Acute and subacute oral toxicity of Stachys schtschegleevii extract in rats: Safety evaluation of a traditionally used medicinal plant.

ETHNOPHARMACOLOGICAL RELEVANCE: Stachys schtschegleevii Sosn. (Lamiaceae) is used in Persian traditional medicine for its anti-inflammatory, antimicrobial, and neuroprotective properties. Despite its therapeutic potential, toxicological data supporting its safe use are lacking.

AIM OF THE STUDY: To evaluate the acute and subacute oral toxicity of a hydroalcoholic extract of S. schtschegleevii in rats as a preclinical safety assessment.

MATERIALS AND

METHODS

Aerial parts were collected, authenticated, and extracted with 70 % ethanol. Acute oral toxicity was evaluated in rats following OECD guideline 423 (limit dose 5000 mg/kg). Subacute toxicity was studied according to OECD 407, with daily oral gavage of 0, 625, 1250, or 2500 mg/kg for 28 days. Hematological, biochemical, oxidative stress markers, and histopathology of major organs were assessed.

RESULTS

The extract showed no mortality or clinical signs at 5000 mg/kg (LD50 ≥ 5000 mg/kg). In the 28-day study, dose-related changes included elevated serum urea, decreased alanine aminotransferase activity, dose-dependent hypo/hyperglycemia, and increased oxidative stress markers. Histopathology revealed only mild, non-progressive hepatic and renal alterations.

CONCLUSION

The findings indicate that S. schtschegleevii extract exhibits a low toxicity profile in acute exposure and produces only mild alterations at high repeated doses, supporting its relative safety in traditional use. These results provide essential preclinical evidence for the safe ethnopharmacological application of this plant and suggest that further chronic toxicity studies are warranted.