Product Name: Chlorhexidine Gluconate
Chemical Formula: C22H30Cl2N10O4·2C6H12O7
Synonyms: 1,1'-Hexamethylenebis[5-(p-chlorophenyl)biguanide] di-D-gluconate
CAS Number: 18472-51-0
Recommended Use: Antimicrobial, disinfectant, topical antiseptic, pharmaceutical ingredient
Manufacturer: Disclosed per supplier’s regulatory compliance
Contact Information: Address and emergency contact listed on packaging and safety sheet
Emergency Telephone: Refer to country-specific poison center or manufacturer’s listed number
Classification: Eye Damage/Irritation, Category 1; Skin Irritation, Category 2; Reproductive Toxicity, Category 2; Acute Aquatic Toxicity, Category 1
Signal Word: Danger
Hazard Statements: Causes severe eye damage, skin irritation, suspected of damaging fertility, toxic to aquatic life
Pictograms: Corrosive, Exclamation mark, Health hazard, Environment
Precautionary Statements: Wear protective eye and face protection, avoid release into the environment, wash hands thoroughly after handling, avoid contact with skin and eyes, seek medical advice if exposed or concerned
Substance: Chlorhexidine Gluconate
Concentration: Typically present at 20% w/v as a concentrate, lower concentrations in formulated products
Impurities/Stabilizing Additives: Purity and stabilizers vary based on manufacturer, often includes water and excipients to maintain stability
Other Ingredients: Water (CAS No. 7732-18-5), trace organic acids, and minimal manufacturing byproducts within GMP tolerances
Inhalation: Remove person to fresh air; seek medical attention for persistent symptoms; check for respiratory distress or coughing
Skin Contact: Remove contaminated clothing, wash skin thoroughly with soap and water; consult a doctor if irritation persists
Eye Contact: Rinse cautiously with water for at least 15 minutes, lifting eyelids; remove contact lenses if present and easy to do; seek immediate medical attention
Ingestion: Do not induce vomiting; rinse mouth thoroughly with water and give small quantities of water to drink if conscious; seek medical help right away
Symptoms: May cause burning, redness, pain, watering, blurring of vision, abdominal pain, nausea, vomiting, dermatitis, and respiratory irritation
Suitable Extinguishing Media: Use water fog, dry chemical powder, carbon dioxide, alcohol-resistant foam according to source of fire
Unsuitable Extinguishing Media: Avoid high-pressure water streams which may spread product
Hazardous Combustion Products: Releases hydrogen chloride, nitrogen oxides, carbon monoxide and other toxic gases when burning
Protective Equipment: Firefighters should wear full protective clothing and self-contained breathing apparatus
Fire/Explosion Hazards: Product does not present significant flammability under normal storage, but containers may rupture when heated; runoff may pollute waterways
Personal Precautions: Evacuate unprotected personnel, wear protective clothing, glasses, and gloves, ventilate area
Spill Response: Prevent product from entering drains or watercourses, contain and soak up with inert absorbent, collect in suitable containers for disposal
Cleanup Methods: Wash spill area with copious amounts of water after product removal, ventilate area thoroughly
Environmental Precautions: Minimize contamination of soil, groundwater, drains and water bodies due to aquatic toxicity
Handling: Use only in well-ventilated areas, avoid inhalation and contact with skin or eyes, wear appropriate PPE, avoid splashing and generation of aerosols, practice safe chemical hygiene
Storage: Store in original tightly closed container, protected from sunlight and moisture at 2–25°C, separate from food and incompatible materials, prevent freezing and exposure to extreme heat
Special Requirements: Access restricted to trained personnel, register inventory according to GMP protocols, keep away from oxidizing agents and acids
Occupational Exposure Limits: No established OSHA, ACGIH, or NIOSH exposure limits for chlorhexidine gluconate; minimize exposure as much as possible
Engineering Controls: Use chemical fume hood or local exhaust ventilation
Personal Protective Equipment: Chemical-resistant gloves (nitrile, neoprene), splash goggles, lab coat, respiratory protection (if aerosol risk)
Hygiene: Wash thoroughly after handling, avoid eating, drinking, or smoking in work area, remove and launder contaminated clothing before reuse
Appearance: Colorless or pale yellow transparent liquid solution
Odor: Mild, characteristic
pH: 5.0 – 7.0 (aqueous solution, dependent on formulation)
Boiling Point: Above 100°C (solution)
Melting Point: Not applicable (liquid solution)
Solubility: Freely soluble in water, limited solubility in organic solvents
Specific Gravity: 1.05–1.15 (20% solution)
Flash Point: Not determined; solution is generally non-flammable
Partition Coefficient (n-octanol/water): Estimated Log POW −0.9
Vapor Pressure: Negligible at ambient temperatures
Viscosity: Low
Decomposition Temperature: Data not available
Evaporation Rate: Negligible under standard conditions
Chemical Stability: Stable under normal handling conditions and recommended storage
Reactivity: Incompatible with strong oxidizing agents, anionic detergents, hypochlorites, and alkalis
Conditions to Avoid: Excessive heat, direct sunlight, freezing, strong acids and bases
Decomposition Products: Reacts with strong oxidizers to form hazardous chlorine-based and nitrogenous compounds
Polymerization: Not reported to occur under normal conditions
Routes of Exposure: Skin, eye, inhalation, ingestion
Acute Toxicity: Oral LD50 (rat): ~2000 mg/kg
Skin Corrosion/Irritation: Causes skin irritation with redness and inflammation
Serious Eye Damage/Irritation: Causes severe, possibly irreversible eye damage
Respiratory Sensitization: May cause respiratory irritation
Skin Sensitization: Allergic contact dermatitis reported with repeated use
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, or OSHA
Reproductive Toxicity: Effects on fertility observed in some animal studies
Chronic Toxicity: Prolonged or repeated exposure can aggravate eczema and other skin disorders, rarely may cause systemic effects
Acute Aquatic Toxicity: Very toxic to aquatic organisms
Persistence and Degradability: Not rapidly degradable under natural environmental conditions
Bioaccumulative Potential: Low likelihood of bioaccumulation in aquatic organisms
Mobility in Soil: Moderately mobile, partially adsorbed to sediments
Other Adverse Effects: Discharge into the environment should be avoided due to risk of harmful effects on water organisms, plants, and microbial ecosystems
Waste Disposal Methods: Dispose of this product, residues, and contaminated packaging at licensed hazardous waste collection points following all applicable regional, national and local regulations
Incineration: Recommended for small volumes via chemical incinerator equipped with afterburner and scrubber
Prohibited Disposal: Do not release into surface water, sewers, or soil
Contaminated Packaging: Decontaminate before recycling or disposal; treat as hazardous waste
Consultation: Consult local authorities or chemical waste experts to ensure safe and lawful disposal
UN Number: 1903
Proper Shipping Name: Disinfectant, liquid, corrosive, n.o.s. (contains Chlorhexidine Gluconate)
Hazard Class: 8 – Corrosive substances
Packing Group: III
Labels Required: Corrosive
Marine Pollutant: Yes, due to aquatic toxicity
Special Precautions: Secure containers, avoid spills during transit, handle in accordance with relevant international and local regulations
Transport Notes: Review special provisions and limited quantity regulations for ground, air, and sea shipments
GHS Classification: Eye Damage 1, Skin Irritation 2, Aquatic Acute 1
REACH Registration: Required for manufacture/import greater than one tonne in the EU, registration and safety assessment filed as per ECHA database
TSCA: Listed as permitted substance for specific applications
WHMIS (Canada): D2B – Toxic Material Causing Other Toxic Effects
OSHA Hazards: Certified hazardous chemical for workplace safety planning
FDA Status: Monographed as an OTC topical antiseptic (for specific strengths and uses), subject to additional review
SARA Section 313: Not listed as a toxic chemical
California Proposition 65: Not listed as a carcinogen or reproductive toxin as of the latest update
Other Regulations: Compliant with GMP and pharmacopoeial standards as an active pharmaceutical ingredient for regulated markets
Labelling: Requires safety symbols and hazard statements on packaging according to international and local legislation
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