{Reference Type}: Guideline
{Title}: Guidance on the selection of cohorts for the extended one-generation reproduction toxicity study (OECD test guideline 443).
{Author}: Moore NP;Beekhuijzen M;Boogaard PJ;Foreman JE;North CM;Palermo C;Schneider S;Strauss V;van Ravenzwaay B;Poole A;
{Journal}: Regul Toxicol Pharmacol
{Volume}: 80
{Issue}: 0
{Year}: Oct 2016
{Factor}: 3.598
{DOI}: 10.1016/j.yrtph.2016.05.036
{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.