Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

Acute and sub-acute studies have shown evidence that the notified substance, AS-100 is absorbed following oral administration in the rat.  Absorption of the notified substance has resulted in clinical signs of toxicity with the principle target organ being the liver.

Changes in clinical chemistry parameters in the 28-day study suggest that AS-100 has caused injury in this organ at
levels >12 mg/kg/day.  Metabolism in the liver and subsequent Phase II conjugation might be expected to result in the major excretion route being via the faeces.

Effects were also seen in the red blood cells indicating some initial binding of AS-100 may have occurred.  Other clinical signs of toxicity were noted in the spleen.

AS-100 is a lipophilic substance with an octanol-water partition coefficient of 5.9 providing initial indications
at least that this substance may bioaccumulate in the fatty tissues within the body.

The results of a sub-chronic study (90 day oral repeat dose) also showed evidence that the substance is absorbed following oral administration.