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Description of key information

After feeding of the hydrochloric salt of the test substance, no disturbance of hepatic choline metabolism is noted even at very high dose levels of 1000 mg/kg bw.

Additional information

Hepatic choline status after treatment with the hydrochloric salt of the test substance was measured in a study performed by the Dow Chemical Company (2009). The samples were originating from the OECD 416 study in rats (ACC and Cefic, 2009). There was no indication of adverse hepatic effects after repeated feeding of the hydrochloric salt of the test substance even at high dose levels of 1000 mg/kg bw as expressed by liver weight of F0 and F1 parental animals of the 2 generation study in rats. In addition, no histopathological changes were noted, when liver sections from the control and high dose parental animals were compared. In addition no difference in hepatic choline levels and their respective metabolites from the analysed F1 parental females were measured. Thus it is concluded that after feeding of the hydrochloric salt of the test substance no disturbance of hepatic choline metabolism is noted even at very high dose levels of 1000 mg/kg bw.