Oral and Dermal Toxicity Profiling of Ethyl Acetate Fraction of Pterospermum lanceifolium Roxb. Leaf in Experimental Rats

Abstract

The species of the Pterospermum genus have been traditionally used to cure inflammation, blood troubles, leprosy, tumors, hemostatic, ear pain, stomachache, smallpox, leucorrhea, and ulcer. Despite its historical and widespread use, there is a significant gap in our understanding of the plant's toxicological profile. As such, this study aims to comprehensively evaluate the acute, sub-acute, and cutaneous toxicity assessments of the ethyl acetate fraction of P. lanceifolium (EAPL) leaf in experimental rats. The present study involved an array of toxicity assessments, including an acute oral toxicity study by administering a single dose of 2000 mg/kg EAPL to rats as per OECD guidelines no- 423. Additionally, a 28-day sub-acute toxicity trial was conducted by administering daily doses of EAPL at 200 and 400 mg/kg p.o. as per OECD 407. To assess cutaneous toxicity, rats were exposed to topically applied concentrations of 1% and 5% EAPL over a fourteen-day period, as per OECD 402. Acute oral toxicity testing revealed no lethal effects or behavioral indicators of toxicity at the tested doses, indicating that the LD50 should be greater than 2000 mg/kg. The sub-acute study demonstrated a EAPL at 200, 400 mg/kg did not impart any significant change in any parameter. Notably, acute dermal toxicity analysis indicated no mortality in rats and no significant change in biochemical parameter when exposed to 1% and 5% EAPL. This study establishes that the oral LD₅₀ (lethal dose, 50%) of the EAPL exceeds 2000 mg/kg. The findings further potentiate the safety of EAPL at the tested ethno-medicinal doses and further pave the path for its potential use in traditional and modern therapeutic applications.