Evaluating the utility of the Threshold of Toxicological Concern (TTC) and its exclusions in the biocompatibility assessment of extractable chemical substances from medical devices.

ABSTRACT: The Threshold of Toxicological Concern (TTC) is a pragmatic approach used to establish safe thresholds below which there can be no appreciable risk to human health. Here, a large inventory of ~45,000 substances (referred to as the LRI dataset) was profiled through the Kroes TTC decision module within Toxtree v3.1 to assign substances into their respective TTC categories. Four thousand and two substances were found to be not applicable for the TTC approach. However, closer examination of these substances uncovered several implementation issues: substances represented in their salt forms were automatically assigned as not appropriate for TTC when many of these contained essential metals as counter ions which would render them TTC applicable. High Potency Carcinogens and dioxin-like substance

SUBMITTER: Patlewicz G 

PROVIDER: S-EPMC9671081 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature