Registration Dossier

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).