SCCS has finalised an opinion on the safety of p-BMHCA (containing alpha-tocopherol at 200 ppm) as a fragrance ingredient in cosmetic products. In a 2017 preliminary report, the Committee had not been able to reach a conclusion on safety, as it was unable to rule out in vivo genotoxicity. In response, the applicant submitted two new studies for evaluation; an Ames mutation test and an in vitro micronucleus test (both conducted to current OECD guidelines and to GLP). The Committee has now ruled out genotoxicity concerns for p-BMHCA and concluded that, on an individual product basis, p-BMHCA can be considered safe when used in different (non-sprayable) cosmetics at concentrations of up to 1.42%. However, p-BMHCA at the proposed concentration could not be considered safe after taking into account aggregate exposures from different products (and from non-cosmetic uses of p-BMHCA, for example as a fragrance in household cleaners/detergents).

 

The above items were taken from the June 2019 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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