2,6-Dihydroxyethylaminotoluene, HC Yellow 16: the safety of these two hair dyes ingredients will be evaluated by the SCCS. The request from the European Commission was published on 11 May 2015.
2,6-Dihydroxyethylaminotoluene
Backgroud
The hair dye 2,6-Dihydroxyethylaminotoluene (Colipa No A138 - CAS No. 149330-25-6) is intended to be used as a direct dye and as an ingredient in oxidative hair dye formulations up to a final on-head concentration of 1%.
Submission I and II on hair dye 2,6-Dihydroxyethylaminotoluene (A138) were transmitted by COLIPA in May 1995 and January 2006 respectively.
Following Submission II, in the safety evaluation of December 2011 the SCCS (SCCS/1425/11) concluded that:
"the positive results found in the
in vitro
gene mutation assay in bacteria were not confirmed nor ruled out in an appropriate
in vivo
test on the same genetic endpoint. Consequently, a final conclusion on the genotoxic potential of 2,6-Dihydroxyethylaminotoluene cannot be drawn.
"
In September 2014, Cosmetics Europe has submitted additional data on genotoxicity in order to review the issues raised by the SCCS in the Opinion of December 2011.
Questions to SCCS
1. In light of the new data provided, does the SCCS consider 2,6-Dihydroxyethylaminotoluene (A138) safe when used as a direct dye and as an ingredient in oxidative hair dye formulations up to a final on-head concentration of 1%?
2. Does the SCCS have any further scientific concerns with regard to the use …
