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Product Name: Racecadotril
Chemical Name: (RS)-N-(2-benzyl-1-oxo-2-mercaptopropyl) glycine benzyl ester
CAS Number: 81110-73-8
Synonyms: Acetorphan
Intended Use: Pharmaceutical active ingredient, antidiarrheal agent
Manufactured by: Contact relevant supplier or manufacturer for specifics
Emergency Contact: Refer to local poison control and emergency response numbers
Molecular Formula: C21H23NO4S
Molecular Weight: 385.48 g/mol
Classification: Not classified as hazardous under GHS criteria for pharmaceuticals in solid form
Hazard Statements: May cause mild skin, eye, or respiratory irritation. Avoid inhalation of dust and contact with eyes or skin.
Interaction: No evidence of carcinogenicity, mutagenicity, or reproductive toxicity in standard studies; occupational exposure data limited.
Signal Word: Caution
Precautionary Statements: Avoid creating dust clouds; use personal protective equipment when handling the bulk substance. Use engineering controls for containment.
Principal Symptoms: Stomach discomfort if ingested in large quantities; may form respiratory tract irritation on inhalation in powder form.
Chemical Identity: Racecadotril
Concentration: Active substance typically provided in high purity (>98%)
Impurities: Residual synthesis intermediates and by-products present at <2%
Other Components: None typically added in pure form; formulations might include excipients if present in completed drug products
Physical State: White to off-white crystalline solid or powder
Inhalation: Remove person to fresh air, seek medical attention for persistent coughing or breathing difficulty.
Skin Contact: Wash thoroughly with soap and water; seek medical advice if irritation develops.
Eye Contact: Rinse carefully under running water for several minutes, remove contact lenses, continue rinsing, seek medical advice.
Ingestion: Rinse mouth with water, do not induce vomiting, seek immediate medical assistance.
Important Notes: Show medical staff the product label or this sheet if available.
Most Relevant Symptoms: Mild irritation to exposed mucous membranes possible; systemic toxicity rare at occupational doses.
Flash Point: Not readily flammable under normal conditions; data not specifically available
Suitable Extinguishing Media: Water spray, dry chemical, foam, or carbon dioxide
Unsuitable Extinguishing Media: High-pressure water jets can disperse powder
Specific Hazards: Combustion may generate CO, CO2, nitrogen oxides, sulfur oxides, and other noxious vapors
Advice for Firefighters: Use self-contained breathing apparatus and full protective gear. Approach upwind or wherever ventilation improves
Explosion Risk: Dust in confined areas may present a mild dust explosion hazard; control static and airborne concentrations during firefighting
Personal Precautions: Wear gloves, goggles, and suitable dust mask or respirator. Avoid contact with skin, eyes, and clothing. Avoid breathing airborne powder.
Environmental Precautions: Prevent material from entering drains, watercourses, or soil.
Spill Cleanup Methods: Sweep or gently vacuum using HEPA-filtered equipment. Place powder in container for disposal. Wash spill area with mild detergent after removal.
Other Considerations: Contain large spills by diking with inert absorbent materials.
Safe Handling: Avoid dust formation and airborne exposure by working in well-ventilated, controlled environments. Use personal protective equipment for hands, eyes, and respiratory tract.
Storage: Store in cool, dry, and well-ventilated areas, away from incompatible chemicals such as strong acids or oxidizing agents.
Packaging: Keep container tightly closed and properly labeled.
Special Precautions: Practice good hygiene by washing after handling, not eating or drinking near storage or use locations.
Occupational Exposure Limits: No established occupational exposure limits; minimize dust generation, keep exposures as low as reasonably achievable.
Engineering Controls: Handle in ventilated enclosures or fume hoods. Use local exhaust ventilation to capture dust.
Personal Protective Equipment: Nitrile gloves, chemical-resistant goggles, clean lab coat or gown. Use half-face respirator with particulate filters if dust generation likely.
Hygiene Measures: Change out of contaminated work clothing, wash thoroughly before breaks or after exposure.
Environmental Controls: Prevent entry into water sources and external soil.
Appearance: White or off-white crystalline solid, odorless
Melting Point: 105–110°C approximate
Boiling Point: Not applicable (decomposes before boiling)
Solubility: Poorly soluble in water, readily soluble in organic solvents (ethanol, methanol, DMSO)
Density: Estimated at 1.3–1.4 g/cm³
pH: Not applicable (insoluble in water)
Vapor Pressure: Negligible at room temperature
Partition Coefficient (log P): Approximate value 2.7–3.3
Odor Threshold: Not determined
Decomposition Temperature: Decomposes above 150°C
Chemical Stability: Stable under normal temperatures and dry storage conditions
Reactivity: Nonreactive with most substances under standard conditions
Conditions to Avoid: Excess moisture, prolonged exposure to light or air, excessive heat
Incompatible Materials: Strong acids, strong oxidizing agents
Hazardous Decomposition: Forms sulfur dioxide, nitrogen oxides, carbon monoxide, carbon dioxide at high temperatures
Polymerization: Will not undergo uncontrolled polymerization
Acute Toxicity: Low toxicity in animal studies; oral LD50 (rat) >2000 mg/kg
Skin Irritation: Not classified as a skin irritant in standard studies
Eye Irritation: Mild irritation may occur on direct exposure
Respiratory Effects: Irritation possible at high airborne concentrations
Chronic Effects: Not mutagenic, not carcinogenic, not teratogenic in preclinical studies
Sensitization: No evidence of sensitizing effects in available data.
Pharmacological Effects: Inhibits enkephalinase in the gut; no systemic opioid effects.
Other Information: Occupational experience supports low hazard with recommended handling practices.
Ecotoxicity: Data suggest low toxicity to aquatic organisms; negligible environmental bioaccumulation
Degradation: Degrades in the environment by photolysis and microbial action
Mobility: Expected to partition to soil or sediment; low water solubility
Persistence: Not persistent in typical environmental compartments
Other Effects: No significant effect on local flora or fauna at typical exposure levels
Product Disposal: Handle as pharmaceutical waste in accordance with local and national regulations
Contaminated Packaging: Rinse and dispose as hazardous material if direct contact occurs, or incinerate in approved facility
Sewage Disposal: Do not dispose of into drains or aquatic environments
Waste Treatment Methods: Use high temperature incineration or chemical destruction methods for unwanted material
UN Number: Not classified as a hazardous material for transport
Transport Hazard Class: Not regulated
Packing Group: Not regulated
Shipping Name: Racecadotril (non-hazardous, pharmaceutical product)
Special Precautions: Prevent damage to containers and leaks in transit; transport in tightly sealed, labeled packaging; maintain cool, dry conditions.
Regulatory Status: Approved for pharmaceutical use as antidiarrheal in many jurisdictions
EU Classification: Exempt from hazardous classification for solid drug substance
US Regulations: Not listed as hazardous chemical under OSHA; subject to FDA pharmaceutical regulations
Environmental Regulations: Not classified as environmentally hazardous
Inventory Status: Included in several national and international pharmacopeias
