Phenethyl Alcohol
What Is It?
Phenethyl 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 colorless, transparent, slightly viscous liquid. In cosmetics and personal care products, Phenethyl Alcohol is used in the formulation of eye area makeup, makeup products, skin care products, shampoos and perfumes and colognes.
Why Is It Used?
Phenethyl Alcohol prevents or retards bacterial growth, and thus protects cosmetics and personal care products from spoilage. Phenethyl Alcohol also imparts a fragrance to a product.
Scientific Facts
Phenethyl Alcohol occurs naturally in the environment. It is produced by microorganisms, plants, and animals. Phenethyl Alcohol has been found in a number of natural essential oils, in food, spices and tobacco, and in undistilled alcoholic beverages, beers and wines.
Safety Information
The Food and Drug Administration (FDA) includes Phenethyl Alcohol on its list of direct food additives. It is permitted for use as a synthetic flavoring substance. The safety of Phenethyl 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. (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Phenethyl Alcohol was safe in cosmetics and personal care products at concentrations of up to 1%. In 2006, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on this ingredient and reaffirmed the above conclusion.
CIR Safety Review: Phenethyl Alcohol was slightly to moderately irritating to the skin and was not a sensitizer. Phenethyl Alcohol, in concentrations of 1% or greater, was irritating to the eyes. Phenethyl Alcohol was neither an irritant nor a sensitizer in human studies. Phenethyl Alcohol was not mutagenic in bacteria or in an Escherichia coli DNA-polymerase-deficient assay system.
Phenethyl Alcohol did inhibit the repair of radiation-induced breaks in the DNA of E. coli. Phenethyl Alcohol did not increase the number of sister chromatid exchanges in human lymphocytes.
Maternal exposure to Phenethyl Alcohol, microencapsulated in the feed, at concentrations of 1000, 3000, and 10,000 ppm had no effect on embryo-fetal loss, or embryo-fetal development. Doses of 0.14, 0.43, and 1.40 ml/kg of Phenethyl Alcohol were applied to the skin and maternal toxicity was marked at the highest dose. Abnormalities in fetuses in the 1.40 ml/kg Phenethyl Alcohol group were observed.
The number of fetuses with moderate degrees of reduced ossification and with cervical rib(s) was significantly greater in the 0.43 ml/kg Phenethyl Alcohol group than in the controls. The incidence of structural changes was slightly greater in 0.14 ml/kg Phenethyl Alcohol-treated group than in the control group. The highest no observed adverse effect level (NOAEL) was 0.43 ml/kg/day for cervical rib malformation (developmental effect).
The dermal NOAEL of 0.43 ml/kg/day was used to estimate a safe use level of 1% Phenethyl Alcohol in cosmetics and personal care products.
Link to FDA Code of Federal Regulations for Phenethyl Alcohol
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
l Phenethyl 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…
More Scientific Information
Phenethyl Alcohol is an aromatic alcohol that is metabolized to phenylacetic acid in mammals. In humans, it is excreted in urine as the conjugate, phenylacetylglutamine. In cosmetics and personal care products, Phenethyl Alcohol functions as a fragrance ingredientSubstances that impart an odor to a product. and as a preservativeIngredients that prevent or retard bacterial growth, and thus protect cosmetic products from spoilage..
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/