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EC number: 814-509-8
CAS number: 62132-67-6
study report describes the experimental procedures and results of 4
studies designed to assess the toxicokinetic profile of 3H-Nexbase
2006 FG in male rats. In
each study, three rats were used per dose for each time point and
Fischer rats were administered a single oral dose of 3H-Nexbase
2006 FG at doses of 30, 210, or 1500 mg/rat.
2. Male Fisher rats were administered a single intravenous dose of 3H-Nexbase
2006 FG (30 mg/rat).
3. Male Fischer rats were administered Nexbase 2006 FG (210 mg/rat/day)
for 14 days followed by a single dose of e of 3H-Nexbase 2006
4. Three rats had bile duct-canulation surgery prior to oral
administration of 3H-Nexbase 2600 FG (210 mg/rat).
Very little of the administered dose was absorbed following single oral
administrations of 30, 210, or 1500 mg/rat 3H-Nexbase 2006 FG. Maximum
plasma radioactivity was measured at 8, 4, and 72 hours, respectively,
with mean concentrations of 0.893, 2.243 and 6.720 µg equivalents/ml. Terminal
rate constants of 81 and 93 hours could only be estimated for the 210
and 1500 mg/rat doses. The
majority of the dose remained in the gastrointestinal (GI) tract and was
excreted in the faeces by 168 hours with ≥ 92% of the dose recovered. Excretion
was rapid with nearly all radioactivity collected by 48 hours for
animals dosed with 30 or 210 mg 3H-Nexbase 2006 FG. Excretion
of the 1500 mg/rat dose took longer with radioactivity still collected
at 168 hours. Urinary
excretion were low (<1%). Although
the majority of the dose was found in the gastrointestinal tract,
radioactivity was also found in the liver, lymph nodes, fat, kidneys,
and spleen. Rats
administered 210 or 1500 mg/rat 3H-Nexbase 2006 FG had oily
fur shortly after dosing (this was also noted by increasing amounts of
radioactivity in the fur). While
the oil was gone by morning in the 210 mg/rat group, it took 48-72 hours
to decline after exposure to 1500 mg/rat.
No pharmacokinetic analysis of plasma radioactivity was possible because
the measured plasma radioactivity in 2 of the 3 rats did not exceed the
limits of quantification 4 hours post-dosing.
overall recovery of radioactivity following repeated exposure to Nexbase
2006 FG was 94.88% (almost exclusively in the faeces) at 168 hours
following the final dose of 3H-Nexbase 2006 FG. The
pattern of excretion of radioactivity at the 210 mg/rat level was almost
identical to the single dose excretion study (Experiment 1).
Following oral administration of a single dose of 3H- Nexbase
2600 FG (210 mg/rat) after bile duct-cannulation, the majority of the
administered dose was recovered in the faeces (70.03%) and GI tract
(24.76%) at sacrifice (48 hours post-dosing).
Very little of
the dose (mean 0.01%) was recovered in the bile. The
fraction of Nexbase 2600 FG absorbed from the GI tract was < 1%. The
bile duct–cannulated rats ate and drank less than the other rats.
study received a Klimisch score of 1 and is classified as reliable
without restrictions because it
generally followed OECD guideline 417 and was GLP compliant.
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