Background: Lycopene is a terpene compound that has pharmacology affect an antioxidant, antidiabetic, and anticancer. Lycopene is abundant in tomatoes. In addition to the benefits test, it is crucial to conduct a safety test. Objective: This study aimed to assess the acute safety effect of purified tomato extract (PTE) in Wistar female rats.

Materials and Methods: PTE was obtained by extracted it using n-hexane: acetone: ethanol = 2: 1: 1. Most of the solvent in the extract was evaporated so that a thick extract was obtained. Rats divided into two groups: normal control and PTE 750 mg/kg BW. Rats observed for seven days include body weight, physiological conditions (feces, activity, tremor, coma), and death. Bodyweight of normal control and PTE were analyzed by SPSS statistics.

Results: Observation of acute toxicity tests carried out every day for seven days according to BPOM regulations. There were no significant differences between body weight of normal control and PTE, which were 182.85 ± 6.36 g and 184.28 ± 6.72 g. Physiological conditions of normal control and PTE were the same, which is: stool was normal, activity was regular, no tremor and no coma. No deaths occurred in the PTE group. This result shows that the administration of PTE is safe and that no solvents remain in the extract.

Conclusion: The administration of PTE 750 mg/kg BB in female rats of the Wistar strain was declared safe because it did not cause physiological changes and death

Key words: lycopene from tomato, acute toxicity study, purified tomato extract (PTE), safety, tomato