我国化学品毒性鉴定技术规范与REACH标准比对研究
Study on the Comparability between Chemical Toxicity Test Instruction in China and REACH Relative Criteria
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摘要:
目的 了解我国现有的《化学品毒性鉴定技术规范》(以下简称"规范")与化学品注册、评估、授权和限制(REACH)标准方法之间的差异,以提高我国的化学品毒性鉴定的质量和水平。 方法 对规范、REACH中的毒性鉴定方法按照不同的毒性分类进行比较。 结果 (1) REACH和规范中使用的方法大部分都源于经济合作与发展组织(OECD)的化学品毒性鉴定及其健康效应评价指南。因此,两者间在方法本质和原则上没有很大的差别。(2)异同点比较:①方法基本相同,特别是原理、试验体系、试验指标和评判终点都一致;② REACH主要采用OECD标准中运用时间长、接受面广、相对成熟的方法;③我国的标准在技术内容上和国际是接轨的,由于考虑到整体的检验水平还不高,因此对一些具体的操作步骤做出了更详细的规定,使标准更具规范性和实用性。 结论 从REACH与我国现行毒理学方法的对比分析中发现,在整体结构和原则上,我国的分析方法与REACH的方法有高度的相似性,但在某些试验方法方面也存在着差异。只有尽快在我国建立国际通用标准的毒理学检测良好实验室规范(GLP)实验室,才能从根本上提高中国实验室的检测能力。 Abstract:Objective To know the difference of toxicity test methods between assessment of chemicals in China and Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH) of Europe. Methods According to the different toxicity classification methods, the analysis and comparison were done between instruction for chemicals toxicity identification promulgated by Ministry of Health and methods for the determination of toxicity and other health effects of REACH. Results The similarities and differences of the methods in our country and REACH were concluded as following:(1)There were little difference between methods of our instruction and REACH, especially they were the same in principle, test system, indicators and judgment end-point. (2)The relatively mature methodologies had been taken in REACH, which had been used for a long time and accepted broadly on Organisation for Economic Co-operation and Development(OECD)criteria.(3)Our instruction was geared to international standards in aspect of technology. But considering the actual testing level, it was essential to make procedures in more details to let our instruction more normal and practicable. Conclusion The methods used in our instruction are mostly originated from OECD as the same as REACH. So there is little essential difference among the methods. The gap of toxicity test between domestic and aboard is depend on quality control system, the former is not geared to international standards and to set Good Laboratory Practice (GLP)laboratory sustem. So there is lack of comparability on data got from our lab. It is more important to set GLP laboratory used for toxicity testing in China in order to improve the test capability fundamentally.
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