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Description of key information

Resorption

Because of the molecular structure, low molecular weight and octanol-water partition coefficient (>5.7), resorption of the test item via the gastrointestinal tract is considered to be likely. After single treatment of rats with the test item at a dose of 2000 mg/kg bw no signs of toxicity were observed (acute oral: key study).

Data from a subacute study are available.

Daily oral treatment with 30, 100 and 300 mg/kg of this test item to rats was clinically tolerated over 28 days.

Effects on hematology, clinical chemistry, liver and kidney weights and minmal hepatocellular hypertrophy werde observed at the main kill (high and partly mid dose). Reversibility was found for all changes. From these effects it can be concluded that the structural analogue is resorbed after oral administration.

Distribution

Due to the low water solubility and the high octanol/water-coefficient, in combination with the low molecular weight, permeation of membranes is assumed to be possible. The toxicological effects found in the repeat dose toxicity study of the test item (28d: key study) clearly show that this compound is distributed throughout the body after oral uptake and is thus systemically available.

Metabolism and Excretion

Specific information on the metabolism and excretion of the substance is not available. From the sbacute study it can be conclududed, that metabolism in the liver can be assumed as a tendency towards an increase of absolute and relative liver weights in both sexes at 100/300 mg/kg/d was found. Because of the reversibility of the observed effects (e.g. on relative organ weight of liver), the substance is most likely eliminated from the body. Due to the molecular properties, excretion via the kidneys is considered to be the main route of elimination.

Key value for chemical safety assessment

Additional information