PEG-5 Soy Sterol

What Is It?

PEG-5 Soy Sterol, PEG-10 Soy Sterol, PEG-16 Soy Sterol, PEG-25 Soy Sterol, PEG-30 Soy Sterol and PEG-40 Soy Sterol are waxy solids. In cosmetics and personal care products, PEG Soy Sterol ingredients are used in the formulation of moisturizers, skin care and cleansing products, shampoos, and eye and facial makeup.

Why Is It Used?

PEG Soy Sterol ingredients help to form emulsions by reducing the surface tension of the substances to be emulsified. PEG-5 and -10 Soy Sterol also enhance the appearance of dry or damaged skin by reducing flaking and restoring suppleness. PEG-40 Soy Sterol also helps other ingredients to dissolve in a solvent in which they would not normally dissolve and cleans the skin and hair by helping water to mix with oil and dirt so that they can be rinsed away.

Scientific Facts

Polyethylene Glycol (PEG) Soy Sterol, or PEG Soya Sterol ingredients, are produced from distilled soybean oil. PEG Soy Sterol ingredients are manufactured by reacting soybean oil sterols with a specific number of units of ethylene oxide. The number in the ingredient name corresponds to the average PEG chain length.

Safety Information

The safety of the PEG Soy Sterol ingredients has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that PEG-5, -10, -16, -25 and -40 Soy Sterol were safe as used in cosmetics and personal care products.

CIR Safety Review: Because PEGs are an underlying structure in the PEG Soy Sterol ingredients, the previous assessment of PEGs was considered. It was recognized that the PEG monomer, ethylene glycol, and certain of its monoalkyl ethers are reproductive and developmental toxins. Given the methods of manufacture of PEGs Soy Sterol, there is no likelihood of ethylene glycol or its alkyl ethers being present. Also, the soybean oil sterol ethers in this ingredient were considered chemically different from the ethylene glycol alkyl ethers of concern. PEGs were not carcinogenic, although kidney toxicity has been reported in burn patients treated several times per day with a PEG-based cream.

No evidence of systemic toxicity or sensitization was found in studies with intact skin. PEG-5-25 Soy Sterol ingredients were not irritants when applied undiluted. Undiluted PEG-5 Soy Sterol did not cause sensitization. PEG Soy Sterol ingredients did not produce ocular toxicity. PEG-5 Soy Sterol was negative in bacterial mutagenicity tests, with or without metabolic activation. PEG-5 Soy Sterol, at concentrations up to 2% in formulation, did not cause dermal or ocular irritation, dermal sensitization, or photosensitization in clinical studies.

Based on the kidney effects observed with PEGs applied to burned skin, it was recommended that PEG Soy Sterol ingredients should not be used in cosmetics and personal care products applied to damaged skin. Small amounts of 1,4-dioxane, a by-product of ethoxylation, may be found in the PEG Soy Sterol ingredients. 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.
http://www.fda.gov/Cosmetics/ProductandIngredientSafety/PotentialContami…

PEG Soy Sterol ingredients 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.

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

More Scientific Information

The PEG Soy Sterol ingredients are polyethylene glycol derivatives of soybean oil sterols. The soy sterols include campesterol, stigmasterol, and beta-sitosterol. The distribution of sterols found in oils derived from common plants is similar, with beta-sitosterol comprising a major component. In cosmetics and personal care products, PEG Soy Sterol ingredients function as surfactants – emulsifying agents. PEG-5 and -10 Soy Sterol also function as skin conditioning agents – miscellaneous and PEG-40 Soy Sterol is used as a surfactant – cleansing agent and a surfactant – solubilizing agent.