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1063

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 oral health and hygiene. However, the dynamic and complex environment of the oral cavity, characterized […]
1062

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 sulfate (SDS), Genapol® X-80 (GP), and Y-4 polymer. Dilute saline and sesame seed oil (SSO) solutions of each […]
1061

Two- and Three-Dimensional Culture Systems: Respiratory In Vitro Tissue Models for Chemical Screening and Risk-Based Decision Making

Risk of lung damage from inhaled chemicals or substances has long been assessed using animal models. However, New Approach Methodologies (NAMs) that replace, reduce, and/or refine the use of animals in safety testing such as 2D and 3D cultures are increasingly being used to understand human-relevant toxicity responses and for the assessment of hazard identification. […]
1060

Assessing nanotoxicity of food-relevant particles: A comparative analysis of cellular responses in cell monolayers versus 3D gut epithelial cultures

Engineered nanoparticles (NPs) are extensively used in the food industry, yet safety concerns remain. The lack of validated methodologies is a bottleneck towards resolving this uncertainty. Hence, the current study aims to compare two cell models by examining the toxicological impacts of two food-relevant NPs (SiO2 and Ag) on intestinal epithelia using monolayer Caco-2 cells and full-thickness […]
1059

Cooperation of Cysteine, Ascorbic Acid, Pyridoxine, and α-Lipoic Acid in Antioxidant Effects on Human Keratinocytes and 3D Human Skin Models

Combinations of cysteine, ascorbic acid, and pyridoxine are frequently used in oral formulations. Although there have been many reports on the efficacy of each of these ingredients, little information is known about their combined effects on skin cells. The purpose of this study was to evaluate the combined effects of cysteine, ascorbic acid, and pyridoxine, […]
1058

Automated Transepithelial Electrical Resistance (TEER) Measurements Allow for Rapid Screening of the Gastrointestinal Toxicity Profile of Therapeutics

Gastrointestinal toxicity (GIT) ranks among the most common clinical side effects for many orally administered pharmaceuticals, in particular for oncology drugs which are administered over an extended time period. Previously, we utilized an in vitro small intestine (SMI) microphysiological tissue model, EpiIntestinal (Mattek Corporation), which contains the epithelial cell types resident in the native human […]
1057

Human keratinocyte caspase-14 expression is altered in human epidermal 3D models by dexamethasone and by natural products used in cosmetics

Caspase-14 is a cysteinyl-aspartate-specific proteinase that is specifically expressed in epidermal keratinocytes. Dysregulation of caspase-14 expression is implicated in impaired skin barrier formation. To elucidate the regulation of caspase-14 in differentiated keratinocytes, we characterized the expression of caspase-14 in normal human epidermal keratinocytes (NHEKs) and two types of three-dimensional (3D) human epidermis culture models, EPI-200 […]
1056

Novel Approach for Characterizing Exposure and Response to Engineered Nanomaterials in the Gut

Despite the expanding number of applications for engineered nanoparticles (ENP), human health concerns associated with ingested nanoparticles are poorly understood. In this study, we utilized a 3D human small intestinal tissue model to develop a physiologically relevant test system that can assess the toxicological profiles of ingestible nanomaterials. We examined the effects of Cupric (II) […]
1055

Sensitivity Analysis and Quality Indicators for an In Vitro Oral Irritation Assay

Biocompatibility testing using in vivo tests is often one of the final evaluations of new dental materials. To reduce the likelihood of failure at this late stage, predictive biocompatibility testing using in vitro methods is needed. In this study, we describe a sensitivity analysis of an oral irritation test by evaluating changes in the viability, […]
1054

Hydrophobic binary mixtures containing amphotericin B as lipophilic solutions for the treatment of cutaneous leishmaniasis

Cutaneous leishmaniasis, caused by Leishmania parasites, requires treatments with fewer side effects than those currently available. The development of a topical solution based on amphotericin B (AmB) was pursued. The considerable interest in deep eutectic solvents (DESs) and their remarkable advantages inspired the search for a suitable hydrophobic excipient. Various mixtures based on commonly used […]