Summit Toxicology, L.L.P. Allenspark, CO, USA.
Regul Toxicol Pharmacol. 2012 Dec;64(3):481-9. doi: 10.1016/j.yrtph.2012.09.001. Epub 2012 Sep 24.
Conventional chemical exposure assessment relies upon measurements or estimates of chemical concentrations in environmental media, food, or products, in combination with assumptions regarding contact rates, in order to estimate external doses (ppm in air) or intake rates of chemicals (e.g., mg/kg/day ingested). A risk assessment is conducted by comparing these external or intake dose estimates to appropriate (e.g., route-specific) exposure guidance values (e.g., Reference Dose or Reference Concentration) to assess whether exposures are exceeding levels of concern. Human biomonitoring, in which concentrations of chemicals are measured in blood or urine, is being increasingly used as an alternative or complementary exposure assessment. The Biomonitoring Equivalent, which is the translation of a Reference Dose to an equivalent concentration of a compound in blood or urine, provides a parallel means to interpret biomonitoring data in order to assess whether chemical-specific exposures exceed levels of concern. This manuscript presents a side-by-side comparison of the two approaches for assessing exposures and risks for a case study compound, 2,4-dichlorophenoxyacetic acid (2,4-D). The findings from this case study indicate that the external dose-based assessments result in estimates of exposure and resulting hazard quotients that are consistently several-fold higher than those based on biomonitoring data. These comparisons support a conclusion that exposure assessments conducted as part of the registration process for 2,4-D incorporate sufficiently conservative assumptions.
传统的化学暴露评估依赖于环境介质、食物或产品中化学物质浓度的测量或估计,结合接触率的假设,以估计外部剂量(空气中的 ppm)或化学物质的摄入量(例如,mg/kg/天摄入)。通过将这些外部或摄入剂量估计值与适当的(例如,特定途径)暴露指导值(例如,参考剂量或参考浓度)进行比较,进行风险评估,以评估暴露是否超过关注水平。人体生物监测,即测量血液或尿液中化学物质的浓度,正越来越多地被用作替代或补充暴露评估方法。生物监测等效物是将参考剂量转换为血液或尿液中化合物的等效浓度,为解释生物监测数据提供了一种并行方法,以评估特定化学物质的暴露是否超过关注水平。本文对评估暴露和风险的两种方法进行了并列比较,案例研究化合物为 2,4-二氯苯氧乙酸(2,4-D)。这项案例研究的结果表明,基于外部剂量的评估导致暴露和由此产生的危害商数的估计值始终比基于生物监测数据的估计值高出数倍。这些比较支持了这样一个结论,即 2,4-D 注册过程中进行的暴露评估包含了足够保守的假设。