Peer Review Panel to Assess Toxicokinetics and Mode of Action for Reproductive Effects

Peer Review Panel to Assess Mode of Action for Reproductive Effects

Expertise needed (6 experts total):

Toxicokinetics Experts (3 experts)

• Experience in assessing rodent/dog/human ADME studies (regulatory/mechanistic studies)

• Experience in PBPK model design, validation and assessment, including pregnancy models, particularly related to the OECD standardisation criteria

• Application of PBPK modelling results to hazard assessment and/or human health risk assessment, particularly within the European regulatory framework in the non-pharma space (chemicals, agrochemicals, biocides…)

Reproductive Toxicology Experts (3 experts)

• Experience in assessing adverse outcomes in reproductive toxicity studies (regulatory/mechanistic studies), particularly in the area of parturition biology (dystocia). 

• Assessment of human relevance of rodent reproductive effect within the context of the EU chemical hazard classification system (CLP), using the IPCS/WHO human relevance framework for assessment of non-cancer mode of actions.