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EC number: 701-362-9
CAS number: -
The test substance,Ethoxylated (3) Bisphenol A Diacrylate, was
evaluated for its genotoxic potential in the Comet assay to induce DNA
damage in liver, glandular stomach, and duodenum cells of male
rats. Corn oil was selected as the vehicle. Test and/or control
substance formulations were administered at a dose volume of 10
mL/kg/day by oral gavage.
In the dose range finding assay (DRF), the maximum dose tested was
2000 mg/kg/day. The additional dose levels tested were 1000 and 500
mg/kg/day in 3 animals/sex. Based upon the results, the high dose for
the definitive assay was 2000 mg/kg/day, which is the highest guideline
recommended dose for this assay, which was estimated to be the maximum
tolerated dose (MTD).
The definitive assay dose levels tested were 500, 1000, and 2000
The definitive assay was repeated due to vehicle values in the
initial assay not being within the expected range. Thus, the initial
assay did not meet the criteria for a valid assay and was repeated. The
results and discussion will only include data from the repeated
definitive assay. The test substance gave a negative (non-DNA damaging)
response in this assay in liver, glandular stomach, and duodenum cells
for males in % Tail DNA. None of the test substance treated animal
slides had significant increases in the % Tail DNA compared to the
respective vehicle controls. The vehicle control % Tail DNA was within
the Testing Facility’s historical range, and the positive control had a
statistically significant increase in % Tail DNA compared to the vehicle
control. Thus, all criteria for a valid assay were met for liver,
glandular stomach, and duodenum cells.
All critiera for a valid study were met as described in the
Under the conditions of this study, the administration of Ethoxylated
(3) Bisphenol A Diacrylate at doses up to and including a dose of 2000
mg/kg/day did not cause a significant increase in DNA damage in liver,
glandular stomach, and duodenum cells relative to the concurrent
vehicle control. Therefore, Ethoxylated (3)
Bisphenol A Diacrylate was concluded to be negative in the in vivo Comet
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