Registration Dossier
Registration Dossier
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EC number: 223-339-8 | CAS number: 3844-45-9
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study for skin sensitization was performed with a commercial product of the pure colorant in 2004. At that time, the OECD testing guideline was not yet available, but the study procedure follows the experimental design of the Local lymph node assay (OECD 429). The study was not performed under GLP, but was performed at a professional Contract Research Organization that routinely works under GLP. The quality of the experimental performance is therefore considered acceptable. The study was performed with doses up to 25% with no specific justification. However, from experience, 25% is a top dose very often used for solid substances as higher concentrations cannot technically be achieved. The high dose is therefore considered to be sufficiently high. In addition, there is no trend towards an increase of the SI below the cut-off level, so that the result "non sensitizing" is of high certainty. The ear thickness was not increased either.
Overall, the data reliably shows that the substance is not a skin sensitizer in mice.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available study is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the seventh time in Regulation (EC) No 2015/1221.
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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