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 LLNA was used to evaluate the sensitizing potential of isomaltulose greens in mice. No local irritations were observed at the application sites of all animals of all test substance groups and the negative control group throughout the study. Therefore isomaltulose greens is not sensitizing.

Migrated from Short description of key information:
A new study examining skin sensitization in mice to isomaltulose greens was conducted under GLP conditions and using the current OECD guideline for the Local Lymph Node Assay. No signs of sensitization were observed. Isomaltulose greens is not sensitizing.

Justification for classification or non-classification

No sensitizing effects were observed in a LLNA conducted under GLP conditions. Isomaltulose greens is not classified as a sensitizer.