Safety evaluation of a polyherbal formulation containing hydroalcoholic extracts of Hippophae salicifolia, Nyctanthes arbor-tristis, Ocimum tenuiflorum, and Reinwardtia indica in rodents

anti-oxidant properties[5]. Reinwardtia indica (family Linaceae) contains saponins, which could potentially help in the management of hyperglycemia[6–7]. We conducted acute and sub-acute oral dose toxicity studies of the test formulation in Swiss albino mice and albino Wistar rats, respectively. Single doses (10 to 5,000 mg/kg) were administered orally to mice. No treatment related deaths or clinical signs of toxicity were recorded at any of the doses at two weeks after drug administration and the lethal dose 50% of the test drug was greater than 5,000 mg/kg. For the sub-acute toxicity assessment, the doses employed ranged from 100 to 800 mg/kg·day (and vehicle as the control), which, in most cases, is acceptable as the limit dose for toxicity studies[8]. The formulation was administered orally to rats for either 14 or 28 days during which food intake and body weight were monitored. At the end of the treatment period, organ weights and haematological and biochemical parameters were measured along with a histopathologic examination. No treatment-emergent toxicities or mortality was observed. Additionally, no treatment related changes in the behaviour of the rats were observed. There was a small and insignificant reduction in body weight and food consumption of the rats in the treatment groups compared with the control group (Table 1), suggesting that sub chronic administration of the test formulation did not affect the normal growth of rats. Similarly, there were no significant changes in the weight of the organs (brain, liver, kidney, heart) following either 14 or 28 days of treatment at any of the doses compared to the controls. Haematological parameters including haemoglobin, red blood cell count, white blood cell count, packed cell volume, mean corpuscular volume, mean corpuscular haemoglobin and mean corpuscular haemoglobin concentration were found to be all within the normal range in both the control and treatment groups (Table 2), with