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:

The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value. In this study Stimulation Indices of 1.31, 1.65 and 1.53 were determined with the test item at concentrations of 5, 10, and 20% in ethanol:deionised water (30+70). The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.

Migrated from Short description of key information:
The test item FAT 40840/A TE was found to be not a skin sensitiser under the described conditions (OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay (LLNA) in Mice

Justification for classification or non-classification

FAT 40840/A E is not classified since the result of the study lies outside the classification criteria