关键词: Cohorts Developmental toxicity EOGRTS Extended one-generation reproductive toxicity study Fertility Rat Reproduction Triggers

Mesh : Animals Female Fertility / drug effects Humans Immune System / drug effects growth & development Male Models, Animal Nervous System / drug effects growth & development Organisation for Economic Co-Operation and Development / standards Rats Reproduction / drug effects Risk Assessment Toxicity Tests / methods standards

来  源:   DOI:10.1016/j.yrtph.2016.05.036   PDF(Sci-hub)

Abstract:
The extended one-generation reproduction toxicity study (EOGRTS; OECD test guideline 433) is a new and technically complex design to evaluate the putative effects of chemicals on fertility and development, including effects upon the developing nervous and immune systems. In addition to offering a more comprehensive assessment of developmental toxicity, the EOGRTS offers important improvements in animal welfare through reduction and refinement in a modular study design. The challenge to the practitioner is to know how the modular aspects of the study should be triggered on the basis of prior knowledge of a particular chemical, or on earlier findings in the EOGRTS itself, requirements of specific regulatory frameworks notwithstanding. The purpose of this document is to offer guidance on science-based triggers for these extended evaluations.
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