ANMAT incorporates the OECD 236 test as an official method for toxicological evaluation
06/08/2025
The National Administration of Drugs, Food and Medical Technology (ANMAT) announced the official incorporation of the OECD 236 test , corresponding to the “Fish Embryo Acute Toxicity Test (FET Test)”, as a valid method for the toxicological evaluation of chemical substances, active ingredients and formulated products.
Microscopic view of zebrafish embryos in an acute toxicity assay.
This decision, which was formally adopted in June 2024 , marks an important step in the adoption of alternative methods to the use of adult animals, promoting more ethical and reproducible evaluations in line with the international principles of the 3Rs (Replacement, Reduction and Refinement).
The OECD 236 assay was developed by the Organization for Economic Cooperation and Development (OECD). Its model is highly sensitive, rapid, and avoids the use of adult fish, as embryos are not legally considered vertebrate animals in many legislations, including the European one.
Who is it aimed at?
The implementation of this trial by ANMAT is aimed at:
Quality control and toxicology laboratories
Pharmaceutical, cosmetic and agrochemical companies
Researchers and scientific institutions
Regulatory authorities and risk assessment bodies
Furthermore, this advancement promotes harmonization with international standards required by organizations such as the OECD, the EMA, and the FDA, facilitating the expansion of Argentine products into global markets.
Zebrafish embryo.
The adoption of OECD 236 reinforces ANMAT’s commitment to evidence-based regulatory science and the progressive implementation of technologies that respect animal welfare without compromising the safety or quality of the products evaluated.
