Trihydroxystearin
What Is It?
Trihydroxystearin is the triester of glycerin and hydroxystearic acid. In cosmetics and personal care products, Trihydroxystearin is used in the formulation of body, hand and skin care preparations. It is also used in makeup preparations including eye makeup, blushers, face powders, foundations and lipstick.
Why Is It Used?
Trihydroxystearin increases the thickness of the lipidFat or fat-like substance found in the cells of plants and animals that includes fats, waxes, oils, and related compounds. (oil) portion of cosmetics products. When used in skin care formulations, it slows the loss of water from the skin by forming a barrier on the skin’s surface.
Scientific Facts
Trihydroxystearin is derived from the fatty acidA natural organic compound that consists of a carboxyl group (oxygen, carbon and hydrogen) attached to a chain of carbon atoms with their associated hydrogen atoms. The chain of carbon atoms may be connected with single bonds, making a ‘saturated’ fat; or it may contain some double bonds, making an ‘unsaturated’ fat. The number of carbon and hydrogen atoms in the chain is what determines the qualities of that particular fatty acid. Animal and vegetable fats are made up of various combinations of fatty acids (in sets of three) connected to a glycerol molecule, making them triglycerides., Hydroxystearic Acid. One method of producing both Trihydroxystearin and hydroxystearic acid involves the catalytic hydrogenation of castor oil.
Safety Information
The Food and Drug Administration (FDA) has reviewed the safety of Castor Oil, hydrogenated trihydroxystearin and approved its use as an indirect food additiveIndirect food additives are additives that may become part of the food in trace amounts due to its packaging, storage or other handling. For example, minute amounts of packaging substances may find their way into foods during storage. for certain adjuvants and production aids. Trihydroxystearin has also been used as a thickening agent for peanut butterAny of various fatty oils remaining nearly solid at room temperature.. The safety of Trihydroxystearin 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, including study summaries from CIR Safety Assessments of Hydroxystearic Acid and Glyceryl Stearate and Glyceryl Stearate SE, and concluded that Trihydroxystearin was safe as used in cosmetic formulations.
CIR Safety Review: The CIR Expert Panel had previously conducted a safety assessment of Glyceryl Stearate and Hydroxystearic Acid and relied on data available from these reports because these two ingredients were chemically similar to Trihydroxystearin. When tested at concentrations up to 20.0%, Glyceryl Stearate was neither an irritant nor a sensitizer. Thus, in the absence of sensitization data on Trihydroxystearin, it was concluded that this ingredient was not likely a sensitizer based on data on a chemically similar ingredient. All of the available data suggested that Trihydroxystearin and its component chemical species were safe as used in cosmetic formulations.
FDA: Link to Code of Federal Regulations for Castor Oil, Hydrogenated
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
Trihydroxystearin may be used in cosmetic 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
Trihydroxystearin is the triester of glycerin and hydroxystearic acid and is used as a skin conditioning agent, solventSubstances, usually liquids, that are used to dissolve other substances., and viscosity increasing agent (nonaqueous) in cosmetics. Nonaqueous viscosity-increasing ingredients are used to thicken the lipid portions of cosmetic products. Their performance is the result of their water insolubility and compatibility with various lipids. They are widely used to thicken or gel various types of oleaginous products, such as lipsticks and pastes.
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/