Diethylhexyl Sodium Sulfosuccinate
What Is It?
Diethylhexyl Sodium Sulfosuccinate, also called Dioctyl Sodium Sulfosuccinate or Sodium Docusate, is a waxy solid. It is used in the formulation of a wide variety of topical products, including bath products, blushers, body and hand preparations, foundations, shaving creams and skin-care products.
Why Is It Used?
Diethylhexyl Sodium Sulfosuccinate enhances the water solubility of other cosmetic ingredients. It also helps form emulsions by reducing the surface tension of the substances to be emulsified and functions 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. or cleansing agent.
Scientific Facts
Diethylhexyl Sodium Sulfosuccinate, often referred to as Dioctyl Sodium Sulfosuccinate, is an anionic surfactant used in a variety of applications, including cosmetics and personal-care products, over-the-counter (OTC) and prescription drugs, and as a food additive.
Safety Information
The Food and Drug Administration (FDA) reviewed the safety of Diethylhexyl Sodium Sulfosuccinate and approved its use as a multipurpose food additive. The safety of Diethylhexyl Sodium Sulfosuccinate was 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 reviewed the scientific data and concluded that Diethylhexyl Sodium Sulfosuccinate was safe as used in topical cosmetic formulations at concentrations up to 5%.
CIR Safety Review: The CIR Expert Panel acknowledged that under the exaggerated exposure conditions of occlusive patch tests, Diethylhexyl Sodium Sulfosuccinate is a cumulative irritant, but not a sensitizer.
The CIR Expert Panel recognized that under exaggerated test conditions, surfactants would be expected to produce some irritation. The CIR Expert Panel stressed that care should be taken to avoid irritancy, especially in those products intended for prolonged contact with the skin.
FDA: Link to Code of Federal Regulations for Diethylhexyl Sodium Sulfosuccinate (under the name Dioctyl Sodium Sulfosuccinate).
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
Diethylhexyl Sodium Sulfosuccinate 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…
The Joint FAO/WHO Expert Committee on Food Additives has established an Acceptable Daily Intake of 0-0.1 mg/kg body weight for Dioctyl Sodium Sulfosuccinate.
http://www.inchem.org/documents/jecfa/jeceval/jec_658.htm
More Scientific Information
Diethylhexyl Sodium Sulfosuccinate is the sodium salt of the diester of a 2-Ethylhexyl 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. and Sulfosuccinic Acid. It functions as a surfactant – cleansing agent and surfactant – hydrotrope in cosmetic products.
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/