Standardization of ex vivo human skin model for alternative assays in assessing the potential for skin irritation and corrosion

• Grant number: 17/15935-6
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: October 01, 2018
• End date: June 30, 2019
• Field of knowledge: Health Sciences - Pharmacy
• Principal Investigator: Samara Eberlin
• Grantee: Samara Eberlin
• Company: Kosmoscience Consultoria e Assessoria Técnica em Cosméticos Ltda (KosmoScience)
• CNAE: Pesquisa e desenvolvimento experimental em ciências físicas e naturais
• City: Valinhos

Abstract

The development of alternative approaches for safety and efficacy assays of products intended for human use that avoid animal use is a worldwide trend that directly reflects on the improvement of models and tools that more closely reflect human biology. The Brazilian commitment to the implementation and validation of these alternative methods resulted, in 2012, in the creation of the Rede Nacional de Métodos Alternativos and the Centro Brasileiro de Validação de Métodos Alternativos. Thus, it was established that until the year 2019 animals used for studies of skin irritation and corrosion should be completely replaced by their respective alternative methods (OECD TG 439 and OECD TG 431). For both methods, commercially available equivalent skin models are validated, but their acquisition in Brazil is unfeasible due to the long time in the import process and short time of tissue viability. Currently one of these models is produced in Brazil, but cannot be marketed due to legal limitations. In this sense, our work consists in the standardization of a test system using ex vivo skin fragments from elective plastic surgery, with high reproducibility, which, in the future, can be validated for alternative skin irritation and corrosion assays, being a reliable to the biological mechanisms of human skin when compared to the reconstructed skin, and at the same time is in line with the non-use of animals in research. In addition, the TG 431 and TG 439 tests will be carried out using four products recommended by the OECD. (AU)

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

EBERLIN, SAMARA; DA SILVA, MICHELLE SABRINA; FACCHINI, GUSTAVO; DA SILVA, GUSTAVO HENRIQUE; TABARINI ALVES PINHEIRO, ANA LUCIA; EBERLIN, SAMIR; PINHEIRO, ADRIANO DA SILVA. The Ex Vivo Skin Model as an Alternative Tool for the Efficacy and Safety Evaluation of Topical Products. ATLA-ALTERNATIVES TO LABORATORY ANIMALS, v. 48, n. 1, p. 10-22, JAN 2020. (17/15935-6, 15/08598-8)

EBERLIN, SAMARA; FACCHINI, GUSTAVO; DA SILVA, GUSTAVO HENRIQUE; EBERLIN, SAMIR; BRAGATTO, ALINE RODRIGUES; TABARINI ALVES PINHEIRO, ANA LUCIA; PINHEIRO, ADRIANO DA SILVA. Ex Vivo Human Skin: An Alternative Test System for Skin Irritation and Corrosion Assays. ATLA-ALTERNATIVES TO LABORATORY ANIMALS, v. 49, n. 4, p. 137-146, JUL 2021. (17/15935-6)