Revision of the opinion on Basic Blue 124 (3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride)

SCCS members: Q. Chaudhry, P. Coenraads, M. Dusinska, W. Lilienblum, E. Nielsen, T. Platzek, C. Rousselle, J. van Benthem
External experts: A. Bernard, L. Bodin, J. Duus-Johansen, J. Ezendam, A. Giménez-Arnau, E. Mirkova, E. Panteri, T. Vanhaecke, A. Varvaresou
Contact:SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1542/14
Adopted on: 25 June 2015, Revision of 16 March 2016

Conclusion of the opinion:

1. In light of the data provided, does the SCCS consider Basic Blue 124 safe when used as a direct hair dye in semi-permanent hair dye formulations at on-head concentration up to a maximum of 0.5% (w/v)?

The SCCS considers Basic Blue 124 safe when used as a direct hair dye in semi-permanent hair dye formulations at on-head concentration up to a maximum of 0.5% (w/v).

2. Does the SCCS have any further scientific concerns with regard to the use of Basic Blue 124 in cosmetic products?

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.

Keywords:

SCCS, scientific opinion, 3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride, Basic Blue 124, Regulation 1223/2009, CAS No. 67846-56-4

Opinion to be cited as:

Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Basic Blue 124, 25 June 2015, SCCS 1542/14, revision of 16 March 2016.