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Administrative data

Link to relevant study record(s)

Description of key information

Short description of key information on bioaccumulation potential result: 
In both dosage groups (100mg/kg and 1000mg/kg) only neglictible amounts of the radioactive substance were detected in the organs and the tissue, in the intestinal tract, in the blood and in the carcasse. The maximal concentration was reached 1 to 2 h after application. As the concentration is close to the detection limit the kinetics of the elimination and the area under the curve could not be calculated. From the study can be stated that the notified substance is not bioavailable when it is applied once orally under the conditions mentioned above.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

The animals were killed 168 h p.a.. During the 168 h 0.3 resp. 0.6% of the applied redioactivity was found in the urine. These small amounts are interpreted as technic-related faecalic impurities.

The part which was incorporated in the faeces were in average 119.7% (low dose group) rsp. 96.0%. The corresponding fraction after 24h was 101.4% rsp. 79.7%. In both dosage groups only neglictible amounts of the radioactive substance were detected in the organs and the tissue, in the intestinal tract, in the blood and in the carcasse. The maximal concentration in the blood was 0.139 ag/g (low dosage group) rsp. 1.152 ag/g and in the plasma 0.140 rsp. 1.048 ag/g. The maxima were reached 1 to 2 h after application. As the concentration is close to the detection limit the kinetics of the elimination and the area under the curve could not be calculated.

From the study can be stated that the notified substance is not bioavailable when it is applied once orally under the conditions mentioned above.