Registration Dossier
Registration Dossier
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EC number: 423-070-8 | CAS number: 58890-25-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Salmonella typhimurium reverse mutation assay
The genetic toxicity of KY-RB was assessed up to and including the precipitating concentration of 3330 µg/plate using S. typhimurium TA100, TA1535, TA98 and TA1537 strains, in accordance with OECD 471 (1983) guideline and according to GLP principles. All strains showed no cytotoxicity at the highest tested concentrations. All bacterial strains showed negative responses with and without metabolic activation in two independently repeated experiments. Based on the results of this study, the substance KY-RB is not mutagenic in the Salmonella typhimurium reverse mutation assay.
Escherichia coli reverse mutation assay
The genetic toxicity of KY-RB was assessed up to and including the precipitating concentration of 5000 µg/plate using Escherichia coli WP2uvrA strain, in accordance with OECD 471 guideline and according to GLP principles. The strain showed no cytotoxicity at the highest tested concentrations and showed negative responses with and without metabolic activation in two independently repeated experiments. Based on the results of this study, the substance KY-RB is not mutagenic in the Escherichia coli reverse mutation assay.
In vitro mammalian chromosome aberration test
KY-RB was tested in a chromosome aberration study performed according to OECD 473 (1983) guideline and GLP principles, in cultured peripheral human lymphocytes in two independent experiments. No toxicity was observed up to and including the highest precipitating tested dose of 100 µg/mL in both main experiments. Both in the presence and absence of S9 -mix the test substance did not induce a statistically and biologically significant increase in the number of cells with chromosome aberrations. Based on the results it is concluded that KY-RB is not clastogenic.
In vitro mammalian cell gene mutation test
The mutagenic activity of KY-RB was tested in the mouse lymphoma assay conducted according to OECD 476 guideline and GLP principles. In the first experiment, KY-RB was tested for 3 hours up to and including concentrations of either 200 µg/mL , in the absence of S9-mix, or 164 µg/mL, in the presence of S9-mix. In the second experiment KY-RB was tested for 24 hours up to concentrations and including of 200 µg/mL in the absence of S9-mix. KY-RB was tested beyond the limit of the solubility. Positive control chemicals, methyl methane sulfonate and cyclophosphamide induced appropriate responses. In the absence and presence of S9-mix, KY-RB did not induce a significant increase in the mutation frequency. It is concluded that KY-RB is not mutagenic in the mouse lymphoma L5178Y test system under the experimental conditions described, in the absence and presence of S9-mix.Justification for selection of genetic toxicity endpoint
No single study was selected, since several relevant studies were performed.
Short description of key information:
Based on the results of 4 performed in vitro studies, the substance is not mutagenic.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the available data, KY-RB is not classified for genotoxicity according to Regulation (EC) No. 1272/2008.
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