EVALUATION OF ORAL TOXICOLOGICAL INVESTIGATION OF A HERBAL COMPOSITE (HERBODIL®) IN EXPERIMENTAL ANIMALS

Abstract

Purpose: The aim of the investigation was to find out the degree of toxicity of the herbal composite for humans, animals, or the environment. Acute and 28 days repeated sub-acute oral toxicity study of herbal composite (Herbodil®) carried out as per the current OECD guidelines.Materials and Methods: 2000mg/kg of the herbal composite was orally administered to the animals to find out the acute toxicity. The treated animals were observed for toxic signs at thirty min, one, two and four hours and thereafter once a day for the next 14 days. In sub-acute study i.e.,28 days repeated dose oral study, the mice were segregated into four groups (two set for each sex) of six mice each. Group-1 mice served as a control (untreated). Group II mice consumed lower dose of herbal composite i.e., 100 mg/kg, Group III mice consumed middle/moderate dose i.e., 200 mg/kg and Group IV mice received high dose of 400 mg/kg (orally) once daily for 28 days respectively.Results: This experimental in vivo study confirm that neither the acute toxicity study of herbal composite at the dose level of 2000mg/kg nor the sub-acute 28 days oral toxicity study developed any toxic signs, behavioural changes, or mortality during the whole study. Haematological and biochemical parameters dose not changes during the sub-acute study. Relative body weight of the mice also not change after the study.Conclusion: Experimental results obtained from the current investigation suggest that LD50 of developed herbal composite was >2000 mg /kg and the herbal composite is completely safe and non-toxic for therapy.