Registration Dossier
Registration Dossier
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EC number: 309-916-8 | CAS number: 101357-19-1
Endpoint summary
Administrative data
Description of key information
Pigment Violet 3 PTM was sensitising to the skin under the test conditions of a Murine Local Lymph Node Assay (LLNA).
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The skin sensitising potential of Pigment Violet 3 PTM was assessed using the radioactive Murine Local Lymph Node Assay (LLNA) according to OECD guideline 429 in compliance with GLP. The assay simulates the induction phase for skin sensitization in mice. It determines the response of cells in the auricular lymph nodes to repeated application of the test substance to the dorsal skin of the ears. The LLNA was performed using test item concentrations of 5, 10, and 25% (w/w). Stimulation Indices (S.I.) of 3.38, 5.63, and 8.40 were determined with the test item at concentrations of 5, 10, and 25% (w/w), respectively. Under the conditions of this study, the target substance was thus sensitising to the skin. An EC3 value could not be determined as for all tested concentrations the S.I. of 3 has been exceeded.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.
Based on the results of a Murine Local Lymph Node Assay (OECD 429, GLP) the substance is classified with Skin sens. 1; H317 under Regulation (EC) No. 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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