POLYSORBATE 80

POLYSORBATE 80

CAS NO: 9005-65-6
EC NO: 500-019-9

SYNONYMS:

Polysorbate 80; Polyethyleneglycol sorbitan monooleate; TW 80; Polyoxyethylene (20) sorbitan monooleate; PS 80; PSB 80; PS80; PSB80; Polysorbate 80 (glycol); Polyoxyethylene 20 sorbitan monooleate; POE 20 sorbitan monooleate; Inhibited ethylene glycol, antifreeze; 2-hydroxyethyl 2-deoxy-3,5-bis-O-(2-hydroxyethyl)-6-O-{2-[(9E)-octadec-9-enoyloxy]ethyl}hexofuranoside; PEG-3 Sorbitan oleate; sorbate80; Polyoxyethylene (20); POE(6) Sorbitan Monooleat; POE (5) sorbitan monooleate; Sorethytan (20) mono-oleate; POE (20) sorbitan monooleate; Sorbitan mono-oleate polyoxyethylene; Polyethylene oxi de sorbitan mono-oleate; 2-[2-[3,5-bis(2-hydroxyethoxy)oxolan-2-yl]-2-(2-hydroxyethoxy)ethoxy]ethyl (E)-octadec-9-enoate; Sorbitan, monooleate polyoxyethylene derivative; CAS-9005-65-6; POLYOXYETHYLENESORBITAN MONOOLEATE; (x)-sorbitan mono-9-octadecenoate poly(oxy-1,2-ethanediyl) derivative; Sorbitan, mono-9-octadecenoate, poly(oxy-1,2-ethanediyl) derivative; Sorbitan, mono-(9Z)-9-octadecenoate, poly(oxy-1,2-ethanediyl) derivative; Sorbitan, mono-9-octadecanoate, poly(oxy-1,2-ethanediyl) derivative, (Z)-; 2-hydroxyethyl 2-deoxy-3,5-bis-O-(2-hydroxyethyl)-6-O-[2-(oleoyloxy)ethyl]hexofuranoside; Polyethylene Glycol sorbitan monooleate; Polyoxyethylene sorbitan oleate; Polyoxyethylene sorbitan monooleate; Polyethylene oxide sorbitan mono-oleate; Polyoxyethylene (20) sorbitan monooleate; 9005-65-6; 2-[2-[(2R,3R)-3,4-bis(2-hydroxyethoxy)oxolan-2-yl]-2-(2-hydroxyethoxy)ethoxy]ethyl (Z)-octadec-9-enoate; Tween 80; Twen 80; POE (20) sorbitan monooleate; Polyethylene glycol sorbitan monooleate; Polyoxyethylenesorbitan monooleate; Polyoxyethylene (20) sorbitan monolaurate solution; Polyethylene glycol sorbitan monolaurate solution; Polyoxyethylenesorbitan monolaurate; Ethoxylated sorbitan monooleate 20 EO Polysorbate 80; Non-ionic emulsifier mixture; Polysorbate 80; POE (20) sorbitan monooleate; Polyethylene glycol; sorbitan monooleate; Polyoxyethylenesorbitan; monooleate; Olothorb; Polyoxyaethylen(20)Sorbitanmonooleate; Polyoxyaethylen(5)Sorbitanmonooleate; Sorlate; polyethylene sorbitol ester; (E433); E433; nonionic surfactant; ethoxylated sorbitan ester; polyethylene sorbitol ester; emulsifier; PEG-20 Sorbitan Monooleate; nonionic surfactant ethoxylated fatty acid ester; sorbitol and C18 fatty acid;  ethoxylated sorbitan; E433; E 433

POLYSORBATE 80

Polysorbates are surfactants that are produced by reacting the polyol, sorbitol, with ethylene oxide. The number in the name of the Polysorbate indicates the average number of moles of ethylene oxide that has been reacted per mole of sorbitol. The polyoxyethylenated sorbitan is then reacted with fatty acids obtained from vegetable fats and oils such as lauric acid, palmitic acid, stearic acid and oleic acid. Polysorbates function to disperse oil in water as opposed to water in oil.

Polysorbate 80 is a nonionic surfactant and emulsifier often used in foods and cosmetics. This synthetic compound is a viscous, water-soluble yellow liquid.

Polysorbate 80 is derived from polyethoxylated sorbitan and oleic acid. The hydrophilic groups in this compound are polyethers also known as polyoxyethylene groups, which are polymers of ethylene oxide. In the nomenclature of polysorbates, the numeric designation following polysorbate refers to the lipophilic group, in this case, the oleic acid.

Polysorbates (20,40, 60, 65, 80) are the ethoxylated sorbitan esters which are manufactured by the reaction among sorbitol, a specific fatty acid, and ethylene oxide (an average of 20 polymerized ethylene oxide per molecule of polysorbate 80)

There are generally two steps in the manufacturing process of polysorbate 80:

-Esterification between oleic acid and sorbitol to obtain sorbitan esters.
-Condensation sorbitan esters with ethylene oxide.

Polysorbate 80 can also be produced by reacting sorbitol and ethylene oxide first then esterified with oleic acid.

-Obtaining the mixture of sorbitol and sorbitan by partially dehydrating sorbitol.
-Adding ethylene oxide to the mixture to obtain sorbitan polyethylene ether.
-Reacting it with oleic acid.

The full chemical names for polysorbate 80 are:

-Polyoxyethylene (20) sorbitan monooleate
-(x)-sorbitan mono-9-octadecenoate poly(oxy-1,2-ethanediyl)

The critical micelle concentration of polysorbate 80 in pure water is reported as 0.012 mM.

Polysorbate 80 is a natural vegetable sourced emulsifier which creates solubility between water based ingredients and oil based ingredients. 

Polysorbate 80 is a natural fragrance and essential oil solubilizer. Polysorbate 80 is soluble in alcohol and water; insoluble in oils.

Some cosmetic grade Polysorbate 80 may potentially contain ethylene oxide, 1,4-dioxane and mono- and diethylene glycol as impurities, although worryingly these carcinogenic contaminants have also been picked up in food additives. Generally, the cosmetic grade Polysorbate 80 is more likely to contain these impurities.

Polysorbate 80 is regarded as a safe chemical in skincare and is used as an emulsifier to combine oil and water.

Properties of Polysorbate 

Appearance:
A viscous, lemon to amber-colored oily liquid at 25°C.

Hydrophilic – Lipophilic Balance (HLB):
15, gives oil-in-water emulsions, O/W

Viscosity:
It is also a viscosity agent with the viscosity 300–500 centistokes (@25°C). 

Solubility In Water:
Soluble in water due to the long polyoxyethylene chains.

In Organic Solvents:
Soluble in most solvents, such as ethanol, methanol, ethyl acetate and toluene.

Saponification number 45-55.

Acid number 0-2.

Hydroxyl number 65-80.

Oxyethylene content 65 percent-69.5 percent.

Polysorbate 80 is a super emulsifier and stabilizer that mixes two or more not compatible ingredients not separate, usually oil and water. Commonly used in food and cosmetics, also with a little application in medicines, vaccines and others. 

Food application:

It is used as a defoamer for the fermenting process of some wines, and also to bind some icecreams and other ‘puddings’, to keep their creamy texture without separating. It is also used to bulk foods up and keep sauces smooth.

Food grade Polysorbate 80 helps water-based liquids and oils-based ingredients mixed together easily. Its common food applications are in ice cream, pickles, vitamins and sauce.  

Ice cream
Provide a creamy texture
Hold fat and water together (or maintain the shape) very well
Prevent ice crystals formation
Make ice cream resistant to melt

Pickles
As a solubilizer to disperse food flavors and colors.

Vitamin supplements
As a solubilizing and dispersing agent in fat-soluble vitamins and vitamin-mineral preparations.

Butter sauce
Polysorbate 80 produces the creamy sauce; enables butter and water not separate; makes the milk solids, salts, flavors, colors and other ingredients distributed evenly in the sauce.

Cosmetic application:

It can also act as a surfactant in soaps and cosmetics, as well as a solubilizer – helping to dissolve ingredients so that they can more easily blend together. It is used as a solubilizer. It makes products look creamier and more attractive. 

The cosmetic grade of polysorbate 80 may have more impurities than the food grade.

Polysorbate 80 can be used in Moisture Cream, Moisture Lotion, Cleansers, Shower Gel, Shampoo etc.

Polysorbate 80 can aid the stability of creams, lotions and gels, especially in those made with cold processed by encourgaing the oils and waters to bond easily.

Medical use:

It is used as an ingredient in some vaccines, as well as in some vitamins and supplements. Polysorbate 80 is used to improve the consistency of gel capsules and to make pills disperse in the stomach.

Polysorbate 80 is an excipient that is used to stabilize aqueous formulations of medications for parenteral administration, and used as an emulsifier in the making of the popular antiarrhythmic amiodarone. It is also used as an excipient in some European and Canadian influenza vaccines. Influenza vaccines contain 2.5 μg of polysorbate 80 per dose. Polysorbate 80 is found in many vaccines used in the United States.

It is also used in the culture of Mycobacterium tuberculosis in Middlebrook 7H9 broth. It is also used as an emulsifier in the estrogen-regulating drug Estrasorb.

Also used in granulation for stabilization of drug and excipients while doing IPA binding.

Polysorbate 80 is a versatile and useful ingredient, so it is present in quite a few products. Here is a short, generalized list of where it is most often found:
• Food shortening
• Chewing Gum
• Ice Cream
• Gelatin
• Vitamins
• Soap
• Shampoo
• Cosmetics
• Skin Creams
• Condiments
• Medicines
• Vaccines

Safety

The United States Food and Drug Administration (FDA) allows polysorbate 80 to be directly added to food as adjuvants of flavoring agents or as multipurpose additives. Additionally, polysorbate 80 has FDA approval as an ophthalmic demulcent and may be used in over-the-counter (OTC) ophthalmic drug products.

The safety of polysorbate 80 has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The Panel evaluated the scientific data and concluded that polysorbate 80 was safe as cosmetic ingredients.

Despite the approval of polysorbate 80 by the CIR Expert Panel, there are concerns about the presence of ethylene oxide in this ingredient. This is because the process of ethoxylation may lead to contamination with 1,4-dioxane, a potentially dangerous by-product. In fact, 1,4-dioxane is a known animal carcinogen that penetrates readily into the skin. This ingredient has also been linked with skin allergies.

The Organic Consumers Organization released a fact sheet on 1,4-dioxane based on information from the Campaign for Safe Cosmetics. The fact sheet outlines facts versus myths regarding 1,4-dioxane in personal care products. One concerning fact is that the levels of 1,4-dioxane found in many personal care products are 1,000 times higher than those found to cause cancer in animal studies. They add that according to the FDA, “Skin absorption studies demonstrated that dioxane readily penetrates animal and human skin from various types of vehicles.”

Polysorbate 80 was shown to be nonmutagenic in the Ames and micronucleus tests. The polysorbates have been shown in numerous studies to be noncarcinogenic when administered in a variety of ways to laboratory animals, although Polysorbate 80 produced some neoplastic changes in mixed mouse epidermal and dermal in vitro tissue culture. Multiple studies have shown that the Polysorbates enhance the activity of known chemical carcinogens while not actually being carcinogenic themselves. Proposed mechanisms of this tumor enhancement effect include induction of cellular hyperproliferation, inhibition of DNA repair, and others. The Polysorbates also exhibit tumor growth inhibition activity under certain conditions.