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