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Lucija Perharič, Katja Ažman Juvan and Lovro Stanovnik Acute effects of a low-dose atropine/scopolamine mixture as a food contaminant in human volunteers Journal of Applied Toxicology 33

Article first published online: 9 AUG 2012 | DOI: 10.1002/jat.2797

A randomized, double-blind, placebo-controlled, crossover study in 20 healthy, human volunteers, aged 19–28 years, was carried out to refine the Acute Reference Doses (ARfD) of an atropine/scopolamine mixture. Bradycardia was identified as a critical effect. We estimate that the No Observed Adverse Effect Levels (NOAELs) for the atropine/scopolamine mixture are between the dose levels 0.12/0.10 and 0.37/0.29 µg kg–1 body mass (BM). By applying the uncertainty factor of 10, we propose a new provisional ARfD of the mixture, i.e. 0.01 µg kg–1 BM for each alkaloid.

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