Abstract

IN-SILICO PREDICTION, PRECLINICAL SAFETY AND TOXICITY EVALUATION OF ETHANOLIC EXTRACT OF DIMOCARPUS LONGAN LOUR FRUIT IN WISTAR RATS

Goutami G Kulkarni, Dr. A H M Viswanatha Swamy*, Khushi J Soni, Swathi D.S., Mallikarjun Hugar and Parvati Patil

ABSTRACT

Background: Dimocarpus longan Lour. (DLL) is a popular fruit commonly used in traditional medicine. However, the prolonged use of herbal products has raised concerns about possible organ toxicities. This study aimed to assess the safety profile of DLL ethanolic fruit extract through acute and sub-acute oral toxicity evaluations in Albino Wistar rats following OECD Guidelines 423 and 407. Methodology: For acute toxicity, a single oral dose of 2000 mg/kg of DLL extract was administered to female rats. For the sub-acute toxicity study, both male and female rats were orally dosed with 1000 mg/kg of the extract daily for 28 days. In-silico toxicity predictions were carried out using Protox 3.0. Pre-clinical observations, including Functional Observational Battery (FOB) assessments, were performed. Serum biochemistry, haematology, urine analysis, necropsy, and histopathology were also evaluated. Results: In-silico studies predicted various organ-related toxicities. However, in vivo acute and sub-acute toxicity evaluations revealed no mortality or significant behavioral changes in DLL-treated rats compared to controls. Acute toxicity showed only slight histological alterations with no notable serum or urine parameter changes. Sub-acute dosing resulted in moderate histopathological changes and minimal alterations in biochemical parameters. Conclusion: DLL extract at an acute oral dose of 2000 mg/kg appeared safe, with no major biochemical or neurological toxicity, placing it in GHS Category 5 with an LD₅₀ range of 2000–5000 mg/kg. However, sub-acute exposure at 1000 mg/kg over 28 days showed some organ-related stress, warranting caution with prolonged use.

Keywords: Dimocarpus longan Lour, acute toxicity and sub-acute toxicity, Functional Observational Battery test, Serum biochemical analysis, Histopathology.