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. 2019 Aug 1:2019:4763015.
doi: 10.1155/2019/4763015. eCollection 2019.

A Toxicological Evaluation of Mango Leaf Extract (Mangifera indica) Containing 60% Mangiferin

Robin A Reddeman  1 , Róbert Glávits  2 , John R Endres  1 , Amy E Clewell  1 , Gábor Hirka  2 , Adél Vértesi  2 , Erzsébet Béres  2 , Ilona Pasics Szakonyiné  2
Affiliations

A Toxicological Evaluation of Mango Leaf Extract (Mangifera indica) Containing 60% Mangiferin

Robin A Reddeman et al. J Toxicol. .

Abstract

A battery of OECD- and GLP-compliant toxicological studies was performed on mango leaf extract (Mangifera indica) containing 60% mangiferin (MLE). No evidence of genotoxicity was found in a bacterial reverse mutation test (Ames). While evidence of clastogenic activity was noted in an in vitro chromosomal aberration test, an in vivo mammalian micronucleus test showed no findings up to the limit dose (2000 mg/kg bw). A 90-day repeated dose oral toxicity study was conducted in rats using doses of 0 (vehicle control), 500, 1000, and 2000 mg/kg bw/day. Based on the lack of mortality or toxic effects in the 90-day study, the NOAEL for MLE in Han:Wist male and female rats was determined to be 2000 mg/kg bw/day, the highest dose tested.

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Conflict of interest statement

AIBMR Life Sciences, Inc., was contracted by the study sponsor, as an independent third party, to determine appropriate study protocols and dose selections, place the studies, approve the study plans, monitor the toxicological studies herein described, analyze and interpret the resulting data, and prepare the manuscript. TOXI-COOP Zrt. was contracted by AIBMR to develop the study plans and to conduct, analyze, interpret, and report the results of the toxicological studies herein described. The authors declared no additional conflicts of interest in regard to the research, authorship, and/or publication of this article.

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