Registration Dossier
Registration Dossier
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EC number: 277-785-3 | CAS number: 74239-96-6
Endpoint summary
Administrative data
Description of key information
Skin sensitising
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
In vitro sensitization test: KeratinoSensTM Keratinocytes test
The substance was evaluated for its potential to induce skin sensitisation according to the procedure described on the OECD guideline 442D.
The study was composed of two independent repetitions. For each repetition the test item and the reference items were replicated on three independent plates for the measurement of induction and two plates for the measurement of cytotoxicity. Each repetition was performed on a different day with fresh stock solution.
Under the retained experimental conditions the test item may be classified as sensitizer.
Human Cell Line Activation Test (h-CLAT)
The test substance was evaluated for its potential to induce skin sensitisation according to the procedure described in the OECD gudeline 442E.
No cytotoxicity was induced on THP-1 cells by the test item. In the assay conditions, a reproducible "increase" of the CD54 expression compared with the negative control at least for two dose-levels of Disperse Blue 354 was noticed.
In the first experiment, a dose-response relationship was noticed only for CD54 marker with an increase of 2.01 to 14.5 fold of expression compared to the negative control.
In the second experiment, a dose-response relationship was also observed for the CD54 marker with an increase of 6.12 to 7.77 fold of expression compared to the negative control. A Slight increase of expression for CD86 marker (fold increase 1.58) was only observed for one close, but without no-dose effect.
Based on these results, the test item demonstrated an in vitro sensitizing potential with a Minimum Induction Threshold (MIT) of 79.6µg/mL (in active substance) in condition of the experimental human Cell Line Activation Test, during this study.
Justification for classification or non-classification
According to the CLP Regulation (EC) no. 1272/2008, a skin sensitiser is an agent that will lead to an allergic response in susceptible individuals following skin contact. As a consequence of a secondary - usually organ-specific - subsequent re-exposure, adverse health effects occur on the skin (allergic contact dermatitis). Skin sensitisers are classified in Category 1 - H317. Where data is sufficient, skin sensitisers can be divided into sub-categories. If data are not sufficient for sub-categorisation, Category 1 must be chosen. The CLP (and UN GHS) criteria for classifying sensitisers are based on standard animal data and human data; data obtained from non-standard methods such as read-across orin vitro/in chemicotest methods may be used in combination in a Weight of Evidence approach.
Indicators of potency of a substance can be obtained fromin chemico/in vitrotesting; specifically, the following tests may be accepted to fulfill the requirements of Annex VII:
(i) Direct Peptide Reactivity Assay (DPRA) addresses AOP Key Event 1: Peptide/protein binding
(ii) ARE-Nrf2 Luciferase Test Method (KeratinoSensTM) addresses AOP Key Event 2: Keratinocyte response
(iii) the Human Cell Line Activation Test (h-CLAT) addresses AOP Key Event 3: Monocytic /Dendritic cell response.
These test methods were developed to address specific events of the skin sensitisation AOP (OECD, 2012). The AOP for skin sensitisation describes the current understanding of key events linked to skin sensitisation. As each of the test methods only addresses a specific key event of skin sensitisation, currently they should not be used in isolation to identify a potential skin sensitiser but rather in combination in a Weight of Evidence approach.
Based on the positive outcome both for KeratinoSens assay (inflammatory response in keratinocytes) and h-CLAT test(dendritic cell activataion), the data is sufficient for a Weight of Evidence approach as requirements for Article 13(3) are fulfilled. Using a Weight of Evidence approach, test item can be considered potentially skin sensitising (Category 1), according to the CLP Regulation (EC 1272/2008).
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