Derivation of biomonitoring equivalents (BE values) for bismuth.

Devika Poddalgoda, Sean M Hays, Andy Nong

Regulatory toxicology and pharmacology : RTP 2020 Jul

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Bismuth (Bi) is a natural element present in the environmental media. Bismuth has been used medicinally for centuries, specifically for the treatment of gastrointestinal (GI) disorders. Although bismuth toxicity is rare in humans, an outbreak of bismuth-induced neurotoxicity was reported in France and Australia in the mid-1970s. The primary source of bismuth exposure in the general population is via food. US FDA (2019) estimated recommended daily intake (RDI) for bismuth as 848 mg bismuth/day (12.1 mg Bi/kg-d assuming a body weight of 70 kg) for GI tract disorders. Exposures to bismuth can be quantified by measuring concentrations in blood and urine. Biomonitoring equivalents (BEs) were derived based on US FDA's RDI as a tool for interpretation of population-level biomonitoring data. A regression between steady state plasma concentrations and oral intakes was used to derive plasma BEs. A whole blood: plasma partitioning coefficient of 0.6 was used to convert plasma BE into whole blood BE. A mass balance equation with a urinary excretion fraction of 0.0003 was used to derive urinary BE. The BE values associated with US FDA's RDI for plasma, whole blood and urine were 8.0, 4.8 and 0.18 μg/L, respectively. These BE values together with bismuth biomonitoring data may be used in screening and prioritization of health risk assessment of bismuth in the general population. Crown Copyright © 2020. Published by Elsevier Inc. All rights reserved.

Citation

Devika Poddalgoda, Sean M Hays, Andy Nong. Derivation of biomonitoring equivalents (BE values) for bismuth. Regulatory toxicology and pharmacology : RTP. 2020 Jul;114:104672