Read Across Assessment for Potential Leachables Without Toxicological Data

If potential leachables exceed established safety thresholds but lack toxicity data, in silico models and the Extractables and Leachables Safety Information Exchange (ELSIE) non-mutagenic parenteral thresholds of toxicological concern (TTCs) may be used to inform the toxicological assessment (ICH M7 (R1), 2017; Chilton et al, 2022; Masuda-Herrera et al. , 2023; Parris et al, 2022; Parris et al, 2023).