Sub chronic oral toxicity study of a herbo-metallic ayurvedic formulation Swarna Guggulu in Wistar rats

Abstract

Safety of herbomineral formulations is being debated worldwide. Swarna Guggulu (SG) is a propriety ayurvedic formulation intended for use in arthritis and other neuromuscular disorders. The ingredients of SG have traditionally been used since long and are reported to be safe. In the present study, the safety profile of SG via repeated dose 90-day oral toxicity study was investigated in Wistar rats. Animals were divided into six groups. Aqueous extract of SG was administered orally once daily for 90 consecutive days to three group of animals at three dose levels (50, 250 and 500 mg/kg BW). One group served as high dose satellite reversal. One group each served as control and satellite control receiving milli- Q water. All the animals were observed for mortality and clinical sign of toxicity. Satellite groups were further observed for 28 days without treatment to detect any delayed toxicity or recovery from toxic effects if any. All the treated and control and satellite group animals exhibited a progressive gain in body weight and feed consumption throughout the dosing period and post-dosing recovery period. Abnormal breathing and lethargy were observed in one animal each in 500 mg/kg BW and satellite reversal group. These mortalities were, however, observed to be incidental findings. Laboratory parameters estimated for the treated and control animals on day 91 and satellite groups on completion of recovery period showed some significant changes in TLC, platelets, PCV and biochemical parameters that were comparable to control. These changes in haematology and biochemistry were inconsistent and therefore, considered incidental findings not related to test item. Urine parameters were found unaffected by treatment with SG. Necropsy of the surviving and found dead animals did not show any pathologically significant lesions. Histopathological examination of animals treated at 50 and 500 mg/kg showed lesions in some organs which were comparable with the control and hence, considered incidental findings. Based on the results, the NOAEL of SG, when administered orally once daily for a period of 90 days in both the sexes of wistar rats was found to be 500 mg/kg BW.