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:

Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 50% v/v, 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 test material as asolution in acetone/olive oil 4:1 at concentrations of 50%,25% or10% v/v. A further group of five animals was treated withacetone/olive oil 4:1alone.

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 are as follows:

Concentration (%v/v) in
acetone/olive oil 4:1

Stimulation Index

Result

10

1.57

Negative

25

0.79

Negative

50

1.04

Negative

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


Migrated from Short description of key information:
A study was performed to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of the following:
* OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted 24 April 2002)
* Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Regulation (EC) No. 440/2008

Respiratory sensitisation

Endpoint conclusion
Additional information:

Reliability

The above study had been ranked reliability 1 according to the Klimish at al system. This ranking was deemed appropriate because the study was conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Justification for classification or non-classification

The test material did not meet the criteria for classification as a skin sensitiser under the condition of the test.