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EC number: 701-173-1
CAS number: -
Bacterial Mutation Assay
Summary of Results - Initial Toxicity-Mutation Assay
Test Article Id
Average Revertants Per Plate ± Standard Deviation
Dose (µg per plate)
Rat Liver S9
Vehicle = Vehicle Control
Positive = Positive Control (50 μL plating aliquot)
Plating aliquot = 50 µL
Summary of Results - Confirmatory Mutagenicity Assay
The test substance was tested in the Bacterial Reverse Mutation Assay
using Salmonella typhimurium tester strains TA98, TA100, TA1535
and TA1537 and Escherichia coli tester strain WP2 uvrA
in the presence and absence of Aroclor‑induced rat liver S9. The assay
was performed in two phases, using the plate incorporation method. The
first phase, the initial toxicity-mutation assay, was used to establish
the dose‑range for the confirmatory mutagenicity assay and to provide a
preliminary mutagenicity evaluation. The second phase, the confirmatory
mutagenicity assay, was used to evaluate and confirm the mutagenic
potential of the test article.
Anhydrous ethylene glycol dimethylether (EGDE) was selected as the
solvent of choice based on the request of the Sponsor, solubility of the
test article and compatibility with the target cells. The test article
formed a soluble and clear solution in EGDE at 500 mg/mL, the maximum
In the initial toxicity-mutation assay, the maximum dose tested was
5000 µg per plate; this dose was achieved using a concentration of
100 mg/mL and a 50 µL plating aliquot. The dose levels tested were 1.5,
5.0, 15, 50, 150, 500, 1500 and 5000 µg per plate. In
the initial toxicity‑mutation assay, no positive mutagenic response was
observed. Precipitate was observed beginning at 500 or
1500 µg per plate. Toxicity was observed
beginning at 150, 500, 1500 or at 5000 µg per plate with most test
conditions. Based on the findings of the initial
toxicity‑mutation assay, the maximum doses plated in the confirmatory
mutagenicity assay were 5000 µg per plate with tester strains TA98 and
TA1535 in the presence of S9 activation and tester strain WP2uvrA
in the presence and absence of S9 activation and 1500 µg per plate with
the remaining test conditions.
In the confirmatory mutagenicity assay, no positive mutagenic response
was observed. The dose levels tested were 15, 50, 150,
500, 1500 and 5000 µg per plate with tester strains TA98 and TA1535 in
the presence of S9 activation and tester strain WP2uvrA in the
presence and absence of S9 activation and 5.0, 15, 50, 150, 500 and 1500
µg per plate with the remaining test conditions. Precipitate
was observed beginning at 150 or 500 µg per plate with all test
conditions except tester strain WP2uvrA in the presence of S9
activation. Toxicity was observed beginning at 150 or
500 µg per plate.
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