Simulation of acute reference dose (ARfD) settings for pesticides in Japan

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  • Yoshida Midori
    Division of Pathology, Biological Safety Research Center, National Institute of Health Sciences
  • Suzuki Daisetsu
    Division of Pathology, Biological Safety Research Center, National Institute of Health Sciences
  • Matsumoto Kiyoshi
    Research Center for Human and Environmental Sciences, Shinshu University
  • Shirota Mariko
    Laboratory of Comparative Toxicology, School of Veterinary Medicine, Azabu University
  • Inoue Kaoru
    Division of Pathology, Biological Safety Research Center, National Institute of Health Sciences
  • Takahashi Miwa
    Division of Pathology, Biological Safety Research Center, National Institute of Health Sciences
  • Morita Takeshi
    Division of Safety Information on Drug, Food and Chemicals, National Institute of Health Sciences
  • Ono Atsushi
    Division of Risk Assessment, Biological Safety Research Center, National Institute of Health Sciences

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In order to develop guidelines for setting acute reference doses (ARfDs) for pesticides in Japan, we conducted simulations of ARfD settings based on evaluation reports for 201 pesticides assessed by the Food Safety Commission (FSC) in Japan over the last 8 years. Our conceptual principles were based on the concepts written by Solecki et al. (2005) and were adapted for toxicological data required in Japan. Through this process, we were able to set the ARfDs for over 90% of the 201 pesticides tested. The studies that provided the rationale for ARfD setting were primarily reproductive and developmental toxicity studies, acute neurotoxicity studies, and pharmacology studies. For approximately 30% of the pesticides simulated in the present study, it was not necessary to establish ARfDs. Some of the simulated ARfDs resulting from their endpoints may be conservative estimates, because the evaluation reports were written for acceptable daily intake settings. Thus, it was sometimes difficult to distinguish acute toxic alerts from repeated toxicities. We were unable to set an ARfD for 14 pesticides because of insufficient data on acute toxicities. This could be improved by more complete recordkeeping. Furthermore, we categorized the 201 pesticides by mechanism of action or chemical structure. Our simulation indicates that the conceptual framework presented here can be used as a basis for the development of guidelines on ARfD settings for pesticides in Japan.

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