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Product Name: Aspirin Lysinate (acetylsalicylic acid lysine salt)
Synonyms: Acetylsalicylate Lysine, Lysine Acetylsalicylate
Chemical Formula: C13H17NO5
CAS Number: 5749-67-7
Intended Use: Pharmaceutical ingredient, analgesic, antipyretic, anti-inflammatory applications
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Recommended Restrictions: Not approved for consumer use outside supervised clinical or laboratory settings; medical supervision required for use and handling
Classification: Eye irritation (Category 2A), Skin sensitization (Category 1), Specific target organ toxicity (single exposure, respiratory system), Acute toxicity (oral, Category 4)
Signal Word: Warning
Hazard Statements: May cause eye irritation, respiratory tract irritation, skin sensitization; harmful if swallowed; prolonged or repeated exposure may cause damage to organs (e.g. gastrointestinal tract, blood).
Pictograms: Exclamation mark
Precautionary Statements: Avoid breathing dust, wash hands thoroughly after handling, use personal protective equipment, seek medical attention if symptoms occur, avoid contact with skin and eyes
Other Hazards: Dust may form explosive mixtures in air under specific circumstances; individuals with asthma, aspirin-sensitive asthma, or sulfite sensitivity may experience heightened reactions
Substance: Aspirin Lysinate
Chemical Name: Acetylsalicylate Lysine
CAS Number: 5749-67-7
Concentration: ≥98% by weight
Impurities: Typical excipients may include trace moisture, unreacted lysine, possible acetylsalicylic acid, and sodium salts (< 1% each); check lot-specific CoA for details
Molecular Weight: 263.28 g/mol
Inhalation: Remove person to fresh air immediately; seek medical attention if breathing difficulty or cough develops; supportive care as required
Skin Contact: Rinse with plenty of soap and water for at least 10 minutes; remove contaminated clothing; seek medical help for persistent irritation or allergic reaction
Eye Contact: Flush eyes with lukewarm running water for at least 15 minutes holding eyelids apart; remove contact lenses; obtain medical attention for discomfort or redness
Ingestion: Rinse mouth with water; do not induce vomiting unless directed by medical personnel; seek immediate medical attention, especially for large quantities or if symptoms include vomiting, sweating, confusion, tinnitus, or rapid breathing
Most Important Symptoms: Respiratory irritation, coughing, sore throat, skin rash, redness, abdominal pain, vomiting, possible risk of salicylate poisoning in higher concentrations
Notes for Physician: Treat symptomatically; monitor for metabolic acidosis, respiratory alkalosis, and signs of gastrointestinal bleeding
Suitable Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide
Unsuitable Extinguishing Media: Strong water jet
Hazardous Combustion Products: Irritating and toxic fumes including carbon oxides, nitrogen oxides, and acetic acid
Protective Equipment: Self-contained breathing apparatus (SCBA), full protective suit
Special Procedures: Minimize dust generation, ventilate area, cool exposed containers with water spray, evacuate unnecessary personnel. Fire residues and contaminated extinguishing water to be collected separately and disposed according to regulations; avoid run-off entering drains
Personal Precautions: Wear personal protective equipment including gloves, goggles, and particulate respirator; avoid creating airborne dust; ensure adequate ventilation
Environmental Precautions: Prevent entry into sewers, surface water, or soil; contain material to minimize spread
Methods for Cleaning Up: Clean up spills using HEPA-filtered vacuum or damp method to prevent dust; sweep up and place in suitable labeled waste container for disposal; wash area with detergent and water; do not mix with incompatible substances
Notification Procedures: Inform relevant authorities if substance enters environment or water courses in large quantities
Safe Handling: Avoid dust inhalation and contact with skin or eyes; use local exhaust ventilation where dust is generated; no eating, drinking, or smoking near handling area; wash thoroughly after use
Storage Requirements: Store in tightly closed, original container; keep in a dry, cool, well-ventilated space away from heat, sparks, and direct sunlight; segregate from incompatible materials such as acids, bases, oxidizers
Storage Temperature: Maintain at 15–25°C (59–77°F)
Packaging Materials: Use glass, polyethylene, or polypropylene; avoid metal containers where possible
Occupational Exposure Limits: No established OSHA/ACGIH values; handle as a pharmaceutical compound, minimize workplace exposure as low as reasonably achievable
Engineering Controls: Handle in fume hood or local exhaust; enclose processes where possible to limit airborne dust
Personal Protective Equipment: Nitrile or latex gloves, safety goggles, protective lab coat, NIOSH-approved respirator for high dust areas
Hygiene Measures: Wash hands and forearms after handling; remove contaminated clothing and launder before reuse; monitor air and surfaces for contamination in production areas
Appearance: White to off-white crystalline powder
Odor: Mild, characteristic (slight acetic odor)
pH (5% Solution): 7–8
Melting Point: Around 140°C
Boiling Point: Decomposes before boiling
Flash Point: Not applicable
Flammability: Not classified as highly flammable; fine dust may form explosive mixture
Vapor Pressure: Negligible at room temperature
Solubility: Freely soluble in water; slightly soluble in ethanol
Partition Coefficient (log Pow): Not determined specifically for lysinate, acetylsalicylic acid logP is 1.1–1.2
Bulk Density: 0.4–0.7 g/cm3
Chemical Stability: Chemically stable under standard handling and storage; decomposes at elevated temperature or with prolonged exposure to moisture
Possibility of Hazardous Reactions: Reacts with strong acids and strong oxidizers; hydrolyzes slowly in contact with water or damp air releasing acetylsalicylic acid and lysine
Conditions to Avoid: Excessive heat, moisture, humidity, open flames, sources of ignition, incompatible chemicals
Incompatible Materials: Strong acids, strong bases, oxidizing agents, reducing agents, metal salts (iron, copper)
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, acetic acid fumes upon burning or decomposition
Acute Toxicity: Oral LD50 (rat): >2000 mg/kg; estimated to be similar to acetylsalicylic acid but may cause gastrointestinal distress, nausea, vomiting, metabolic disturbances
Skin and Eye Irritation: May cause mild to moderate irritation; risk of allergic skin reaction in sensitive individuals
Respiratory Effects: Prolonged inhalation may induce cough, irritation, or asthma-like symptoms in sensitive people
Chronic Toxicity: May lead to gastrointestinal bleeding, metabolic acidosis, and tinnitus; repeated high exposure can affect blood, kidneys, and liver
Carcinogenicity: Not classified as carcinogenic by NTP, IARC, or OSHA
Reproductive/Developmental Toxicity: Cautioned for use in late pregnancy (potential risks as with all NSAIDs); possible risk of fetal complications at high dosages
Sensitization: Documented cases of skin sensitization and respiratory hypersensitivity in aspirin-sensitive individuals
Ecotoxicity: Harmful to aquatic organisms in high quantities, may cause long-term adverse effects in the aquatic environment
Persistence and Degradability: Moderately biodegradable; hydrolyzes in water to acetylsalicylic acid and lysine, both of which degrade further in environment
Bioaccumulation Potential: Low, based on physicochemical properties and rapid metabolism in higher organisms
Mobility in Soil: Medium to high; may migrate to groundwater if released in bulk
Other Adverse Effects: Limited chronic toxicity documented in fish and invertebrates at environmental concentrations typically observed from pharmaceutical waste streams
Waste Disposal Methods: Dispose of substance in accordance with local, regional, and national regulations for pharmaceuticals; incineration preferred in approved facility
Contaminated Packaging: Clean containers by triple-rinsing; dispose of as hazardous chemical waste if not decontaminated; do not reuse packaging for food or water storage
Sewage Disposal: Do not dispose of via wastewater system or natural water bodies; prevent environmental release of bulk quantities
Regulatory Considerations: Classified as hazardous pharmaceutical waste; contact local environmental agency for approved disposal facilities
UN Number: Not classified as a dangerous good under UN recommendations
Proper Shipping Name: Aspirin Lysinate, not otherwise specified
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Environmental Hazards: Not a marine pollutant
Special Precautions: Protect from moisture and physical damage during transport; avoid packaging with foods, drinks, or animal feeds; ensure clear labeling and safety data available to carriers
US Federal Regulations: Not listed under TSCA, SARA Title III; treat as hazardous chemical due to pharmaceutical activity
EU Regulations: Meets the definition of a medicinal product under EMA guidelines; CLP Regulation applies in context of workplace safety
Labeling Requirements: Signal word, hazard pictograms, risk and safety phrases as specified by GHS/CLP; keep container tightly closed and out of reach of unauthorized persons
Other National Regulations: Subject to pharmaceutical and workplace chemical safety regulations in most jurisdictions; site-specific occupational exposure guidelines may apply
Chemical Inventory Status: Not listed on TSCA; may be listed under EINECS/ELINCS as pharmaceutical intermediate in Europe; check regional inventory for compliance if manufactured, imported, or used in bulk quantities
