Isoamyl Acetate
What Is It?
Amyl Acetate and Isoamyl Acetate are solvents used to dissolve other ingredients. In cosmetics and personal care products, Amyl Acetate is used in nail polish and enamels, nail enamel removers and manicure preparations.
Why Is It Used?
Amyl Acetate and Isoamyl Acetate may be used to dissolve other ingredients. Amyl Acetate and Isoamyl Acetate are also used as a fragrance ingredients due to their pear- or banana-like aromas.
Scientific Facts
Amyl Acetate, as used in cosmetic products, is the esterAn organic compound formed by the reaction of an acid with an alcohol. of mixed isomers of Amyl 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 Acetic Acid. Amyl and Isoamyl Acetates are simple molecules that occur naturally in various fruits but they are typically synthesized for commercial use.
Safety Information
The Food and Drug Administration reviewed the safety of Amyl Acetate and approved its use as an indirect food additiveIndirect food additives are additives that may become part of the food in trace amounts due to its packaging, storage or other handling. For example, minute amounts of packaging substances may find their way into foods during storage. as a component of adhesives. The safety of Amyl Acetate and Isoamyl 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 evaluated the scientific data and concluded that Amyl Acetate and Isoamyl Acetate were safe as used in cosmetic products.
CIR Safety Review: The CIR Expert Panel noted that Amyl Acetate and Isoamyl Acetate were non-mutagenic in a series of mutagenicity assays. The acute oral toxicity of Amyl Acetate was very low and other studies did not indicate toxicity. No evidence of delayed contact hypersensitivity, phototoxicity, or photoallergy due to Amyl Acetate or Isoamyl Acetate was observed in human repeat insult patch test studies.
FDA: Link to the Code of Federal Regulations for Amyl Acetate
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
The use of Amyl Acetate and Isoamyl Acetate are permitted in Europe subject 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…
The Joint FAO/WHO Expert Committee on Food Additives has established an Acceptable Daily Intake of 0-3 mg Isoamyl Acetate/kg body weight. No safety concern was indicated at current levels of intake when used as a flavoring agentIngredients that impart a flavor or a taste to a product..
http://www.inchem.org/documents/jecfa/jeceval/jec_1138.htm
More Scientific Information
Amyl Acetate, or Pentyl Acetate, is the ester of mixed isomers of Amyl Alcohol and Acetic Acid and is used as a solventSubstances, usually liquids, that are used to dissolve other substances. for nitrocellulose or in combination with other solvents. Isoamyl Acetate, or Isopentyl Acetate, is primarily used as a fragrance ingredientSubstances that impart an odor to a product..
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/