Jul 2026· Journal of Drug Delivery and Therapeutics· Vol 16, pp. 116-123· 0 citations· 30 references
TL;DR
The results indicate that the dry hydroethanolic extract of S. setigera leaves did not provoke adverse effects that can lead to death or internal histological lesions in Wistar rats after 28-day oral administration.
Abstract
Background: Sterculia setigera is a plant used in traditional medicine for many purposes. We previously reported that its dry hydroethanolic leaf extract (SSE) protected cerebellar granule neurons and PC12 cells against H₂O₂, 6-OHDA, and serum deprivation-induced cell death, and mitigated ethanol neurotoxicity in the cerebellar cortex of neonatal Wistar rats while preserving motor coordination. This study aims to establish the toxicological profile of Sterculia setigera leaves' hydroethanolic extract, using appropriate in vitro and in vivo models.
Methods : The brine shrimp (Artemia salina) lethality assay served as a cytotoxicity test (in vitro model). An acute oral toxicity test was conducted according to OECD TG 423 (2000 mg/kg). The repeated dose oral toxicity of 28 days was performed following the OECD TG 407 (100, 200, and 400 mg/kg) on Wistar rats.
Results: The 50% lethal concentration (LC50) was 1.84 mg/mL. Based on acute oral toxicity, the LD50 value of the extract was up to 2000 mg/kg of body weight. The 28-day repeated oral administration of Sterculia setigera leaves hydroethanolic extract did not provoke negative effects on rats, as they were safe based on body and organ weight, hematological, biochemical, and histopathological results.
Conclusion : These results indicate that the dry hydroethanolic extract of S. setigera leaves did not provoke adverse effects that can lead to death or internal histological lesions in Wistar rats after 28-day oral administration.
Keywords: Sterculia setigera; cytotoxicity; Artemia salina; toxicological profile
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