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EC number: -
CAS number: -
This study was performed to investigate the potential of AC 436 to
induce gene mutations in comparison to negative control according to the
plate incorporation test (Trial I) and the pre-incubation test (Trial
II) using the Salmonella typhimurium strains TA 1537, TA 1535, TA 98,
TA 100 and TA 102.
The assay was performed in two independent experiments both with
and without liver microsomal activation. Each concentration, including
the negative and positive controls was tested in triplicate. Based on
the solubility and precipitation test results eight different
concentrationsviz.,0.002, 0.005, 0.016, 0.050, 0.158, 0.501, 1.582 and 5
mg/plate were selected for pre-experiment.
Based on the pre-experiment results, the test item was tested with
the following concentrations: 0.005, 0.016, 0.050, 0.158, 0.501 mg/plate
for main study, both in the presence of metabolic activation (+S9) and
in the absence of metabolic activation (-S9).
No substantial increase in revertant colony numbers in any of the
tester strains were observed following treatment with AC 436 at any dose
level in both the trials, neither in the presence nor in the absence of
metabolic activation (S9 mix). There was also no tendency of higher
mutation rates with increasing concentrations in the range below the
generally acknowledged border of biological relevance.
The spontaneous reversion rates in the negative and positive
controls are within the range of in-house historical data.
The positive controls used for various strains showed a distinct
increase in induced revertant colonies in both the methods i..e. Plate
incorporation method and Pre-incubation method.
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