A 28 days oral toxicity of Dronedarone in Wistar Rats (Rattus norvegicus)

The aim of the present experiment was to study clinical signs, haemato-biochemical alterations and pathomorphological changes induced by Dronedarone administration in rats. In present study, 48 Wistar rats (5–8 weeks old) were divided in to four different groups with equal numbers of male and female. Group I rats (Corn oil) severed as vehicle control. Group II, III and IV rats were administered Dronedarone @ 50, 100 and 200 mg/kg b.wt. respectively, orally daily for 28 days. The blood samples were collected on day 29 of the study from all the animals from retro-orbital plexus under carbon dioxide anaesthesia.

All animals were euthanized on day 29 of the study using carbon dioxide asphyxiation. The haematological parameter viz. Hb, erythrocyte count, PCV, MCV, MCHC, eosinophils and basophiles percent and biochemical parameters such as total bilirubin and urea revealed significant (P < 0.05) alteration as compared to control group animals. Gross morphological changes include congestion in lung and dilatation of uterus while microscopic changes were characterized by individual cortical cell necrosis in thymus, focal to multifocal thickened alveolar septa in lung and dilatation of uterine lumen. Changes of gross and microscopic were spontaneous or incidental finding. Based on above finding it can be concluded that sub-acute exposure to Dronedarone administered at the dose rate up to 200 mg/kg/day by oral route over a period of 28 days did not produce any appreciable changes.