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Both in the absence and presence of S9-mix ZOR-F did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in two independent experiments with human lymphocytes. Moreover, ZOR-F tested in the Salmonella typhimurium reverse mutation assay and in the E. Coli reverse mutation assay in concentrations up to 5000 µg/plate did not express any mutagenic potential. All tests were considered valid. Thus, it is concluded that ZOR-F is not expressing genetic toxicity potential in vitro under the experimental conditions described.

Short description of key information:
In vitro genotoxicity of 7-aminodesacetoxycephalosporanic acid was tested in cultured human lymphocytes (chromosomal aberration) and in cultured E. Coli and S. Typhimurium cells (Ames test).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification