Murray F J
Murray & Associates, San Jose, California 95120, USA.
Regul Toxicol Pharmacol. 1995 Dec;22(3):221-30. doi: 10.1006/rtph.1995.0004.
A human health risk assessment was conducted to derive an appropriate safe exposure level in drinking water of inorganic boron-containing compounds (boric acid and borax). Several regulatory agencies have set or plan to set drinking water guidelines or standards for boron (B). Recent publication of reproductive and developmental toxicity studies by the National Toxicology Program prompted this risk assessment, along with the understanding that boron may be nutritionally essential. A rat developmental toxicity study with a NOAEL of 9.6 mg B/kg/day was selected as the pivotal study on which to base this risk assessment, since it represents the most sensitive endpoint of toxicity. A detailed evaluation of these and other studies allowed modifications of the default values for uncertainty factors to account for the pharmacokinetic similarities among species, the lack of metabolism of inorganic boron-containing compounds, the similarity of the toxicity profile across species, the quality of the toxicological database, and other factors according to the approach described by Renwick previously. Benchmark dose calculations were performed, and the results were in close agreement with the NOAEL selected for this risk assessment. The Reference Dose was calculated to be 0.3 mg B/kg/day, resulting in an acceptable daily intake of 18 mg B/day. Considering that the U.S. average dietary intake of boron is 1.5 mg B/day, 16.5 mg B/day could be available for drinking water or other exposures, if any. A preliminary review of boron data in the National Inorganic Radionuclide Survey by the EPA indicates the median boron level in U.S. drinking water supplies to be 0.031 mg B/liter, and most exposures are less than 2.44 mg B/liter (99th percentile). It is concluded that boron in U.S. drinking water would not be expected to pose any health risk to the public.
进行了一项人体健康风险评估,以确定无机含硼化合物(硼酸和硼砂)在饮用水中的适当安全暴露水平。几个监管机构已经或计划制定硼(B)的饮用水指南或标准。美国国家毒理学计划最近发表的生殖和发育毒性研究促使了这项风险评估,同时人们也认识到硼可能是营养必需元素。一项大鼠发育毒性研究的无观察到有害作用水平为9.6毫克硼/千克/天,该研究被选为此次风险评估的关键研究,因为它代表了最敏感的毒性终点。对这些研究和其他研究进行详细评估后,根据Renwick之前描述的方法,对不确定性因素的默认值进行了修改,以考虑物种间的药代动力学相似性、无机含硼化合物缺乏代谢、不同物种毒性特征的相似性、毒理学数据库的质量以及其他因素。进行了基准剂量计算,结果与本次风险评估所选的无观察到有害作用水平密切一致。计算得出的参考剂量为0.3毫克硼/千克/天,由此得出可接受的每日摄入量为18毫克硼/天。考虑到美国硼的平均膳食摄入量为1.5毫克硼/天,如果有饮用水或其他暴露途径,那么每天可用于这些途径的硼量为16.5毫克。美国环境保护局对国家无机放射性核素调查中的硼数据进行的初步审查表明,美国饮用水供应中硼的中位数水平为0.031毫克硼/升,大多数暴露水平低于2.44毫克硼/升(第99百分位数)。结论是,预计美国饮用水中的硼不会对公众健康构成任何风险。