Safety assessment of boron by application of new uncertainty factors and their subdivision

Ryuichi Hasegawa, Mutsuko Hirata-Koizumi, Michael L. Dourson, Ann Parker, Atsushi Ono, Akihiko Hirose

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14 Citations (Scopus)


The available toxicity information for boron was reevaluated and four appropriate toxicity studies were selected in order to derive a tolerable daily intake (TDI) using newly proposed uncertainty factors (UFs) presented in Hasegawa et al. (2010). No observed adverse effect levels (NOAELs) of 17.5 and 8.8mgB/kg/day for the critical effect of testicular toxicity were found in 2-year rat and dog feeding studies. Also, the 95% lower confidence limit of the benchmark doses for 5% reduction of fetal body weight (BMDL05) was calculated as 44.9 and 10.3mgB/kg/day in mouse and rat developmental toxicity studies, respectively. Measured values available for differences in boron clearance between rats and humans and variability in the glomerular filtration rate (GFR) in pregnant women were used to derive chemical specific UFs. For the remaining uncertainty, newly proposed default UFs, which were derived from the latest applicable information with a probabilistic approach, and their subdivided factors for toxicokinetic and toxicodynamic variability were applied. Finally, overall UFs were calculated as 68 for rat testicular toxicity, 40 for dog testicular toxicity, 247 for mouse developmental toxicity and 78 for rat developmental toxicity. It is concluded that 0.13mgB/kg/day is the most appropriate TDI for boron, based on rat developmental toxicity.

Original languageEnglish
Pages (from-to)108-114
Number of pages7
JournalRegulatory Toxicology and Pharmacology
Issue number1
Publication statusPublished - Feb 1 2013
Externally publishedYes


  • Application of new uncertainty factor (UF)
  • Chemical risk assessment
  • Derivation of boron TDI
  • Subdivision of new uncertainty factor (UF)

ASJC Scopus subject areas

  • Toxicology


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