Registration Dossier
Registration Dossier
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EC number: 303-757-8 | CAS number: 94213-53-3
Endpoint summary
Administrative data
Description of key information
Skin sensitizer (category 1B)
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
There is no information about the sensitization potential of Direct Violet 051, therefore, the available data on structural analogous Similar Substance 01 have been taken into account. The read across approach can be considered as reliable and adequate for the purpose; details and explanations are detailed in the report attached to the IUCLID section 13.
In an LLNA test 4 female mouse/concentration were dermally (back of the ears) exposed to the substance at 0, 5, 10 and 25% during 3 consecutive days. After injection with3H-thymidine, 3HTdR incorporation was measured in a β-scintillation counter in cell suspensions of pooled lymphnodes (per concentration). The EC3 calculated from the stimulation indices was 5.2%. The substance is considered sensitizing to the skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data the substance needs to be classified as H317 (skin sensitizer category 1B) according to Regulation (EC) No 1272/2008 (CLP).
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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