Registration Dossier
Registration Dossier
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EC number: 701-263-0 | CAS number: -
Endpoint summary
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.
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