EPISKIN engagement to support Brazil move to alternative methods



In Brazil, the creation in 2008 of the National Council for the Control of Animal Experimentation (CONCEA) is the starting point of an active policy for reducing animal experimentation.

In 2014 (resolution No. 18/2014)1 then in 2016 (resolution No. 31/201)2 CONCEA listed 24 OECD test guidelines for 7 toxicological endpoints and established a five year transition period before mandatory used of these alternative methods in replacement or refinement of existing animal methods. From the 24 OECD TGs listed, 14 are in vitro methods, such as the OECD TG439 for skin irritation with reconstructed human epidermis (RhE) and the OECD TG492 for eye irritation with reconstructed human cornea (RhCE). The deadline for the use of the first one was September 2019 and will be August 2021 for the second one. In the Brazilian legislation, replacement is generally based on the toxicological endpoint rather than the category of product. This situation explains the huge demand in training from several industries, cosmetics, pesticide, chemical or medical device.

As early as 2017, EPISKIN Academy organized, in partnership with the Instituto Nacional de Metrologia (INMETRO), the first training to OECD 439 for skin irritation with the SkinEthicTM RHE models3.

(Click picture to start watching EPISKIN Training session in Brazil)

In 2019, with the opening of our Brazilian subsidiary hosted by L'Oreal R&I laboratories in Rio de Janeiro, EPISKIN's reconstructed human skin models and all associated safety methods are now available to the Brazilian and Latin American scientific community for product testing purposes.

In the framework of our partnership with INMETRO and to meet the market needs for the 2021 deadline, EPISKIN Academy trained in February 2020, 20 scientists to the OECD TG492 for eye irritation on SkinEthicTM HCE model. The one-week workshop allowed all the participants to have an overview of the regulatory context, the existing validated methods and the way to combine them through top-down and bottom-up approaches as recommended in the OECD IATA for eye irritation. This theoretical lessons were completed by handling session in INMETRO laboratory on the SkinEthicTM HCE model for liquids and solids protocols. Each trainee performed all steps of the protocol to analyze in real situation unknown chemicals in comparison to positive and negative controls. Thanks to Msc Marian de Aguilera from ALS Laboratorios they were also trained in the OECD TG 437 (Bovine Cornea Permeability and Opacity Test).

Given the success of this teaching and the continuous demand for training, EPISKIN Academy will continue its partnership with INMETRO and its collaboration with PReMASUL to support the development of these alternative methods throughout South America countries.

Thanks to our presence in three major continents, Europe, Asia and America and to our commitment for development of non-animal methods EPISKIN Academy is actively participating to a global change toward replacement of animal in toxicology.



1 https://translate.google.com/translate?sl=auto&tl=en&u=http%3A%2F%2Fwww.lex.com.br%2Flegis_26001436_RESOLUCAO_NORMATIVA_N_18_DE_24_DE_SETEMBRO_DE_2014.aspx

2 https://translate.google.com/translate?sl=auto&tl=en&u=https%3A%2F%2Fwww.legisweb.com.br%2Flegislacao%2F%3Fid%3D327623

3 https://www.youtube.com/watch?v=_daWZdYxh6Q&t=35s