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Product Name: Ketorolac Tromethamine
Synonyms: Ketorolac, Toradol, Acular
Chemical Formula: C15H13NO6·C4H11NO3
Molecular Weight: 376.41 g/mol
Manufacturer / Supplier: Contact the pharmaceutical manufacturer or distributor for specific company details
Recommended Use: Nonsteroidal anti-inflammatory drug for short-term management of moderate to severe pain
Emergency Phone Number: Provided by manufacturer on packaging or shipping documents
UN Number: Not classified as dangerous goods under current transport guidelines
Classification: Not classified as hazardous according to GHS criteria, but can cause eye, skin, and respiratory tract irritation
Label Elements: No pictogram required, precautionary statements apply
Potential Health Effects: Inhalation may irritate respiratory system, ingestion can cause gastrointestinal upset, skin contact may cause irritation or allergy, eye contact results in irritation or damage
Chronic Exposure: Long-term or repeated exposure could impact kidney, gastrointestinal tract, or other organ systems if absorbed systemically
Environmental Hazards: Avoid release into the environment as aquatic toxicity data is limited but not excluded
Other Hazards: Dust can exacerbate pre-existing asthma or respiratory conditions
Main Component: Ketorolac Tromethamine (CAS#: 74103-06-3)
Purity: Pharmaceutical grade, typically >98% pure
Impurities: Trace levels of synthetic byproducts from manufacturing process
Supplementary Ingredients: None for pure API; see separate data for finished formulations
Eye Contact: Rinse eyes cautiously with water for at least 15 minutes, remove contact lenses if present and easy to do, seek medical attention
Skin Contact: Wash thoroughly with soap and water, remove contaminated clothing and launder before reuse
Inhalation: Move to fresh air, monitor for respiratory symptoms, seek medical care if symptoms develop
Ingestion: Rinse mouth, drink water if conscious, do not induce vomiting, seek medical attention for advice
Acute Symptoms: Nausea, vomiting, headache, drowsiness, dizziness
Medical Attention: Always consult a healthcare provider in case of exposure
Suitable Extinguishing Media: Use water spray, dry chemical, foam, or carbon dioxide
Unsuitable Extinguishing Media: High volume water jet potentially spreads contamination
Hazards Arising: Combustion may release fumes of carbon oxides, nitrogen oxides, and toxic organic vapors
Special Protective Equipment: Firefighters wear self-contained breathing apparatus and full protective gear
Additional Information: Move containers from fire zone if safe, water spray can cool unbroken containers
Personal Precautions: Wear gloves, goggles, and dust mask if powder is present, avoid dust generation and breathing particles
Environmental Precautions: Prevent further leakage or spillage, contain material to avoid release into water sources
Containment/Clean-up: Sweep up gently to avoid dusting, place in properly labeled waste container, ventilate area, dispose using approved procedures
Decontamination: Wash area with water and suitable detergent after bulk removal
Handling: Use with adequate ventilation, avoid contact with eyes, skin, and clothing, prevent inhalation of dust, wash hands thoroughly after handling, avoid eating or drinking near substance
Storage Conditions: Store in tightly closed containers, protected from light and moisture, store at 20–25°C (68–77°F) unless otherwise specified by manufacturer
Incompatibilities: Strong oxidizers, strong acids, and bases
Safe Practices: Keep away from children and unauthorized personnel
Exposure Limits: Occupational exposure limits not established for ketorolac tromethamine
Engineering Controls: Local exhaust ventilation or use in a fume hood if dust or aerosol can form
Personal Protective Equipment: Wear splash-proof safety goggles, nitrile or latex gloves, lab coat, use dust mask or respirator if airborne particles are present
Hygiene Measures: Do not eat, drink, or smoke in handling area, always wash thoroughly after exposure
Environmental Controls: If large quantities handled, use containment systems to avoid environmental release
Appearance: White to off-white crystalline powder
Odor: Odorless
Melting Point: Approximately 162–164°C
Solubility: Soluble in water and ethanol
pH (1% Solution): 6.5–8.0
Boiling Point: Information not available (decomposes before boiling)
Flash Point: Not flammable
Vapor Pressure: Not applicable (solid)
Partition Coefficient: logP ~ -0.3 (for tromethamine salt)
Stability: Stable under standard storage conditions
Other Properties: No explosive or oxidizing properties reported
Chemical Stability: Stable under recommended storage conditions, sensitive to light and moisture
Reactivity: Does not react dangerously under normal conditions
Hazardous Decomposition: Decomposition can release toxic fumes including carbon oxides and nitrogen oxides
Polymerization: No risk of hazardous polymerization
Incompatible Materials: Avoid strong oxidizers and acids
Acute Toxicity: Oral LD50 in rats exceeds 200 mg/kg, low acute toxicity but may cause symptoms like irritation, headache, or drowsiness
Chronic Exposure: Repeated exposure in animals led to kidney, GI injury, similar to effects in overdose in humans
Routes of Exposure: Inhalation, ingestion, skin, and eye contact
Symptoms: Nausea, dizziness, headache, gastrointestinal upset, renal impairment possible at high exposure
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, or OSHA
Mutagenicity/Teratogenicity: Not mutagenic or teratogenic at typical pharmaceutical exposures
Sensitization: May cause allergic skin reactions in sensitive individuals
Aquatic Toxicity: Data limited, may be harmful if large quantities enter waterways
Persistence and Degradability: Not readily biodegradable in standard tests, some risk for environmental persistence
Bioaccumulation Potential: Not expected to bioaccumulate significantly in aquatic organisms
Soil Mobility: Moderate mobility predicted
Hazard to Wildlife: Avoid environmental release, long-term consequences of pharmaceutical residues in surface water still under study
Disposal Methods: Dispose of in accordance with local, regional, and national regulations for pharmaceutical waste
Special Precautions: Do not flush into sewer system or surface water
Container Disposal: Triple-rinse and render empty packaging unusable before disposal
Other Disposal Recommendations: Work with licensed chemical waste disposal contractor if large quantities involved
UN Number: Not regulated for transport
UN Proper Shipping Name: Not regulated
Transport Hazard Class: Not assigned
Packing Group: Not classified
Special Precautions: Protect from moisture, store in original container, secure shipment to prevent breakage and release
Environmental Hazards: Bulk transport should avoid waterway exposure
Safety, Health and Environmental Regulation: Subject to pharmaceutical regulations for controlled substances in many regions, not controlled as hazardous chemical in standard industrial use
OSHA Hazcom: Not specifically listed, general duty applies
TSCA Status: Not listed
GHS Label Elements: Not a hazardous substance per GHS; standard caution required
Other Regulations: Drug Enforcement Administration (DEA), European Medicines Agency (EMA), and other national agencies provide guidance for pharmaceutical handling and reporting
