Registration Dossier
Registration Dossier
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A mixture of: N,N-diethylpropane-1,3-diamine 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2,2-iminodiethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2-methylaminoethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate
EC number: 403-410-1 | CAS number: 114565-65-0
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
In order to assess the allergenic potential of the test article when applied on the skin of female albino guinea pigs, a Guinea Pig Maximization Test according to Magnusson and Kligman (1970) as recommended by the OECD TG 406 was undertaken. Ten animals were treated as control group and twenty animals were treated as test group.
Based on the results of a pretest, the induction was conducted using 3% test article in vehicle (physiol. saline) for intradermal induction, followed by 25% test article in vehicle (physiol. saline) for epicutaneous induction one week later. Challenge and rechallenge were both performed using the highest non-irritating concentration of 10% test article in vehicle (physiol. saline).
First and second readings after the first challenge (24 and 48 h) revealed 80% (16/20) and 70% (14/20) positive reactions for the test article, respectively. First and second readings after rechallenge (24 and 48 h) revealed 60% (12/20) and 55% (11/20) positive reactions for the test article, respectively.
Thus, the test article was sensitizing when tested in the GPMT.
Migrated from Short description of key information:
A valid Guinea Pig Maximization Test (GPMT) conducted according to Magnusson and Kligman (1970) as recommended in the OECD TG 406 is available for assessment of the sensitizing potential of the test article (RCC 205558). The results of the test were positive, indicating that the test article was a sensitizer in the GPMT.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- Migrated from Short description of key information:
No data available
Justification for classification or non-classification
A valid GPMT ist available, which revealed that the test article is a skin sensitizer. Thus, the test article has to be classified as R43 according to the EU Directive 67/548/EEC and in Cat 1B according to the CLP Regulation EC/1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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