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EC number: 700-204-6
CAS number: 1174627-68-9
In vitro Bacterial
mutagenicity (Ames Tests)
Rhodiasolv Polarclean has
been evaluated in a bacterial mutagenicity assay in vitro (OECD
471/472) using four strains of Salmonella typhimurium (TA1535, TA1537,
TA98, TA100) and one strain of Escherichia coli (WP2PuvrA) (Key study -
Agh, 2009) .
In two separate experiments, the test
substance did not induce any significant, reproducible increases in the
observed numbers of revertant colonies in any strain with or without an
auxiliary metabolising system (S9). Under the conditions of this assay,
the test substance was considered non-mutagenic.
These results were confirmed in a second
Ames test, assigned as supporting study and conducted for Japan
registration purpose (Nakamura, 2014), where the
test item did not induce gene mutations by base pair changes or
frameshifts in the genome of any of the strains used.
In vitro mammalian
Rhodiasolv Polarcleanwas tested in the in
vitro HPRT test in hamster
V79 cellsin two independent experiments in the presence and
absence of an auxiliary metabolising system (S9).No
substantial and reproducible dose dependent increase of the mutation
frequency was observed.
In vitro mammalian
cell chromosome aberration
Rhodiasolv Polarclean was
tested in the chromosome aberration assay using human lymphocytes in
vitro, in two independent experiments in the presence and absence of
an auxiliary metabolising system (S9). Neither
a statistically significant nor a biologically relevant increase in the
number of cells carrying structural chromosomal aberrations was observed
after treatment with the test item. No evidence of an increase in
polyploid metaphases was noted after treatment with the test item as
compared to the control cultures.
In vivo mammalian
erythrocyte micronucleus test
Rhodiasolv Polarclean was tested in the mouse micronucleus test to
investigate potential to produce damage to chromosomes or aneuploidy.
There were no statistically significant increases in the frequency of
micronucleated PCE in any test item dose groups. Rhodiasolv Polarclean
was considered to be non-genotoxic under the conditions of the test.
Rhodiasolv Polarclean was concluded not
to have genotoxic potential.
absence of mutagenicity and clastogenicity in four studies in vitro and
one in vivo study, it
is concluded that the Rhodiasolv Polarclean is
not genotoxic. Therefore no
classification is warranted according to the criteria of Annex VI
Directive 67/548/EEC or EU Regulation 1272/2008 (CLP).
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