{"title":"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。","authors":"Yoshiyuki Inoue, Yuka Koga, Ryoko Takeshige, Hidekazu Murakami, Takumi Takamura","doi":"10.1007/s00244-023-01035-9","DOIUrl":null,"url":null,"abstract":"<div><p>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 (BMF<sub>K</sub><sub>g</sub>) 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 (BMF<sub>5%</sub>, <i>n</i> = 5) for the test substance and reference substance should be less than 3.0, and (2) For the measured BMF<sub>5%</sub> of the test substance (<i>n</i> = 5), the probability that the next (the sixth) BMF<sub>5%</sub> is below 0.0334 should exceed 95% based on statistical post-processing. It is worth noting that the BMF<sub>5%</sub> 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.</p></div>","PeriodicalId":8377,"journal":{"name":"Archives of Environmental Contamination and Toxicology","volume":null,"pages":null},"PeriodicalIF":3.7000,"publicationDate":"2023-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Statistical Post-Processing Method for Evaluating Bioaccumulation in Fish Due to Dietary Exposure in Japan\",\"authors\":\"Yoshiyuki Inoue, Yuka Koga, Ryoko Takeshige, Hidekazu Murakami, Takumi Takamura\",\"doi\":\"10.1007/s00244-023-01035-9\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>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 (BMF<sub>K</sub><sub>g</sub>) 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 (BMF<sub>5%</sub>, <i>n</i> = 5) for the test substance and reference substance should be less than 3.0, and (2) For the measured BMF<sub>5%</sub> of the test substance (<i>n</i> = 5), the probability that the next (the sixth) BMF<sub>5%</sub> is below 0.0334 should exceed 95% based on statistical post-processing. It is worth noting that the BMF<sub>5%</sub> 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.</p></div>\",\"PeriodicalId\":8377,\"journal\":{\"name\":\"Archives of Environmental Contamination and Toxicology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2023-10-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Archives of Environmental Contamination and Toxicology\",\"FirstCategoryId\":\"93\",\"ListUrlMain\":\"https://link.springer.com/article/10.1007/s00244-023-01035-9\",\"RegionNum\":4,\"RegionCategory\":\"环境科学与生态学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ENVIRONMENTAL SCIENCES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Archives of Environmental Contamination and Toxicology","FirstCategoryId":"93","ListUrlMain":"https://link.springer.com/article/10.1007/s00244-023-01035-9","RegionNum":4,"RegionCategory":"环境科学与生态学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ENVIRONMENTAL SCIENCES","Score":null,"Total":0}
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.
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.