Development of an oral mucosal irritation test using a three-dimensional human buccal oral mucosal model

Cosmetic Formulations from Natural Sources: Safety Considerations and Legislative Frameworks in the European Union

“…Non-animal alternatives, such as the human cornea epithelium (HCE) 3D model, have emerged for detecting eye irritation potential [71]. The SkinEthic HCE time-to-toxicity test method (OECD TG 492) has been recommended as a conditional replacement for the in vivo eye irritation test, which is a major achievement in accelerating regulatory adoption of NAMs [6,90] Other in vitro assays developed for mucosal membrane and eye irritation include the EpiOral assay (mouth and lips) [91], the HET-CAM, and the EpiOcular eye irritation test [90].…”

VitroScreen Seminar - Substance-based medical device qualification and classification: Pre-clinical approaches to mechanism of action

“…While ISO 10993-23 has replaced rabbit irritation tests with in vitro methods, it still recommends in vivo irritation tests to assess the irritation potential of MDs in contact with mucosal membranes (e.g., eyes, penis, oral, rectal and vaginal mucosa). Some publications are available on the use of 3D models on these mucosal tissues to evaluate in vitro ocular (Meloni et al, 2019;Yun et al, 2016), vaginal (Ayehuni et al, 2018;Sica et al, 2022), and oral (Yang et al, 2021;Aizawa et al, 2023) irritation of MDs; together with methods validated for eye irritation potential of chemicals (OECD TG 492, 492B), these could represent potential in vitro methods for MD assessment. In the case of skin sensitization, ISO TS 11796 has recently been approved and will soon be published to drive qualification for MD assessment of OECD methods already validated with and for neat chemicals (as described in Annex C of ISO 10993-10:21).…”