Safety assessment of methanolic extract of Terminalia chebula fruit, Terminalia arjuna bark and its bioactive constituent 7-methyl gallic acid: In vitro and in vivo studies.

Terminalia chebula and Terminalia arjuna were widely used in traditional medicine for the treatment of memory impairment, inflammatory disorders and as an anti-aging agent. However, reports regarding their safety aspects are lacking. Hence, the present study was carried out to investigate the toxicity of methanolic extracts of Terminalia chebula fruit (TCF), Terminalia arjuna bark (TAB) and its bioactive constituent 7- Methyl gallic acid (7MG) under in vitro and in vivo conditions. In vitro toxicity profile of TCF, TAB and 7MG (250-2000 μg/ml) were assessed through cytotoxicity, hemolytic activity, mutagenicity and genotoxicity assays. Results of Ames test, comet assay, MTT and hemolytic assays illustrated that TCF, TAB and 7MG exhibited neither cytotoxic and genotoxic effect in PBMC nor hemolytic activity in RBC and no mutagenic effect in TA 98 and TA 100 up to a limited dose of 2000 μg/ml. Acute and subacute toxicity studies showed no significant change in body weight, behavior, hematology, biochemical parameters, organ weight and histopathology. Over all the results of acute and subacute toxicity studies conclude that oral administration of TCF, TAB and 7MG were observed to be relatively non-toxic and affords practical guidance for selecting safe dose for further clinical trials.