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.
Highlights
Mangifera indica is a large, dome-shaped evergreen tree in the Anacardiaceae family that grows to a height of 10-45 meters [1]
As we are interested in the safety profile of Mango leaf extract micronucleated PCEs (MPCEs) (MLE) at higher doses, investigation utilizing internationally recognized guidelines, and the determination of a no observed adverse effect level (NOAEL) for MLE, we submit the first in vitro and in vivo toxicological assessment of a mango leaf extract containing 60% MGF (MLE) conducted in accordance with the Organization of Economic Cooperation and Development (OECD) Principles of Good Laboratory Practices (GLP), ENV/MC/CHEM(98)17 [11], and the respective OECD guidelines
The test was conducted in accordance with OECD Test Guideline 471 [15], European Commission Regulation No 440/2008 B13/14 [16], Environmental Protection Agency (EPA) Health Effects Test Guidelines, Office of Prevention, Pesticides, and Toxic Substances (OPPTS) 870.5100, EPA 712-C-98-247 (1998) [17], and International Council on Harmonization Guidance S2(R1) (2012) [18]
Summary
Mangifera indica is a large, dome-shaped evergreen tree in the Anacardiaceae family that grows to a height of 10-45 meters [1]. The fruits of the mango tree have been consumed as a food for many hundreds of years in and outside of Asia. There is one other 90-day study on a MLE containing 62% MGF [10] utilizing dose groups of 100, 300, and 900 mg/kg bw/day; it was not reported as adhering to published test guidelines and histopathological examination was not performed. As we are interested in the safety profile of MLE at higher doses, investigation utilizing internationally recognized guidelines, and the determination of a NOAEL for MLE, we submit the first in vitro and in vivo toxicological assessment of a mango leaf extract containing 60% MGF (MLE) conducted in accordance with the Organization of Economic Cooperation and Development (OECD) Principles of Good Laboratory Practices (GLP), ENV/MC/CHEM(98)17 [11], and the respective OECD guidelines. As the authors frequently perform this battery of toxicology studies, the methods description partly reproduces wording from other works [12,13,14]
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