Chemical characterization and toxicological evaluation of acrylic-based dental implant devices used for different purposes within the scope of ISO 10993.

Medical devices have the potential to release chemical constituents, either as residual manufacturing additives or as leachable under clinical conditions, which may pose potential toxicological risks. Therefore, comprehensive chemical characterization is crucial to identify and quantify extractable compounds that could migrate from the device during clinical use, in accordance with ISO 10993 standards. This study provides a comprehensive chemical characterization and toxicological risk assessment of acrylic-based dental devices intended for various clinical applications. By adhering to ISO 10993-12:2021 for extraction protocols and employing both polar (water) and apolar (50:50 ethanol-water) solvents, leachable were analyzed after 72-h incubations at 50 °C. Fourier Transform Infrared Spectroscopy (FTIR) confirmed the use of polymethyl methacrylate (PMMA) in device matrices, while thermogravimetric analysis (TGA) revealed the presence of inorganic pigments. Extractable compounds were identified by using a broad range of analytical techniques-including Gas Chromatography-Mass Spectrometry (GC-MS), High Performance Liquid Chromatography (HPLC), UV-VIS-NIR Spectrophotometry because of extractable studies, Liquid Chromatography - Tandem Mass Spectrometry (LC-MS/MS) and Inductively Coupled Plasma-Optical Emission Spectrometry (ICP-OES) techniques, detecting compounds such as phenyl benzoate, N,N-dimethyl-p-toluidine, benzoyl peroxide, ethylene glycol dimethacrylate, and benzoic acid. Toxicological risk assessments were subsequently conducted in accordance with ISO 10993-17:2023, demonstrating that all tested devices were biocompatible and posed no toxicological hazard under intended clinical conditions.