MSDS for Chlorhexidine Gluconate Solution (GMP)

Identification

Product Name: Chlorhexidine Gluconate Solution
Synonyms: CHG, Chlorhexidine Digluconate Solution
CAS Number: 18472-51-0
Recommended Use: Antiseptic, disinfectant
Manufacturer: [Manufacturer details]
Emergency Contact: [24-hour phone number]
Product Code: [specific batch or product code if available]
Address: [Company or plant address]
Email: [Safety or technical support email]
Prepared By: [Name or department responsible for MSDS]

Hazard Identification

GHS Classification: Eye Damage/Irritation (Category 1), Skin Sensitization (Category 1), Aquatic Chronic Toxicity (Category 2)
Signal Word: Danger
Hazard Statements: Causes serious eye damage, may cause allergic skin reaction, toxic to aquatic life with long lasting effects
Precautionary Statements: Wear protective gloves/eye protection, avoid release to environment, wash hands thoroughly after handling
Health Hazards: Eye irritation, skin sensitization, potential respiratory irritation
Environmental Hazards: Harmful to aquatic organisms and ecosystems
Physical Hazards: Non-flammable, may emit toxic fumes if heated to decomposition
Pictograms: Corrosive, Exclamation Mark, Environment (per GHS)

Composition / Information on Ingredients

Main Ingredient: Chlorhexidine Gluconate
Concentration: 2% to 4% w/v (typical medical formulation)
CAS Number (Chlorhexidine Gluconate): 18472-51-0
Other Ingredients: Purified water (60–98%), Ethanol or Isopropanol (solvent, up to 70% depending on formula), Glycerin (moisturizer, 1–2%), additional stabilizers or surfactants as required for product stability
Impurities: No hazardous impurities above reporting thresholds identified in typical GMP manufacturing

First Aid Measures

Eye Contact: Rinse immediately with running water for several minutes, lift eyelids to ensure complete removal, seek immediate medical attention
Skin Contact: Remove contaminated clothing, wash affected skin thoroughly with soap and water, consult healthcare provider for persistent irritation
Inhalation: Move exposed individual to fresh air, monitor for respiratory symptoms, provide oxygen and seek medical advice if breathing difficulty persists
Ingestion: Do not induce vomiting, rinse mouth with water, offer small amounts of water to dilute, get medical help immediately
Most Important Symptoms: Burning sensation, redness, severe eye damage, dermatitis, allergic reactions

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, alcohol-resistant foam, dry chemical, carbon dioxide
Unsuitable Extinguishing Media: Direct water jets (risk of spread)
Special Hazards: Container rupture possible in intense heat, toxic fumes of hydrogen chloride and carbon oxides if combusted
Advice for Firefighters: Wear self-contained breathing apparatus, full protective clothing, keep containers cool with water spray, prevent runoff to sewers/waterways
Explosion Data: No explosive properties identified, but some formulations may include alcohols with flammable characteristics

Accidental Release Measures

Personal Precautions: Evacuate area, avoid contact with eyes or skin, wear chemical splash goggles and protective gloves
Environmental Precautions: Prevent spillage from entering drains, waterways, or soil
Clean-Up Methods: Absorb with inert non-combustible material (sand, earth), collect for disposal, wash surface with plenty of water, ventilate area well
Other Considerations: Use nonsparking tools if alcohol is present in formulation, dispose of cleanup materials as hazardous waste where required by local regulation

Handling and Storage

Safe Handling: Avoid breathing vapors or spray, avoid skin or eye contact, wash hands after use, use only in well-ventilated areas or appropriate fume hoods
Storage Conditions: Store in tightly sealed original containers, keep in cool, dry, and well-ventilated area, away from direct sunlight and incompatible substances
Incompatibilities: Do not mix with strong oxidizers, anionic surfactants, hypochlorites
Special Precautions: Segregate from food and animal feeds, store away from heat sources or flames if alcohol content is high

Exposure Controls and Personal Protection

Occupational Exposure Limits: Chlorhexidine Gluconate not assigned specific OSHA or ACGIH PEL/TLV
Engineering Controls: Use local exhaust ventilation, process enclosures as needed
Personal Protective Equipment (PPE): Chemical-resistant gloves (nitrile or PVC), safety goggles or face shield, lab coat or apron, use respirator if ventilation insufficient for large-scale handling
Hygiene Measures: Wash hands before eating, avoid touching eyes or face during use, remove contaminated clothing promptly

Physical and Chemical Properties

Appearance: Clear to pale yellow, aqueous solution
Odor: Mild, occasionally medicinal
pH: Slightly acidic to neutral (typically 5.0–7.0)
Boiling Point: Approximately 100°C (water-based solutions)
Melting Point: Not applicable (solution)
Solubility: Miscible in water, partially miscible in alcohol
Density: Approx. 1.0–1.1 g/cm³
Vapor Pressure: Not significant under ambient conditions
Flash Point: Above 70°C (hydroalcoholic formulations)
Viscosity: Similar to water, may be slightly higher if thickener included

Stability and Reactivity

Chemical Stability: Stable under proper storage, affected by strong acids and bases
Hazardous Reactions: Reacts with anionic detergents or hypochlorites forming potentially toxic products
Conditions to Avoid: Avoid heat, direct sunlight, and incompatible substances
Incompatible Materials: Strong oxidizers, hypochlorites, anionic surfactants
Hazardous Decomposition Products: Hydrogen chloride, nitrogen oxides, carbon oxides on decomposition

Toxicological Information

Routes of Exposure: Inhalation, skin contact, eye contact, ingestion
Acute Effects: Causes eye and skin burns, may cause irritation to respiratory tract
Chronic Effects: Prolonged or repeated exposure may result in sensitization or dermatitis
Oral Toxicity (LD50, Rat): 1800 mg/kg (for Chlorhexidine Gluconate)
Skin Sensitization: Documented among healthcare workers using antiseptic solutions
Additional Toxicity Data: Not classified as carcinogenic or mutagenic by NTP, IARC, or OSHA

Ecological Information

Environmental Behavior: Highly toxic to aquatic organisms
Persistence and Degradation: Poorly biodegradable, persistence likely in water and soil
Bioaccumulation Potential: Low potential for bioaccumulation
Aquatic Toxicity: LC50 for fish < 2 mg/L, severe acute effects on daphnia and algae
Mobility: Moves through soil into groundwater possible if large releases occur
Other Adverse Effects: Harmful to microorganisms in sewage treatment

Disposal Considerations

Waste Treatment Methods: Dispose as hazardous chemical waste through licensed waste disposal contractor
Disposal of Containers: Triple rinse, puncture, dispose of according to local regulations
Special Precautions: Do not release into drains, water courses, or open environment
Regulations: Follow national and regional hazardous waste handling protocol

Transport Information

UN Number: Varies (not regulated unless alcohol is above threshold)
Proper Shipping Name: Chlorhexidine Gluconate Solution (or Hydroalcoholic Solution if flammable)
Hazard Classes: 8 (Corrosive) or 3 (Flammable liquid if containing >24% alcohol)
Packing Group: II or III depending on formulation
Special Precautions: Protect from physical damage, handle in accordance with regulation
Environmental Hazard: Classified as marine pollutant if shipped in bulk

Regulatory Information

US Regulations: Listed on TSCA; FDA-approved for medical use; regulated under OSHA Hazard Communication Standard
EU Regulations: Registered under REACH, classified according to CLP Regulation
Labeling: GHS-compliant labeling required, signal words and pictograms as specified
Other Approvals: Approved by regulators such as US EPA and Health Canada for relevant applications
Restrictions: Use only as directed for approved applications; workplace exposure limits not established but recommended by some manufacturers
Safety Assessment: Routine toxicological review conducted for every major change in formulation or use-case