Registration Dossier
Registration Dossier
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EC number: 810-533-8 | CAS number: 330459-31-9
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Under the test conditions, the test substance was well absorbed following oral administration to rats. It was extensively metabolized and rapidly excreted, primarily via the bile and faeces, with little tissue retention. Major routes of metabolism of the test substance in rats were oxidation (hydroxylation) of the thiophene ring, followed by conjugation primarily with glucuronic acid, and reductive cleavage and subsequent hydrolysis of the oxadiazole ring.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
Additional information
A study was performed to determine the pharmacokinetics, routes of elimination, mass balance, tissue distribution, and metabolite profiles of [14C] labeled residues after oral or intravenous administration of [phenyl (PH)-UL-14C] labeled test substance or [thiophene (TH)-2 -14C] labeled test substance at dose 3 and 100 mg/kg bw to rats, according to OECD Guideline 417 and OPPTS 870.7485, in compliance with GLP.This study was conducted in multiple phases: a pilot phase, a pharmacokinetic phase, a disposition and metabolite identification phase, and a quantitative whole body autoradiography (QWBA) phase. Also, major metabolites of these compounds were quantified and identified or characterized to the extent possible using LC/MS/MS.The test substance was well absorbed following oral administration to rats. It was extensively metabolized and rapidly excreted, primarily via the bile and faeces, with little tissue retention. There may have been a slight increase in relative plasma levels of the test substance and/or its metabolites after dosing at 100 mg/kg bw vs. 3 mg/kg bw but there were no major differences in excretion or metabolism due to route of administration, dose level, sex of the animals, or single vs. repeat dosing. Major routes of metabolism of the test substance in rats were oxidation (hydroxylation) of the thiophene ring, followed by conjugation primarily with glucuronic acid, and reductive cleavage and subsequent hydrolysis of the oxadiazole ring (Thomas J, 2014).
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