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Administrative data

Link to relevant study record(s)

Description of key information

Not likley to accumulate following multpile dosing; OECD Guideline 417

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

The pharmacokinetics of the test item showed that it was rapidly absorbed and eliminated and did not accumulate following repeated administration. The bioavailability of the test item decreased from 30.2% to 5.58%, indicating a saturation in absorption as the dose increased from 50 mg/kg bw to 1000 mg/kg bw.

 

In a second study, following oral gavage administration of 20 and 500 mg/kg, the bioavailability (F) were 65.90 ± 43.37% and 34.42 ± 27.57% respectively. In the 7 days repeated oral administration of 20 mg/kg of test material, the bioavailability and exposure in rat body were both slightly decreased, with no accumulation. Absorbed test material was distributed in the whole body of the rat. The concentration of test material in each organ had not reduced significantly. After oral administration of test material at 20 mg/kg, the cumulative % average excretion in feces and urine were 15.3951 ± 15.9400% and 0.7239 ± 0.3189%, and 16.1190% in total. The test material excreted via feces was unabsorbed unchanged test material. Absorbed test material, which has been entered the systemic circulation, would be partly excreted via urine and bile as unchanged test material. Test material could be metabolically transformed in rats, dogs and human liver microsomal incubation system, especially quick in rat and dog liver microsomes. The main enzyme for metabolizing the test material was CYP19, secondly with CYP4, CYP2C9, CYP2E1, CYP1A2 and CYP2D6 did not metabolize test material.