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Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

The toxicokinetic behaviour of the test substance was assessed in male rats after oral, dermal and intravenous administration of radioactively labelled test substance (Kao and Birnbaum, 1986). The test substance was not completely absorbed from the gastrointestinal tract and skin and was shown to be distributed to organs, metabolized and excreted via urine and faeces.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential
Absorption rate - oral (%):
Absorption rate - dermal (%):

Additional information

Groups of male Fischer 344 rats received 14C-labelled test substance by the oral, dermal, and intravenous route.

Oral doses were 10, 100, and 1000 mg/kg bw. Intravenous and dermal applications administered 10 mg/kg bw. An additional experiment was conducted to monitor the excretion of radioactivity into bile.

Excreta were collected over a period of 3 days after which the animals were sacrificed and tissues were collected. Expired air was sampled to monitor volatile metabolites.

The samples were analysed by thin layer chromatography (TLC), high performance liquid chromatography (HPLC), nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry (MS).

Three days after oral administration of [14C]-test substance at 10, 100, or 1000 mg/kg bw, more than 90% of each dose was excreted in urine and faeces. Comparison of disposition after intravenous, dermal, or oral administration indicated that the test substance was not completely absorbed from the gastrointestinal tract or skin. An oral absorption of 70 % was concluded. Dermal absorption was found to be approximately 62 %.

Most of the administered test substance was excreted and the tissue levels were generally low within 3 days post administration (except for the dermal study where 32 % of the total dose was found at the skin site). However, the highest concentration of test substance-derived radioactivity was found in the kidney during the whole measuring period. In addition, the studies also indicated that enterohepatic circulation was involved in disposition. Biliary excretion of the test substance was dose-dependent, with proportionally less test substance-derived radioactivity being excreted in the bile as the dose was raised. The major in vivo metabolites were glucuronyl conjugates of the test substance and hydroxylated test substance. Glutathione conjugates were also present in urine.