Dipartimento di Sanità Pubblica Veterinaria e Sicurezza Alimentare, Istituto Superiore di Sanità, Rome, Italy.
Ann Ist Super Sanita. 2011;47(4):429-44. doi: 10.4415/ANN_11_04_16.
Reproductive toxicity, with its many targets and mechanisms, is a complex area of toxicology; thus, the screening and identification of reproductive toxicants is a main scientific challenge for the safety assessment of chemicals, including the European Regulation on Chemicals (REACH). Regulatory agencies recommend the implementation of the 3Rs principle (refinement, reduction, replacement) as well as of intelligent testing strategies, through the development of in vitro methods and the use of mechanistic information in the hazard identification and characterization steps of the risk assessment process. The EU Integrated Project ReProTect (6th Framework Programme) implemented an array of in vitro tests to study different building blocks of the mammalian reproductive cycle: methodological developments and results on male and female germ cells, prostate and placenta are presented.
生殖毒性具有众多靶点和机制,是毒理学的一个复杂领域;因此,生殖毒物的筛选和鉴定是化学品安全性评估的主要科学挑战,包括欧洲化学品法规 (REACH)。监管机构建议实施 3Rs 原则(优化、减少、替代)以及智能测试策略,通过开发体外方法并在风险评估过程的危害识别和特征描述步骤中使用机制信息来实现。欧盟综合项目 ReProTect(第六框架计划)实施了一系列体外测试来研究哺乳动物生殖周期的不同构建块:介绍了男性和女性生殖细胞、前列腺和胎盘的方法学发展和结果。