A new reconstructed human epidermis for in vitro skin irritation testing

Abstract

Different models of reconstructed human epidermis (RHE) are currently validated to assess skin irritation in vitro and ultimately to the animal replacement of the Draize test. The development of a new RHE model is a challenge for many laboratories, representing a potential gain of autonomy and improvement of technological knowledge. The Organization for Economic Co-operation and Development (OECD) encourages the development of new models and, for this purpose, offers a thorough guideline on quality control parameters (OECD TG 439 performance standards). This work aimed to develop an RHE model (i.e. USP-RHE) for in vitro skin irritation assays, following the OECD TG 439. The developed model presents a well-differentiated epidermis similar to the Validated Reference Methods (VRM) and to native human epidermis. Quality parameters, i.e. optical density of negative control, tissue integrity and barrier function, were similar to VRM and in accordance with OECD TG 439. Moreover, the USP-RHE model was shown to have 85,7% of specificity (6/7), 100% of sensitivity (6/6) and 92,3% of accuracy (12/13) when compared to in vivo UN GHS classification. The within-laboratory reproducibility was 92.3% (12/13). Thus, we demonstrated that USP-RHE model attends to all OECD TG 439 performance standards and is ready to be used by private and public laboratories and companies for future validation studies.

An Effective Translation: The Development of Hyaluronan-Based Medical Products From the Physicochemical, and Preclinical Aspects

“…Apart from cytotoxicity, only sensitization and irritation tests are required for all types of medical devices. Nowadays, different models are currently validated to assess skin irritation in vitro i.e., the reconstructed human skin model (EpiDerm®, MatTek Corp.) (Hayden et al, 2015 ; Pedrosa et al, 2017 ).…”

Effects of transgenic silk materials that incorporate FGF‐7 protein microcrystals on the proliferation and differentiation of human keratinocytes

“…Three‐dimensional NHEK cultures can be used as a model of human epidermis to substitute for in vivo tests involving animals, which successfully assess skin irritations caused by the acute toxicity, 31,32 allergenicity, 33 and inflammation 34 of test compounds. We used PSGPs with H1/FGF‐7 polyhedra to construct a 3D epidermis model to examine the gradual release of H1/FGF‐7 from these polyhedra.…”

The Reconstructed Human Epidermis in vitro — a Model for Basic and Applied Research of Human Skin

“…Также биоинженерная кожа всегда вызывала большой интерес как в качестве модельной системы биологии и патологии кожи, так и для тестирования терапевтических средств и косметологических продуктов. Учитывая существующий дефицит и ряд ограничений применения донорской кожи, эквиваленты кожи крайне востребованы для увеличения эффективности заживления ран при различных поражениях кожи (механические повреждения, термические, химические ожоги, не поддающиеся лечению длительно незаживающие раны) [20,21]. Многие заменители кожи являются коммерческими продуктами и могут содержать различный вариант биоразлагаемого матрикса, как самостоятельный элемент или в сочетании с клеточным компонентом [22,23].…”