Acute And 28-Day Repeated Dose Toxicity Studies With Polyherbal Formulation Of Isabgol Husk, Swarnapatri Leaf Extract And Triphala Fruits Extract (Tlpl/Ay/01/2008)

Abstract

The acute and sub-chronic 28-day repeated dose toxicity studies in rodents were performed to assess the safety of polyherbal formulation of Isabgol husk (Plantago ovate), Swarnapatri leaf extract (Cassia angustifolia) and Triphala fruits extract (Emblica officinalis, Terminalia chebula and Terminalia belerica) (TLPL/AY/01/2008). The studies were conducted according to current OECD toxicology guidelines for acute and repeated dose. No mortalities or evidence of adverse effects were observed following acute oral gavage administration up to 2000 mg/kg of TLPL/AY/01/2008 in Sprague dawley rats. The 28-day repeated dose study involving daily oral administration of 70, 175 and 350 mg/kg body weight of TLPL/AY/01/2008, with a post trial 14 day no treatment observation period at high dose level, resulted in no clinical signs and animal deaths. No toxicological significant differences were observed in any of the TLPL/AY/01/2008 treatment groups for body weights, feed consumption, physical appearance, neurological behaviour and urine analysis. Evaluation of haematology and clinical chemistry parameters revealed no toxicological and treatment related effects. No treatment related changes noted in absolute and relative organ weights. Macroscopic and microscopic evaluation of organs revealed no treatment related. Results of this study demonstrate that polyherbal formulation TLPL/AY/01/2008 is not acutely toxic at 2000 mg/kg of body weight/day, with a NOAEL (no-observed-adverse-effect-level) of greater than 350 mg/kg of body weight/day for systemic toxicity from repeated dose 28-day oral gavage administration. The present study demonstrates the non-adverse nature of the polyherbal formulation TLPL/AY/01/2008 on long term administration.