Ethyl Hexanediol

The safety of Ethyl Hexanediol 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 Ethyl Hexanediol was safe as a cosmetic ingredient.

CIR Safety Review: Data indicated that Ethyl Hexanediol was absorbed through the skin and was metabolized and eliminated in the urine. In subchronic oral studies, slight toxicity was manifested as reduced growth and increased liver weight. In a laboratory study, oral delivery of Ethyl Hexanediol showed evidence of developmental effects only at levels at which significant maternal toxicity was seen.

Dermal exposure also resulted in developmental changes, again at levels that also caused maternal effects. Chomosome damage was reported in vitroExperiments performed in a test tube or another artificial, controlled environment, rather than in a whole animal., but several other genotoxicity assays were negative. Dermal exposure resulted in no dose-related increases in tumor incidence. In clinical studies, undiluted Ethyl Hexanediol was a weak irritant and a weak sensitizer.

The concentration at which this ingredient is expected to be used in cosmetics and personal care products is no greater than 5%. The CIR Expert Panel concluded that at the use concentration, Ethyl Hexanediol was safe as an ingredient in cosmetics and personal care products. Ethyl Hexanediol 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…