Acute and sub-acute (30-day) toxicity studies of Aegialitis rotundifolia Roxb., leaves extract in Wistar rats: safety assessment of a rare mangrove traditionally utilized as pain antidote

摘要

Aegialitis rotundifolia Roxb., (Plumbaginaceae) is a small mangrove tree or shrub traditionally used by the local healers of mangroves for curing pain and inflammation. However, there are no scientific reports of its toxicological properties which would guarantee the safety of its folkloric usage as a potent pain reliever. Therefore, the present study deals in acute and sub-acute (30-day) toxicity studies of Aegialitis rotundifolia ethanolic leaves extract (ARELE) on male and female Wistar rats administered through oral gavage. Acute toxicity study was conducted at a single oral dose of 1000, 1500, and 2000?mg/kg, body weight (b.wt.) for 14?days with a special emphasis on the first four hours after drug administration to find out any mortality and morbidity. In sub-acute toxicity, the extract at the doses of 125, 250 and 500?mg/kg, b.wt., was administered orally for 30?days. Important parameters such as general behaviour, body and organ weight, urinalysis, haematological and biochemical profile, organ macroscopy and microscopy were conducted. Organ sample of liver, kidney, pancreas, heart, lungs, and stomach were taken from both male and female rats, whereas the sample of testis and ovary was taken from male and female rats respectively for organ necropsy and histopathological studies. Neurobehavioral toxicity was conducted by performing a functional observational battery (FOB) and locomotor activity on the initial and final week of the 30-day study period. No mortality or any major signs of morbidity was recorded for acute toxicity except for the limit dose (2000?mg/kg, b.wt.) which produced a slight short-term sedative effect. In sub-acute toxicity, no major alteration was observed in the evaluated parameters. However, few minor changes were recorded for high dose (500?mg/kg, b.wt.) group. The results of the present study showed that oral administration of Aegialitis rotundifolia ethanolic leaves extract did not produce any severe toxic effects in both acute and sub-acute studies in Wistar rats. Therefore, usage of an appropriate amount of Aegialitis rotundifolia leaves extract preferably at low doses for its traditional use should be considered safe.