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EC number: 218-451-9 | CAS number: 2155-60-4
In an AMES test, performed according to OECD/EC guidelines and GLP principles, Dibutyl itaconate was found not to be mutagenic with or without metabolic activation. Structural analogues of DBI were found to give (false) positive results when tested in in vitro tests with mammalian cells. As no reliable outcome is expected from the required in vitro tests with mammalian cells, it is proposed to address the potential genotoxic properties of DBI in an in vivo COMET assay. Based on the current data-set, there are no indications that the substance has genotoxic properties.
In strains TA1537 (absence and presence of S9-mix, experiment 1+2) and TA98 (absence of S9-mix, experiment 1), fluctuations in the number of revertant colonies below the laboratory historical control data range were observed. However, since no dose-relationship was observed, these reduction are not considered to be caused by toxicity of the test item. It is more likely these reductions are caused by an incidental fluctuation in the number of revertant colonies.
An AMES test was performed with Dibutyl itaconate according to OECD/EC guidelines and GLP principles. All bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of revertants with or without metabolic activation in two experiments was seen. In the second experiment the test item precipitated on the plates in the absence and presence of S9-mix, except in tester strain TA98 in the presence of S9-mix, where no precipitation was observed. Cytotoxicity, as evidenced by a decrease in the number of revertants and/or bacterial background lawn, was observed in tester strains TA1535, TA1537 and TA100 in the absence of S9-mix. The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Based on the results of this study it is concluded that Dibutyl itaconate is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay with or without metabolic activation.
Based on the available data, DBI is not classified for genotoxicity according to Regulation EC (No.) 1272/2008 (CLP).
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