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EC number: 907-605-7
CAS number: 68815-47-4
Mutagenic activity of the test item was investigated in Salmonella
typhimurium strains TA 1535, TA 1537, TA98 and TA100 as well as
Escherichia coli strain WP2 uvrA with (induced rat liver S9 mix at 10 %
(v/v)) and without metabolic activation at concentrations of 25, 75,
200, 600, 1800 and 5000 µg/plate (restesting of strain TA1537 with
metabolic activation at various S9 mix concentrations (i.e. 5, 10 or 15
% (v/v)) was done at 25, 75, 200, 600, 1800, 2500, 3333, and 5000
µg/plate using) in the plate incorporation assay. Toxicity was observed
beginning at 1800 µg per plate up to the highest dose tested. No
precipitate was observed.
The test item did not reveal any mutagenic activity under the
conditions tested. The appropriate reference mutagenes showed distinct
positive mutagenic effects.
The results of this study was confirmed in another bacterial
reverse mutation assay using Salmonella typhimurium strains TA 1535, TA
1537, TA98 and TA100 with (induced rat liver S9 mix at 16 % (v/v)) and
without metabolic activation (MA). Without MA dose levels tested were
0.3, 1, 4, 20, 100 and 300 µg/plate, with MA tests were performed at
concentrations of 1, 4, 20, 100, 300 and 1000 µg/plate in the plate
Assessment of the potential of the test item to induce gene
mutations in mammalian cells in vitro was conducted using Chinese
hamster ovary cells looking for forward mutations at the HGPRT locus.
The assay was performed in two independent experiments, using identical
procedures, both with and without rat liver microsomal activation.
The test article was tested with the following concentrations:
without S9-mix: 10, 50, 100, 175, and 250 µg/ml (5 hours treatment
with test material)
with S9-mix: 1, 10, 100, 500, and 1000 µg/ml (5 hours treatment
with test material)
According to the preliminary experiment for toxicity the
concentration ranges were selected. Starting from 100 µg/ml relative
initial survival was slightly decreasing with increasing concentrations
tested, reaching cytotoxicity effect level (i.e. only 10 -20% survival
of control) at concentrations of 333 µg/ml in the test without metabolic
activation and at 1000 µg/ml in these tests with various concentrations
of the S-9 mix. Nevertheless up to the highest concentration tested in
the mutagenicity assay no distinct decrease of the cloning efficiency
was observed. Up to the highest investigated dose no increase in mutant
colony numbers was obtained in two independent experiments. Appropriate
reference mutagens were used as positive controls and showed a distinct
increase in induced mutant colonies. In conclusion, the test item does
not induce gene mutations in the HGPRT-test with Chinese hamster cells,
either in the presence or in the absence of a metabolic activation
system, under the experimental conditions described. Therefore the test
item is considered to be non-mutagenic in this HGPRT assay.
The findings in mammalian cells were supported by the results of
an in vitro rat hepatocyte DNA repair assay (in vitro UDS assay). DNA
damaging effects indicate for mutagenic events which may occur
thereafter. The test item was therefore tested for the ability to induce
unscheduled DNA synthesis. Results of both the preliminary and the
replicate assay demonstrated that the test item is not a genotoxic agent
under the conditions tested in this mammalian cell assay.
Chromosomal aberrations assay
To investigate cytogenetic potential of the submission substance an in
vivo rat bone marrow assay was performed comparable to OECD TG 475.
In a reliable set of various bacterial mutation assay and gene
mutation test in mammalian cells in vitro and in vivo the test item is
considered to be non-mutagenic.
Based on the available data no classification according to Regulation
(EC) No. 1272/2008 and Council Directive 67/548/EEC on mutagenicity is
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