Recientes avances en la validación y aceptación de métodos alternativos in vivo e in vitro

Zusammenfassung

Experimental alternative methods include any procedure that replaces the use of animals, that reduces the need for animals in a particular test, or that refines a technique in order to reduce the amount of suffering endured by the animal. To be used in the toxicity tests required for the register prior to the commercialization, transportation and use of a new chemical compound, it is necessary to the experimental procedure to be accepted by regulatory authorities. Thus, after its development, the method has to fulfil the phases of prevalidation (previous interlaboratory assessment), validation of its reproducibility and relevance to in vivo toxicity (final interlaboratory assessment), the independent assessment of the study by a panel of experts and the progression toward regulatory acceptance. Things have been happening quickly in this area since 1990. The acceptance by international regulatory authorities of the fixed dose procedure in vivo as alternative to the classical assay of determination of the acute toxicity by the mean lethal dose (LD50), the establishment of the European Centre for the Validation of Alternative Methods (ECVAM) and the ban of the testing of cosmetics on animals from 1998 by the European Union are key points on the promotion of the validation and acceptance of in vivo and in vitro alternative methods.