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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 a homologues substance 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 100, 300 and 1000 mg/kg of a homologues substance to rats was clinically tolerated over 28 days (OECD 407).

At 300 mg/kg only motor activity was reduced on day 28 with no behavioural correlate in the FOB. At 1000 mg/kg minimal clinical findings observed, slight reduction of motor activity, without correlate in FOB, slight changes of body weight, body weight gain (females), and water consumption were noted. These findings proved to be reversible. No treatment-related histopathological findings diagnosed in the organs the dose groups. From these effects it can be concluded that the structural analogue is resorbed after oral administration. In the OECD 421 with the test item slight findings on developmental parameters were observed.

Overall, this indicated that the substance is absorbed via the gastrointestinal tract.

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 homologues substance (28d: key study) and the reproscreening study with the test item 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 subacute study it can be concluded, that metabolism in the liver can be assumed as a tendency towards an increase of absolute and relative liver weights in both sexes at 1000 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