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EC number: 916-736-9
CAS number: -
Heavy Ends was tested in an in vitro mammalian cell gene mutation test
with L5178Y mouse lymphoma cells to studythe
induction of forward mutations at the thymidine-kinase locus (TK-locus)
in L5178Y mouse lymphoma cells (Verspeek-Rip, 2015). The test was
performed in the absence of S9-mix with a 3 and 24 hour treatment period
and in the presence of S9-mix with a 3 hours treatment period (rat liver
S9-mix induced by a combination of phenobarbital and ß-naphthoflavone).
the first experiment, SMPO Heavy Ends was tested up to concentrations of
65 µg/mL and 164 µg/mL in the absence and presence S9-mix, respectively.
The incubation time was 3 hours. Relative total growth (RTG) was reduced
to 9% and 6% in the absence and presence of S9-mix, respectively. SMPO
Heavy Ends precipitated in the culture medium at the dose level of 164
the second experiment, SMPO Heavy Ends was tested up to concentrations
of 60 µg/mL in the absence of S9-mix. The incubation time was 24 hours.
The RTG was reduced to 13%.The
spontaneous mutation frequencies in the solvent-treated control cultures
were within the minimum and maximum value of the historical control data
range and within the acceptability criteria of this assay.
the absence of S9-mix, SMPO Heavy Ends did not induce a significant
increase in the mutation frequency in the first experiment. This result
was confirmed in an independent experiment with modifications in the
duration of treatment time.
the presence of S9-mix, SMPO Heavy Ends did not induce a significant
increase in the mutation frequency.
on these results and according
to the Regulation (EC) No 1272/2008 on classification, labelling and
packaging of substances and mixtures (including all amendments), it
is concluded that SMPO Heavy Ends is not mutagenic in the mouse lymphoma
L5178Y test system under the experimental conditions described in this
report. Although the in vitro mammalian gene mutation is
not an Annex VII study but an Annex VIII study, it is considered
relevant for the Genetic toxicity endpoint section and is closer to
human than the bacterial mutation. Therefore the study is considered
relevant, adequate and reliable instead of the Ames test.
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