现有的《化学物质注册与评价法》等测试数据

Q3 Medicine
Bong-In Choi, B. Ryu, S. Na, Seon-Yong Chung
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引用次数: 0

摘要

在本研究中,研究了利用韩国和其他地方提供的现有测试数据进行化学物质注册的可能性。分析了根据《化学物质注册和评价等法案》(K-REACH)第一批注册的510种化学物质的数据。方法对2015年7月申报注册的510种化学物质,利用16个参考数据库现有数据的可能性进行分析。结果符合K-REACH规定的化学物质注册可靠性要求的测试数据占物理化学特性要求的48.4%,健康危害要求的6.5%,环境危害要求的9.4%。一些现有的试验数据不在本研究的范围内,包括在欧盟(EU)注册的数据。因此,考虑到这510种中有350种已在欧盟化学品注册,评估,授权和限制中注册,除了本研究确定的数据外,可能还存在更多可以利用的测试数据。此外,K-REACH规定,非测试数据(通过Read Across预测的测试结果,定量结构-活性关系)和证据权重(基于低可靠性测试数据预测的测试结果)也可以用于注册数据。因此,如果积极审查使用这些数据的方法,就有可能降低获得化学物质注册所需的测试数据的成本。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Existing test data for the Act on Registration & Evaluation, etc. of Chemical Substances
Objectives In this study, the possibility of using existing test data provided in Korea and elsewhere for the registration of chemical substances was examined. Data on 510 chemical substances that are among the first subject to registration under the “Act on the Registration and Evaluation, etc. of Chemical Substances (K-REACH)” were analyzed. Methods The possibility of using existing data from 16 reference databases was examined for 510 chemical substances notified in July 2015 as being subject to registration. Results Test data with the reliability required for the registration of chemical substances under the K-REACH constituted 48.4% of the required physicochemical characteristics, 6.5% of the required health hazards, and 9.4% of the required environmental hazards. Conclusions Some existing test data were not within the scope of this research, including data used for registration in the European Union (EU). Thus, considering that 350 of these 510 species are registered in EU Registration, Evaluation, Authorisation & Restriction of Chemicals, more test data may exist that can be utilized in addition to the data identified in this study. Furthermore, the K-REACH states that non-testing data (test results predicted through Read Across, Quantitative Structure- Activity Relationships) and the weight of evidence (test results predicted based on test data with low reliability) can also be utilized for registration data. Therefore, if methods for using such data were actively reviewed, it would be possible to reduce the cost of securing test data required for the registration of chemical substances.
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来源期刊
Environmental Health and Toxicology
Environmental Health and Toxicology Medicine-Public Health, Environmental and Occupational Health
CiteScore
2.50
自引率
0.00%
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0
审稿时长
8 weeks
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