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Product Name: Diclofenac Sodium
Chemical Name: Sodium 2-[(2,6-dichlorophenyl)amino]phenylacetate
Synonyms: Voltaren, Dicloflex, Cataflam
Recommended Use: Nonsteroidal anti-inflammatory drug (NSAID) for treatment of pain and inflammation
CAS Number: 15307-79-6
Manufacturer: Pharmaceutical suppliers and laboratories
Emergency Contact: Local regulatory number, Poison Control Center, or Health/Safety authority
Address: Refer to supplier’s latest contact information for direct reporting
Restrictions on Use: Not for veterinary or household use outside prescription
Classification: Acute toxicity (oral, dermal, inhalation), Serious eye damage/eye irritation, Specific target organ toxicity (repeated exposure)
Label Elements: Skull and crossbones pictogram, exclamation mark, health hazard symbols
Signal Word: Danger
Hazard Statements: Harmful if swallowed or inhaled, may damage liver and kidneys, causes serious eye irritation, may cause skin sensitization, toxic to aquatic life with long lasting effects
Precautionary Statements: Avoid breathing dust or fumes, wear protective gloves and eye/face protection, avoid release to the environment, wash thoroughly after handling, take off contaminated clothing and wash before reuse
Symptoms of Exposure: Nausea, headaches, abdominal pain, skin rash, allergic reactions, respiratory difficulties, eye redness
Chemical Identity: Diclofenac Sodium
Purity: Typically over 98% in formulated products
Impurities: Trace materials from synthesis (chlorinated hydrocarbons, manufacturing residues)
Form: Powder, crystalline solid, sometimes found in tablet or injectable forms for medical applications
Other Components: May include binders, fillers, coloring agents for formulated dosage forms, but bulk diclofenac sodium contains little else
Inhalation: Move person to fresh air, keep at rest in a position comfortable for breathing, seek medical attention if symptoms develop
Skin Contact: Wash skin thoroughly with soap and water, remove contaminated clothing, get medical advice if irritation persists
Eye Contact: Rinse immediately with water for at least 15 minutes, open eyelids wide, remove contact lenses if present and easy, call physician
Ingestion: Rinse mouth, do not induce vomiting unless directed by medical personnel, provide water only if person is conscious, obtain medical attention
Most Important Symptoms/Effects: Gastrointestinal upset, kidney or liver injury, possible allergic responses, risk of serious harm with large doses
Notes for Physician: Symptomatic treatment, monitor kidney and liver function, activated charcoal can be used in hospital setting for significant ingestion
Suitable Extinguishing Media: Water spray, dry chemical, foam, carbon dioxide
Specific Hazards: Emits toxic fumes of sodium oxides, nitrogen oxides, chlorine compounds on thermal decomposition
Protective Equipment: Wear self-contained breathing apparatus, full protective suit
Special Instructions: Use water spray to cool fire-exposed containers, prevent runoff to sewers or waterways due to ecotoxic potential
Explosion Data: No data for explosive properties under normal use, may form flammable dust-air mixtures
Personal Precautions: Evacuate unnecessary personnel, ensure proper ventilation, avoid breathing dust, use protective equipment including gloves and goggles
Environmental Precautions: Prevent spillage from reaching drains, sewers, soil or waterways, collect for safe disposal
Methods for Clean Up: Sweep up and place in labeled container for disposal, minimize dust generation, wash spill area with water if possible, dispose according to regulations
Decontamination: Use detergent solution for final cleaning, ventilate area to remove any dust residue, monitor for airborne particles
Precautions for Safe Handling: Avoid contact with skin, eyes, or clothing, avoid breathing dust or vapor, use engineering controls like local exhaust ventilation, keep containers tightly closed
Storage Conditions: Store at controlled room temperature (15–30°C), keep away from heat sources, direct sunlight and moisture, store in original container, segregate from incompatible materials such as strong oxidizers and acids
Further Information: Post warning signs as appropriate, maintain material safety procedures, keep away from food, beverages, and animal feed
Occupational Exposure Limits: No established national occupational exposure limits; best practice suggests keeping airborne levels as low as possible
Engineering Controls: Use of fume hoods, local exhaust ventilation, closed handling systems for weighing and dispersing bulk powder
Personal Protective Equipment: Chemical resistant gloves (nitrile or latex), safety goggles, laboratory coat, dust mask or respirator in case of significant dust generation
Hygiene Measures: Wash hands after handling, avoid eating or drinking near work area, do not smoke while handling
Environmental Controls: Minimize release through closed handling and proper ventilation systems
Appearance: White to slightly yellow crystalline powder
Odor: None or very faint
pH: Slightly basic (in aqueous solution)
Melting Point: 296–298°C (with decomposition)
Boiling Point: Decomposes prior to boiling
Solubility: Freely soluble in water, methanol, ethanol, sparingly soluble in chloroform
Vapor Pressure: Negligible at room temperature
Partition Coefficient (log Kow): 4.51 (octanol/water)
Flash Point: Not applicable (decomposes before ignition)
Auto-ignition Temperature: Data not available
Evaporation Rate: Not volatile
Relative Density: About 1.6 g/cm³
Other Data: Non-explosive, not self-reactive, stable under ordinary storage
Chemical Stability: Stable under recommended storage conditions, decomposes at high temperatures
Incompatible Materials: Strong oxidizing agents, strong acids, strong bases, chlorinating agents
Hazardous Decomposition Products: Nitrogen oxides, hydrogen chloride, sodium oxide gases on burning or decomposition
Hazardous Polymerization: Does not occur
Reactivity: Not considered reactive in normal use, avoid strong chemicals, do not mix with incompatible materials
Routes of Exposure: Inhalation, ingestion, skin and eye contact
Acute Toxicity: Oral LD50 (rat): 55 mg/kg, skin toxicity higher (less dangerous), harmful if swallowed or inhaled
Chronic Exposure: Repeated high doses linked to liver and kidney injury, gastrointestinal bleeding, and allergic skin or respiratory reactions
Corrosiveness: Not considered corrosive, but can irritate skin and eyes
Carcinogenicity: No proven human carcinogenic risk at therapeutic doses; animal studies show possible increase in some tumor types at high exposure
Mutagenicity: Some positive findings in in-vitro genetic toxicity studies, not confirmed in humans
Reproductive Toxicity: Possible risk for fetus, especially late in pregnancy; evidence of teratogenic effects in animal studies
Sensitization: Can cause skin or respiratory sensitization in predisposed individuals
Ecotoxicity: Harmful to aquatic organisms, acute and long-term impact on aquatic life, particularly fish and birds
Persistence and Degradability: Moderate; does not break down quickly in environment, potential to persist in surface water, effect on wastewater treatment processes documented
Bioaccumulative Potential: Significant evidence for accumulation in aquatic organisms, especially fish
Mobility in Soil: Can leach through soil to reach groundwater, risk of drinking water contamination in areas near manufacturing or disposal sites
Other Adverse Effects: Linked with vulture population collapse in certain regions due to veterinary use; low doses impact avian health
Waste Disposal Methods: Incinerate using approved facility, do not discharge to surface water or sewage system, landfill only if incineration not available and according to local regulations
Container Disposal: Triple rinse and puncture container before disposal, follow legal requirements for hazardous waste
Special Precautions: Avoid disposal near water sources, seek guidance from regional waste management authorities
Waste Codes: Assign hazardous waste codes as per national or state regulations, health care and industry usually follow pharmaceutical waste streams
UN Number: Not regulated for ground shipment in most countries; bulk powder may be classed as hazardous depending on packaging
UN Proper Shipping Name: Diclofenac sodium or pharmaceutical preparations containing diclofenac
Transport Hazard Class: Not classified as a dangerous good under many shipping regulations, but specific rules may apply internationally
Packing Group: Not assigned, ship in containers that prevent dust release and are moisture tight
Transport Labels: General caution label, toxic if ingested, environmental hazard pictogram if required
Special Precautions: Avoid transport with foodstuffs or feed, follow carrier guidelines, report significant spills or leaks immediately to authorities
Inventory Status: Listed on major chemical inventories (e.g., EU REACH, US TSCA, Japan ENCS)
Regulatory Classification: Prescription-only medicine (Rx-only) in most countries, restricted for manufacturing and distribution
Occupational Health Regulations: Subject to OSHA regulations for laboratory or workplace exposure, recommendations for PPE and hygiene, not assigned specific exposure limits
Environmental Regulations: Controlled substances for wastewaters and effluents in many jurisdictions, veterinary use tightly restricted in some countries
Risk Phrases: R22 (harmful if swallowed), R36/37/38 (irritating to eyes, respiratory system and skin)
Safety Phrases: S26 (In case of contact with eyes, rinse immediately), S28 (after contact with skin, wash immediately with water)
Reference Documents: Consult national legislation, EPA, local authorities for safe handling, storage, and disposal practices
