2,6- dihydroxyethylaminotoluene
The hair dye 2,6-Dihydroxyethylaminotoluene was assessed for use and deemed safe in oxidative hair dye formulations at a maximum concentration of 1%.
“In the light of the new data provided, SCCS considers that the use of 2,6-dihydroxyethylaminotoluene as an ingredient in oxidative hair dye formulations at a maximum concentration of 1.0% on the head is safe,” says the Opinion.
“2,6-Dihydroxyethylaminotoluene is a secondary amine, and thus, it is prone to nitrosation. It should not be used together with nitrosating agents. Nitrosamine content should be <50 ppb,” it adds.
Submission I and II on hair dye 2,6-Dihydroxyethylaminotoluene (A 138) were transmitted by COLIPA (now Cosmetics Europe) 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 genotoxicpotential of 2,6- dihydroxyethylaminotoluene cannot be drawn."
In September 2014, Cosmetics Europe submitted additional data on genotoxicity in order to review the issues raised by the SCCS in the Opinion of December 2011.
