n-Butyl Alcohol

What Is It?

n-Butyl Alcohol is a solvent. In cosmetics and personal care products, it is used in nail care formulations. n-Butyl Alcohol can also be found in bath soaps and detergents, eye makeup, foundations, lipstick, underarm deodorants and aftershave lotions, all at low concentrations.

Why Is It Used?

n-Butyl Alcohol is used primarily to dissolve other substances in cosmetic product formulations.

Scientific Facts

n-Butyl Alcohol, or Butanol, is a colorless liquid with an odor that resembles wine.

Safety Information

The Food and Drug Administration (FDA) reviewed the safety of n-Butyl Alcohol and approved its use in flavoring substances for direct addition to food. The safety of n-Butyl Alcohol has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated scientific data and concluded that n-Butyl Alcohol was safe as a cosmetic ingredient.

CIR Safety Review: When the CIR Expert Panel previously reviewed the safety of n-Butyl Alcohol, the only reported uses were in nail care products. The original safety assessment was specific in limiting the conclusion only to the use of n-Butyl Alcohol in nail products. Since then, additional non-nail care cosmetic uses have been reported. Since the original safety assessment was completed, new safety testing data has become available.

Neither the original safety assessment data nor the new data suggested any concern about the use of n-Butyl Alcohol in nail care products (at concentrations up to 15%) or in other product categories (at concentrations up to 0.002%). While these other product categories include routes of exposure not found with nail care products, the CIR Expert Panel noted that the uses outside of nail products have been reported at extremely low concentrations, and as noted above, there were no toxicity concerns at these use levels.

FDA: Link to Code of Federal Regulations for Butyl Alcohol
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

n-Butyl Alcohol may be used in cosmetics 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…

The Joint FAO/WHO Expert Committee on Food Additives did not consider it necessary to limit the Acceptable Daily Intake of Butyl Alcohol. The Committee believes there is no safety concern at current levels of intake when Butyl Alcohol is used as a flavoring agent.
http://www.inchem.org/documents/jecfa/jeceval/jec_254.htm

More Scientific Information

n-Butyl Alcohol is a primary aliphatic alcohol used as a solvent in cosmetics products. Alcohols are organic compounds in which a hydroxyl group (-OH) is attached to a saturated carbon atom. Alcohols have the general formula ROH, where R may be aliphatic or alicyclic and may include aromatic rings. Alcohols are further classified as primary, secondary or tertiary, according to the position of the hydroxyl group on the aliphatic carbon chain. If the hydroxyl group is attached directly to an aromatic ring, the compound is classified as a phenol.

Alcohols are widely used in cosmetics. The low molecular weight alcohols, e.g., isopropyl, butyl and especially ethyl alcohol, are employed as solvents as well as for their astringent function in aftershaves, mouthwashes and similar products. n-Butyl Alcohol is different from ethanol, which is the alcohol in alcoholic beverages. Sometimes products will claim to be “alcohol-free.” This claim means free of ethanol and does not apply to the many other alcohol ingredients used in personal care 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): 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/