国外新化学物质管理中的健康效应数据需求分析  

Health Effect Data Needs in Foreign New Chemicals Management

作　　者：余若祯[1] 方征[1] 王宏[1] 杨霓云[1] 周俊丽[1] 刘征涛[1] 

机构地区：[1]中国环境科学研究院,国家环境保护化学品生态效应与风险评估重点实验室,北京100012

出　　处：《环境科学研究》2009年第7期810-816,共7页Research of Environmental Sciences

基　　金：环保公益性行业科研专项(2007HBGY26)

摘　　要：概要介绍了欧盟、美国、日本、加拿大和澳大利亚等国家和地区的新化学物质管理的相关法规、行政机构设置和审查制度流程,并详细阐述了在化学物质申报制度中对健康效应的数据需求及其测试方法.欧盟、加拿大和澳大利亚以眼睛/皮肤刺激、皮肤致敏、急性毒性和基因/染色体毒性等作为最基本的检测指标;日本侧重于持久性、蓄积性和人类/环境毒性的评价,不要求提供急性毒性试验数据;美国较偏重结构活性相关关系(SAR)/定量结构活性相关关系(QSARs)技术预测的健康效应数据,在不能判定物质是否有潜在的健康/环境风险时,才要求提供相应的试验数据;相反,澳大利亚对QSARs采取了较为审慎的态度.结合其他国家和组织的相关经验,为完善我国新化学物质的健康效应数据需求和管理,提出了关于建设已登记物质数据库,QSARs技术,持久性、生物蓄积性和毒性(PBT)评估体系和优良实验室等方面的建议.The relevant acts, regulations and executive department and evaluation frameworks for new chemicals management in the EU, United States, Japan, Canada and Australia were introduced and summarized in this paper. The health effect data needs and their test methods for chemicals declaration were expounded in detail. The test data of ocular/dermal irritation/corrosion, skin sensitization, acute toxicity and genetic/chromosomal toxicity are elemental requirements in the EU, Canada and Australia. Japan pays much attention on new chemicals test data of persistence, bioaccumulation, and human/environmental toxicity rather than acute toxicity. In the United States, the predicted health effect data by SARs/QSARs are essential; if it is difficult to make a conclusion whether a chemical poses potential risk of injury to human health/environment, testing data is required. On the contrary, QSARs method is accepted with discretion in Australia. Finally, the management regulation of new chemicals in China was presented briefly. In view of other countries＇ experience, some complementary proposals about the registered new chemicals data base, QSARs, PET assessment and GLP laboratory on the health effect data needs and their management were presented.

关 键 词：新化学物质 健康效应 数据需求 QSARS 

分 类 号：X592[环境科学与工程—环境工程]