Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

An AMES test was performed according to the OECD guideline and GLP principles. All bacterial strains showed negative responses up to precipitating concentrations (precipitation was observed at 333 µg/plate and above at the end of the incubation period), i.e. no significant dose-related increase in the number of revertants with or without metabolic activation was seen. No cytotoxicity of the test substance was observed.

A second AMES test was performed equivalent to OECD guideline and following GLP principles. All bacterial strains showed negative responses up to 5000 ug/plate, i.e. no significant dose-related increase in the number of revertants with or without metabolic activation was seen. Precipitation was seen at 313 µg/ plate and above, with and without metabolic activation. No cytotoxicity was observed.

In a chromosome aberration study, cultured Chinese hamster fibroblasts (CHL/IU cells) were exposed to different concentrations of Y-513 (suspended in 0.5 w/v% CMC solution), in the presence and absence of S9-mix according to Japanese guidelines, OECD guideline 473 and GLP principles. Y-513 did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in the absence and presence of S9-mix, in either of the two independently repeated experiments. No effects of Y-513 on the number of polyploid cells and cells with endoreduplicated chromosomes were observed both in the absence and presence of S9-mix. Therefore it can be concluded that Y-513 does not disturb mitotic processes and cell cycle progression and does not induce numerical chromosome aberrations nor polyploidy.

A mouse lymphoma assay was conducted with L5178Y according to EC/ OECD guidelines and GLP principles. The test substance was tested up to and including precipitating concentrations (substance precipitated at 17 μg/mL and above). No toxicity was observed and dose levels up to and including precipitating concentration (at 17 μg/mL) were evaluated in the absence and presence of S9-mix in two independent experiments. As no significant increase in mutation frequency was seen in any of the experiments, it is concluded that Y-513 is not mutagenic in the mouse lymphoma L5178Y test system under the experimental conditions described in this report when tested up to and beyond precipitating concentrations.


Justification for selection of genetic toxicity endpoint
No single study is selected, as the endpoint conclusion is based on a Weight-of-Evidence approach.

Short description of key information:
Two AMES studies, a chromosome aberration test and a mouse lymphoma assay are available (all Klimisch 1). None of the data indicate that the substance has genotoxic properties.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data, Y-513 is found to have no indication of genotoxic properties and is not classified according to Regulation (EC) 1272/2008.