PEG-6 Sorbitan Oleate

What Is It?

The PEGs Sorbitan and Sorbitol Fatty Acid Esters (PEG-20 Sorbitan Cocoate, PEG-40 Sorbitan Diisostearate, PEG-2 Sorbitan Isostearate, PEG-5 Sorbitan Isosteatate, PEG-20 Sorbitan Isostearate, PEG-40 Sorbitan Lanolate, PEG-75 Sorbitan Lanolate, PEG-10 Sorbitan Laurate, PEG-40 Sorbitan Laurate, PEG-44 Sorbitan Laurate, PEG-75 Sorbitan Laurate, PEG-80 Sorbitan Laurate, PEG-3 Sorbitan Oleate, PEG-6 Sorbitan Oleate, PEG-80 Sorbitan Palmitate, PEG-40 Sorbitan Perisostearate, PEG-40 Sorbitan Peroleate, PEG-3 Sorbitan Stearate, PEG-6 Sorbitan Stearate, PEG-40 Sorbitan Stearate, PEG-60 Sorbitan Stearate, PEG-30 Sorbitan Tetraoleate, PEG-40 Sorbitan Tetraoleate, PEG-60 Sorbitan Tetraoleate, PEG-60 Sorbitan Tetrasterate, PEG-160 Sorbitan Triisostearate; PEG-20 Sorbitan Triisostearate, Sorbeth-40 Hexaoleate, Sorbeth-50 Hexaoleate, Sorbeth-30 Tetraoleate Laurate, Sorbeth-60 Tetrastearate) range from tan, waxy solids and amber-colored pastes to clear yellow liquids. The PEGs Sorbitan and Sorbitol Fatty Acid Esters are used in the formulation of a variety of products, including shampoos, hair conditioners, hair dyes and colors, bath products, skin cleansers, skin fresherners, makeup bases and foundations, and other hair and skin care products

Why is it used in cosmetics and personal care products?

The PEG Sorbitan/Sorbitol Fatty Acid Esters help to form emulsions by reducing the surface tension of the substances to be emulsified and they help other ingredients to dissolve in a solvent in which they would not normally dissolve. The PEGs Sorbitan/Sorbitol Fatty Acid Esters also clean the skin and hair by helping water to mix with oil and dirt so that they can be rinsed away.

Scientific Facts:

The PEG Sorbitan/Sorbitol Fatty Acid Esters are ethoxylated sorbitan and sorbitol esters of fatty acids. In cosmetics and personal care products, the PEG Sorbitan/Sorbitol Fatty Acid Esters function as surfactants (emulsifying, cleansing, and solubilizing agents).

Safety Information:

The safety of PEGs Sorbitan/Sorbitol Fatty Acid Esters has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that PEG-20 Sorbitan Cocoate, PEG-40 Sorbitan Diisostearate, PEG-2 Sorbitan Isostearate, PEG-5 Sorbitan Isosteatate, PEG-20 Sorbitan Isostearate, PEG-40 Sorbitan Lanolate, PEG-75 Sorbitan Lanolate, PEG-10 Sorbitan Laurate, PEG-40 Sorbitan Laurate, PEG-44 Sorbitan Laurate, PEG-75 Sorbitan Laurate, PEG-80 Sorbitan Laurate, PEG-3 Sorbitan Oleate, PEG-6 Sorbitan Oleate, PEG-80 Sorbitan Palmitate, PEG-40 Sorbitan Perisostearate, PEG-40 Sorbitan Peroleate, PEG-3 Sorbitan Stearate, PEG-6 Sorbitan Stearate, PEG-40 Sorbitan Stearate, PEG-60 Sorbitan Stearate, PEG-30 Sorbitan Tetraoleate, PEG-40 Sorbitan Tetraoleate, PEG-60 Sorbitan Tetraoleate, PEG-60 Sorbitan Tetrasterate, PEG-160 Sorbitan Triisostearate, PEG-20 Sorbitan Triisostearate, Sorbeth-40 Hexaoleate, Sorbeth-50 Hexaoleate, Sorbeth-30 Tetraoleate Laurate, Sorbeth-60 Tetrastearate were safe for use as cosmetic ingredients.

More safety Information:

CIR Safety Review: Related ingredients, the Polysorbates were previously reviewed by the CIR Expert Panel. Most of the available safety test data related to the Polysorbates or their components; Sorbitan Fatty Acids, PEGs, and Fatty Acids which also have completed safety assessments. These ingredients were readily hydrolyzed by blood and pancreatic lipases, with the fatty acid moiety absorbed and metabolized as any dietary fatty acid and the PEG Sorbitan moiety excreted mainly in the urine. 

Polysorbates had low toxicity in both acute and long-term toxicity studies. Sorbitan Esters and PEGs also were relatively nontoxic. Growth retardation and diarrhea, microscopic changes of the urinary bladder, spleen, kidneys, and gastrointestinal tract, and decreased body and organ weights, and hepatic lesions were noted in subchronic feeding studies, whereas other studies found no effects. One chronic toxicity study noted microscopic lesions of the urinary bladder, kidneys, spleen, and gastrointestinal tract, whereas other studies were negative. 

The Polysorbates were nonirritating to mildly irritating in both in ocular an dermal irritation assays at concentrations ranging from 1% to 100%. In developmental toxicity studies of thalidomide, the PEG-20 Sorbitan Laurate vehicle (10 ml/kg) had no effect on the developing embryo. In other studies, reproductive and developmental effects were seen primarily at exposure levels that were maternally toxic. In subchronic and chronic oral toxicity studies, PEGs did not cause adverse reproductive effects. The Polysorbates were nonmutagenic in a number of test systems. 

Data were available showing that treatment of cells in culture with Sorbitan Oleate reduces DNA repair following UV irradiation, but these data were not considered significant in view of the available carcinogenesis data. The Polysorbates were not oral or dermal carcinogens. Data on the cocarcinogenesis of certain Sorbitan Esters were positive, but only with high exposure levels and a high frequency of exposure, and the results lacked a dose-response. The Polysorbates also had antitumor activity in some studies. 

The Polysorbates had little potential for human skin irritation, sensitization, and phototoxicity in extensive clinical studies. Likewise, PEGs were nonsensitizers, but cases of kidney toxicity were observed in burn patients that were treated with PEG-based topical ointments. Overall, these data were considered an adequate basis for assessing the safety of the entire group of ingredients. 

The CIR Expert Panel concluded that these ingredients were safe for use in cosmetics at the levels in current use (not more than a 25% concentration) with the caveat that they should not be used on damaged skin. Small amounts of 1,4-dioxane, a by-product of ethoxylation, may be found in PEG Sorbitan/Sorbitol Fatty Acid Esters. The potential presence of this material is well known and can be controlled through purification steps to remove it from the ingredients before blending into cosmetic formulations. 

Link to more information about what the Food and Drug Administration (FDA) is doing to assure that cosmetics do not contain unsafe levels of 1,4-dioxane.
 

When all components are derived from plants, the PEG Sorbitan/Sorbitol Fatty Acid Esters may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union. Ingredients of animal origin must comply with European Union animal by-products regulations. 

EU Cosmetic Regulation