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EC number: 939-253-5
CAS number: 68424-85-1
A study was conducted to determine the basic
toxicokinetics of the test substance according to EPA OPP 85-1, in
compliance with GLP. Sprague-Dawley rats (10 animals per sex per group)
were treated with radiolabelled test substance. The study was conducted
in four experiments: a single low dose (10 mg/kg); a single high dose
(50 mg/kg); a14-day repeated dietary exposure with non-radiolabelled
test substance (100 ppm) and single low dose of radiolabelled (14C) test
substance (10 mg/kg); and a single intravenous dose (10 mg/kg).
Following the single doses or the last dietary dose, urine and faeces
were collected for 7 days. Tissues, urine and faeces were collected and
analysed for radioactivity and faeces were analysed by TLC, HPLC and MS
for metabolites and parent compound. Following oral administration,
radiolabelled test substance was rapidly absorbed, although in very
limited amounts, consistent with its highly ionic nature. Residual 14C
in tissues was negligible after administration by gavage both after
single and repeated dosing, indicating low potential for
bioaccumulation. After i.v. administration, a higher amount of
radioactivity (30−35%) was found as residue in the tissues.
Approximately6−8% of orally administered test substance was excreted in
the urine whereas 87−98% was found in the faeces. Since no data on bile
duct-cannulated rats are available, it was not possible to conclude if
this radioactivity accounted exclusively for unabsorbed test substance
or not. However, the i.v. experiment showed that 20−30% was excreted in
urine and 44-55% in faeces, suggesting that both the kidney and liver
were capable of excreting test substance once absorbed and that
absorption was higher than the % found in the urine after oral
administration. Less than 50% of the orally administered test substance
was metabolised to side-chain oxidation products. In view of the limited
absorption of the test substance, the four major metabolites identified
may be at least have been partially formed in the gut of rats,
apparently by microflora. No significant difference in metabolism
between male and female rats or amongst dosing regimens was
observed. Repeated dosing did not alter uptake, distribution or
metabolism of the test substance (Selim, 1987).
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