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根据加州第65号提案确定和列出已知会导致发育毒性的物质的标准。

Criteria for identifying and listing substances known to cause developmental toxicity under California's Proposition 65.

作者信息

Mattison D R, Hanson J W, Kochhar D M, Rao K S

机构信息

Division of Human Risk Assessment, National Center for Toxicological Research, Jefferson, Arkansas 72079.

出版信息

Reprod Toxicol. 1989;3(1):3-12. doi: 10.1016/0890-6238(89)90032-4.

Abstract

Because of the automatic restrictions and warning requirements imposed on substances identified by the state as "known to cause developmental toxicity," the Expert Committee recommends the use of criteria that emphasize human relevancy, biological plausibility, and evidence in support of a selective, adverse developmental effect at non-maternally-toxic doses. In many instances, data for substances of public concern will be insufficient at present to meet these criteria. The fact that a substance is not listed as "known to cause developmental toxicity" does not create a presumption that the substance is safe. The Expert Committee, therefore, urges that these substances be recommended for further testing and that high priority be given to conducting the necessary tests. The Expert Committee reiterates its concern that substances listed by the SAP be identified according to the toxic endpoints (cancer, male reproductive toxicity, female reproductive toxicity, and/or developmental toxicity) that led to listing. Further, the Expert Committee recommends that the state Health and Welfare Agency institute education programs emphasizing appropriate courses of action for citizens informed of exposures to substances known to the state to cause cancer, birth defects, or reproductive toxicity.

摘要

由于国家对被认定为“已知会导致发育毒性”的物质实施了自动限制和警示要求,专家委员会建议采用强调人类相关性、生物学合理性以及支持在非母体毒性剂量下产生选择性不良发育影响的证据的标准。在许多情况下,目前公众关注的物质的数据不足以满足这些标准。一种物质未被列为“已知会导致发育毒性”这一事实,并不能推定该物质是安全的。因此,专家委员会敦促对这些物质建议进行进一步测试,并高度优先开展必要的测试。专家委员会重申其关切,即应由毒理学评价项目(SAP)列出的物质应根据导致其被列入清单的毒性终点(癌症、雄性生殖毒性、雌性生殖毒性和/或发育毒性)来确定。此外,专家委员会建议国家卫生和福利机构开展教育项目,向公民强调对于已知会导致癌症、出生缺陷或生殖毒性的物质暴露后应采取的适当行动。

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