Isopropyl Isostearate

The safety of Isopropyl Isostearate 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 scientific data and concluded that Isopropyl Isostearate was safe as a cosmetic ingredient in the present practices of use and concentration. In 2007, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on Isopropyl Isostearate and reaffirmed the above conclusion.

CIR Safety Review: In addition to the review of data on Isopropyl Isostearate, a summary of the data on chemically similar cosmetic ingredients as such as Isopropyl Stearate, Isopropyl Palmitate, Isopropyl Myristate, and Isopropyl Lanolate was also included in the report as these have been reviewed previously by the CIR Expert Panel and found to be safe at concentrations used in cosmetics and personal care products. These ingredients, including Isopropyl Isostearate, are isopropyl esters resulting from the reaction of isopropyl alcohol with long-chain saturated aliphatic acids. Like Isopropyl Isostearate, cosmetic use concentrations of these ingredients range from less than 0.1% to 50.0%.

A collective evaluation of the data in this report indicates that the isopropyl esters, undiluted or at use concentrations, are relatively harmless, are not significant ocular irritants, induce skin irritation reactions ranging from none to moderate, are not sensitizers or photosensitizers, and are not carcinogenic.

In studies involving healthy human subjects, these esters, undiluted or at use concentrations, produced, at most, slight skin irritation but not sensitization. Based on the information included in the report, the CIR Expert Panel concluded that Isopropyl Isostearate was safe as a cosmetic ingredient in the present practices of use and concentration. If it is made from plants, Isopropyl Isostearate 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.. Ingredients of animal origin must comply with the European Union animal by-products regulations.

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