PEG-25 Soy Sterol
What Is It?
PEG-5 Soy SterolA class of solid cyclic unsaturated alcohols found in plant and animal tissues. Sterols are waxy and insoluble in water., 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 solventSubstances, usually liquids, that are used to dissolve other substances. 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 ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (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 monomerA molecule that comprises the repeating unit of a polymer., 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 UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..
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 surfactantAn ingredient that helps two substances that normally do not mix to become dissolved or dispersed in one another. Also called a surface active agent. – cleansing agent and a surfactant – solubilizing agent.
Resources
Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/