Toxicity Assessment of Hydroalcoholic Extract of Kelussia odoratissima Mozaff : An Acute and Repeated Dose in Female Wistar Rat

Document Type : Original Article

Authors

1 1 Pharm D ,PhD Student , Faculty of Pharmacy and Pharmaceutical Sciences , Islamic Azad University, Tehran Medical Sciences University (IAUTMU), Tehran –Iran.

2 2Pharm D, PhD, Department of Toxicology and Pharmacology, Faculty of Pharmacy and Pharmaceutical Sciences, Islamic Azad University, Tehran Medical Sciences University (IAUTMU), Tehran –Iran.

3 3Pharm D, PhD, Department of Pharmacognosy , Faculty of Pharmacy and Pharmaceutical Sciences, Islamic Azad University, Tehran Medical Sciences University (IAUTMU), Tehran –Iran.

Abstract

This study aimed to evaluate the acute and repeated dose toxicity of hydroalcoholic extract of Kelussia odoratissima Mozaff as medicinal plant which is restricted to western Iran based on its potential nutraceutical applications. To determine the clinical, hematological, biochemical, necropsy and histopathological effects of the herb’s extract, aerial parts were collected from Shahrekord in spring 2019. After careful evaluation and issuance of the Herbarium Code Number, herb’s powder was provided and the extracted by maceration method using ethanol. Acute and repeated dose toxicity tests were performed by OECD 425 and 407 guidelines through oral gavages to female Wistar rats. Acute test didn’t show any sign of toxicity in doses up to 2000 mg/kg and in delayed acute toxicity assessment no sign of toxic reaction was recordable .In repeated dose test all animals in three different dose groups (50,500 and 1000 mg/kg) survived healthy according to the clinical and necropsy observations . Biochemical, hematological and histopathological studies showed some mild to moderate congestions in the kidney and liver of high dose group of animals despite normal feature in the lung, spleen and heart of animals in all dose groups. Kelussia odoratissima Mozaff extract is a tolerable herbal remedy even in high doses, in female rats but dose adjustment studies should be performed in future clinical setting to provide safe and effective pharmaceutical oral dosage forms.

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