Acute and Subchronic Toxicity Study of Flavonoid Rich Extract of Glycyrrhiza glabra (GutGard®) in Sprague Dawley Rats

Abstract

Glycyrrhiza glabra (G. glabra) is well known for its health benefits based on the traditional and current scientific evidence. The aim of the present study was to evaluate the safety of GutGard, a standardised-flavonoid rich extract of G. glabra. The study was designed to evaluate the acute and subchronic oral toxicity of GutGard in Sprague Dawley rats according to the procedures and methods of Organisation for Economic Cooperation and Development (OECD) test guidelines for acute and subchronic toxicity. A single dose of GutGard at 5000 mg/kg body weight did not produce treatment related clinical signs of toxicity or mortality in any of the animals tested during the 14-day observation period. Therefore, the median lethal dose was estimated to be more than 5000 mg/kg. A subchronic oral toxicity study for 90 days in rats at the dose levels of 250, 500, and 1000 mg/kg did not show any treatment related adverse clinical signs. The treated animals exhibited normal weight gain and comparable feed intake. Ophthalmoscope examination did not reveal any abnormalities. Further, GutGard administration in rats did not show any clinical evidence of toxicity with respect to urinalysis, haematology, and blood chemistry parameters. The relative organ weight of vital organs did not differ significantly as compared to control. Gross and histopathological findings did not show any remarkable and treatment related changes. Based on the current experimental study findings, the median lethal dose (LD50) of GutGard was found to be >5000 mg/kg b.wt and the no observed adverse effect level (NOAEL) was found to be 1000 mg/kg rat b.wt.

The Repeated Dose 28-Day Oral Toxicity Study of Combined Extract of Cajanus cajan Leaf and Zingiber officinale Rhizome in Male and Female Sprague-Dawley Rats

“…18 Hence, these changes in hematological parameters were considered biologically insignificant and incidental. 21 So, the administration of the combined extract of C. cajan and Z. officinale for 28-day treatment did not change the hematological parameter in male and female rats. In previous results, 28-day exposure to C. cajan did not change hematological parameters in male and female rats.…”

“…So, these findings supported that the significant changes in ALT, AST and triglyceride were considered biologically insignificant and incidental (Table 5). 21 The liver plays regulation and metabolism of total cholesterol and triglycerides. The high total cholesterol and triglycerides increased lipid deposition in the hepatic cytoplasm.…”

Acute and sub-chronic toxicity of Liberin, an anti-diabetic polyherbal formulation in rats

“…Since G. glabra has no biologically meaningful toxicity after a single oral treatment to female Sprague Dawley rats, the median fatal dose of the plant can be estimated to be > 5000 mg/kg body weight. Further, it has been demonstrated that the component is safe after 90 days of continuous oral administration at tested doses, including the maximum dose of 1000 mg/kg body weight in rats [ 36 ].…”

Medicinal plants utilized in the management of epilepsy in Ethiopia: ethnobotany, pharmacology and phytochemistry

“…Acute toxicity studies provide preliminary data about the safety profiles of a single dose of chemical agents [ 225 ], consequently, it is considered as shallow and sometimes misleading. Better information about the safety of chemicals of synthetic and natural origin can be obtained from the subacute toxicity studies, which involve repeated administration of the chemical agent under consideration.…”