Registration Dossier

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:

Theaim of this study was to determine the skin sensitisation potential of Triazin UV-Absorber following dermal exposure.

Based on results of the Preliminary Compatibility Test and on recommendations of the OECD Test Guideline 429, the test item was dissolved in Dimethyl-sulphoxide (DMSO). The maximum attainable concentration based on solubility of the test item in DMSO was 5 %.

A Preliminary Irritation/Toxicity Test was performed with the test item at concentrations of 5 % and 2.5 % in the selected vehicle. According to this test, the applicability and biocompatibility of the test item to the animals’ ears (2 female CBA/J@Rj mice/dose) at the maximum concentration of 5 % was acceptable.

In the main assay twenty female CBA/J@Rj mice were allocated to five groups of four animals each:

-   three groups received the appropriate formulation of Triazin UV-Absorber at concentrations of 5 %, 2.5 % and 1 %,

-   the negative control group received the vehicle (DMSO),

-   the positive control group received 25 %a-Hexylcinnamaldehyde (HCA) in DMSO.

The test item solutions were applied to the dorsal surface of both ears of the mice (25 µl/ear) for three consecutive days (Days 1, 2, and 3). There was no treatment on Days 4, 5, and 6. On Day 6, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI).

No mortality or systemic clinical signs were observed during the study. No treatment related effects were observed on animal body weights in any of the treated groups. No cutaneous reactions were observed at the site of the treatment in any of the treated groups.

No significant lymphoproliferative response (SI ³ 3) of Triazin UV-Absorber was observed at the concentrations applied compared to the negative control. The stimulation index values of the test item were 0.6, 0.7, and 0.8 at treatment concentrations of 5 %, 2.5 %, and 1 %, respectively. No conventional dose-response to treatment was observed.

A significant lymphoproliferative response (stimulation index value of 4.8) was noted for the positive control chemical HCA. This result confirmed the validity of the assay.

In conclusion, under the conditions of the present assay Triazin UV-Absorber (Batch Number: JDH 4126), tested in a suitable vehicle, proved to have no sensitization potential (non-sensitizer) in the Local Lymph Node Assay.

Migrated from Short description of key information:
No sensitizing properties observed

Justification for classification or non-classification