Toxicology Reports · 7 authors, 4 centres
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A 28-day sub-acute oral toxicity study of an aqueous Passiflora edulis f. edulis leaf extract was conducted in Wistar rats at a single high dose of 1000 mg/kg/day. The extract did not cause lethality, morbidity, or clinically significant organ toxicity, establishing a NOAEL of 1000 mg/kg/day.
This preclinical study evaluated the sub-acute oral toxicity of an aqueous leaf extract from Passiflora edulis Sims f. edulis (Gulupa) in Wistar rats over 28 days at 1000 mg/kg/day, selected based on prior acute toxicity data showing safety at 2000 mg/kg in mice. No mortality, morbidity, or adverse clinical signs were observed. Weight gain occurred throughout the study, and no changes in relative organ weights were found. Serum ALT was elevated in extract-treated rats (184 U/L in males, 328 U/L in females) compared to controls (50.25 U/L and 64.17 U/L, respectively), but liver histopathology showed only slight monomorphonuclear infiltrate without correlating cellular damage. No significant alterations were found in GGT, FA, total protein, total bilirubin, urea, creatinine, or BUN levels. Histological examination of kidneys and liver showed only minor changes not considered toxicologically significant. Significant differences in leukocyte profiles were noted but were attributed to high data variability.
