EC says it cannot assess hair dye ingredient

In its Opinion​, Commission's Scientific Committee on Consumer Safety (SCCS) says it considers the ingredient a strong skin sensitiser, and that further studies will now need to be carried out on its gene mutation potential.

“The safety of Basic Blue 124 cannot be assessed since no final conclusion on mutagenicity can be drawn without further studies to exclude gene mutation potential,”​ says the Opinion.

“The SCCS considers Basic Blue 124 as a strong skin sensitiser. Basic Blue 124 is a tertiary amine. It should not be used together with nitrosating agents. Total nitrosamine content should be < 50 ppb. The purity determination of Basic Blue 124 should be performed adequately.”​

The Committee's assessment was based on a dossier submitted by the European Federation for Cosmetic Ingredients (EFfCI) transmitted in May 2014.

Opinion​

Hair dye Basic Blue 124, which has the chemical name 3-Amino-7- (dimethylamino)-2-methoxyphenoxazin-5-ium chloride, is a solid in the form of a fine powder and is intended to be used as a direct hair dye in semi-permanent hair dye formulations.

The SCCS says it is intended to be used at on-head concentrations in the range between 0.01% up to a maximum of 0.5% (w/v), and the regular frequency of application is intended to be once per month up to once per 8 weeks.

However, it adds that it cannot fully assess the ingredient at present without further studies to exclude gene mutation potential.

Comments on the Opinion can be submitted until 4 September, 2015.