Toxicology Reports · 7 authors, 4 centres
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This study evaluated the sub-acute oral toxicity of an aqueous leaf extract of Passiflora edulis f. edulis in Wistar rats at 1000 mg/kg/day for 28 days. No mortality or treatment-related clinical signs were observed, and the no-observed-adverse-effect level (NOAEL) was determined to be 1000 mg/kg/day. The findings support the traditional use of this extract as relatively safe, though slight hematological and histopathological changes warrant further investigation.
**Background:** Passiflora edulis Sims f. edulis (gulupa, purple passion fruit) is used in traditional medicine for its sedative, anxiolytic, anti-inflammatory, and antioxidant properties. Despite widespread use, systematic toxicity data are limited. This study aimed to evaluate the sub-acute oral toxicity of an aqueous leaf extract of Passiflora edulis f. edulis in Wistar rats, following OECD guideline 407, to support its safe use in traditional medicine.
**Methods:** Twenty Wistar rats (9 weeks old) were divided into two groups of ten (five males and five females each). The treatment group received 1000 mg/kg/day of the aqueous extract by oral gavage for 28 days; the control group received 0.5 ml of physiological saline. The extract was prepared by infusion (1:10 plant-to-water ratio) and lyophilized, with batch-to-batch consistency confirmed by UPLC-PDA and UHPLC-MS-QTOF. Clinical observations, body weight, and mortality were recorded. On day 29, blood was collected for hematological (erythrocyte count, leukocyte count, platelet count, hemoglobin, hematocrit) and biochemical (ALT, GGT, alkaline phosphatase, bilirubin, urea, creatinine, BUN, total protein) analyses. A complete necropsy was performed; organ weights were recorded, and liver and kidney samples were processed for histopathology (H&E staining). Statistical analysis used factorial ANOVA (p < 0.05).
**Key Results:** No mortality or treatment-related clinical signs were observed. Body weight gain was similar between groups, though male rats receiving the extract had lower initial body weights but greater weight gain (32.22%) compared to controls; these differences were not statistically significant. Organ weights showed no significant differences between groups. Hematological analysis revealed a significant decrease in monocyte and eosinophil counts in both male and female treated rats (p < 0.05). Biochemical analysis showed a significant increase in ALT levels in treated rats (males: 184.4 ± 271.9 U/L vs. control 50.25 ± 4.19 U/L; females: 328.0 ± 325.0 U/L vs. control 64.17 ± 10.15 U/L; p < 0.05). Other liver function markers (GGT, alkaline phosphatase, bilirubin) and kidney function markers (urea, creatinine, BUN, total protein) were not significantly different. Histopathological examination of the liver showed a slight periportal mono-morphonuclear infiltrate and increased hepatocyte binucleation in treated rats, but no necrosis or fatty accumulation. Kidney histology showed a slight generalized increase in intraglomerular mesangium and focal corticomedullary tubular nephrocalcifications in both control and treated groups.
**Clinical Implications:** The NOAEL for the aqueous extract of Passiflora edulis f. edulis in this sub-acute study was 1000 mg/kg/day. The extract was well tolerated with no mortality or major adverse effects. The observed increase in ALT without corresponding histopathological liver damage suggests a possible adaptive or non-toxic response, but further studies are needed to clarify this. The slight decreases in monocyte and eosinophil counts may indicate mild immunomodulatory effects. These findings support the relative safety of the extract at the tested dose, consistent with traditional use. However, chronic toxicity, genotoxicity, and carcinogenicity studies are recommended to fully establish its safety profile.