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EC number: 915-730-3
CAS number: -
Disposition of β-OTNE, was investigated following a single oral (20
mg/kg bw) dose of [14C] β-OTNE to male Fisher rats. The study was rated
Klimisch 2, since the study was not conducted according to a guideline
(not available), but the study design is documented well and the results
are presented clearly. Single radiolabeled oral doses were administered
to male rats, by intra-gastric gavage, in a dose volume of 5 mL/kg bw
via a syringe. Following administration, animals were returned to
metabolism cages. Groups of 4 animals were sacrificed at 4, 8, 24 and 48
h following administration. A group of bile duct cannulated male rats
were also given 20 mg/kg bw as above and sacrificed after 48 h following
Disposition of radioactivity was measured at 4, 8, 24 or 48h following
oral administration (tissues, organs, feces, urine, bile). Blood and
tissue toxicokinetic parameters (T1/2, Mean Residence Time, AUC,
Terminal elimination rate constant, Tmax, Cmax) were determined, as well
as excretion of radioactivity following administration. The data
indicate that the substance was well-absorbed following a single oral
administration of 20 mg/kg bw [14C] β-OTNE in male rats. At least 86% of
a 20 mg/kg bw oral dose was absorbed. b-OTNE was distributed to tissues,
with bladder, pancreas, liver, adipose, and kidney showing the highest
exposure to the test substance. Excretion of the test substance was
mainly via urine and feces following both routes of administration.
Biliary excretion and enterohepatic recirculation contributed to the
high and prolonged excretion in feces. The reported oral absorption
level of 86%, is considered valid for use in further risk assessment for
this substance. The substance is extensively metabolised because no
beta-OTNE could be detected, the glucuronic conjugated is one of the key
metabolites. The DT50 for OTNE based on radiolable is 34.3 hours: 1.43
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