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Directorate-General for Health and Food Safety
Executive Summary
1. General data
1.1 Identity of the ingredient : 1-((2'-Methoxyethyl)-amino)-2-nitro-4-(di(2'- hydroxyethyl)-amino)-benzene
1.2 CAS n° : 23920-15-2
1.3 Use : Oxidative hair dye : max. use 3.0 %, 1.5 % in combination with H2O2. Hair tinting products and colouring setting lotions max. concentration of 2%
2. Terms of reference
2.1 Context of the question
The adaptation to technical progress of the Annexes to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products.
2.2 Request to the SCCNFP
The SCCNFP is requested to answer the following questions :
* Is 1-((2'-Methoxyethyl)-amino)-2-nitro-4-(di(2'-hydroxyethyl)-amino)-benzene safe for use in cosmetic products?
* Does the SCCNFP propose any restrictions or conditions for its use in cosmetic products?
3. Safety Assessment & Classification
The assessment followed the Notes of Guidance under scientifically based premises of consumer safety and leads to a classification 1 for the intended use.
Evaluation of acute toxicity (oral), skin and mucous membrane irritation, sub-chronic toxicity (oral), reproductive toxicity (oral), genotoxicity, percutaneous absorption have shown that the compound can be safely used under the conditions stated in the Opinion.
4. Opinion
The SCCNFP is of the opinion that 1-((2'-Methoxyethyl)-amino)-2-nitro-4-(di(2'-hydroxyethyl)-amino)-benzene can be used safely in permanent hair dye formulations at a maximum concentration of 3.0%. Since permanent hair dyes are mixed with hydrogen peroxide before application, the in-use concentration is 1.5%. In hair tinting products and colouring setting lotions the concentration of 1-((2'-Methoxyethyl)-amino)-2-nitro-4-(di(2'-hydroxyethyl)-amino)-benzene should not exceed 2.0%.
The sensitisation data in the dossier was generated with a too low induction concentration. However, no further sensitisation data are requested provided that cosmetic products containing this substance carry a label warning of a risk of sensitisation.
5. Statement on the toxicological evaluation
The SCCNFP is the scientific advisory body to the European Commission in matters of consumer protection with respect to cosmetics and non-food products intended for consumers.
The Commission's general policy regarding research on animals supports the development of alternative methods to replace or to reduce animal testing when possible. In this context, the SCCNFP has a specific working group on alternatives to animal testing which, in co-operation with other Commission services such as ECVAM (European Centre for Validation of Alternative Methods), evaluates these methods.
SCCNFP opinions include evaluations of experiments using laboratory animals; such tests are conducted in accordance with all legal provisions and preferably under chemical law regulations. Only in cases where no alternative method is available will such tests be evaluated and the resulting data accepted, in order to meet the fundamental requirements of the protection of consumer health.
1. General data
1.1 Identity of the ingredient : 1-((2'-Methoxyethyl)-amino)-2-nitro-4-(di(2'- hydroxyethyl)-amino)-benzene
1.2 CAS n° : 23920-15-2
1.3 Use : Oxidative hair dye : max. use 3.0 %, 1.5 % in combination with H2O2. Hair tinting products and colouring setting lotions max. concentration of 2%
2. Terms of reference
2.1 Context of the question
The adaptation to technical progress of the Annexes to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products.
2.2 Request to the SCCNFP
The SCCNFP is requested to answer the following questions :
* Is 1-((2'-Methoxyethyl)-amino)-2-nitro-4-(di(2'-hydroxyethyl)-amino)-benzene safe for use in cosmetic products?
* Does the SCCNFP propose any restrictions or conditions for its use in cosmetic products?
3. Safety Assessment & Classification
The assessment followed the Notes of Guidance under scientifically based premises of consumer safety and leads to a classification 1 for the intended use.
Evaluation of acute toxicity (oral), skin and mucous membrane irritation, sub-chronic toxicity (oral), reproductive toxicity (oral), genotoxicity, percutaneous absorption have shown that the compound can be safely used under the conditions stated in the Opinion.
4. Opinion
The SCCNFP is of the opinion that 1-((2'-Methoxyethyl)-amino)-2-nitro-4-(di(2'-hydroxyethyl)-amino)-benzene can be used safely in permanent hair dye formulations at a maximum concentration of 3.0%. Since permanent hair dyes are mixed with hydrogen peroxide before application, the in-use concentration is 1.5%. In hair tinting products and colouring setting lotions the concentration of 1-((2'-Methoxyethyl)-amino)-2-nitro-4-(di(2'-hydroxyethyl)-amino)-benzene should not exceed 2.0%.
The sensitisation data in the dossier was generated with a too low induction concentration. However, no further sensitisation data are requested provided that cosmetic products containing this substance carry a label warning of a risk of sensitisation.
5. Statement on the toxicological evaluation
The SCCNFP is the scientific advisory body to the European Commission in matters of consumer protection with respect to cosmetics and non-food products intended for consumers.
The Commission's general policy regarding research on animals supports the development of alternative methods to replace or to reduce animal testing when possible. In this context, the SCCNFP has a specific working group on alternatives to animal testing which, in co-operation with other Commission services such as ECVAM (European Centre for Validation of Alternative Methods), evaluates these methods.
SCCNFP opinions include evaluations of experiments using laboratory animals; such tests are conducted in accordance with all legal provisions and preferably under chemical law regulations. Only in cases where no alternative method is available will such tests be evaluated and the resulting data accepted, in order to meet the fundamental requirements of the protection of consumer health.
