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EC number: 619-228-2 | CAS number: 96556-05-7
Table 1: Summary of Experiment 1
± S9 Mix
Mean number of colonies/plate
Base-pair Substitution Type
Mean no. colonies/plate
ENNG = N-ethyl-N’-nitro-N-nitrosoguanidine
4NQO = 4-Nitroquinoline-1-oxide
9AA = 9-aminoacridine
2AA = 2-aminoanthracene
BP = benzo(a)pyrene
Table 2: Summary of Experiment 2
The genetic toxicity of the test material was investigated in accordance with the standardised guidelines OECD 471, EU Method B13/14, EPA OCSPP 870.5100 and the major Japanese Regulatory Authorities including METI, MHLW and MAFF, under GLP conditions in the Bacterial Reverse Mutation Test.
Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA were treated with the test material using both the Ames plate incorporation and pre-incubation methods at eight dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolizing system (10% liver S9 in standard co-factors). The dose range for Experiment 1 was predetermined and was 1.5 to 5000 μg/plate. The experiment was repeated on a separate day (pre-incubation method) using fresh cultures of the bacterial strains and fresh test material formulations. The dose range was the same as Experiment 1 (1.5 to 5000 μg/plate). Eight test material concentrations were selected in Experiment 2 in order to achieve both four non-toxic dose levels and the toxic limit of the test material following the change in test methodology.
The vehicle (sterile distilled water) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.
The maximum dose level of the test material in the first experiment was selected as the maximum recommended dose level of 5000 μg/plate. In the first mutation test (plate incorporation method), the test material caused a visible reduction in the growth of the bacterial background lawns of all of the tester strains initially from 1500 μg/plate in the absence of S9-mix and at 5000 μg/plate in the presence S9-mix. These results were not indicative of toxicity sufficiently severe enough to prevent the test material being tested up to the maximum recommended dose level of 5000 μg/plate in the second mutation test. The test material again induced a toxic response in the second mutation test (pre-incubation method), with weakened bacterial background lawns noted to all of the tester strains in both the absence and presence of S9-mix at 5000 μg/plate. The sensitivity of the bacterial tester strains to the toxicity of the test material varied slightly between strain type, exposures with or without S9-mix and experimental methodology. No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.
There were no significant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation (S9-mix) in Experiment 1 (plate incorporation method). Similarly, no toxicologically significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation (S9-mix) in Experiment 2 (pre-incubation method). Small but statistically significant increases in TA100 revertant colony frequency were observed in the absence of S9-mix at 150 and 1500 μg/plate in the second mutation test. These increases were considered to be of no biological relevance because there was no evidence of a dose-response relationship or reproducibility. Furthermore, the individual revertant colony counts at the statistically significant dose levels were within the in-house historical untreated/vehicle control range for the tester strain and the maximum fold increase was only 1.3 times the concurrent vehicle control.
Under the conditions of this study, the test material was considered to be non-mutagenic.
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