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Key value for chemical safety assessment

Additional information

The test substance did not induce an increase of the gene-mutation frequency in two independent Ames/Salmomella assays when tested up to cytotoxic dose levels. No increase of the chromosme aberration frequency was observed in CHO cells following treatment with the test substnce at up to cytotoxic concentrations. The test substance did not induce an increase of the mutant frequency in L5178Y mouse lymphoma cells when tested up to cytotoxic concentrations. All in vitro studies were conducted with and without rat liver derived S9 metabolic activation.


Justification for selection of genetic toxicity endpoint
Test substance was negative in three difference in vitro genotoxicity assays.

Short description of key information:
The test substance, Bisphenol A, epichlorohydrin polymer, 2-methylimidazole condensate, was evaluated for genotoxicity in a bacterial gene-mutation assay (O.E.C.D. 471), in vitro chromosome aberration study (O.E.C.D. 473) and an in vitro mammalian cell gene-mutation test (O.E.C.D. 476).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test substance was not genotoxic in vitro. No in vivo data is available, no Classification and Labeling is required.