Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

No study with the registered substance is available but for a closely related structure differing by one methyl group at the oxime carbon atom from the registered substance. The test substance is a C9 aldoxime whereas the registered substance is a C9 ketoxime. The C9 aldoxime showed a clear potential for skin sensitisation in an LLNA study and therefore the registered substance is also labelled as a skin sensitiser according to this read across. A repetition of the LLNA study appears to be inappropriate.

In the study, the test item dissolved in acetone:olive oil (4+1) was assessed for its possible contact allergenic potential. The study was performed according to OECD 429 guideline and GLP.

For this purpose a local lymph node assay was performed using test item concentrations of 10, 25, and 50%.

The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. A statistically significant increase in ear thickness was observed in the animals treated with 10 and 25 % test item concentration (p < 0.001). In this study Stimulation Indices of 12.80, 16.10 and 15.74 were determined with the test item at concentrations of 10, 25 and 50 % in acetone:olive oil (4 +1) respectively. The test item was found to be a skin sensitiser. Based on the available data, no sub-classification into Cat. 1A or 1B was possible.

Migrated from Short description of key information:
Based on read across assumptions the registered substance is considered to be a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The stimulation index found in an LLNA study with the structural homologue exceeded the cut-off value of 3. The registered substance by way of read across is therefore also labelled as a skin sensitiser (R43/Cat. 1) according to DSD-DPD and CLP. However based on the available data, no distinction between category 1A and 1B according to CLP can be made as the lowest dose tested was at 10 %.