Ethoxyethanol
What Is It?
Ethoxyethanol and Ethoxyethanol are liquids. In the past, these ingredients had reported use in hair and nail care products.
Why Is It Used?
Ethoxyethanol and Ethoxyethanol Acetate dissolve other substances and decrease the thickness of liquid cosmetic and personal care products.
Scientific Facts
Ethoxyethanol is an aliphatic 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., and Ethoxyethanol Acetate is an aliphatic etherAn organic compound that contains an oxygen atom bound to two hydrocarbon groups. An ether compound is often represented by R-O-R’..
Safety Information
The Food and Drug Administration (FDA) includes Ethoxyethanol on its list of indirect food additives. It is permitted for use in the manufacture of rubber articles intended for repeated use. The safety of Ethoxyethanol and Ethoxyethanol Acetate 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 reviewed the scientific data and concluded that Ethoxyethanol and Ethoxyethanol Acetate were unsafe for use in cosmetic and personal care products.
CIR Safety Review: In 1998, at the time the CIR report was written, no uses of Ethoxyethanol and Ethoxyethanol Acetate in cosmetic and personal were identified. It was noted that both Ethoxyethanol and Ethoxyethanol Acetate were metabolized to ethoxyacetic acid. Acute oral toxicity studies in several species reported kidney damage, including extreme tubular degeneration. Kidney damage was also seen in acute dermal toxicity studies. Ethoxyethanol and Ethoxyethanol Acetate were mild to moderate eye irritants, mild skin irritants nonsensitizers.
Most genotoxicity tests were negative, but chromosome aberrations and sister-chromatid exchange were among the positive results reported. Numerous reproductive and developmental toxicity studies, across several species, involving various routes of administration, indicate that Ethoxyethanol and Ethoxyethanol Acetate were reproductive and developmental toxicants. Mild anemia was reported in individuals exposed occupationally to Ethoxyethanol, which resolved when the chemical was not used. Reproductive effects have been noted in men exposed occupationally to Ethoxyethanol. The CIR Expert Panel noted that the available data indicated that Ethoxyethanol and Ethoxyethanol Acetate were well absorbed across human skin, and that these compounds were clearly reproductive and developmental toxicants via dermal exposure.
The CIR Expert Panel noted that a threshold for reproductive and developmental toxicity following dermal exposure to Ethoxyethanol and Ethoxyethanol Acetate has not been determined. Therefore, based on the demonstrated reproductive and developmental toxicity associated with dermal and other routes exposures, the CIR Expert Panel concluded that these ingredients were unsafe for use in cosmetic and personal care product formulations.
Link to FDA Code of Federal Regulations for Ethoxyethanol
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
Ethoxyethanol and Ethoxyethanol Acetate are not permitted for use in cosmetics and personal care products marketed in the European Union (see Annex II).
Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…
Ethoxyethanol and Ethoxyethanol Acetate are not permitted for use in cosmetics and personal care products in Canada. Link to the Health Canada website:
http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-cri…
More Scientific Information
Other technical names for Ethoxyethanol include 2-ethoxyethanol, ethylene glycol ethyl ether, and ethylene glycol monoethyl ether. Other technical names for Ethoxyethanol Acetate include 2-ethoxyethanol acetate and ethylene glycol monoethyl ether acetylated.
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/