日本用于评估因饮食暴露导致的鱼类生物累积的统计后处理方法。

IF 3.7 4区 环境科学与生态学 Q2 ENVIRONMENTAL SCIENCES Archives of Environmental Contamination and Toxicology Pub Date : 2023-10-29 DOI:10.1007/s00244-023-01035-9
Yoshiyuki Inoue, Yuka Koga, Ryoko Takeshige, Hidekazu Murakami, Takumi Takamura
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摘要

2018年,经济合作与发展组织第305号测试指南的膳食暴露生物累积鱼类测试被引入日本《化学物质管制法》。日本政府对不存在高生物累积性采用了一个明确的测试标准:生长校正的动态膳食放大因子(BMFKg)必须小于0.007。本研究的目的是减少监管限制,以增加新开发的化学物质及其随后对其生产和进口的批准,即本研究的动机是担心该标准过于严格,而不是科学问题,例如标准的不确定性。我们使用统计后处理来评估扩大不具有高度生物累积性标准的可能性。根据我们的研究结果,我们提出了一个标准,即如果满足以下两个条件,则应认为受试物质不具有高度生物累积性:(1)在摄取阶段结束时测得的5%脂质标准化生物放大因子的最大值与最小值之比(BMF5%,n = 5) 对于试验物质和对照物质,应小于3.0,以及(2)对于测量的BMF5%试验物质(n = 5) ,基于统计后处理,下一个(第六个)BMF5%低于0.0334的概率应超过95%。值得注意的是,BMF5%值应仅适用于不可离子化的脂溶性化合物。将我们建议的方法应用于日本意味着,在饮食暴露-生物累积鱼类试验中,不具有高度生物累积性的化学物质的标准将从0.007提高到0.0149。
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Statistical Post-Processing Method for Evaluating Bioaccumulation in Fish Due to Dietary Exposure in Japan

In 2018, the dietary exposure bioaccumulation fish test of the Organization for Economic Co-operation and Development Test Guideline No. 305 was introduced into Japan’s Chemical Substances Control Law. The Japanese government has adopted a single definitive testing criterion for the absence of high bioaccumulation: the growth-corrected kinetic dietary magnification factor (BMFKg) must be less than 0.007. The aim of this study was to decrease regulatory restrictions in order to increase newly developed chemical substances and their subsequent approval of their manufacture and import, i.e., the present study was motivated by concerns over the criterion being too restrictive, rather than scientific concerns, such as uncertainty in criterion. We used statistical post-processing to assess the possibility of expanding the criteria for not being highly bioaccumulative. Based on our results, we proposed the criterion that the test substance should be considered not highly bioaccumulative if the following two conditions are met: (1) The ratio of the maximum to the minimum measured 5% lipid-standardized biomagnification factor at the end of the uptake phase (BMF5%, n = 5) for the test substance and reference substance should be less than 3.0, and (2) For the measured BMF5% of the test substance (n = 5), the probability that the next (the sixth) BMF5% is below 0.0334 should exceed 95% based on statistical post-processing. It is worth noting that the BMF5% values should only be applied for non-ionizable lipid soluble compounds. Application of our suggested approach to Japan implies that the criterion for chemical substances that are not highly bioaccumulative in the dietary exposure bioaccumulation fish test would be increased from 0.007 to 0.0149.

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来源期刊
CiteScore
7.00
自引率
2.50%
发文量
63
审稿时长
8-16 weeks
期刊介绍: Archives of Environmental Contamination and Toxicology provides a place for the publication of timely, detailed, and definitive scientific studies pertaining to the source, transport, fate and / or effects of contaminants in the environment. The journal will consider submissions dealing with new analytical and toxicological techniques that advance our understanding of the source, transport, fate and / or effects of contaminants in the environment. AECT will now consider mini-reviews (where length including references is less than 5,000 words), which highlight case studies, a geographic topic of interest, or a timely subject of debate. AECT will also consider Special Issues on subjects of broad interest. The journal strongly encourages authors to ensure that their submission places a strong emphasis on ecosystem processes; submissions limited to technical aspects of such areas as toxicity testing for single chemicals, wastewater effluent characterization, human occupation exposure, or agricultural phytotoxicity are unlikely to be considered.
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