Poddalgoda Devika, Macey Kristin, Jayawardene Innocent, Krishnan Kannan
Health Canada, Ottawa, ON, Canada.
ESPUM, Université de Montréal, QC, Canada.
Regul Toxicol Pharmacol. 2016 Nov;81:430-436. doi: 10.1016/j.yrtph.2016.09.030. Epub 2016 Sep 28.
Population-level biomonitoring of tin in urine has been conducted by the U.S. National Health and Nutrition Examination Survey (NHANES) and the National Nutrition and Health Study (ENNS - Étude nationale nutrition santé) in France. The general population is predominantly exposed to inorganic tin from the consumption of canned food and beverages. The National Institute for Public Health and the Environment of the Netherlands (RIVM) has established a tolerable daily intake (TDI) for chronic exposure to inorganic tin based on a NOAEL of 20 mg/kg bw per day from a 2-year feeding study in rats. Using a urinary excretion fraction (0.25%) from a controlled human study along with a TDI value of 0.2 mg/kg bw per day, a Biomonitoring Equivalent (BE) was derived for urinary tin (26 μg/g creatinine or 20 μg/L urine). The geometric mean and the 95th percentile tin urine concentrations of the general population in U.S. (0.705 and 4.5 μg/g creatinine) and France (0.51 and 2.28 μg/g creatinine) are below the BE associated with the TDI, indicating that the population exposure to inorganic tin is below the exposure guidance value of 0.2 mg/kg bw per day. Overall, the robustness of pharmacokinetic data forming the basis of the urinary BE development is medium. The availability of internal dose and kinetic data in the animal species forming the basis of the assessment could improve the overall confidence in the present assessment.
美国国家健康与营养检查调查(NHANES)以及法国的国家营养与健康研究(ENNS - Étude nationale nutrition santé)对人群尿液中的锡进行了生物监测。普通人群主要通过食用罐装食品和饮料接触无机锡。荷兰国家公共卫生与环境研究所(RIVM)根据大鼠为期两年的喂养研究中得出的每日无观察到有害作用水平(NOAEL)为20毫克/千克体重/天,确定了慢性接触无机锡的每日耐受摄入量(TDI)。利用一项人体对照研究中的尿排泄分数(0.25%)以及每日0.2毫克/千克体重的TDI值,得出了尿锡的生物监测等效值(BE)(26微克/克肌酐或20微克/升尿液)。美国普通人群尿锡浓度的几何平均值和第95百分位数(分别为0.705和4.5微克/克肌酐)以及法国普通人群尿锡浓度的几何平均值和第95百分位数(分别为0.51和2.28微克/克肌酐)均低于与TDI相关的BE,这表明人群对无机锡的接触低于每日0.2毫克/千克体重的接触指导值。总体而言,构成尿BE推导基础药代动力学数据的稳健性中等。构成评估基础的动物物种内部剂量和动力学数据的可得性可能会提高对当前评估的总体信心。