Genotoxicity and acute and subchronic toxicity studies of a standardized methanolic extract of Ficus deltoidea leaves

Abstract

OBJECTIVE:Ficus deltoidea leaves have been used in traditional medicine in Southeast Asia to treat diabetes, inflammation, diarrhea, and infections. The present study was conducted to assess the genotoxicity and acute and subchronic toxicity of a standardized methanol extract of F. deltoidea leaves.METHODS:Sprague Dawley rats were orally treated with five different single doses of the extract and screened for signs of toxicity for two weeks after administration. In the subchronic study, three different doses of the extract were administered for 28 days. Mortality, clinical signs, body weight changes, hematological and biochemical parameters, gross findings, organ weights, and histological parameters were monitored during the study. Genotoxicity was assessed using the Ames test with the TA98 and TA100 Salmonella typhimurium strains. Phytochemical standardization was performed using a colorimeter and high-performance liquid chromatography. Heavy metal detection was performed using an atomic absorption spectrometer.RESULTS:The acute toxicity study showed that the LD50 of the extract was greater than 5000 mg/kg. In the subchronic toxicity study, there were no significant adverse effects on food consumption, body weight, organ weights, mortality, clinical chemistry, hematology, gross pathology, or histopathology. However, a dose-dependent increase in the serum urea level was observed. The Ames test revealed that the extract did not have any potential to induce gene mutations in S. typhimurium, either in the presence or absence of S9 activation. Phytochemical analysis of the extract revealed high contents of phenolics, flavonoids, and tannins. High-performance liquid chromatography analysis revealed high levels of vitexin and isovitexin in the extract, and the levels of heavy metals were below the toxic levels.CONCLUSION:The no-observed adverse effect level of F. deltoidea in rats was determined to be 2500 mg/kg.

Acute and subacute (28 days) oral toxicity assessment of the oil extracted from Acrocomia aculeata pulp in rats

“…However, toxicological studies are required to determine the toxicity and thus establish criteria for the selection of a safe dose (Berenguer-Rivas et al, 2013;Farsi et al, 2013). The present study may represent the first study that demonstrates the absence of toxicity of the oil extracted from the pulp of A. aculeata, which can contribute to the safe use of this species.…”

Assessment of the cytotoxic, genotoxic, and mutagenic potential of Acrocomia aculeata in rats

“…Recently, the number of studies of plant extracts and their biological activities in humans and animals has increased (Farsi et al, 2013). However, the pharmacological studies reported have not been sufficient to validate the effects of these plant compounds on whole organisms (Reyes-García, 2010).…”

The phytochemical and anti‐inflammatory studies of Dillenia suffruticosa leaves

“…A 50 mg/kg pharmacological dose of betulinic acid was 20‐fold lower than the 1,000 mg AOT dose reported to be nontoxic (Jain et al, ). Hitherto, no AOT study for koetjapic acid has been documented for comparison at 50 mg/kg, kaempferol was 200‐fold less than the 10,000 mg/kg dose reported (Shih et al, ), vitexin was 100‐fold less than the 5,000 mg/kg tested (Farsi et al, ), and tiliroside was 20‐fold less than the 1,000 mg/kg tested (Nagatomo et al, ) for AOT studies where the doses tested were nontoxic. The above evidences therefore confirmed the safety of the doses for pharmacological studies of the isolated phytoconstituents in D .…”