Development and implementation of alternative methods to the use of animals under good laboratory practice

• Grant number: 16/06985-7
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: May 01, 2017
• End date: September 30, 2019
• Field of knowledge: Biological Sciences - Biology
• Principal Investigator: Cynthia Bomfim Pestana
• Grantee: Cynthia Bomfim Pestana
• Company: ALS Laboratórios LS Ltda
• Associated research grant: 14/21499-6 - Development and implementation of alternative methods to the use of animals under good laboratory practice, AP.PIPE
• Associated scholarship(s): 19/07710-0 - Validation of an in-house model of in vitro Reconstituted human Epidermis (RhE) for evaluation of cutaneous irritation by OECD method 439, BP.TT; 17/20836-7 - Validation of fibroblast cytotoxicity test; validation of culture micronucleus test; and standardization of flow cytometry micronucleus test evaluation, BP.TT; 17/12506-7 - Validation of an in-house model of in vitro reconstituted human epidermis (RhE) for evaluation of cutaneous irritation by OECD method 439, BP.TT

Abstract

Tecam is a national contract laboratory performing tests for almost 25 years on toxicology, ecotoxicology, microbiology, molecular biology and physical chemistry fields. The laboratory is accredited under the Good Laboratory Practice (GLP) by INMETRO and by the National Council for Animal Experimentation (CONCEA). At Tecam, toxicological and ecotoxicological studies are carried out mostly in vivo to meet the regulatory requirements of national agencies as IBAMA, MAPA and ANVISA for pesticides, chemicals, cosmetics, medical devices, among others products. Reduction, refinement and replacement of animal models in the evaluation of compounds depend on the development and validation of alternative tests, as well as the acceptance by the regulatory agencies. In Brazil the regulatory framework has evolved considerably in recent years since 2008 when the Law 11794 established the procedures for the use of animals for scientific purposes and created the National Council for Control of Animal Experimentation (CONCEA), institution related to the Ministry of Science, Technology and Innovation (MCTI). In 2014 CONCEA published the Normative Resolutions 17 and 18 that recognized 17 validated alternative methods and established a deadline of 5 years to adopt them in the Brazilian laboratories. Acceptance of in vitro assays by the regulatory agencies depends on the performance of those methods under the Good Laboratory Practice (GLP). On 09/03/2014, ANVISA's board (Dicol) decided for the acceptance of these 17 alternative methods. On 05/10/2015, ANVISA published the new Public Consultation 87 in which alternative methods are mentioned for toxicological evaluation and classification of pesticides, as well as the obligation to conduct such methods in Good Laboratory Practice (GLP) recognized laboratories. Tecam is a GLP recognized laboratory since 2002 and since then has been conducting testing required by regulatory agencies, including 3 of the 17 alternative methods recommended by CONCEA. In Phase I of the present project, we proposed the implementation of 2 of the 17 alternative methods recommended by CONCEA : 1- Dermal Sensitization (OECD 442 ) and 2 - In vitro ocular irritation (OECD 437 ). These methods were properly developed and are being offered to the market, which shows the viability of the research proposed in Phase I. Also, in the former phase, a cell culture laboratory was established. In Phase II it is expected the use the cell culture laboratory structured in Phase I for development of three methods which completely replace the use of animals: 1- Cytotoxicity test; 2- In vitro micronucleus test and 3- Skin irritation test in vitro. These methods are listed in CONCEA resolutions and in ANVISA's public consultation for agrochemical registration. However, these methods are not yet commercially available in Brazil. The expansion of Tecam's activities to the in vitro methods is extremely important and urgent since these tests are not commercially available in Brazil. If there is no supply to this new demand in Brazil, the companies may contract studies from foreign laboratories, causing a strong impact to the national laboratories. We believe that Tecam as a center that generates research could be a player in this area of knowledge which today is restricted to the academia. (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)

GAGOSIAN, VIVIANA S. C.; CLARO, FRANCINE CECCON; SCHWARZER, ANA CAROLINA DE A. P.; CRUZ, JULIANA VARELLA; THA, EMANOELA L.; TRINDADE, EDVALDO DA S.; MAGALHAES, WASHINGTON L. E.; PESTANA, CYNTHIA B.; LEME, DANIELA M.. The potential use of kraft lignins as natural ingredients for cosmetics: Evaluating their photoprotective activity and skin irritation potential. International Journal of Biological Macromolecules, v. 222, p. 10-pg., 2022-12-01. (17/12506-7, 19/07710-0, 16/06985-7)