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EC number: 291-454-0
CAS number: 90411-76-0
In 2012, Nigrosin was initially investigated in the Ames test according
to OECD TG 471 and GLP using the Salmonella typhimurium TA 98, TA100,
TA102, TA1535, TA1537 and concentrations up to and including 5000
µg/plate. Bacteriotoxicity was not reached. None of the 5 strains used
showed a dose-related and biologically relevant increasein mutant counts
over those of the negative controlsneither in the presence nor in the
absence of the metabolic activation system S9 -mix. The positve controls
The study was performed to investigate the potential of Nigrosin WLF to
induce gene mutations at the HPRT locus in V79 cells of the Chinese
hamster according to OECD TG 476. The assay was performed in two
independent experiments, using two parallel cultures each. The first
main experiment was performed with and without liver microsomal
activation and a treatment period of 4 hours. The second experiment was
performed with a treatment time of 4 hours with and 24 hours without
metabolic activation. . The dose-range of the main experiments was
limited by cytotoxic effects; no precipitation of the test item at the
end of treatment was noted. No substantial and reproducible dose
dependent increase of the mutation frequency was observed in both main
Appropriate reference mutagens, used as positive controls, induced a
distinct increase in mutant colonies and thus, showed the sensitivity of
the test system and the activity of the metabolic activation system.
Therefore, it can be stated that under the experimental conditions
reported the test item did not induce gene mutations at the HPRT locus
in V79 cells. Thus, Nigrosin WLF is considered to be non-mutagenic in
this HPRT assay.
MNT in vitro
Nigrosin WLF was examined for mutagenic activity in the micronucleus
test in vitro according to OECD TG 487 in the presense and in th absence
of a metabolic activation system..No cytotoxic effects were observed. in
the 4 hour treatment with and without S9- mix up to 200 µg/ml or during
24 hour treatment in the absence of S9 -mix up to 500 µg/ml.
Precipitation in the medium could be observed at 50 µg/ml and above
without S9 -mix and at 200 µg/ml in the presence of S9 -mix. No
biologically relevant increase in the frequencies of micronucleus
containing V79 cells treated with the test item in the absence (4 hours
or 24 hours treatment) or in the presence of S9 mix.were seen.
Evaluation of the data does not indicate that Nigrosin WLF is a mutagen
in the micronucleus test in vitro in the absence or presence of
Nigrosin WLF was tested for mutagenicity using the Ames test, the HPRT
test and the micronucleus test in vitro. In none of these tests
Nigrosine WLF revealed mutagenic activity. Thus it can be concluded that
Nigrosin WLF is not mutagen and not clastogen..
Based on the available data no classification or labelling with respect
to mutagenicity is required.
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