Cocamidopropylamine Oxide

The safety of Cocamidopropylamine Oxide 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 Cocamidopropylamine Oxide was safe as a cosmetic ingredient in rinse-off cosmetic products. The CIR Expert Panel concluded that the data were insufficient to complete a determination of the safety of Cocamidopropylamine Oxide for use in leave-on cosmetics and personal care products.

CIR Safety Review: A 28-day repeated oral dose toxicity study found hemolytic anemia at 150 and 1000 mg/kg/day, with no effects at a dose of 15 mg/kg/day. At 5%, Cocamidopropylamine Oxide was not a dermal irritant.

Application of 81.5% Cocamidopropylamine Oxide caused moderate irritation to skin, but severe irritation to the eyes. A maximization study classified Cocamidopropylamine Oxide as a non-sensitizer to skin. Cocamidopropylamine Oxide was not mutagenic in bacteria. No evidence of increased chromosomal aberrations was noted in human lymphocytes treated with 81.5% Cocamidopropylamine Oxide.

In a clinical study, 7.5% Cocamidopropylamine Oxide was not a sensitizer, although it did produce some reactions typical of mild irritation. Two repeat insult patch tests using a facial wash with 1% raw material containing 35-36.5% Cocamidopropylamine Oxide did not find evidence of dermal sensitization. Tests for dermal phototoxicity and photoallergenicity with the same facial wash product also did not produce evidence of effect. Overall, the data reviewed by the CIR Expert Panel demonstrated that Cocamidopropylamine Oxide has low toxicity in various tests.

While there were no available carcinogenicity data, the available genotoxicity data, combined with the absence of any structural alerts, suggested no carcinogenic potential. The CIR Panel noted the absence of reproductive and developmental toxicity data. Because this ingredient has a highly polarized molecular structure, the CIR Expert Panel considered that it would be, at most, slowly absorbed.

Given that most of the uses and the highest use concentration of 4% was found in rinse-off products, the CIR Expert Panel determined that the available data supported the safe use of Cocamidopropylamine Oxide in rinse-off products. Although dermal penetration may be slow, the CIR Expert Panel requested dermal penetration data to support the use of this ingredient in leave-on products.

Depending on the results of the dermal penetration data, additional data may alos be needed. Cocamidopropylamine Oxide 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…