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Expert opinion

N,N'-Bis-(2-hydroxyethyl)-2-nitro-p-phenylenediamine (B34) - Submission IV

Final Opinion

Details

Publication date
16 September 2016
Author
Scientific Committee on Consumer Safety (SCCS)

Description

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:SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1572/16
Adopted on: 16 September 2016

Conclusion of the opinion:

(1) In light of the new data provided, does the SCCS consider N,N'-Bis-(2-hydroxyethyl)-2- nitro-p-phenylamine (B34) safe when used as an oxidative hair dye with a concentration onhead of maximum 1.0 % and as a non-oxidative hair dye with a concentration up to 1.5 %?

On the basis of new submitted data, the SCCS considers N,N’-bis(2-hydroxyethylamino)-2- nitro-pphenylenediamine safe for use as an oxidative hair dye with an on-head concentration of maximum 1.0% and as a non-oxidative hair dye with a concentration up to 1.5%.

(2) Does the SCCS have any further scientific concerns with regard to the use of N,N’-Bis-(2- hydroxyethyl)-2-nitro-p-phenylamine (B34) in other cosmetic products?

N,N’-bis-(2-hydroxyethyl)-2-nitro-p-phenylenediamine is a secondary amine and prone to nitrosation. The nitrosamine content in the dye should be < 50 ppb. It should not be used in the presence of nitrosating agents.

A selective analytical method, such as HPLC with PDA detection, should be used to demonstrate stability for up to 60 min. under oxidative conditions.

Keywords:

SCCS, scientific opinion, N,N'-Bis-(2-hydroxyethyl)-2-nitro-p-phenylenediamine (B34), Regulation 1223/2009, CAS No. 84041-77-0, EC No. 281-856-4

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on N,N'- Bis-(2-hydroxyethyl)-2-nitro-p-phenylenediamine (B34), 16 March 2016, final version of 16 September 2016, SCCS/1572/16.

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