CORRELATIONS IN SILICO/IN VITRO/IN VIVO REGARDING DETERMINATING ACUTE TOXICITY IN NON-CLINICAL EXPERIMENTAL TRIAL, ACCORDING TO BIOETHIC REGULATIONS INFORCED BY THE EUROPEAN UNION

A non-clinical experimental trial on laboratory animals was conducted in order to determine the acute toxicity of 7 newly synthesized compounds (derivatives of beta phenyl-ethyl-amine) with potential antidiabetic/antiobesity effect. The trial objective was to reduce to minimum, according to European regulations, the number of laboratory animals employed in order to determine the lethal dose 50% (DL50). To this end, alternative methods of toxicity evaluation were used: in silico (QSAR method) and in vitro (plant cell inhibition), which were applied in consecutively performed in vivo trial (white male mice, NMRI strain). The research established a good correlation between the performed tests and may serve as a screening model for active substances with high biological potential. Rezumat A fost condus un studiu non-clinic, pentru determinarea toxicităţii acute la animale de laborator, pentru evaluarea a sapte compusi nou sintetizaţi (structură chimică de beta fenil etilamină), cu potenţial efect antidiabetic/antiobezitate. Obiectivul studiului a fost de a reduce la minim conform reglementărilor europene, numărul de animale de laborator necesar pentru determinarea dozei letale 50% (DL 50 ). In acest scop, am utilizat metode alternative de evaluare a toxicităţii: in silico (metoda QSAR) si in vitro (inhibiţie pe celula vegetală), pe care le-am utilizat ulterior in testul efectuat in vivo (soareci albi, masculi, susa NMRI). Cercetarea a stabilit o bună corelaţie intre testele utilizate, si poate servi ca model de screening si pentru alte substanţe active cu potenţial biologic ridicat.