Reproductive toxicity risk assessment for pesticides

Human health risk assessment for pesticides is based mainly on animal studies submitted by the applicant and aims to determine safe exposure levels for operators (farmers and agricultural workers) and consumers of all age groups. Critical effects, including those resulting from reproductive toxicity, are identified during hazard assessment from an evaluation of all studies in the toxicity package. Reproductive or developmental effects are considered critical if they are more severe or occur at lower doses than other toxicities. Reference values for human exposure are then derived from No Adverse Effect Levels for the relevant critical effects by applying safety factors. This paper describes methods and caveats applicable to the evaluation of prenatal toxicity and two-generation studies from the view of a regulator, stressing the importance of individual litter data and the relationship between different endpoints.