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Updated: Jun 14, 2025
An In Vitro Skin Irritation Test SIT using the EpiDerm Reconstructed Human Epidermal RHE Model
Published on: July 13, 2009
Reliability and relevance of the ES®-RHE model for in vitro skin irritation test application
C A Mini1, G Ballestero1, C C Munari1
1Eleve Science Pesquisa e Desenvolvimento Ltda., SUPERA Parque Tecnológico de Ribeirão Preto USP, Ribeirão Preto, SP, Brazil.
Introduction:
In vitro methods have been widely used to assess adverse effects. Reconstructed Human Epidermis (RHE) poses as a fascinating test system employed to assess the dermal irritation hazard potential of chemicals. Although several RHE models are reported in the OECD Test Guideline No. 439, the OECD Document No. 220 encourages the scientific community to develop and validate new RHE test systems due to its relevance for socio-economic advancement.
Methods:
Following the criteria documented in the OECD No. 220, a blind study for skin irritation (OECD 439) was conducted employing the Minimum List of Reference Chemicals for Determination of Reproducibility and Predictive Capacity using ES®-RHE. Structural and functional characteristics were assessed alongside the prediction model.
Results:
The model has shown reproducibility of optical density and barrier function, similarly to internationally validated methods. Furthermore, it shows the cell layers' development and differentiation ability due to Cytokeratin14, Cytokeratin10, and filaggrin expression. The prediction model resulted in sensitivity, specificity and accuracy rates of 100, 70, and 77 %, respectively.
Conclusions:
The ES®-RHE demonstrated reliability and relevance, with similar structural and functional characteristics comparable to internationally validated models, in addition to the accepted predictive capacity according to OECD required minimum criteria, thus confirming the suitability of the national ES®-RHE in the hazard prediction of dermal irritation based on OECD Test Guideline No. 439.
