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

Grant number: 14/21499-6
Support type:Research Grants - Innovative Research in Small Business - PIPE
Duration: October 01, 2015 - March 31, 2016
Field of knowledge:Biological Sciences - Biology
Principal Investigator:Cynthia Bomfim Pestana
Grantee:Cynthia Bomfim Pestana
Company:TECAM Tecnologia Ambiental São Roque Ltda
City: São Roque
Associated grant(s):16/06985-7 - Development and implementation of alternative methods to the use of animals under good laboratory practice, AP.PIPE

Abstract

Tecam is a contract laboratory committed to providing good quality and reliable data on biological and chemical fields. Performing tests since 1992, Tecam has more than 22 years’ experience in conducting toxicological and ecotoxicological studies under GLP for submission to regulatory agencies. The laboratory is accredited under the Good Laboratory Practice (GLP) by INMETRO, by the National Council for Animal Experimentation (CONCEA) and associated to the National Net of Alternative Methods (Renama). Toxicological and ecotoxicological studies are carried out to meet the requirements of national agencies as IBAMA, MAP and ANVISA for regulatory purposes 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 of the acceptance of the regulatory agencies. Efforts in this direction began in 1991 in the European countries, when the European Centre of Validation of Alternative Methods (ECVAM) was created. In 1997, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) was created in the United States. In Brazil the first law concerning animal welfare was published in 2008 (Law 11.794) and created CONCEA, National Council for Animal Experimentation. This council has the responsibility of establishing guidelines for animal experimentation, as well as monitoring and evaluating the introduction of alternative techniques in replacement to animals, when there is such an alternative. In 2012, Renama was created to promote the development, validation and certification of alternative methods to the use of animals according to the OECD. In 2014, two resolutions have been published by CONCEA to recommend 17 alternative methods and to establish a deadline of 5 years to adopt them in the Brazilian laboratories. Acceptance of the in vitro assays by the regulatory agencies depends on the performance of those methods under the Good Laboratory Practice (GLP) to be able to guarantee the traceability and reliability of data. Tecam Laboratories offers 3 of the 17 alternative methods recommended by the CONCEA: OECD 420, 423 and 425. The Ames test which is another in vitro genotoxicity assay is also established in our laboratory.Tecam Laboratories needs to adjust to the international trends by replacing the use of animals for alternative methods when possible. Therefore, the aim of this project is to enable the company to establish the alternative methods in order to: 1 - refine or replace the traditional methods currently used, fulfilling CONCEA's guidelines; 2 - offer studies according the Good Laboratory Practice (GLP) to the market and 3 - prevent the companies to contract alternative tests in other countries due to under qualification of national laboratories. Phase I of the project consists of establishing a cell culture laboratory, as well as qualify and prepare the staff on basic techniques of cellular culture. This is necessary, as cultivated cells are the base of most alternative methods. At the same time, we intend to establish two alternative methods listed by the CONCEA: 1- Dermal sensitization according to the guideline OECD 442 and 2 - Eye Irritation in vitro according to the guideline OECD 437. (AU)