ABSTRACT
This chapter focuses on the design of developmental neurotoxicity (DNT) experiments, and presents some statistical models for analyzing data from these experiments. It also presents some modeling structures that provide ways of estimating the risk. As other non-cancer endpoints, the traditional method for risk assessment for developmental neurotoxicants was based on the calculation of no-observed-adverse-effect-level (NOAEL) as a point of departure and dividing it by a series of safety factors to determine a safe exposure level. If the analysis of the DNT data indicates a significant dose effect, then the first step for quantitative estimation of risk is the development of an appropriate mathematical dose-response function. As in all toxicological experiments with continuous responses, for developmental neurotoxicity outcomes, one of the difficulties in risk assessment for neurotoxic effects is that the endpoints of interest are quantitative measures and there is not a clear definition of the degree of change that is considered “adverse.”.
