دورية أكاديمية
Reliability and relevance of the ES®-RHE model for in vitro skin irritation test application.
| العنوان: | Reliability and relevance of the ES®-RHE model for in vitro skin irritation test application. |
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| المؤلفون: | Mini CA; Eleve Science Pesquisa e Desenvolvimento Ltda., SUPERA Parque Tecnológico de Ribeirão Preto USP, Ribeirão Preto, SP, Brazil. Electronic address: camila.mini@elevescience.com., Ballestero G; Eleve Science Pesquisa e Desenvolvimento Ltda., SUPERA Parque Tecnológico de Ribeirão Preto USP, Ribeirão Preto, SP, Brazil. Electronic address: giulia.ballestero@elevescience.com., Munari CC; Eleve Science Pesquisa e Desenvolvimento Ltda., SUPERA Parque Tecnológico de Ribeirão Preto USP, Ribeirão Preto, SP, Brazil., Carrão DB; Eleve Science Pesquisa e Desenvolvimento Ltda., SUPERA Parque Tecnológico de Ribeirão Preto USP, Ribeirão Preto, SP, Brazil. Electronic address: daniel.carrao@elevescience.com., Fonseca BC; Eleve Science Pesquisa e Desenvolvimento Ltda., SUPERA Parque Tecnológico de Ribeirão Preto USP, Ribeirão Preto, SP, Brazil. Electronic address: bruna.coeli@elevescience.com., Albuquerque NC; Eleve Science Pesquisa e Desenvolvimento Ltda., SUPERA Parque Tecnológico de Ribeirão Preto USP, Ribeirão Preto, SP, Brazil. Electronic address: nayara.albuquerque@elevescience.com., Marquele-Oliveira F; Eleve Science Pesquisa e Desenvolvimento Ltda., SUPERA Parque Tecnológico de Ribeirão Preto USP, Ribeirão Preto, SP, Brazil. Electronic address: franciane.oliveira@elevescience.com. |
| المصدر: | Toxicology in vitro : an international journal published in association with BIBRA [Toxicol In Vitro] 2024 Sep 01, pp. 105932. Date of Electronic Publication: 2024 Sep 01. |
| Publication Model: | Ahead of Print |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Pergamon Press Country of Publication: England NLM ID: 8712158 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-3177 (Electronic) Linking ISSN: 08872333 NLM ISO Abbreviation: Toxicol In Vitro Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Oxford ; New York : Pergamon Press, c1987- |
| مستخلص: | 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. Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Franciane Marquele-Oliveira reports financial support was provided by State of Sao Paulo Research Foundation. Franciane Marquele-Oliveira reports financial support was provided by Finep. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2024. Published by Elsevier Ltd.) |
| فهرسة مساهمة: | Keywords: ES®-RHE; In vitro model; OECD 439; Reconstructed human epidermis; Skin irritation test |
| تواريخ الأحداث: | Date Created: 20240903 Latest Revision: 20240903 |
| رمز التحديث: | 20240904 |
| DOI: | 10.1016/j.tiv.2024.105932 |
| PMID: | 39226997 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1879-3177 |
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| DOI: | 10.1016/j.tiv.2024.105932 |