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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

The vast majority of test compound was excreted via faeces. Urinary excretion accounted for less than 9% of the administered substance. No significant bioconcentration or -accumulation was evident in any of the organs investigated.

Key value for chemical safety assessment

Additional information

One toxicokinetic study investigating the absorption, distribution and excretion of the test substance is available. In this study, the routes and rates of excretion of total radioactivity were determined after single oral doses of 50 and 1000 mg of 14C labelled test material per kg body weight to male rats. The majority of the radiolabel (92-93%) was excreted with the faeces, predominantly during the first 24 hours postdose. Urinary excretion was ≤ 9%. Excretion of radioactivity via the expired air was negligible (< 0.03%). Cumulative excretion was virtually complete within 96 h after administration (101 and 98% after the low and the high dose, respectively). The excretion half-life in faeces was shorter than in urine in all individual animals. Mean urinary excretion half-lives were 11.8 and 14.6 hours after the low and the high dose, respectively. Mean faecal excretion halflives were 9.1 and 8.6 hours for the low and high dose, respectively. There was no indication for non-linearity in the excretion kinetics over the dose range studied At 96 h postdose, the highest tissue concentration of test material was observed in the fat (2.42 and 116 mg/kg tissue at low and high dose, respectively, comprising 0.01 and 0.02% of the total applied dose only), followed by thymus, liver and kidney (overall range of 1.39-1.88 and 13.6-25.9 mg/kg tissue for low and high dose, respectively), and at the high dose by skin, gastrointestinal tract and carcass (overall range of 11.9-17.4 mg/kg tissue). The retention of the administered radiolabel was minimal. Expressed in % of the applied dose this represents only 0.25 and 0.39% for the sum of the organs for low and high dose, respectively, and 0.72 and 1.14% for the carcass for the low and the high dose, respectively. Generally, the organs and tissues examined contained less than 0.01% of the dose, except for liver (< 0.15%), and the kidney and gastrointestinal tract (< 0.03%). There were no significant differences in the pattern of distribution between the high and low dose. There was no significant bioconcentration or accumulation in any of the organs investigated.