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POLYSORBATE 80

Polysorbate 80 is a nonionic surfactant, emulsifier, solubilizer, and dispersing agent produced by the ethoxylation of sorbitan monooleate — the ester of sorbitan (a dehydrated sugar alcohol derived from sorbitol) and oleic acid (a C18 monounsaturated fatty acid) — with approximately 20 moles of ethylene oxide, yielding a viscous, amber-colored to yellow-brown oily liquid with an HLB value of approximately 15, a molecular weight of approximately 1,310 g/mol, and a critical micelle concentration of 0.012 mM in pure water, that is miscible with water, soluble in ethanol, cottonseed oil, corn oil, ethyl acetate, methanol, and toluene, and practically insoluble in fatty oils and liquid paraffin.
Polysorbate 80 functions simultaneously as an oil-in-water (O/W) emulsifier, solubilizer, wetting agent, dispersing agent, and stabilizer across cosmetics and personal care, pharmaceuticals, food and beverage, agrochemicals, textiles, coatings, inks, and industrial chemical formulations, and is one of the most widely used members of the polysorbate surfactant family globally, distinguished by its oleic acid lipophilic group, its high water solubility, its excellent compatibility with anionic, cationic, and amphoteric ingredients, and its low toxicity and broad regulatory approval profile.
Polysorbate 80 is approved as a food additive under E number E433 in the European Union under Regulation (EC) No 1333/2008, is GRAS-approved by the US FDA, is used as a pharmaceutical excipient complying with USP-NF, EP, BP, and JP monographs, is listed in REACH and CLP-related regulatory datasets under ECHA (EC/List Number 500-019-9, CAS 9005-65-6), and is generally not classified as hazardous under GHS/CLP under current regulatory assessment.

CAS Number: 9005-65-6
EC Number: 500-019-9
Molecular Formula: C₆₄H₁₂₄O₂₆ (representative average; polydisperse mixture)
Molecular Weight: ~1,310 g/mol (average; polydisperse)

Synonyms: Polysorbate 80, Polyoxyethylene (20) Sorbitan Monooleate, PEG-20 Sorbitan Monooleate, Sorbitan Monooleate Ethoxylated, Tween 80, Kolliphor PS 80, Montanox 80, Alkest TW 80, Scattics, Canarcel, Poegasorb 80, Kotilen-80, PS 80, E433, INS 433, Sorbimacrogol Oleate 300, (x)-Sorbitan Mono-9-Octadecenoate Poly(Oxy-1,2-Ethanediyl), CAS 9005-65-6, RTECS WG2932500

Polysorbate 80 is derived from polyethoxylated sorbitan and oleic acid; the hydrophilic groups in Polysorbate 80 are polyethers (polyoxyethylene groups, polymers of ethylene oxide) and in the nomenclature of polysorbates the numeric designation "80" refers to the lipophilic group — oleic acid — distinguishing it from Polysorbate 20 (lauric acid), Polysorbate 40 (palmitic acid), and Polysorbate 60 (stearic acid).
Polysorbate 80 is identified by ECHA InfoCard 100.105.529, UNII 6OZP39ZG8H, CompTox DTXSID0021175, ChEMBL ChEMBL1697847, KEGG D01067, RTECS WG2932500, and is commercially available under the brand names Tween 80 (registered trademark of Croda Americas, Inc.), Kolliphor PS 80 (BASF), Montanox 80 (Seppic), and Kotilen-80 (Kolb AG).

Polysorbate 80 is a polydisperse mixture because the ethoxylation reaction produces a distribution of polyethylene oxide chain lengths; the representative molecular formula C₆₄H₁₂₄O₂₆ and the average molecular weight of approximately 1,310 g/mol represent the statistical average of this mixture; high HLB value (~15) makes Polysorbate 80 strongly hydrophilic and particularly effective for oil-in-water emulsification and for solubilizing essential oils and fragrance oils into clear aqueous formulas without cloudiness.
Polysorbate 80 is not a scheduled substance under CLP/GHS regulation, is biodegradable in the natural environment, is safe for the aquatic environment at normal use concentrations, is non-ionic and therefore fully compatible with cationic, anionic, and amphoteric ingredients, and the cosmetic grade may contain more impurities than pharmaceutical or food grade material — the appropriate grade must be selected for each regulated application.

Uses of Polysorbate 80:
Polysorbate 80 is used in cosmetics and personal care products including body sprays, room mists, face and body lotions, creams, serums, toners, micellar waters, shampoos, conditioners, cleansing gels, cleansing oils, bath oils, bath bombs, sugar and salt scrubs, whipping and foaming body creams, shower gels, deodorants without alcohol, air fresheners, anti-hair loss products, and sparkling bath balls as a solubilizer for essential oils and fragrance oils into water-based systems, as an O/W emulsifier, as a surfactant that lowers surface tension, and as a wetting and dispersing agent at typical use levels of 1–2% for leave-on skin products and up to 5–10% for rinse-off cleansers.
Polysorbate 80 is used in cosmetic formulations to help essential oils, fragrance oils, carrier oils (sunflower, argan, and other thick carrier oils), and other oil-based active ingredients blend seamlessly into water-based systems, preventing separation and cloudiness; it is characteristically added during the oil phase of formulation to achieve a uniform consistency, and it helps creams, lotions, and gels remain stable particularly in cold-process formulations.

Polysorbate 80 is used as a pharmaceutical excipient and stabilizer in oral and topical pharmaceutical products, in soft gel formulations, in liquid medicines and vitamin oils, in injectable drug formulations and biologics as a protein aggregation inhibitor, in vaccines (influenza vaccines contain 2.5 µg of Polysorbate 80 per dose; it is found in many US vaccines including the Janssen COVID-19 vaccine), in the antiarrhythmic drug amiodarone as an emulsifier, in the estrogen-regulating drug Estrasorb as an emulsifier, in granulation for stabilization of drugs and excipients during IPA binding, and in tablet excipient formulations; pharmaceutical-grade Polysorbate 80 complies with USP-NF, EP, BP, and JP monographs.
Polysorbate 80 is used as a food additive (E433) in ice cream at up to 0.5% (v/v) to make the ice cream smoother and easier to handle, to increase its resistance to melting, and to prevent milk proteins from completely coating fat droplets allowing them to join in chains and nets that hold air in the mixture providing a firmer texture; it is also used in dairy products, baked goods, beverages, sauces, dressings, non-dairy creamers, chocolate, and flavored foods as an emulsifier and stabilizer to improve texture, extend shelf life, prevent oil-water separation, and ensure even distribution of flavors, colors, and fat-soluble vitamins.

Polysorbate 80 is used in the pharmaceutical biotechnology laboratory for culture of Mycobacterium tuberculosis in Middlebrook 7H9 broth, and as a neutralizer on RODAC agar plates used in microbiological control to counteract disinfectants often found on sampled surfaces, allowing microbes to grow for identification; it is also used in a colorimetric mycobacterial lipase assay — species containing lipase break down Polysorbate 80 causing a phenol red indicator solution to change color, enabling phenotypic identification of strains.
Polysorbate 80 is used in agrochemical formulations as an emulsifier and wetting agent in emulsifiable concentrate (EC), soluble liquid (SL), emulsion-in-water (EW), microemulsion (ME), wettable powder (WP), and water-dispersible granule (WG) formulations to prepare stable pesticide emulsions and suspensions, enhancing adhesion and penetration of the pesticide solution on plant leaves and improving efficacy.

Polysorbate 80 is used in the textile industry as a fabric leveling agent and softener to improve uniform adsorption of dyes and enhance fabric feel, as an antistatic agent for fibers to eliminate static electrostatics, and to improve the efficiency and effectiveness of the dyeing process.
Polysorbate 80 is used in industrial coatings, inks, and paints as a pigment dispersant to improve the dispersibility of pigments in water-based systems, enhance coating leveling, and improve ink printability; it is also used in cooling fluids containing conventional base oils and in flame retardant hydraulic fluids for its emulsifying properties, and in drilling fluids as a dispersant and emulsifier.

Polysorbate 80 is used in the explosives industry as an emulsifier in explosive formulations in the form of emulsions, where its ability to form stable water-in-oil emulsions is critical for the production of emulsion explosives used in mining and construction.
Polysorbate 80 is used in the metalworking industry as a component of metalworking fluids (MWF), soluble oils, and emulsifiable cutting oils to stabilize oil-in-water emulsions, improve lubrication efficiency, and extend fluid service life in machining operations.

Benefits or Advantages of Polysorbate 80:
Polysorbate 80 has a high HLB value of approximately 15, making it one of the most effective nonionic surfactants for oil-in-water emulsification and for the solubilization of essential oils, fragrance oils, and other hydrophobic ingredients into clear aqueous systems without cloudiness or precipitation.
Polysorbate 80 is a nonionic surfactant and is therefore fully compatible with anionic (sulfates, carboxylates), cationic (quaternary ammonium), and amphoteric (betaines) ingredients across cosmetic, pharmaceutical, food, and industrial formulations, enabling its use in virtually any formulation type without risk of ionic incompatibility.

Polysorbate 80 is generally regarded as a low-hazard material with low acute toxicity, no skin sensitization classification, no respiratory sensitization classification, no mutagenicity, no carcinogenicity, and no reproductive toxicity classification under current GHS assessment, supporting its widespread use in food, pharmaceutical, and cosmetic applications.
Polysorbate 80 has broad regulatory approval: it is GRAS (US FDA), E433 (EU food additive), USP-NF/EP/BP/JP (pharmaceutical grade), REACH registered (EC 500-019-9), and not classified as a hazardous substance, giving formulators confidence in its regulatory compliance across multiple markets and application categories.

Polysorbate 80 is biodegradable in the natural environment, has low volatility (flash point minimum 150°C), is not classified as a marine pollutant or environmentally hazardous substance for transport purposes, and is generally not regulated as dangerous goods under ADR/RID, IMDG, or IATA/ICAO, simplifying storage, handling, and transport logistics.
Polysorbate 80 is a plant-derived ingredient from sorbitol and oleic acid, can be sourced from vegetable-origin oleic acid, and carries an antistatic function useful in textile and plastic applications, making it a multifunctional single-ingredient solution across personal care, pharmaceutical, food, and industrial systems.

Features of Polysorbate 80:
Polysorbate 80 is a viscous, amber-colored to yellow-brown oily liquid at ambient temperature with a mild characteristic odor, density of approximately 1.08–1.102 g/mL, refractive index n20/D 1.473, melting point approximately -25°C (solidifies below approximately -20°C), boiling point greater than 100°C, flash point minimum 150°C, viscosity of approximately 300–500 centistokes at 25°C, and pH of 5–7 (aqueous solution).
Polysorbate 80 is miscible with water (solubility approximately 100 mL/L), soluble in ethanol, cottonseed oil, corn oil, ethyl acetate, methanol, and toluene, and practically insoluble in fatty oils and liquid paraffin; its critical micelle concentration (CMC) in pure water is approximately 0.012 mM, confirming its high surfactant efficiency and self-assembly into micelles at very low concentrations.

Polysorbate 80 has an HLB (hydrophilic-lipophilic balance) value of approximately 15, classifying it as a strongly hydrophilic emulsifier ideal for O/W emulsions; it is typically used at 1–2% in leave-on cosmetic products, up to 5–10% in rinse-off cleansers, and recommended at 1–50% for various applications depending on formulation requirements.
Polysorbate 80 is a nonionic surfactant; its molecular structure contains both hydrophilic polyethylene oxide chains (providing water solubility and the high HLB) and lipophilic oleic acid and sorbitan portions (providing oil affinity and interfacial activity), enabling it to position itself at oil-water interfaces and reduce interfacial tension, stabilizing emulsions and solubilizing hydrophobic ingredients into aqueous systems.

Chemical Properties of Polysorbate 80:
Polysorbate 80 has the IUPAC name polyoxyethylene (20) sorbitan monooleate and the systematic name (x)-sorbitan mono-9-octadecenoate poly(oxy-1,2-ethanediyl); it is produced by ethoxylation of sorbitan monooleate with ethylene oxide, and its representative molecular formula is C₆₄H₁₂₄O₂₆ with average molecular weight approximately 1,310 g/mol, though in practice it is a polydisperse mixture with a distribution of polyoxyethylene chain lengths.
Polysorbate 80 is chemically stable under recommended storage conditions and not classified as reactive; it may undergo ester hydrolysis under prolonged exposure to strong acids or strong bases, and may be oxidized by strong oxidizing agents; its polyoxyethylene chains can undergo slow oxidative degradation over extended storage, generating peroxides, which is why peroxide value is controlled in pharmaceutical specifications.

Polysorbate 80 is not classified as explosive, not oxidizing, not self-reactive, and not flammable at ambient temperature (flash point minimum 150°C); it has low vapor pressure at ambient temperature, minimizing inhalation exposure under normal handling conditions; thermal decomposition above the flash point may generate carbon monoxide, carbon dioxide, aldehydes, organic acids, and irritating organic fumes.
Polysorbate 80 has a saponification value of 45–55 mg KOH/g, hydroxyl value of 65–80 mg KOH/g, acid value of maximum 2.0 mg KOH/g, iodine value of 18–24 g I₂/100g, and water content of maximum 3.0% (Karl Fischer) in commercial pharmaceutical and food grades.

Production of Polysorbate 80:
Polysorbate 80 is produced commercially in a two-stage process: sorbitol is first dehydrated under acidic conditions to produce sorbitan (a cyclic anhydrosorbitol), which is then esterified with oleic acid under controlled temperature and pressure to yield sorbitan monooleate (Span 80); the sorbitan monooleate is then subjected to ethoxylation by reaction with approximately 20 moles of ethylene oxide per mole of sorbitan monooleate in the presence of an alkaline catalyst at elevated temperature and pressure, producing the final Polysorbate 80 product with its characteristic polyoxyethylene hydrophilic chains.
Polysorbate 80 quality is controlled through verification of acid value (≤2.0 mg KOH/g), saponification value (45–55 mg KOH/g), hydroxyl value (65–80 mg KOH/g), iodine value (18–24), water content (≤3.0% KF), peroxide value, 1,4-dioxane residue, ethylene oxide residue, fatty acid composition, heavy metals, and microbiological quality for pharmaceutical and food grades; cosmetic grades may have higher levels of impurities than pharmaceutical or food grades.

Polysorbate 80 is commercially available in cosmetic grade, food grade (E433), and pharmaceutical grade (USP-NF, EP, BP, JP) from major global producers including Croda (Tween 80), BASF (Kolliphor PS 80), Seppic (Montanox 80), Kolb AG (Kotilen-80), PCC Exol SA (ROKwinol 80), and other specialty chemical producers.
Polysorbate 80 is supplied in drum, IBC, and bulk tanker packaging as a clear to amber viscous liquid; it should be stored in tightly sealed containers at 15–25°C in a cool, dry, well-ventilated area protected from excessive heat, direct sunlight, freezing conditions (solidifies below approximately -20°C), and strong oxidizing agents; shelf life is typically 24 months in original sealed containers under recommended conditions.

Material Safety Data Sheet (MSDS) of Polysorbate 80:

Handling of Polysorbate 80:
Polysorbate 80 should be handled in accordance with good industrial hygiene practices and in compliance with the applicable Safety Data Sheet; it is generally regarded as a low-hazard material, but prolonged eye and skin contact should be avoided, generated aerosols or mist should not be inhaled, and spills should be cleaned up immediately as the liquid creates extremely slippery surfaces.
Polysorbate 80 handling requires keeping containers tightly closed when not in use, protecting the product from excessive heat and oxidation, using only the appropriate grade (food, pharmaceutical, or cosmetic) for regulated applications, and washing hands thoroughly after handling.

SDS of Polysorbate 80:

Stability and Reactivity of Polysorbate 80:

Chemical stability:
Polysorbate 80 is stable under recommended storage conditions in sealed containers at 15–25°C protected from heat, oxidation, and contamination.

Reactivity:
No hazardous reactions are normally expected during proper use.
Polysorbate 80 may undergo ester hydrolysis under prolonged exposure to strong acids or strong bases.
Strong oxidizing agents may react with the organic material.

Conditions to avoid:
Excessive heat and prolonged high-temperature exposure.
Direct flame.
Freezing conditions (solidifies below approximately -20°C; re-warm gently to restore liquid state).
Prolonged exposure to strong oxidizing agents.
Contamination.

Incompatible materials:
Strong oxidizing agents.
Strong acids.
Strong bases.
Highly reactive chemicals.

Hazardous decomposition products:
Carbon monoxide (CO).
Carbon dioxide (CO2).
Aldehydes.
Organic acids.
Irritating organic fumes (under severe heating or combustion conditions).

Handling and Storage of Polysorbate 80:

Handling:
Handle in accordance with good industrial hygiene practices.
Avoid prolonged eye and skin contact.
Avoid inhaling aerosol or mist generated during high-temperature processing or spraying.
Clean spills immediately — Polysorbate 80 creates severely slippery surfaces.
Keep containers tightly closed when not in use.
Use appropriate grade (food, pharmaceutical, cosmetic) for the intended regulated application.
Wash hands after handling.

Storage:
Store in tightly sealed containers at 15–25°C in a cool, dry, well-ventilated area.
Protect from excessive heat, direct sunlight, and strong oxidizing agents.
Avoid freezing (solidifies below approximately -20°C); warm gently to restore liquid state if frozen.
Shelf life: typically 24 months in original sealed containers under recommended storage conditions.

First Aid Measures of Polysorbate 80:

Inhalation:
Move affected person to fresh air.
If mist or aerosol causes respiratory irritation, seek medical advice.

Skin contact:
Wash affected skin with soap and water.
Polysorbate 80 is not generally expected to cause serious skin irritation; seek medical advice if redness or irritation develops or persists.

Eye contact:
Rinse immediately with plenty of clean water for at least 15 minutes while holding eyelids open.
Seek medical attention if irritation, redness, or discomfort persists.

Ingestion:
Polysorbate 80 has low acute oral toxicity (it is used as a food additive at regulated levels).
Rinse mouth with water.
Seek medical advice if large quantities are ingested or gastrointestinal symptoms (nausea, abdominal discomfort, diarrhea) develop.

Firefighting Measures of Polysorbate 80:

Suitable extinguishing media:
Foam, dry chemical powder, carbon dioxide, or water spray.

Specific hazards:
Polysorbate 80 has a flash point of minimum 150°C and is not readily flammable under normal conditions; it may burn under intense fire.
Thermal decomposition produces carbon monoxide, carbon dioxide, aldehydes, and irritating organic fumes.

Protective equipment for firefighters:
Wear self-contained breathing apparatus (SCBA) and full protective clothing.

Firefighting instructions:
Cool exposed containers with water spray.
Prevent contaminated firefighting water from entering drains or waterways.

Accidental Release Measures of Polysorbate 80:

Personal precautions:
Spilled Polysorbate 80 creates an extremely slippery surface — contain immediately and prevent personnel from slipping.
Avoid skin and eye contact; wear gloves and eye protection.

Environmental precautions:
Prevent large quantities of Polysorbate 80 from entering drains or waterways; high organic loading may increase oxygen demand during environmental degradation.

Methods for cleaning up:
Absorb with sand, diatomaceous earth, vermiculite, or other inert absorbent; collect into labeled waste containers.
Clean contaminated surfaces with detergent and water after bulk material removal.
Ventilate area after cleanup.

Exposure Controls / Personal Protective Equipment of Polysorbate 80:

Engineering controls:
Provide adequate general ventilation; use local exhaust ventilation where mist or aerosol may be generated during heated processing or spray application.

Eye protection:
Wear safety glasses with side shields; use chemical splash goggles where splashing is possible.

Hand protection:
Wear nitrile or other chemical-resistant gloves for prolonged handling.

Skin and body protection:
Wear suitable protective clothing where splash exposure is possible.

Respiratory protection:
Not normally required under adequate ventilation for non-volatile Polysorbate 80 at ambient temperature; use appropriate mist/aerosol respirator during spray application or heated processing.

Hygiene measures:
Wash hands after handling Polysorbate 80 and before eating, drinking, or smoking; do not eat or drink in handling areas.

Identifiers of Polysorbate 80:
CAS Number: 9005-65-6
EC Number: 500-019-9
ECHA InfoCard: 100.105.529
IUPAC Name: Polyoxyethylene (20) sorbitan monooleate
INCI Name: Polysorbate 80
E Number: E433 (EU food additive)
Molecular Formula: C₆₄H₁₂₄O₂₆ (representative average)
Molecular Weight: ~1,310 g/mol (average)
UNII: 6OZP39ZG8H
CompTox (EPA): DTXSID0021175
ChEMBL: ChEMBL1697847
KEGG: D01067
RTECS: WG2932500
HLB Value: ~15 (strongly hydrophilic; O/W emulsifier)
CMC (water): ~0.012 mM
GHS Classification: Not classified as hazardous
US FDA: GRAS; food additive approved
EU: E433 (food additive, Regulation EC 1333/2008)
Pharmacopeial grades: USP-NF; EP; BP; JP
Transport: Not classified as dangerous goods (ADR/RID, IMDG, IATA)
Ionic character: Nonionic

Properties of Polysorbate 80:
Physical state: Liquid (viscous)
Appearance: Amber-colored to yellow-brown viscous oily liquid
Odor: Mild characteristic odor
Density: ~1.08–1.102 g/mL
Viscosity: ~300–500 centistokes at 25°C
Melting point: ~-25°C (solidifies below approximately -20°C)
Boiling point: >100°C
Flash point: ≥150°C
Refractive index (n20/D): 1.473
pH: 5–7 (aqueous solution)
HLB value: ~15 (strongly hydrophilic; O/W)
CMC (pure water): ~0.012 mM
Solubility in water: Miscible (~100 mL/L)
Solubility in ethanol: Soluble
Solubility in organic solvents: Soluble in cottonseed oil, corn oil, ethyl acetate, methanol, toluene
Solubility in fatty oils/liquid paraffin: Practically insoluble
GHS: Not classified
Transport: Not classified as dangerous goods

Specifications of Polysorbate 80:
Product name: Polysorbate 80
CAS Number: 9005-65-6
EC Number: 500-019-9
INCI Name: Polysorbate 80
E Number: E433
Molecular Formula: C₆₄H₁₂₄O₂₆ (representative)
Molecular Weight: ~1,310 g/mol (average)
Appearance: Amber to yellow-brown viscous oily liquid
Odor: Mild characteristic
Acid value: ≤2.0 mg KOH/g
Saponification value: 45–55 mg KOH/g
Hydroxyl value: 65–80 mg KOH/g
Iodine value: 18–24 g I₂/100g
Water content: ≤3.0% (Karl Fischer)
Flash point: ≥150°C
pH: 5–7
Density: ~1.08–1.102 g/mL
Viscosity: ~300–500 cSt (25°C)
HLB: ~15
Grades: Food grade (E433); Pharmaceutical grade (USP-NF/EP/BP/JP); Cosmetic grade
Storage: 15–25°C; sealed; cool, dry, ventilated; protect from heat, oxidation, freezing

Names of Polysorbate 80:
Polysorbate 80
Polyoxyethylene (20) Sorbitan Monooleate
PEG-20 Sorbitan Monooleate
Sorbitan Monooleate Ethoxylated
Tween 80
Kolliphor PS 80
Montanox 80
Alkest TW 80
Kotilen-80
Scattics
Canarcel
Poegasorb 80
PS 80
E433
INS 433
Sorbimacrogol Oleate 300
ROKwinol 80
CAS 9005-65-6

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