Steareth-4
What Is It?
The Steareth ingredients (Steareth-2, Steareth-4, Steareth-6, Steareth-7, Steareth-10, Steareth-11, Steareth-13, Steareth-15, Steareth-20) are polyethylene glycol ethers of stearci acid. They are waxy compounds. In cosmetics and personal care products, Steareth ingredients are used in the formulation of personal cleanliness products and deodorants, as well as suntan, fragrance, skin, eye and hair products.
Why Is It Used?
When added to cosmetics and personal care products, the Steareth ingredients reduce the interactive forces between molecules of other liquids so that an emulsionA mixture of two liquids that normally cannot be mixed, in which one liquid is dispersed in the other liquid as very fine droplets. Emulsifying agents are often used to help form the emulsion and stabilizing agents are used to keep the resulting emulsion from separating. The most common emulsions are oil-in-water emulsions (where oil droplets are dispersed in water) and water-in-oil emulsions (where water droplets are dispersed in oil). is formed. If an ingredient such as a Steareth is not added to some personal care products, the ingredients in the product would separate like some salad dressings.
Scientific Facts
The Steareths are prepared by reacting ethylene oxide with stearyl alcohol where the numerical value in the name corresponds to the average number of units of ethylene oxide. For example, Steareth-2 is prepared using an average of 2 units of ethylene oxide reacted with stearyl alcohol.
Safety Information
The Food and Drug Administration (FDA) permits fatty alcohols (including stearic alcoholAlcohols are a large class of important cosmetic ingredients but only ethanol needs to be denatured to prevent it from being redirected from cosmetic applications to alcoholic beverages.) reacted with polyethylene glycol to be used as indirect food additives as components of textiles and textile fibers. The safety of Steareth-2, Steareth-4, Steareth-6, Steareth-7, Steareth-10, Steareth-11, Steareth-13, Steareth-15 and Steareth-20 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 these ingredients were safe as cosmetic ingredients in the present practices of use and concentration. In 2006, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on the Steareth ingredients and reaffirmed the above conclusion.
CIR Safety Review: The CIR Expert Panel decided that the data on Steareth-2, -10, and -20 were sufficient to reach a decision on the entire group of Steareth ingredients, including Steareth-4, -6, -11, -13 and -15 because of the chemical similarity of all the Steareths. Steareth-2 and -10 were nontoxic in acute oral toxicity studies. In subchronic testing, Steareth-20 was nontoxic when administered dermally at concentrations of 4%. Steareth-2 and -10, at concentrations up to 60% in water, were at most mildly irritating to eyes and only mild irritants when tested in cosmetic formulations at concentrations up to 60%. Structurally similar polyoxyethylene alkyl ethers were neither mutagenic nor tumor promoters. Steareth-2, -10 and -20 in water were neither primary irritants nor sensitizers to human skin. Steareth-20 was not phototoxic. Small amounts of 1,4-dioxane, a by-product of ethoxylation, may be found in the Steareth 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…
Link to the FDA Code of Federal Regulations:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
Steareth-2, Steareth-4, Steareth-6, Steareth-7, Steareth-10, Steareth-11, Steareth-13, Steareth-15 and Steareth-20 may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union. Ingredients of animal origin must comply with European Union animal by-products regulations.
Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…
More Scientific Information
The Steareth ingredients are a series of polyoxyethylene stearyl ethers. In cosmetics and personal care products, the Steareths function mainly as 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. – emulsifying agents. They may also be used as wetting agents, solubilizers and nonionic surfactants.
Resources
Find out more about the regulation of Food Additives by the Food and Drug Administration
Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm
Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…
Substances Generally Recognized As Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm
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/