Characterization of medical device constituents and development of duration-based non-cancer threshold of toxicological concern values.

ABSTRACT:

Introduction

In the absence of sufficient constituent-specific dose-response toxicity data, threshold of toxicological concern (TTC) values are commonly used in toxicological risk assessment of medical device (MD) constituents. When experimental data or predictions suggest that a constituent is not likely to have genotoxic effects, categorizing the constituent into its appropriate Cramer Class and application of the corresponding TTC value is recommended. This paper presents the uniqueness of the MD chemical space when compared to the historical Munro TTC dataset via structure-based chemical taxonomy, ToxPrint chemotypes, physicochemical properties and molecular descriptors, and proposes duration-based MD non-cancer TTC values.

Methods

More than 15,000 MD constituents were i

SUBMITTER: Builee T 

PROVIDER: S-EPMC12175843 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature