دورية أكاديمية
A new reconstructed human epidermis for in vitro skin irritation testing.
| العنوان: | A new reconstructed human epidermis for in vitro skin irritation testing. |
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| المؤلفون: | Pedrosa TDN; Clinical Chemistry & Toxicology Department, School of Pharmaceutical Sciences, University of São Paulo, Av. Professor Lineu Prestes, 580, Bloco 17, 05508-000 São Paulo, SP, Brazil., Catarino CM; Clinical Chemistry & Toxicology Department, School of Pharmaceutical Sciences, University of São Paulo, Av. Professor Lineu Prestes, 580, Bloco 17, 05508-000 São Paulo, SP, Brazil., Pennacchi PC; Clinical Chemistry & Toxicology Department, School of Pharmaceutical Sciences, University of São Paulo, Av. Professor Lineu Prestes, 580, Bloco 17, 05508-000 São Paulo, SP, Brazil., Assis SR; Clinical Chemistry & Toxicology Department, School of Pharmaceutical Sciences, University of São Paulo, Av. Professor Lineu Prestes, 580, Bloco 17, 05508-000 São Paulo, SP, Brazil., Gimenes F; Department of Clinical Analysis and Biomedicine, State University of Maringá, Avenida Colombo, 5790, CEP, 87020-900 Maringá, Paraná, Brazil., Consolaro MEL; Department of Clinical Analysis and Biomedicine, State University of Maringá, Avenida Colombo, 5790, CEP, 87020-900 Maringá, Paraná, Brazil., Barros SBM; Clinical Chemistry & Toxicology Department, School of Pharmaceutical Sciences, University of São Paulo, Av. Professor Lineu Prestes, 580, Bloco 17, 05508-000 São Paulo, SP, Brazil., Maria-Engler SS; Clinical Chemistry & Toxicology Department, School of Pharmaceutical Sciences, University of São Paulo, Av. Professor Lineu Prestes, 580, Bloco 17, 05508-000 São Paulo, SP, Brazil. Electronic address: silvya@usp.br. |
| المصدر: | Toxicology in vitro : an international journal published in association with BIBRA [Toxicol In Vitro] 2017 Aug; Vol. 42, pp. 31-37. Date of Electronic Publication: 2017 Mar 23. |
| 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- |
| مواضيع طبية MeSH: | Models, Biological* , Skin Irritancy Tests*, Epidermis/*drug effects , Irritants/*toxicity, Animal Testing Alternatives ; Cell Survival/drug effects ; Cells, Cultured ; Epidermis/metabolism ; Humans ; Keratinocytes |
| مستخلص: | 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. (Copyright © 2017 Elsevier Ltd. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Irritation assays; New skin models; OECD; RHE |
| المشرفين على المادة: | 0 (Irritants) |
| تواريخ الأحداث: | Date Created: 20170328 Date Completed: 20180323 Latest Revision: 20180323 |
| رمز التحديث: | 20231215 |
| DOI: | 10.1016/j.tiv.2017.03.010 |
| PMID: | 28344105 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1879-3177 |
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| DOI: | 10.1016/j.tiv.2017.03.010 |