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EC number: -
CAS number: -
reverse gene mutation assay in bacteria, strains TA 97, TA 98a, TA 100,
TA 102, TA 1535 of Salmonella typhimurium were exposed to 400160 in
sterile ethanol at concentrations of 5002 / 1501 / 500 / 150 / 50
µg/plate in the plate incorporation method and at concentrations of 5003
/ 2502 / 1251 / 626 / 313 µg/plate in the pre-incubation method. Both
test methods were conducted in the presence and absence of mammalian
tested at limit concentration (5000 µg/plate) for cytotoxicity. No
cytotoxicity could be observed. The positive controls induced the
appropriate responses in the corresponding strains. There was no
evidence of induced mutant colonies over background.
test conditions 400160 is not mutagenic.
was performed according to test guidelines OECD guideline 471 and EU
B.13/14 for bacterial reverse gene mutation data in a GLP certified
genotoxic potential of the test item, 400160 was evaluated in an in
vitro micronucleus assay in human peripheral blood lymphocytes, both in
the presence and in the absence of metabolic activation by rat S9 mix.
The assay was performed according to OECD guideline No. 487 and under
GLP compliance. In two independent experiments, cells were exposed to
concentrations of the test item ranging from 4 to 500 µg/mL in ethanol
for 4 h [with (exp.I + II) and without metabolic activation (exp. I)] or
18 h [without metabolic activation (exp. II)]. Cyclophosphamide
monohydrate at concentrations of 15 and 7.5 µg/mL in 0.9% NaCl (for
experiments with metabolic activation) and mitomycin C at concentrations
of 0.15 and 0.3 µg/mL in aqua demin. (for experiments without metabolic
activation) were used as positive controls. There were no signs of
cytotoxicity during the study. The positive controls induced the
appropriate response. Treatment of the cells with the test item did not
induce significant increase in the number of micronucleated cells, as
compared to vehicle controls after any incubation time. Thus, the
results of this study indicate that the test item 400160 is not
genotoxic to human peripheral blood lymphocytes under the experimental
was performed to investigate the potential of 400160 to induce mutations
at the mouse lymphoma thymidine kinase locus using the cell line L5178Y.
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 h. The second
experiment was performed with a treatment period of 24 h in the absence
of metabolic activation and 4 hours in the presence of metabolic
concentration (4200 µg/mL) applied in the pre-experiment was chosen with
regard to the solubility of the test item in organic solvents and
aqueous media. The concentration range of the main experiments was
limited by precipitation of the test item.
substantial and reproducible dose dependent increase in mutant colony
numbers was observed in both main experiments. No relevant shift of the
ratio of small versus large colonies was observed up to the maximal
concentration of the test item.
conclusion it can be stated that under the experimental conditions
reported the test item 400160 did not induce mutations in the mouse
lymphoma thymidine kinase locus assay using the cell line L5178Y in the
absence and presence of metabolic activation.
to the negative results of three in vitro genotoxicity assays, it can be
concluded that 400160 is not genotoxic. 400160 does not
meet the current EU-CLP criteria for classification as a genotoxic
substance. No risk phrase is required.
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