Choleth-24
What Is It?
Choleth-24 is the polyethylene glycol etherAn organic compound that contains an oxygen atom bound to two hydrocarbon groups. An ether compound is often represented by R-O-R’. of cholesterol that has an average of 24 ethylene glycol units. It is a waxy solid used in the formulation of makeup, lotions, and skin and hair care products.
Why Is It Used?
Choleth-24 reduces the surface tension of cosmetic ingredients which helps to form 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).. The efficacy of emulsifying agents depends on their ability to reduce surface tension, to form complex films on the surface of emulsified droplets, and to create a repulsive barrier on emulsified droplets to prevent their coalescence.
Scientific Facts
Choleth-24 is the polyethylene glycol ether of Cholesterol. Choleth-24 is derived from the cholesterol fraction of lanolin from sheep’s wool.
Safety Information
The safety of Choleth-24 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 concluded that Choleth-24 is safe for topical application to humans in the present practices of use and concentration.
In 2002, as part of the scheduled re-review of ingredients, the CIR Expert Panel considered available new data on this ingredient and reaffirmed the above conclusion.
CIR Safety Review: The CIR Expert Panel noted that their earlier review of the safety of the Laneth ingredients was relevant to the safety assessment of the Choleth ingredients because of their similarity. The CIR Expert Panel already determined the Laneths to be safe at concentrations used in cosmetic formulations. Results from irritation and sensitization studies with Choleths correspond well with those for Laneths. Choleth-24 (undiluted and in formulation) was found to be nonirritating to mildly irritating and nonsensitizing. Limited data were available for the phototoxicity and photoallergenicity of Choleth-24 but clinical experience with it and the Laneths reveals no evidence suggesting that Choleth-24 is phototoxic or photoallergenic. Small amounts of 1,4-dioxane, a by-product of ethoxylation, may be found in Choleth-24. 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…
Choleth-24 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.. 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
Choleth is the ethoxylated cholesterol fraction of lanolin alcohol and 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. – emulsifying agent in cosmetics. Choleths are related to another group of lanolin-derived ingredients, Laneths, which may contain as much as 38% Choleth.
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/