Indian Journal of Pharmaceutical Education and Research | Vol 54 | Issue 1 | Jan-Mar, 2020 135 Original Artcle www.ijper.org Preliminary Assessment of Acute and 28-Day Repeated Dose Oral Toxicity of a Newly Developed Herbal Mixture on Experimental Animal Soumendra Darbar 1,2 , Srimoyee Saha 3 , Kausikisankar Pramanik 2 , Atiskumar Chattopadhyay 1, * 1 Faculty of Science, Jadavpur University, Raja SC Mallick Road, Kolkata, West Bengal, INDIA 2 Department of Chemistry, Jadavpur University, Raja SC Mallick Road, Kolkata, West Bengal, INDIA 3 Department of Physics, Jadavpur University, Raja SC Mallick Road, Kolkata, West Bengal, INDIA ABSTRACT Objectives: Toxicity is an expression of being poisonous, indicating the state of adverse effects led by the interaction between toxicants and cells. The present study was designed to evaluate the acute oral toxicity study and 28 days repeated toxicity study of Herbal Mixture (HM) according to OECD guidelines. Materials and Methods: In acute oral toxicity study, Herbal mixture was administered at 2000mg/kg orally and animals were observed for toxic signs at 30 min, 1, 2 and 4 hr and thereafter once a day for the next 14 days. In repeated dose-28-day toxicity study, the animals were divided into four groups of 6 animals each. Group-1 animals served as a control. Group II Animals received low dose of test drug 100 mg/kg (orally). Group III animals received middle dose of test drug 200 mg/kg (orally) once daily for 28 days respectively. Group IV animals received high dose of test drug 400 mg/kg (orally) once daily for 28 days respectively. Results: The study results showed that neither the acute toxicity study of herbal mixture at the dose level of 2000mg/kg nor the repeated dose study did not produce any toxic sign or mortality during study. In repeated dose toxicity study, no signifcant changes were observed in the haematological and biochemical parameters, relative organ weight, gross necropsy and histopathological examination with herbal mixture treatment. Conclusion: The results of the present study suggest that LD 50 of newly developed Herbal Mixture (HM)>2000mg/kg and the mixture is completely safe and non-toxic for therapy. Key words: Acute oral toxicity, Sub acute toxicity, Herbal mixture, Haematology, Liver function test, Histology. DOI: 10.5530/ijper.54.1.16 Correspondence: Dr. Atiskumar Chattopadhyay, Faculty Council of Science, Jadavpur University, Raja SC Mallick Road, Kolkata-700032, West Bengal, INDIA. Phone: +91 9433144548 E-mail: atischatterjee@gmail. com Submission Date: 30-04-2019; Revision Date: 12-06-2019; Accepted Date: 27-10-2019 INTRODUCTION Medicinal plants have burgeoned in recent times due to increased effciency of drugs derived from plants, growing interest in natural products and raising concerns about the side effects of conventional medicine. 1 Herbal drug combinations have shown that they possess better effcacy and reduced side-effects in comparison with single herbal drugs. The World Health Organi- zation (WHO) estimates that 80% of the world’s population relies on these “alter- native” plant-based medicines as their pri- mary medical intervention especially in the developing and in the developed countries where modern medicines are predominantly used. 2 Over the years, the use of herbs in the treatment of illnesses has been very suc- cessful and its historic usage has been use- ful in drug discovery development. Herbal prescriptions and natural remedies are com- monly employed in developing countries for the treatment of various diseases. 3,4 Toxicology may be defned as the study of harmful/poisonous effects of drugs and other chemicals with emphasis on detec- tion, prevention and treatment of poison- ings. After gaining relevant information on the harmful effects of a compound, the levels for its safe usage or the degree of its safety is established, this is known as its