Registration Dossier

Administrative data

Description of key information

Test article dosed up to the level of 50% did not cause irritation to skin and provided a stimulation index of <3 under the experimental conditions. Thus, the substance is considered not sensitising to skin.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A GLP study following OECD guideline 429 was performed to assess the skin sensitisation potential of the test article. A total of 30 female mice was applied at dose levels of 50%, 5%, and 0.5% in vehicle (DAE 433). The test substance did not show a tendency to increase ear weight - it means the test substance did not cause irritation of skin. The test substance showed a dose dependent increase in radionuclide incorporation but the Stimulation Indexes of all treated groups were < 3. Statistically significantly increased radionuclide incorporation was recorded at concentration of 50% and 5%. The highest concentration was the technically practicable maximum concentration. The increase in the cell proliferation cannot be attributed to irritation effects because no increase in the ear weight was seen in concurrence.

Under the experimental conditions, the test substance dosed up to the maximum concentration of 50% did not Iead to irritation and provided a stimulation index below the classification threshold in a LLNA study.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data, the test substance dosed up to the maximum concentration of 50% did not lead to irritation and provided a stimulation index below the classification threshold in LLNA study; therefore, the test article is not to be classified for skin sensitisation under the CLP (Regulation EC No.1272/2008).