02515nas a2200217 4500008004100000245016600041210006900207260001500276300001200291490000600303520173000309653002402039653002702063653001702090653001702107653002402124100002602148700002302174700003202197856006802229 2017 eng d00aPreclinical Toxicological Evaluation of IDM01: The Botanical Composition of 4‑Hydroxyisoleucine‑ and Trigonelline‑based Standardized Fenugreek Seed Extract0 aPreclinical Toxicological Evaluation of IDM01 The Botanical Comp cApril 2017 a138-1500 v93 a

Objective: To evaluate acute oral toxicity (AOT), subchronic (90‑day repeated dose) toxicity, mutagenicity, and genotoxicity potential of IDM01, the botanical composition of 4‑hydroxyisoleucine‑ and trigonelline‑based standardized fenugreek (Trigonella foenum‑graecum L) seed extract in laboratory rats. Materials and Methods: The AOT and subchronic (90‑day repeated dose) toxicity were evaluated using Sprague‑Dawley rats as per the Organisation for Economic Co‑operation and Development (OECD) guidelines No. 423 and No. 408, respectively. During the subchronic study, the effects on body weight, food and water consumption, organ weights with hematology, clinical biochemistry, and histology were studied. The mutagenicity and genotoxicity of IDM01 were evaluated by reverse mutation assay (Ames test, OECD guideline No. 471) and chromosome aberration test (OECD guideline No. 473), respectively. Results: The IDM01 did not show mortality or treatment‑related adverse signs during acute (limit dose of 2000 mg/kg) and subchronic (90‑day repeated dose of 250, 500, and 1000 mg/kg with 28 days of recovery period) administration. The IDM01 showed oral median lethal dose (LD50) >2000 mg/kg during AOT study. The no‑observed adverse effect level (NOAEL) of IDM01 was 500 mg/kg. IDM01 did not show mutagenicity up to a concentration of 5000 μg/plate during Ames test and did not induce structural chromosomal aberrations up to 50 mg/culture. Conclusions: IDM01 was found safe during preclinical acute and subchronic (90‑day repeated dose) toxicity in rats without mutagenicity or genotoxicity.

10aAcute oral toxicity10aFenugreek seed extract10aGenotoxicity10aMutagenicity10aSubchronic toxicity1 aDeshpande, Pallavi, O1 aMohan, Vishwaraman1 aThakurdesai, Prasad, Arvind uhttps://www.phcogres.com/article/2017/9/2/1041030974-8490204649