Isostearyl Neopentanoate

The safety of Isostearyl Neopentanoate 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 Isostearyl Neopentanoate was safe as a cosmetic ingredient in the present practices of use. In 2003, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on Isostearyl Neopentanoate and reaffirmed the above conclusion.

CIR Safety Review: Much of the safety data available to the CIR Expert Panel consisted of unpublished reports supplied by the cosmetic industry. The CIR Expert Panel noted that the alcohol and the acid resulting from hydrolysisDecomposition of a chemical compound into smaller constituents by reaction with water. of Isostearyl Neopentanoate ester would be expected to be metabolized along predictable pathways and would not be expected to be converted to metabolites that would result in mutagenicity, carcinogenicity, and/or developmental toxicity. The undiluted ingredient was shown to be relatively non-toxic in short- and long-term studies.

Test data indicated the undiluted ingredient was neither an irritant nor a sensitizer. A cosmetic formulation containing 16% Isostearyl Neopentanoate produced no phototoxicity and no photoallergenicity. The use of Isostearyl Neopentanoate in the formulation of cosmetic and personal care products is allowed 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.. If it is derived from animal sources, it must comply with European Union animal by-products regulations.

Link to the EU Cosmetic Regulation: 
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…