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EC number: 219-372-2
CAS number: 2425-85-6
Introduction. A study was performed to assess the potential of the test
item to induce DNA repair in isolated rat hepatocytes following in vivo
administration. The method used has been designed to be compatible with
the OECD Guidelines for Testing of Chemicals No. 486 and follows the
recommendations of the UKEMS Sub-Committee on Guidelines for
Mutagenicity Testing: Report, Part II revised (Supplementary
Mutagenicity Tests: UKEMS recommended procedures, 1993).
Methods. A range-finding test was performed to find suitable dose levels
of the test item, route of administration and to determine if the there
was any differences in toxicity in male and female rats. As there was no
difference in toxicity between sexes the main test was performed using
male rats only. The UDS assay was conducted using the oral route of
administration using only male animals and with the test item at the
maximum dose level of 2000 mg/kg, with 1000 mg/kg as the lower dose
level. The study was performed in two parts, in Experiment 1 perfusion
of the livers commenced approximately 16 hours after dosing and in
Experiment 2 perfusion was performed approximately 4 hours after dosing.
Following perfusion the liver hepatocytes were processed to give stained
slides which were then scored using a microscope and an automated image
analysis system. The method used for scoring the hepatocytes was an area
counting method which is compatible with the UKEMS guidelines and OECD
test method. Further groups of rats were given a single oral dose of
arachis oil, or dosed with 2-acetylaminofluorene (2AAF) at 16 hours or
N,N’-dimethylhydrazine dihydrochloride (NDHC) at 4 hours to serve as
vehicle and positive controls respectively.
Results. There were no marked increases in the incidence of unscheduled
DNA synthesis in animals dosed with the test item at either time point.
The positive controls produced marked increases in net nuclear grain
counts and in the incidence of cells in repair, and the vehicle control
groups gave acceptable values for net nuclear grain counts.
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