ventilate if indoors
Handling: Work in well-ventilated area, use dust extraction systems wherever possible
Protection: Avoid skin, eye, or respiratory contact, do not eat or drink while handling
Hygiene: Wash hands before breaks and after work
Storage Conditions: Store in original container tightly closed, away from direct sunlight, moisture, and incompatible materials
Temperature: 15-25°C recommended, humidity below 60%
Incompatibilities: Strong oxidizers, acids, bases
Exposure Limits: No established occupational exposure limits for Erdosteine
Engineering Controls: Local exhaust recommended, closed operations minimize dust
Personal Protective Equipment:
Gloves: impervious material such as nitrile
Eyes: safety glasses with side shields
Clothing: lab coat or equivalent
Respiratory: dust mask or half-mask respirator if dusty
Environmental Controls: Dispose of contaminated waste according to regulations, avoid discharge to environment
Appearance: White or off-white crystalline powder
Odor: Slight sulfur odor (characteristic)
pH: 4 – 5 (1% solution in water)
Solubility: Freely soluble in water; slightly soluble in ethanol
Melting Point: 103 – 105°C
Boiling Point: Decomposes before boiling
Vapor Pressure: Negligible
Density: 1.2 g/cm³ (approximate)
Partition Coefficient (log Kow): Estimated <0
Flash Point: Not flammable
Explosive Properties: Not expected to pose explosion risk except as dust cloud in confined spaces
Chemical Stability: Stable under normal and recommended storage conditions
Conditions to Avoid: High humidity, strong sunlight, excessive temperatures
Materials to Avoid: Strong oxidizing agents, bases, acids
Hazardous Decomposition: Thermal decomposition produces sulfur and carbon oxides
Polymerization: Does not occur
Acute Toxicity: Low acute toxicity based on available animal data
LD50 (oral, rat): >2000 mg/kg
Skin Irritation: Mild irritation possible with prolonged contact
Eye Irritation: Slightly irritating
Sensitization: No sensitization data; not known to sensitize
Chronic Toxicity: No evidence of carcinogenicity, mutagenicity, or reproductive toxicity in studies to date
Other Effects: Overexposure can produce gastrointestinal irritation
Aquatic Toxicity: No data for acute toxicity in aquatic species; not classified as dangerous for the environment
Persistence & Degradability: Likely to be biodegradable based on structure and experience with related compounds
Bioaccumulation: Not expected given low log Kow
Mobility in Soil: Should be quite mobile due to high water solubility
Other Adverse Effects: Avoid significant discharges to environment to prevent unnecessary ecological burden
Waste Treatment: Dispose in accordance with local, regional, national, and international regulations for pharmaceutical substances
Methods: Incinerate in licensed facility or landfill only where permitted
Container Disposal: Triple rinse and dispose of containers as controlled waste
Contractor: Consider use of professional hazardous waste disposal services
UN Number: Not regulated
Transport Hazard Class: Not hazardous material under ADR, IATA, IMDG, DOT regulations
Packing Group: Not applicable
Environmental Hazards: Not marine pollutant
Bulk Transport: Not subject to regulations for large quantity bulk transport
Special Precautions: Protect from moisture and excessive heat during transport
GHS Label: Not classified as hazardous
TSCA Listing: Not listed
REACH Status: Exempt or registered for pharmaceutical use
Other International Regulations: Meets compliance for APIs in most jurisdictions, schedule and handling may vary globally
Restrictions: Use governed by prescription and medical regulatory frameworks
Workplace Controls: Follow occupational exposure guidance where available; pharmaceutical containment and controls recommended
