t-Butyl Alcohol

What Is It?

t-Butyl Alcohol 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 denaturant and a solvent.

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 Review 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 (RIPT) 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 Union.

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): 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/