In a Comment article for Environmental Health, Axel Mie and Christina Rudén discuss how a study showing that a variant of the herbicide glyphosate causes negative effects on brain development in rats was not disclosed to regulatory EU authorities.
]. A group of companies submitted a dossier to support a renewed EU approval of glyphosate in 2012. This dossier supported glyphosate as well as its isopropylammonium, potassium, and ammonium salts. Glyphosate was re-approved in 2017, and the current approval expires in December 2022.
The DNT study has been evaluated by the U.S. EPA in 2005, and the US authority concluded that it demonstrates behavioural effects in rat offspring following exposure to maternal animals []. The doses were 0, 10, 25 and 100 mg glyphosate trimesium/kg body weight /day, administered to maternal animals from gestational day 7 through postnatal day 11 by gavage. The maternal lowest observed adverse effect level was > 100 mg, i.e. no maternal toxicity, deemed as adverse, was noted.
Importantly, the DNT effect was recognised by the test laboratory in the original study report, as cited in the evaluation by U.S. EPA [ In the EU, an active substance shall be approved “if it may be expected, in the light of current scientific and technical knowledge”, that its proper use does not cause harmful effects on human health. It is the responsibility of the applicant to demonstrate this in the dossier. For the present case, at least one of the applicant companies had scientific knowledge that the glyphosate molecule, i.e.
First, the study could be used as such to assess and characterise DNT of glyphosate and the salts currently under assessment, in conjunction with academic animal and epidemiological studies of DNT-related effects from glyphosate or its formulations [Second, it could trigger the conduct of a new DNT study for glyphosate or one of the salts currently under evaluation .
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