Reference Libraries

March 27, 2025

Development of an In Vitro Method for Assessing the Potential Irritation of Medical Devices and OTC Products Used in the Oral Cavity

The aim of this study was to evaluate an in vitro method using the EpiOralTM model, a three-dimensional cultured human buccal epithelium, for assessing the oral irritation potential of various products. We evaluated different concentrations of nine chemicals commonly found in... Read More

March 26, 2025

Applicability of the in vitro skin irritation methods (EpiSkin™, EpiDerm™ SIT) to organosilicon-based substances

It is now widely accepted that the reconstructed human epidermis models (OECD TG 439) can be used as a standalone replacement of the in vivo rabbit assay (OECD TG 404) to accurately predict skin irritancy. Many legislations have now introduced the legal... Read More

March 11, 2025

Evaluation of Biocompatible Materials for Enhanced Mesenchymal Stem Cell Expansion: Collagen-Coated Alginate Microcarriers and PLGA Nanofibers

Mesenchymal stem cells (MSCs) hold significant potential in regenerative medicine, tissue engineering, and cultivated meat production. However, large-scale MSC production is limited by their need for surface adherence during growth. This study evaluates two biocompatible materials—collagen-coated alginate microcarriers and polylactic-coglycolic... Read More

February 20, 2025

Exploring the potential of reconstructed human epithelial tissue models for safety assessment of intraoral medical devices

Medical devices are integral to a wide array of medical interventions and are increasingly utilized in both clinical and home settings. Within the oral cavity, intraoral medical devices are employed for various applications, to improve quality of life and maintain... Read More

February 19, 2025

Evaluation of the medical devices benchmark materials in the controlled human patch testing and in the RhE in vitro skin irritation protocol

Several irritants were used in the in vitro irritation medical device round robin. The objective of this study was to verify their irritation potential using the human patch test (HPT), an in vitro assay, and in vivo data. The irritants were lactic acid (LA), heptanoic acid (HA), sodium dodecyl... Read More