Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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