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EC number: 237-136-7
CAS number: 13653-62-8
The potential of LUPEROX®
520M50 to induce reverse mutations was
evaluated in Salmonella typhimurium. The study was performed
according to the international guidelines (OECD No. 471 and Commission
Directive No. B.13/14) and in compliance with the principles of Good
Laboratory Practice. A preliminary toxicity test was performed to define
the dose-levels of the test item, diluted in ethanol, to be used for the
mutagenicity experiments. The test item was then tested in two
independent experiments, both with and without a metabolic activation
system, the S9 mix, prepared from a liver post-mitochondrial fraction
(S9 fraction) of rats induced with Aroclor 1254. Treatments were
performed according to the direct plate incorporation method except for
the second experiment with S9 mix, which was performed according to the
pre-incubation method (60 minutes, 37°C). Five strains of bacteria Salmonella
typhimurium were used: TA 1535, TA 1537, TA 98, TA 100 and TA 102.
Each strain was exposed to five dose-levels of the test item
(three plates/dose-level). After 48 to 72 hours of incubation at 37°C,
the revertant colonies were scored. The evaluation of the toxicity was
performed on the basis of the observation of the decrease in the number
of revertant colonies and/or a thinning of the bacterial lawn. Since the
test item was found poorly soluble in the final treatment medium but
non-toxic in the preliminary test, the highest dose-level selected for
the main experiments was 5000 µg/plate, according to the criteria
specified in the international guidelines.
The mean number of revertants for the
vehicle and positive controls met the acceptance criteria. Also, there
were five analysable dose-levels for each strain and test condition. The
study was therefore considered to be valid. The selected dose-levels
were 312.5, 625, 1250, 2500 and 5000 µg/plate (expressed as
2,2-di-(tert-amylperoxy) butane) for the five strains in both
mutagenicity experimentswith and without S9 mix. A moderate to strong
emulsion, which did not prevent any scoring, was observed in the Petri
plates from the lowest selected dose-levels. No noteworthy toxicity was
noted at any of the tested dose-levels, towards the five strains used,
either with or without S9 mix.
LUPEROX® 520M50 did not induce
any biologically relevant increase in the number of revertants, in any
strains or test conditions. Consequently, the results met the criteria
of a negative response.
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