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Material Safety Data Sheet: Diclofenac Potassium

Identification

Product Name: Diclofenac Potassium
Chemical Name: 2-[(2,6-dichlorophenyl)amino]benzeneacetic acid, monopotassium salt
Molecular Formula: C14H10Cl2KNO2
Molecular Weight: 344.24 g/mol
Synonyms: Potassium 2-[(2,6-dichlorophenyl)amino]phenylacetate
Recommended Use: Nonsteroidal anti-inflammatory drug (NSAID)
Supplier Details: Refer to the packaging for contact information
Emergency Contact Number: Local emergency services or poison control center
CAS Number: 15307-81-0

Hazard Identification

Hazard Classification: Classified as hazardous according to GHS: Acute toxicity (oral, category 4), Eye irritation (category 2), Specific target organ toxicity (single exposure, category 3)
GHS Label Elements: Exclamation mark symbol, signal word: Warning
Hazard Statements: Harmful if swallowed, causes eye irritation, may cause drowsiness or dizziness
Precautionary Statements: Avoid breathing dust, wash hands thoroughly after handling, do not eat, drink or smoke when using this product, use only outdoors or in a well-ventilated area, wear protective gloves/eye protection/face protection
Potential Health Effects: Can irritate eyes, skin, and respiratory system; ingestion may cause abdominal pain, nausea, headache, or dizziness; chronic exposure may affect kidney or liver function
Environmental Hazard: May cause long-lasting harmful effects to aquatic life
Other Hazards: No known significant effects or critical hazards beyond those stated

Composition / Information on Ingredients

Ingredient: Diclofenac Potassium
Concentration: 98-100%
Chemical Formula: C14H10Cl2KNO2
CAS Number: 15307-81-0
Impurities/Additives: Trace solvents (<1%) and water (<0.5%) possible from synthesis
Other Components: No significant non-hazardous additives identified

First Aid Measures

Inhalation: Move exposed person to fresh air, keep at rest in a position comfortable for breathing, seek medical help if symptoms persist
Skin Contact: Remove contaminated clothing, rinse skin with plenty of water for several minutes, wash with soap, get medical attention if irritation develops
Eye Contact: Flush eyes gently with running water for at least 15 minutes, hold eyelids apart, remove contact lenses if present and easy to do, consult an ophthalmologist if discomfort continues
Ingestion: Rinse mouth with water, do not induce vomiting unless directed by medical personnel, never give anything by mouth to an unconscious person, get prompt medical assistance
Most Important Symptoms: Drowsiness, nausea, irritation of eyes and mucous membranes, headache
Note for Physicians: Provide symptomatic treatment, observe for gastrointestinal and renal complications, administer activated charcoal if large ingestion occurs within one hour

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, foam, dry chemical powder, carbon dioxide
Unsuitable Extinguishing Media: Strong water jets may spread powdered material
Special Fire Hazards: Emits toxic fumes of HCl, NOx, and Cl2 if burned
Firefighter Protection: Wear full protective gear and a self-contained breathing apparatus, avoid inhalation of combustion products
Advice: Prevent contaminated fire extinguishing water from entering drains or waterways
Explosion Hazards: Not considered explosive by current safety standards, dust can pose minor risk in highly concentrated air

Accidental Release Measures

Personal Precautions: Avoid breathing dust, ventilate area, use appropriate personal protective equipment including gloves, mask, goggles
Environmental Precautions: Prevent further spillage or leakage, do not discharge into surface waters, sewers or soil
Cleanup Methods: Sweep up or vacuum spilled material gently, avoid creating dust, transfer to a labeled waste container for disposal, wash spill area with plenty of water after material has been removed
Extra Instructions: Dispose of in accordance with local and national regulations, report incidents involving significant spills to proper authorities

Handling and Storage

Handling: Handle in accordance with industrial hygiene and safety guidelines, minimize dust generation, avoid contact with skin, eyes or clothing, wash hands thoroughly after handling
Storage Conditions: Store in a tightly closed original container, keep away from incompatible materials such as strong acids or oxidizers, protect from moisture and heat, store at room temperature in a dry, ventilated area
Packaging Materials: Use corrosion-resistant, airtight packaging to avoid contamination and decomposition; never return unused product to original packaging
Fire Protection: Keep away from ignition sources, use non-sparking tools and grounded equipment if bulk handling
Other Recommendations: Keep storage area clearly labeled and restricted to trained personnel

Exposure Controls and Personal Protection

Occupational Exposure Limits: No established limit for diclofenac potassium, minimize exposure as with pharmaceutical substances
Engineering Controls: Use local exhaust ventilation or process enclosure to control airborne dust
Personal Protective Equipment: Respirator with P2 or N95 filter if dust forms, chemical-resistant gloves, laboratory coat or apron, safety goggles or face shield
Hygiene Measures: Wash hands, forearms and face after handling, change contaminated clothing promptly, keep work area clean
Environmental Protection: Ensure workplace emissions adhere to environmental standards, filter and treat process air before discharge if necessary
Monitoring: Assess airborne levels in high volume use settings

Physical and Chemical Properties

Appearance: White to off-white crystalline powder
Odor: Odorless or faint medicinal odor
Odor Threshold: Not determined due to low volatility
pH (1% solution): Typically 6.0–7.5
Melting Point/Freezing Point: 283–285 °C
Boiling Point: Decomposes before boiling
Flash Point: Not determined
Evaporation Rate: Not applicable
Flammability: Not classified as flammable
Vapor Pressure: Negligible at room temperature
Relative Density: Approximately 1.3–1.5 g/cm³
Solubility: Freely soluble in water, sparingly soluble in ethanol, insoluble in chloroform
Partition Coefficient (log Pow): Around 0.5–1.0
Auto-ignition Temperature: No data available
Decomposition Temperature: >250 °C (emitting toxic fumes)
Viscosity: Not applicable for solids

Stability and Reactivity

Reactivity: No dangerous reactions under recommended storage and handling conditions
Chemical Stability: Stable under standard conditions, sensitive to prolonged moisture exposure and strong heat
Possibility of Hazardous Reactions: Incompatible with strong acids, strong bases, oxidizing or reducing agents, may react vigorously
Conditions to Avoid: Excess heat, direct sunlight, humidity, open flames
Incompatible Materials: Concentrated acids, alkalis, oxidizers
Hazardous Decomposition Products: Emits toxic fumes including hydrochloric acid, nitrogen oxides, and carbon monoxide at high temperatures

Toxicological Information

Acute Toxicity: Oral LD50 (rat): 389 mg/kg; moderate toxicity
Skin Irritation: May cause mild irritation with repeated or prolonged contact
Eye Irritation: Causes moderate reversible irritation
Respiratory Sensitization: Dust inhalation can lead to irritation of respiratory tract
Chronic Effects: Long-term use may impair kidney or liver function, rare risk of gastrointestinal bleeding
Carcinogenicity: Not classed as carcinogenic by IARC, NTP, OSHA
Reproductive Toxicity: Studies indicate possible risk of adverse effects on reproductive capacity and fetal development in animals
Mutagenicity: Negative in most standard genetic toxicity assays
Symptoms of Overexposure: Nausea, headache, drowsiness, dizziness, abdominal pain

Ecological Information

Aquatic Toxicity: Toxic to aquatic organisms, may cause long term adverse effects in aquatic environments (EC50 for Daphnia > 100 mg/L)
Persistence and Degradability: Not readily biodegradable; persistent in soil or natural waters
Bioaccumulative Potential: Low potential (log Pow < 2), but may persist in food chains
Mobility in Soil: Moderate to high in wet conditions, risk of leaching to groundwater
Other Adverse Effects: Has been detected in wastewaters and municipal effluents; pharmaceutical residues of diclofenac reported in wildlife, highlighted in the decline of vulture populations in Asia
Precautions: Prevent product from reaching waterways, sewers or soil to avoid long-term ecological impact

Disposal Considerations

Waste Treatment Methods: Dispose through licensed chemical waste contractor following regional and national regulations
Product Waste: Incinerate in a chemical incinerator with afterburner and scrubber, or deposit in a secure landfill designed for hazardous pharmaceutical waste
Container Disposal: Empty containers remain hazardous, decontaminate before recycling or dispose as hazardous waste
Recommended Disposal Practices: Prevent contamination of ground, surface water, or sewer systems; avoid uncontrolled disposal
Community Impact: Take unused medicines back to pharmacy or hazardous waste collection centers, discourage flushing or throwaway in regular trash

Transport Information

UN Number: Not assigned
UN Proper Shipping Name: Not regulated as a hazardous material for ground, air, or sea transport
Transport Hazard Class: None
Packing Group: None required
Special Precautions for User: Prevent spillage during loading or unloading, keep containers securely closed, label all containers clearly
Environmental Hazards in Transit: Minimize risk of leakage, prevent contamination of public waterways during transit

Regulatory Information

International Regulations: Listed on inventories such as TSCA (USA), EINECS (Europe), DSL (Canada)
OSHA Hazard Communication: Meets criteria for hazardous chemical under OSHA HCS
WHMIS Classification (Canada): D2B (Toxic material)
EPA TSCA Status: Listed
REACH Status: Registered under EU regulations
Other Relevant Regulations: May be subject to pharmaceutical regulations under FDA, EMA, or local equivalents
Workplace Labeling: Require hazard symbols and emergency procedures poster displayed in areas of use or storage
Local Requirements: Workers must receive training and documentation in handling hazardous pharmaceuticals, maintain SDS on site for reference by all staff