Genotoxic Assessment of the Metabolite M-11 of Mepanipyrim, the Active Ingredient in the Plant Protection Product FRUPICA SC

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Hubert Dirven
Jan Ludvig Lyche
Marit Låg
Asbjørn Magne Nilsen
Katrine Borgå
Ole Martin Eklo
Merete Grung
Line Emilie Sverdrup
Torsten Källqvist

Abstract

The VKM Panel for plant protection products considered Frupica SC in a meeting on 25.11.2010, and found the active ingredient problematic with regard to carcinogenic effects and possible genotoxicity. M11 is a metabolite of mepanipyrim which is the active ingredient the plant protection product Frupica SC. The Norwegian Food Safety Authority has asked the applicant for further assessment of the genotoxic potential of the metabolite M11. The applicant has submitted a rat liver in vivo Comet assay of the metabolite, and the panel has been requested to consider if the genotoxic properties of mepanipyrim and the metabolite M11 is adequately documented.

 The metabolite M11 caused positive findings in in vitro studies for bacterial mutation and chromosomal aberrations. Three in vivo studies (Micronucleus, unscheduled DNA synthesis and Comet assay) did not show evidence of genotoxicity. Based on the documentation available, VKMs Panel on Plant Protection Products concludes that mepanipyrim and the metabolite M11 should not be considered genotoxic in vivo. The lack of demonstrated in vivo genotoxicity makes it likely that mepanipyrim induces liver tumors in rats and mice by a mechanism that involves a threshold below which tumors are not expected to develop. This conclusion is strengthened by the finding of a promoter-like behavior of mepanipyrim for induction of gamma-glutamyl-transpeptidase positive foci in rat liver.

Keywords:
VKM, risk assessment, Norwegian Scientific Committee for Food Safety, Frupica SC, mepanipyrim, metabolite M11, genotoxicity.

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How to Cite
Dirven, H., Lyche, J., Låg, M., Nilsen, A., Borgå, K., Eklo, O., Grung, M., Sverdrup, L., & Källqvist, T. (2019). Genotoxic Assessment of the Metabolite M-11 of Mepanipyrim, the Active Ingredient in the Plant Protection Product FRUPICA SC. European Journal of Nutrition & Food Safety, 9(3), 306-307. https://doi.org/10.9734/ejnfs/2019/v9i330072
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Grey Literature