Journal
REGULATORY TOXICOLOGY AND PHARMACOLOGY
Volume 72, Issue 2, Pages 323-334Publisher
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.yrtph.2015.05.003
Keywords
Fenugreek seed extract; Glycosides; Acute toxicity test; Subacute toxicity tests; LD50; No observed adverse effect levels
Categories
Funding
- Indus Biotech Private Limited, Pune India
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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 lb (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 5000 mg/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 250 mg/kg. However, SFSE-G (1000 mg/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 4350 mg/kg and no-observed adverse effect levels (NOAEL) of 250 mg/kg for both sexes during AOT and sub-acute toxicity study, respectively. (C) 2015 Elsevier Inc. All rights reserved.
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