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HomeOpinion on N,N'-Bis-(2-hydroxyethyl)-2-nitro-p-phenylenediamine (B34)
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The hair dye N,N'-Bis-(2-hydroxyethyl)-2-nitro-p-phenylamine (B34) CAS No 84041-77-0, EC No 281-856-4 is intended to be used as hair dye in cosmetic hair colouring products with or without the addition of an oxidizing agent (e.g. hydrogen peroxide). The final on-head concentration of B34 is up to a maximum of 1.0 % or 1.5 % respectively in the presence or absence of hydrogen peroxide. Submission I and II on hair dye N,N'-Bis-(2-hydroxyethyl)-2-nitro-p-phenylamine (B34) were transmitted by COLIPA in May 1994 and May 2005 respectively. The latest safety evaluation on hair dye N,N'-Bis-(2-hydroxyethyl)-2-nitro-p-phenylamine (B34) was adopted by the Scientific Committee on Consumer Safety (SCCS) in September 2012 in reply to Submission III of December 2010. The SCCS concluded that: "a conclusion on the gene mutation potential of N,N'-bis-(2-hydroxyethyl)-2-nitro-pphenylenediamine cannot be drawn without further testing. On the basis of the submitted data, the SCCS considers N,N'-bis(2-hydroxyethylamino)-2- nitro-p-phenylenediamine not safe for use as an oxidative hair dye with a concentration on head of maximum 1.0 % or as a non-oxidative hair dye with a concentration up to 1.5 %." (SCCS/1463/12) In December 2014, Cosmetics Europe submitted additional data on mutagenicity in order to review the issues raised by the SCCS in the Opinion of September 2012.
- Published:
- Corporate author(s): Directorate-General for Health and Food Safety (European Commission)
- Themes: Scientific and technical research , Pharmaceutical and cosmetics industry
- Subject: analytical chemistry , consumer protection , cosmetic product , directive (EU) , dyestuff , health policy , toxic substance
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| ISSN 1831-4767 | ISBN 978-92-79-65666-8 | DOI 10.2875/8077 | Catalogue number EW-AQ-17-010-EN-N |
- Released on EU publications website:
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