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EC number: 204-398-9
CAS number: 120-46-7
This study was performed to assess the genotoxic potential of
1,3-diphenylpropane-1,3-dione by measuring the ability to induce
DNA-strand breaks in different organs of rats (liver, duodenum and
stomach). The organs were selected to cover two first-contact organs
(stomach and duodenum) upon peroral exposure and liver as theprimary
organ for the metabolism of absorbed chemicals.
The test item was suspended in PEG400and applied to 5 male rats by
daily gavage at10 mL/kg bw (body weight) for two days. The organs were
collected 4 h after the second application of the test item.
Basedon the outcome of a dose range finding study, a dose of 2000
mg/kg bw was selected as maximum tolerated dose (MTD).
In the main experiment three dose levels (500, 1000 and 2000 mg/kg
bw/d) were used covering a range from the maximum tolerated dose to
little or no toxicity.
The animals treated with a dose of 1 MTD showed slight signs of
systemic toxicity (reduction of spontaneous activity). Slight diarrhea
was observed in the solvent and test item dose groups in the main
experiment after the second application. As the test item was
resuspended in the solvent PEG400 and the symptom was also present in
the solvent control group, the diarrhea was induced by the solvent and
not related to the test item.
Cells from liver, duodenum and stomach were isolated, embedded in
agarose, lysed and DNA allowed to migrate under electrophoresis
conditions.150 cells per animal tissue were evaluated if possible.DNA
migration during electrophoresis was determined and expressed as tail
intensity. The tail intensities of each concentration and tissue per sex
are summarised inTable 1.
The validity criteria were met:
Negative controls fell into the historic control range of the test
facility and were within the literature reference datafor
theacceptance criteria of the negative control group.
The tail intensities of the concurrent solvent controls were
within the ranges of the reference data set. Therefore, the data
were accepted for addition to the laboratory solvent control data set.
Ethyl methansulfonate (200 mg/kg bw) administered orally was used
as positive control, which induced a statistically significant increase
in DNA damage for all evaluated organs compared to the solvent control
group or negative control group.
In liver and stomach cells, the test item values were in the same
range as the corresponding solvent control group. In duodenum cells, the
solvent control was increased, however the tail intensities of the
middle and high test item dose group were lower than the negative
control. As the tail intensities induced by the test item were all
within the literature reference dataand no biologically relevant
increase of tail intensity were found after treatment with the test item
in any of the dose groups evaluated as well asin absence of a
dose-response,the test item did not induce DNA damage under the
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