t-Butyl Alcohol
What Is It?
t-Butyl 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. is a clear liquid with a camphor-like odor. In cosmetics and personal care products, t-Butyl Alcohol is used in the formulation of perfumes, colognes, hair sprays, aftershave lotions, nail polish and shaving products.
Why Is It Used?
t-Butyl Alcohol is used as a denaturantIngredients added to ethyl alcohol (grain alcohol) to make it unsuitable for drinking, usually by imparting an intensely bitter taste. In the United States, the use of denaturants are controlled by the Alcohol and Tobacco Tax and Trade Bureau in the Department of Treasury. and a solventSubstances, usually liquids, that are used to dissolve other substances..
Scientific Facts
tert- or t-Butyl Alcohol, a tertiary alcohol, is used as an alcohol denaturant for a number of cosmetic and noncosmetic uses. A tertiary alcohol means that the carbon that is bound to the hydroxyl group (-OH) is bound to three other carbon atoms.
Safety Information
The Food and Drug Administration (FDA) includes t-Butyl Alcohol on its list of indirect food additives. t-Butyl Alcohol may be used as a defoaming agent in coatings of paper and paperboard used to package food. The safety of t-Butyl Alcohol 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. Expert (CIR) Panel. The CIR Expert Panel evaluated the scientific data and concluded that t-Butyl Alcohol was safe in cosmetics and personal care products.
CIR Safety Review: The CIR Expert Panel noted that t-Butyl Alcohol has little acute oral toxicity. In short-term oral studies, t-Butyl Alcohol at 2% (w/v) or less in drinking water did not cause gross organ or tissue damage, although weight loss was reported and microscopic damage to the liver and kidneys was noted at high concentrations. Treatment of male rats with t-Butyl Alcohol has been associated with kidney effects known as alpha-2u globlin nephropathy. This effect is specific to rats, especially males and is not relevant to humans. t-Butyl Alcohol (99.9%) was a moderate to severe ocular irritant and caused mild to moderate dermal irritation.
It was not considered to be a dermal irritant. In oral developmental studies, fetotoxicity generally increased with concentration, and fetal weights were slightly depressed at concentrations of 0.5% to 1% t-Butyl Alcohol. Developmental effects were considered to be secondary to maternal effects. A repeat-insult patch test (RIPTRIPT stands for Repeat Insult Patch Test. In RIPT, a small amount of product is applied to the skin of each individual subject and monitored for its effect. Over a certain interval of time, the skin is observed, graded, and tested again.) showed no potential for eliciting either dermal irritation or sensitization by 100% t-Butyl Alcohol.
Link to FDA Code of Federal Regulations for tert-Butyl Alcohol
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
t-Butyl Alcohol 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…
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/