ACUTE AND SUB-ACUTE ORAL TOXICITY ASSESSMENT OF THE POLYHERBAL FORMULATION IN ALBINO WISTER RATS
Keywords:
Polyherbal formulation, Acute and Sub-acute toxicity, Hematology, Biochemistry, HistopathologyAbstract
Objective: Polyherbal formulation (PHF) is prepared from five herbs; these herbs are well-known and widely used in the traditional system of medicine for the treatment of diabetes and various diseases. Individually, each herb is completely safe, but the combined effects of these herbs are not known. Thus, the main objective of the present study was to assess the toxicological profile of PHF by acute and sub-acute oral toxicity in rats.
Methods: The acute and sub-acute oral toxicity study was carried out as per OECD guidelines 423 and 407 respectively. In the acute toxicity study female albino Wistar rats administered single oral dose (2000 mg/kg) of PHF, while in sub-acute toxicity study male and female albino Wistar rats administered daily oral doses (100, 200 and 400 mg/kg) of PHF for 28 d. At the end of the study, the animals were humanely sacrificed and assessed for the effect of PHF on body weight and relative organ weights and hematological, biochemical and histopathological parameters.
Results: In the acute toxicity study no mortality or behavioral changes were observed in rats treated with a single dose of PHF (2000 mg/kg) indicating that the LD50 is higher than 2000 mg/kg. In the sub-acute toxicity study, PHF was administered at three dose levels (100, 200 and 400 mg/kg), showed no significant changes in body weight and relative organ weights and hematological, biochemical and histopathological parameters.
Conclusion: These results exhibit the absence of acute and sub-acute oral toxicity after treatment of PHF in rats. However, further studies in animals and in humans are needed in order to have sufficient safety evidence for its use in humans.
Keywords: Polyherbal formulation, Acute and sub-acute toxicity, Hematology, Biochemistry, Histopathology
Downloads
References
Petchi RR, Chockalingam V, Parasuraman S. Antidiabetic activity of polyherbal formulation in streptozotocin–nicotinamide induced diabetic Wistar rats. Afr J Tradit Complementary Altern Med 2014;4:108-17.
Mardi M. Algandaby. Assessment of acute and subacute toxic effects of the Saudi folk herb Retama raetam in rats. J Chin Med Assoc 2015;78:691-701.
Kifayatullah M, Mustafa MS, Sengupta P, Sarker MMR, Das A, Das SK. Evaluation of the acute and sub-acute toxicity of the ethanolic extract of Pericampylus glaucus (Lam.) Merr. in BALB/c mice. J Acute Disease 2015;4:309-15.
Abbas KA, Mohamed A, Abdulamir AS, Abas HA. A review on supercritical fluid extraction as a new analytical method. Am J Biochem Biotechnol 2008;4:345-53.
Andrea C, Massimo EM, Andrea O. Supercritical fluid extraction of plant flavors and fragrances: a review. Molecules 2013;18:7194-238.
Faizal P, Suresh S, Satheesh KR, Augusti KT. A study on the hypoglycemic and hypolipidemic effects of an ayurvedic drug Rajanyamalakadi in diabetic patients. Indian J Clin Biochem 2009;24:82-7.
Shanmugasundaram ER, Gopinath KL, Radha SK, Rajendran VM. Possible regeneration of the islets of Langerhans in streptozotocin-diabetic rats given Gymnema sylvestre leaf extracts. J Ethnopharmacology 1990;30:265-79.
Vaidya AB. Terminalia arjuna in cardiovascular therapy. J Assoc Physicians India 1994;42:281-2.
Tamboli SB, Sontakke SP, Parsode RB. Study of hypoglycemic activity of Tinospora cordifolia in alloxan-induced diabetic rabbits. Int J Basic Clin Pharmacol 2013;2:559-1.
Sivakumar V, Dhana RMS. Antioxidant effect of Tinospora cordifolia extract in alloxan-induced diabetic rats. Indian J Pharm Sci 2010;72:795-8.
Al-Amin ZM, Thomson M, Al-Qattan KK, Peltonen SR, Ali M. Anti-diabetic and hypolipidaemic properties of ginger (Zingiber officinale) in streptozotocin-induced diabetic rats. Br J Nutr 2006;96:660-6.
OECD. Guidelines for the Testing of Chemicals: Acute Oral toxicity 423-Acute Toxic Class Method. Organization for Economic Cooperation and Development, Paris, France; 2001.
OECD. Repeated dose oral toxicity test method. In: OECD 407, Guidelines for testing of chemicals, Organization for Economic Cooperation and Development, Paris, France; 2008.
Walum E. Acute oral toxicity. Environ Health Perspect 1998;106 Suppl 2:497-3.
Malone MH, Robichaud RC. A Hippocratic screen for pure or crude drug materials. Llordya 1962;25:320-31.
Neyres ZTJ, Ibere FSJ, Joaquim CSL, Edson MC, Domingos TOM. Hippocratic screening and subchronic oral toxicity assessments of the methanol extract of Vatairea macrocarpa heartwood in rodents. Rev Bras Farmacogn 2012;22:1308-14.
Raina P, Chandrasekaran CV, Deepak M, Agarwal A, Ruchika KG. Evaluation of subacute toxicity of methanolic/aqueous preparation of aerial parts of O. sanctum in Wistar rats: Clinical, hematological, biochemical and histopathological studies. J Ethnopharmacol 2015;175:509-7.
Traesel GK, Souza JC, Barros AL, Souza MA, Schmitz WO, Muzzi RM, et al. Acute and subacute (28 d) oral toxicity assessment of the oil extracted from Acrocomia aculeata pulp in rats. Food Chem Toxicol 2014;74:320-5.
Dan Wan, Xihong Zhou, Chunyan Xie, Xugang Shu, Xin Wu, Yulong Yin. Toxicological evaluation of ferrous N-carbamyl glycinate chelate: Acute, sub-acute toxicity, and mutagenicity. Regul Toxicol Pharmacol 2015;73:644-51.
Kadhare AD, Bodhankar SL, Mohan V, Thakurdesai PA. Acute and repeated doses (28 d) oral toxicity study of glycosides based standardized fenugreek seed extract in laboratory mice. Regul Toxicol Pharmacol 2015;72:323-34.
Sangeetha MK, Vallabi DE, Sali VK, Thanka J, Vasanthi HR. Sub-acute toxicity profile of a modified resveratrol supplement. Food Chem Toxicol 2013;59:492-500.
Aboudoulatif D, Kwashie EG, Amegnona A, Kodjo A, Edmond EC, Messanvi G. Acute and subchronic (28-day) oral toxicity studies of hydroalcohol leaf extract of Ageratum conyzoides L (Asteraceae). Trop J Pharm Res 2010;9:463-7.
Joshi CS, Ekambaram SP, Venkataraman S. Acute and subacute toxicity studies on the polyherbal antidiabetic formulation Diakyur in experimental animal models. J Health Sci 2007;53:245-9.
Amenya HZ, Gathumbi PK, Mbaria JM, Thaiyah AG, Thoithi GN. Sub-acute toxicity of the chloroformic extract of Rapanea melanophloeos (L.) mez in rats. J Ethnopharmacol 2014; 154:593-9.