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EC number: 840-203-9
CAS number: 2295746-51-7
The objective of this study was to determine the potential of
PF-07202371-S7 and/or its metabolites to induce reverse mutations at the
histidinelocus in several strains of Salmonella typhimurium (S.
typhimurium; TA98, TA100, TA1535, and TA1537), and at the
tryptophan locus of Escherichia coli (E. coli) strain WP2uvrA in the
presence or absence of an exogenous mammalian metabolic activation
The study procedures described in this report were based on the most
recent OECD and EC guidelines.
Batch 19-AN-00524 of the test item was a white powder with a
purity of 99.9%. The vehicle of the test item was ethanol.
In the dose-range finding study, the test item was initially tested up
to concentrations of 5000 µg/plate in the strains TA100 and WP2uvrA in
the absence and presence of 5% (v/v) S9-mix. In the first mutation
experiment, the test item was again tested up to concentrations of 5000
µg/plate in the strains TA1535, A1537 and TA98 in the absence and
presence of 5% (v/v) S9-mix. In a follow-up experiment of the assay with
additional parameters, the test item was tested at a concentration range
of 492 to 5000 µg/plate in the absence and presence of 10% (v/v) S9-mix
in the tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA. In
all three experiments the test item did not precipitate on the plates at
this dose level. The bacterial background lawn was not reduced at any of
the concentrations tested and no biologically relevant decrease in the
number of revertants was observed, except in tester strain TA100 in the
absence of S9-mix in the first experiment and in the absence and
presence of S9-mix in the second experiment, where toxicity, as
evidenced by a decrease in the number of revertants, was observed.
The test item did not induce a significant dose-related increase in the
number of revertant (His+) colonies in each of the four tester strains
(TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+)
colonies in the tester strain WP2uvrA both in the absence and presence
of S9-metabolic activation. These results were confirmed in a follow-up
The negative and strain-specific positive control values were within the
laboratory historical control data ranges indicating that the test
conditions were adequate and that the metabolic activation system
In conclusion, based on the results of this study it is concluded that
PF-07202371-S7 is not mutagenic in the Salmonella typhimurium reverse
mutation assay and in the Escherichiacoli reverse mutation assay.
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