Introduction: Development of a new galenic form containing vegetables extracts for paediatric use could be a good therapeutic alternative to overcome chemoresistance and therapeutic failures observed with conventional antimalarial drugs. The aim of this work was to verify in laboratory rats, the toxicity of hydroethanolic extract from stem and leaf powder of A. annua (Asteraceae), in order to provide scientific evidence to support its use in rectal dosage forms preparation. Methodology: Acute toxicity assessment was possible by performing OECD Test Guideline 425, 2008 limit test in laboratory rats. Examination of spontaneous exploratory activities and motor coordination was respectively realized according to methods described by Colman, 2015 and Deacon, 2013. In addition, we monitored body weight changes, food and water consumption including the impact of extract on relative organs weight such as liver, kidney, lung and heart. Results: Single administration of A. annua stem and leaf extract at 5000mg/kg was not toxic in rats, even less to liver, kidney, lungs and heart functions. Elsewhere it was noted that consumption of A. annua extract significant increase curiosity and motor activity (number of lines crossed: 76.50 s ± 45.30; grasping time: 92.25 ± 38.85) compared to control (number of lines crossed: 54.00 ± 20.78 s; grasping time: 51.00 s ± 20.28). Conclusion: Extract of stems and leaves of A. annua at 5000mg/kg can be considered non-hazardous and non-toxic category 5 according to the Harmonised System of Classification of Toxic Substances.