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:

GUIDELINE

A study was performed in accordance with OECD 429 and EU method B.42 to assess the skin sensitisation potential of the test item in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear.

METHODS

Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 100%, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of five animals, were treated with 50 µL (25 µL per ear) of the undiluted test item or the test item as a solution in acetone/olive oil 4: 1 at concentrations of 10% or 1% v/v. A further group of five animals was treated with acetone/olive oil 4: 1 alone. A concurrent positive control test, using a group of five animals, was also performed with the known sensitizer, α-Hexylcinnamaldehyde tech., 85%, at a concentration of 25% v/v in acetone/olive oil 4: 1.

RESULTS

The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group were found to be 0.75 (1 % test item v/v in acetone/olive oil 4:1), 1.30 (10 % test item v/v in acetone/olive oil 4:1) and 2.96 (100 % test item v/v in acetone:olive oil 4:1). The positive control, α-Hexylcinnamaldehyde, tech., 85% gave a Stimulation Index of greater than 3 (4.46) when tested at a concentration of 25% v/v in acetone/olive oil 4: 1 thus demonstrating the sensitivity and reliability of the test system.

CONCLUSION

The test item was considered to be a non-sensitiser under the conditions of the test.


Migrated from Short description of key information:
The test item was considered to be a non-sensitizer under the conditions of the test.

Justification for selection of skin sensitisation endpoint:
GLP guideline study

Justification for classification or non-classification

The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group were found to be 0.75 (1 % test item v/v in acetone/olive oil 4:1), 1.30 (10 % test item v/v in acetone/olive oil 4:1) and 2.96 (100 % test item v/v in acetone: olive oil 4:1).