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EC number: 947-478-5 | CAS number: -
Preliminary Toxicity Test
The test item exhibited toxicity at 5000 µg/plate to TA100 and WP2uvrA in the presence of S9-mix only. No toxicity was noted to either strain in the absence of S9-mix. The test item formulation and S9-mix used in this experiment were both shown to be sterile.
The numbers of revertant colonies for the toxicity assay were:
With (+) or without (-) S9‑mix
* : Partial absence of bacterial background lawn
The individual plate counts, the mean number of revertant colonies and the standard deviations, for the test item, positive and vehicle controls, both with and without metabolic activation, are presented in Table 2 and Table 3 for Experiment 1 and Table 4
and Table 5 for Experiment 2. The results are also expressed graphically in Figure 1 to Figure 4 (see attached background material for Tables and Figures).
A history profile of untreated/vehicle and positive controls (reference items) is presented in attached background material.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, at any dose level either with or without metabolic activation or exposure method.
All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the 59-mix and the sensitivity of the bacterial strains.
Table 1: Spontaneous Mutation Rates (Concurrent Negative Control)
Experiment 1 (Range-finding Test)
Number of revertants (mean number of colonies per plate)
Base-pair substitution type
Experiment 2 (Main Test)
A study was conducted to determine the in vitro mutagenic potential of the test substance according to OECD Guideline 471, EU Method B13/14 and US EPA OPPTS guidelines, in compliance with GLP. Salmonella typhimuriumstrains TA1535, TA1537, TA98 and TA100 andEscherichia colistrain WP2uvrAwere treated with the test item,Esterification products of Phosphorus Pentoxide and Alcohols C6-C10 (Even numbered), using both the Ames plate incorporation and pre-incubation methods at up to seven dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolising system (10% liver S9 in standard co-factors). The dose range for the range-finding test was determined in a preliminary toxicity assay and ranged between 5 and 5000 µg/plate, depending on bacterial strain type. The experiment was repeated on a separate day (pre-incubation method) using a dose range of 5 to 5000 µg/plate, fresh cultures of the bacterial strains and fresh test item formulations.
Additional dose levels and an expanded dose range were selected in both experiments in order to achieve both four non-toxic dose levels and the toxic limit of the test item.The vehicle (dimethyl sulphoxide) 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.In the range-finding test (plate incorporation), the test item caused a visible reduction in the growth of the bacterial background lawns of the majority of tester strains, initially from 1500 µg/plate in both the absence and presence of S9-mix. In the main test (pre-incubation), the test item again induced a visible reduction in the growth of the bacterial background lawns of the majority of tester strains, initially noted from 500 and 1500 µg/plate in the absence and presence of S9-mix respectively. The sensitivity of the bacterial tester strains to the toxicity of the test item varied between strain type, exposures with and without S9-mix and experimental methodology. These results were not indicative of toxicity sufficiently severe enough to prevent the test item being tested up to the maximum recommended dose level of 5000 µg/plate. A test item precipitate (globular in appearance) was observed at 5000 µg/plate.No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item either with or without metabolic activation or exposure method. Under the study conditions, the test substance was considered to be non-mutagenic (Bowles and Thompson, 2012).
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