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Material Safety Data Sheet (MSDS) - Polysorbate 65

Identification

Product Name: Polysorbate 65
Chemical Name: Polyoxyethylene (20) sorbitan tristearate
CAS Number: 9005-71-4
Recommended Use: Emulsifier for food, pharmaceuticals, cosmetics, and industrial applications
Manufacturer/Supplier: Listed on product packaging or invoice
Contact Information: Emergency contact provided on supplier’s label
Synonyms: E 436, Tween 65, Sorbitan monostearate ethoxylated, Polyoxyethylene sorbitan tristearate

Hazard Identification

Classification: Non-hazardous according to OSHA, GHS standard; not classified as dangerous
Potential Health Effects: Mild skin and eye irritation
Label Elements: None required under current GHS classification
Signal Word: None
Hazard Statements: Not expected to present significant hazards under normal conditions
Precautionary Statements: Avoid direct contact with eyes and prolonged skin exposure; maintain hygiene

Composition / Information on Ingredients

Chemical Component: Polysorbate 65
CAS Number: 9005-71-4
Concentration: 100% (pure product); blended versions may contain minor percentage of related fatty acid esters
Impurities: Trace amounts of free fatty acids or unreacted sorbitol derivatives

First Aid Measures

Inhalation: Move person away from exposure, fresh air recommended, seek medical help if breathing becomes difficult
Skin Contact: Wash affected area with plenty of soap and water; remove contaminated clothing
Eye Contact: Rinse immediately with plenty of water for at least 15 minutes; do not rub eyes; seek medical advice for persistent irritation
Ingestion: Rinse mouth; seek medical attention if symptoms occur or feel unwell
Most Important Symptoms: Redness or mild irritation of eyes or skin
Protection for First Responders: Wear gloves and eye protection if direct contact expected

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, alcohol-resistant foam, dry chemical, carbon dioxide
Unsuitable Extinguishing Media: Do not use high-pressure water jet (may spread product)
Specific Hazards: Product may burn with release of carbon monoxide, carbon dioxide, and possible toxic fumes
Protective Equipment: Wear self-contained breathing apparatus and full protective gear
Special Precautions: Cool exposed containers with water spray, keep away from open flames and hot surfaces

Accidental Release Measures

Personal Precautions: Use gloves, eye protection; prevent skin and eye contact
Environmental Precautions: Prevent further leakage or spillage if safe to do so; avoid release to waterways or sewers
Clean-up Methods: Small spills: wipe up with absorbent, dispose appropriately; larger spills: dike area, collect for disposal, clean residue with detergent and water
Disposal of Waste: Place in appropriate waste container, consult local/national regulations

Handling and Storage

Safe Handling: Use only in well-ventilated areas; avoid contact with skin, eyes, clothing; keep containers sealed; good industrial hygiene practices reduce risk
Storage Conditions: Store in tightly closed original container, cool, dry, well-ventilated place; keep away from heat, flames, incompatible materials (strong oxidizers)
Incompatible Materials: Strong acids, strong bases, oxidizing agents

Exposure Controls and Personal Protection

Occupational Exposure Limits: Not established for Polysorbate 65; general nuisance dust or mist limits apply
Engineering Controls: Use adequate ventilation; local exhaust recommended for large-scale operations
Personal Protective Equipment: Protective gloves (nitrile or latex), goggles or face shield for splash risk, protective clothing
Hygiene Measures: Wash hands after use, do not eat or smoke when handling, change contaminated clothing

Physical and Chemical Properties

Appearance: Thick liquid, waxy or semi-solid
Color: Pale yellow to amber
Odor: Faint, characteristic
Odor Threshold: Not reported
pH: 5.0 to 7.0 (10% aqueous suspension)
Melting Point: Approximately 35–45°C
Boiling Point: Not determined; decomposition before boiling
Flash Point: >138°C (closed cup)
Solubility in Water: Dispersible (forms milky emulsion)
Vapor Pressure: Negligible at ambient conditions
Vapor Density: Not volatile
Relative Density: 1.07–1.10 g/cm³
Partition Coefficient: Not available
Evaporation Rate: Not volatile
Viscosity: Highly viscous
Explosive Properties: No data available, not explosive
Oxidizing Properties: Not oxidizing

Stability and Reactivity

Chemical Stability: Stable under normal conditions of use and storage
Conditions to Avoid: Excessive heat, moisture, direct sunlight
Materials to Avoid: Strong oxidizers, acids, and bases
Hazardous Decomposition Products: Carbon oxides, possible minor amounts of other organic products
Reactivity: No dangerous reactions known under recommended use

Toxicological Information

Acute Toxicity: Oral LD50 (rat): >25,000 mg/kg (extremely low toxicity)
Skin Corrosion/Irritation: Mild irritation possible after repeated or prolonged contact
Serious Eye Damage/Irritation: May cause slight eye discomfort
Respiratory Sensitization: Not a known sensitizer
Skin Sensitization: Not recognized as a skin sensitizer
Carcinogenicity: Not classified as carcinogenic based on current data
Mutagenicity: Negative in mutagenicity studies
Reproductive Toxicity: No effects observed in animal studies
Chronic Effects: No reported chronic health effects from workplace exposures

Ecological Information

Ecotoxicity: Low toxicological hazard to aquatic organisms in normal use; very high concentrations may affect aquatic life
Persistence and Degradability: Readily biodegradable
Potential for Bioaccumulation: Low; does not concentrate in living tissues
Mobility in Soil: Product disperses in water and soil; low potential for groundwater contamination
Other Information: Avoid bulk release into waterways or soil to reduce local environmental impact

Disposal Considerations

Waste Disposal Methods: Dispose of bulk material, contaminated packaging, and cleanup materials through licensed waste disposal contractor; follow municipal, regional, and national regulations
Non-hazardous Waste: May qualify for non-hazardous waste stream but confirmation with local authority advised
Reuse and Recycling: Product residues and spilled material, if uncontaminated, may be recoverable or recyclable in suitable applications

Transport Information

UN Number: Not regulated for transport
Proper Shipping Name: Not dangerous goods
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Marine Pollutant: Not classified
Special Precautions: Transport in sealed, upright containers away from incompatible materials and excessive heat

Regulatory Information

US TSCA: Listed
FDA Status: Approved for use as food additive (21 CFR 172.836)
EU EINECS/ELINCS: Exempt (polymer); regulated under E number E436
OSHA Regulation: Not hazardous chemical
SARA Title III: Not subject to reporting under Sections 302, 304, 313
Canadian DSL: Listed
Other Regulations: Check compliance with local and regional regulations for workplace handling, disposal, and labeling