Alternative methods in toxicology: pre-validated and validated methods

Abstract

The development of alternative methods to animal experimentation has progressed rapidly over the last 20 years. Today, in vitro and in silico methods have an important role in the hazard identification and assessment of toxicology profile of compounds. Advanced alternative methods and their combinations are also used for safety assessment of final products. Several alternative methods, which were scientifically validated and accepted by competent regulatory bodies, can be used for regulatory toxicology purposes, thus reducing or fully replacing living animals in toxicology experimentation. The acceptance of the alternative methods as valuable tools of modern toxicology has been recognized by regulators, including OECD, FDA and EPA.This paper provides a brief overview of the topic “alternative methods in toxicology” and focuses on pre-validated and validated alternative methods and their position in the modern toxicology.

Regulatory toxicology in the twenty-first century: challenges, perspectives and possible solutions

“…Consequently, most of these tests were never validated. Meanwhile, validation is an indispensable requirement for any new test system, not the least as to warrant regulatory acceptance and the necessary legal certainty (Balls 1995;Garthoff 1995;Kandárová and Letašiová 2011). Nevertheless, the choice of commonly accepted standards for validation remains a problem.…”

“…OECD TG 405,420,423,425,436 and 443). However, some of the implemented test guidelines, including cellular assays, actually do replace animal experiments (Kandárová and Letašiová 2011;Liebsch et al 2011). They can be subdivided into three main categories:…”

Animal use for science in Europe

“…At present, safety testing plays a strong role, but also scientists and organizations interested in efficacy testing and broad biomedical research are involved. With all the past success of 3Rs in the field of safety testing (Kandarova and Letasiova, 2011;Bouvier d'Yvoire et al, 2012;Leist et al, 2012a) it is important that the experience gained there is leveraged to the basic research and R&D field. Over nine million animals are used there per year, and very few coordinated research activities are ongoing to reduce this number.…”

Kozmetik Ürünlerin Fototoksik Etkileri: Mekanizması ve Alternatif Test Metotları

“…Bu in vivo testler bahsedildiği gibi hayvan refahı ve etiksel açıdan pek çok sorun teşkil etmektedir. Hayvan kullanılmayan fototoksisite testleri bu sorunların üstesinden gelmek açısından oldukça önem taşımaktadır (40,41). …”