Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Bisphenol F Diglycidylether induced gene-mutation in the Ames/Salmonella mutation test and chromosomal aberrations in human lymphocytes in multiple independent testing guideline GLP studies. Furthermore, the structural analog, Bisphenol A Diglycidylether (BPADGE) induce a significant increase of the mutant frequency in L5178Y mouse lymphoma cells in culture supporting the other findings. Therefore, BPFDGE is genotoxic in vitro.

However, when Bisphenol F Diglycidylether was evaluated for genotoxicity potential in multiple GLP in vivo assays including the mouse micronucleus, rat in vivo/in vitro UDS and MutaMouse tests no evidence of genotoxicity was observed. The results of other in vivo tests for genotoxicity also supported these negative findings for BPFDGE. Therefore, Bisphenol F Diglycidylether is not genotoxic in vivo.   


Short description of key information:
Bisphenol F Diglycidylether (BPFDGE) was evaluated for the potential to induce evidence of genotoxicity in multiple in vitro and in vivo assays. These assays included tests for gene-mutation and chromosome aberrations in vitro and gene-mutation, chromosome damage repairable DNA damage in vivo.

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

Because Bisphenol F Diglycidylether is not genotoxic in vivo, Classification and Labeling as a Mutagen is not required.