sentence: In the eye irritation study , no adverse effects were observed.Even though at the time of the first approval of the active substance , no conclusions on the infectivity of this microorganism could be directly drawn from the available evidence due to the intrinsical limitations in the studies ’ experimental design , the lack of any observed adverse effect in any acute toxicity study with Bacillus thuringiensis subsp. kurstaki strain PB 54 by any exposure route ( oral , intratracheal / inhalation and intraperitoneal ) was then considered per se sufficient to address this concern and complete the risk assessment ( EFSA , 2012 ) .