Trypsin is a pharmacologically active or chemically reactive compound used in pharmaceutical manufacturing as an active ingredient, synthetic intermediate, or process reagent, requiring toxicological characterisation to establish protective occupational exposure limits. Available data from in vitro and in vivo studies are evaluated in a weight-of-evidence assessment to identify the critical study, the most sensitive adverse effect endpoint, and the applicable NOAEL or LOAEL that serves as the point of departure for PDE calculation. Data gaps are addressed through read-across from structurally related compounds, (Q)SAR predictions, or application of TTC defaults where scientifically justified.
Interspecies uncertainty factor F1 refinement for Trypsin is achievable when comparative toxicokinetic data characterise the AUC ratio between humans and the test species at relevant doses, replacing the default allometric scaling assumption.