Opinion on Tetrabromophenol Blue, 4,4’-(4,5,6,7-tetrabromo-1,1-dioxido-3H-2,1-benzoxathiol-3-yliden)bis-2,6-dibromophenol (C183)

WG on Cosmetic Ingredients
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: SANCO-C2-SCCSec [dot] europa [dot] eu (SANCO-C2-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1573/16
Adopted on: 16 March 2016

Conclusion of the opinion:

1. In light of the new data provided, does the SCCS consider Tetrabromophenol Blue (C183) safe when used as a direct dye in oxidative and non-oxidative hair colouring products with a final on-head concentration up to 0.2%?

The margin of safety calculated in this Opinion relates to the previously supplied batch quality of the material. However, because of the large discrepancies noted between the specifications provided for the representative market quality batch intended for commercial use and that used in toxicological testing, SCCS cannot conclude on the safety of Tetrabromophenol Blue (C183).

The test material is not composed of a single substance, but of different homologues. Analysis of different batches has shown a large variation in the homologue mixture composition of the test material intended for commercial use. The safety assessment of Tetrabromophenol Blue (C183) will require a clear well-defined set of specifications for the composition of the substance intended for use in cosmetic products. This will also require toxicological data on a representative batch, and/or a scientifically valid justification for showing toxicological similarities amongst the homologues.

2. Does the SCCS have any further scientific concerns with regard to the use of Tetrabromophenol Blue (C183) in other cosmetic products?

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Keywords:

SCCS, scientific opinion, Tetrabromophenol Blue, 4,4’-(4,5,6,7-tetrabromo-1,1-dioxido-3H-2,1-benzoxathiol-3-yliden)bis-2,6-dibromophenol (C183), Regulation 1223/2009, CAS 4430-25-5

Opinion to be cited as:

Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Tetrabromophenol Blue, 4,4’-(4,5,6,7-tetrabromo-1,1-dioxido-3H-2,1-benzoxathiol-3-yliden)bis-2,6-dibromophenol (C183), 16 March 2016, SCCS/1573/16.