Registration Dossier
Registration Dossier
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EC number: 239-784-6 | CAS number: 15687-27-1
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
A review provided information on the absorption and distribution of the test substance, investigated in mice, rats, and dogs after oral administration for periods of up to 6 months (Adams, 1969). The test material administered orally was rapidly absorbed from the intestine and to a lesser, though significant, extent from the stomach. Four metabolites of the test substance were detected in rabbit plasma, 3 of these were also in rat plasma, but none were detected in dog plasma. Distribution studies with 14C-labeled test material revealed that oral repeated dosing of rats led to some accumulation of radioactivity in the adrenals, ovaries, thyroid, skin, and fat, without structure or function being affected. Dogs, however, had high levels only in bile.
The inversion of the test substance was investigated in the rat H4IIE and human Hep G2 hepatoma cell line, to determine the suitability for future use considering possible inversion properties (Menzel-Soglowek, 1992). The test substance was incubated under varying conditions with the cell lines for 5 days and samples were taken ± every 24 hours. The test substance and metabolites were quantified with HPLC. A decrease in serum concentration shows an increase in elimination rate of the R-form of the test substance and an increase in formation of the S-form of test substance. Additonally, the study shows that the test substance (R-form) may be converted to its antipode (S-form) in the rat H4IIE and human Hep G2 hepatoma cell line, but no conversion of the S-form takes place.
PBTK modelling was used to simulate the concentration-time profile of the test substance and estimate the distribution of the test material in the portal vein, hepatic vein and in general circulation after oral gavage administration (Mielke, 2011). The concentration used in the model was 94 mg/kg and considered to be administered orally by gavage with an assumed absorption of 55%. Elimination was not included in the model. The estimated concentrations were 141.6 mg/L in the portal vein, hepatic vein and blood circulation.
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