Registration Dossier

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

Two pharmacokinetic studies were performed in the rat (Hainje and El-hawari, 1982; Babin 1996). Both studies demonstrated that the test material was absorbed via the oral route and distributed throughout the body. The highest levels of the radioactivity were found in the pancreas, thyroid, and liver. Urinary excretion was the primary route of elimination up to 24 hours, with fecal elimination occuring to a lesser extent. Approximately 50 to >60% of the test material was eliminated during the first 24 hours. Metabolites were evaluated at 24 hours and suggested active phase I and phase II metabolism with approximately 44.2% of the radiolabel contained in the water soluble fraction (not acid labile), 37.6% of the label consisted of acid-labile conjugates, and approximately 18.2% of the label was contained in the organic fraction.