title: Acute and repeated doses (28 days) oral toxicity study of glycosides based standardized fenugreek seed extract in laboratory mice.
abstract: The objective of the present work was to study acute and subacute (28-days repeated dose) oral toxicity effect of glycosides based standardized fenugreek seed extract (SFSE-G) in vivo. SFSE-G was prepared by resin-based chromatography and standardized to glycosides namely trigoneoside Ib (76%) and vicenin 1 (15%). The acute oral toxicity (AOT) and subacute toxicity studies were performed in Swiss albino mice (5 mice/sex/group) as per OECD 425 (up-and-down procedure) and OCED 407 guidelines respectively. Acute oral administration of 5000mg/kg of SFSE-G showed 40% mortality with no mortality in lower dosages. The subacute oral administration of SFSE-G did not show observational or toxicological effects on the body or organ weights, food consumption, ophthalmic effects, locomotor activity, hematology, blood biochemistry, urinalysis, or histopathology at dose 250mg/kg. However, SFSE-G (1000mg/kg) showed mortality and minor alterations to body weight, relative liver weights, hematology and blood chemistry parameters related to treatment but it was within normal laboratory ranges. In conclusion, SFSE-G showed median lethal dose (LD50) more than 4350mg/kg and no-observed adverse effect levels (NOAEL) of 250mg/kg for both sexes during AOT and sub-acute toxicity study, respectively.
authors.affiliation: Department of Pharmacology, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Erandwane, Paud Road, Pune 411 038, India.
authors.forename: Amit D
authors.initials: AD
authors.lastname: Kandhare
authors.affiliation: Department of Pharmacology, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Erandwane, Paud Road, Pune 411 038, India. Electronic address: sbodhindus@gmail.com.
authors.forename: Subhash L
authors.initials: SL
authors.lastname: Bodhankar
authors.affiliation: Indus Biotech Private Limited, 1, Rahul Residency, Off SalunkeVihar Road, Kondhwa, Pune 411 048, India.
authors.forename: V
authors.initials: V
authors.lastname: Mohan
authors.affiliation: Indus Biotech Private Limited, 1, Rahul Residency, Off SalunkeVihar Road, Kondhwa, Pune 411 048, India.
authors.forename: Prasad A
authors.initials: PA
authors.lastname: Thakurdesai
mesh_terms: D000284:Administration, Oral; D000818:Animals; D005260:Female; D006027:Glycosides / Q000633:toxicity*; D007928:Lethal Dose 50; D008297:Male; D051379:Mice; D010936:Plant Extracts / Q000633:toxicity*; D012639:Seeds; D023382:Toxicity Tests, Acute; D059551:Toxicity Tests, Subacute; D029910:Trigonella
chemical_list: D006027:Glycosides; D010936:Plant Extracts
keywords: Acute toxicity test; Fenugreek seed extract; Glycosides; LD(50); No observed adverse effect levels; Subacute toxicity tests