Background: Trachyspermum ammi (Ajwain) is widely used in traditional medicine across South Asia and the Middle East; however, systematic toxicological evaluations remain limited. This study assessed the acute and sub-acute oral toxicity of T. ammi hydroalcoholic seed extract (TAHE) in Wistar rats, with emphasis on hepatic safety.
Methods: Acute toxicity was evaluated according to OECD Guideline 423 following a single oral dose of 2000 mg/kg in female rats (n=5). Subacute toxicity was assessed through repeated oral administration for 28 days at doses of 75, 150, and 300 mg/kg/day in male rats (n=10/group). Assessments included clinical observations, body weight changes, hematological and serum biochemical analyses, and histopathological examination of liver tissue.
Results: No mortality or treatment-related clinical signs occurred in either study. Body weight gain, food consumption, and hematological parameters remained comparable among the groups. Among the hepatic biomarkers, aspartate aminotransferase (AST) showed a statistically significant difference among groups (P=0.041); however, this difference was not maintained in post hoc pairwise comparisons with the control group (all P>0.55). Alanine aminotransferase (ALT), total bilirubin, albumin, and total protein remained unchanged. A dose-dependent increase in serum uric acid reached statistical significance at 300 mg/kg (P=0.009). Histopathological examination revealed preserved hepatic architecture, with no significant differences in congestion, hemorrhage, inflammatory infiltration, or degeneration scores (all P>0.35).
Conclusion: TAHE demonstrated a favorable safety profile, with an oral LD₅₀ exceeding 2000 mg/kg and a no-observed-adverse-effect level (NOAEL) of 150 mg/kg/day in the 28-day study. The isolated elevation in uric acid at the highest dose warrants monitoring in longer-duration studies.