Monograph 031 – Guidance on Evaluation of Reproductive Toxicity Data


Mono 031 : Guidance on Evaluation of Reproductive Toxicity Data | February 2002

The reproductive process is complex and there are many stages that are vulnerable to external influences; such influences include chemical exposure. Thus, where there is the likelihood of significant exposure to chemicals, it is important to evaluate their potential to affect adversely reproduction in humans. The interpretation of data from reproductive and developmental toxicity studies requires expert scientific judgement. Hazard assessment involves the identification of pertinent, treatment-related findings, attributing a level of concern that takes into account data from the study as a whole. The level of concern will depend on the type and incidence of response to treatment, as well as the overall conditions under which the response is elicited. Currently, there is no generally accepted framework that can be applied to perform such an assessment in a consistent and transparent manner. In this Monograph, guidance is provided in the form of a structured approach for the interpretation of reproductive toxicity data. The approach is illustrated through the use of examples from several fertility and developmental toxicity studies, drawn from the collective experience of the Task Force. This guidance takes into account the possible role of maternal toxicity in the interpretation of the study findings. Since the publication, in 1992, of ECETOC’s previous guidance on this topic, new insights into the manner in which chemicals might impair reproductive function have become available. Some of these have been incorporated into updated versions of international or national test guidelines on the assessment of reproductive toxicity. These advances in testing methodology are also highlighted and discussed in this Monograph. In addition, specific mention is made of emerging issues, such as endocrine activity and developmental neurotoxicity.