Reproductive toxicology postnatal effects

In some reproductive toxicity studies in experimental animals the only effects recorded may be considered of low or minimal toxicological significance and classification may not necessarily be the outcome. These include for example small changes in semen parameters or in the incidence of spontaneous defects in the foetus, small changes in the proportions of common foetal variants such as are observed in skeletal examinations, or in foetal weights, or small differences in postnatal developmental assessments. 

Reproductive and developmental toxicology studies, with information on rangefinding studies and supportive TK evaluations, are to be ordered by nonpivotal studies and pivotal studies, which include fertility and early embryonic development to implantation, effects on embryo-fetal development, effects on pre- and postnatal development including maternal function. If conducted, studies in which juvenile animals are dosed and evaluated are to be included in this section. 

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