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.
出处
《环境科学研究》
EI
CAS
CSCD
北大核心
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)
