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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:

The skin sensitisation potential of DYNS 2246 following dermal exposure was tested in a Local Lymphnode Assay in the mouse.

Based on results of the Preliminary Compatibility Test and on recommendations of the OECD Test Guideline 429, the test item was dissolved inN,N-Dimethyl-formamide (DMF).The maximum attainable concentration based on solubility of the test item in DMF was 25%.

A Preliminary Irritation/Toxicity Test was performed with the test item at concentrations of 25% and 10% in the selected vehicle. According to this test, the applicability and biocompatibility of the test item to the animals’ ears (2 female CBA/CaOlaHsd mice/dose) at the maximum concentration of 25% was acceptable.

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

-     three groups received the appropriate formulation of DYNS 2246 at concentrations of 25%, 10% and 5%,

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

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

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) of DYNS 2246 was observed at the concentrations applied compared to the negative control. The stimulation index values of the test item were 1.3, 1.3, and 1.1 at treatment concentrations of 25%, 10%, and 5%, respectively. No conventional dose-response to treatment was observed.

A significant lympho­proliferative response (stimulation index value of 12.7) 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 DYNS 2246 (Batch Number: DYNS 3677 (D06-00693-008)), tested in a suitable vehicle, was shown 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