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:

Mice were treated with vehicle, 2 %, 10 % or 50 % Gelbpigment E4GN in DMF.

The NMRI mice did not show an increase in the stimulation indices for cell counts or for weights of the draining lymph nodes after application of the test item Gelbpigment E4GN.

The “positive level”, which is 1.4 for the cell count index, was never reached or exceeded in any dose group.

These findings were verified by the results obtained with the positive control compound Alpha Hexyl Cinnamic Aldehyde.


Migrated from Short description of key information:
A modified Local Lymph Node Assay (IMDS) indicate for up to and including a 50% suspension of Gelbpigment E4GN no sensitisation potential.

Respiratory sensitisation

Endpoint conclusion
Additional information:

no data


Migrated from Short description of key information:
no data

Justification for classification or non-classification

Due to the results of the LLNA a classification for skin sensitisation is not justified