Abstract
Aster glehni, a traditional plant on Ulleung Island in the Republic of Korea, has been recognized for its multiple medicinal properties. However, potential toxicity and safety analyses of A. glehni have not been previously investigated. Therefore, this study aimed to evaluate the safety profile of ethanolic extract of A. glehni leaves and stems (EAG) in terms of genotoxicity and subchronic oral animal toxicity under OECD guidelines and GLP conditions. Toxicological assessments were performed at doses of 1,250, 2,500, and 5,000 mg/kg/day in a 13-week oral repeated-dose toxicity study of EAG in male and female SD rats. In addition, an Ames test, an in vitro mammalian chromosomal aberration test, and a micronucleus test were performed. No toxicological changes in clinical signs, body weights, water and food consumption, urinalysis, hematology, clinical biochemistry, gross findings, and histopathological examinations were observed in subchronic oral animal toxicity. In addition, EAG gave negative results when evaluated using in vitro and in vivo genotoxicity tests. In conclusion, the no-observed-adverse-effect level (NOAEL) of EAG was considered to be 5,000 mg/kg/day, and no target organs were identified in both sexes of rats. EAG was also classified as nonmutagenic and nonclastogenic in genotoxicity testing. Collectively, these results show a lack of general toxicity and genotoxicity for EAG that supports clinical work for development as a herbal medicine.
Highlights
Medicinal plants have been used traditionally therapeutic agents, but recently, they have seen more and more as substitutes for chemical agents with side effects or drug resistance [1, 2]
The final A. glehni extract was standardized by 3,5dicaffeoylquinic acid (3,5-DCQA) based on high-performance liquid chromatography (HPLC) at 330 nm. e content of the marker compound (3,5-DCQA) in the extract of A. glehni (EAG) was 2.37 mg/g. e results of the amino acid composition analysis are shown in Table 1. e total protein content in EAG was 1,759.84 mg/100 g
One mouse at 500 mg/kg/day died after the first administration, but it was not considered to be EAG-related, and there were no noticeable macroscopic signs in all other survivors that could be attributed to EAG. ere was no statistically significant increase or a dose-related increase in the frequencies of Micronucleated polychromatic erythrocytes (MNPCE) at any dose level of EAG compared to the negative control (Table 8). e polychromatic erythrocytes (PCE):RBC ratio showed no difference at any dose level of EAG
Summary
Medicinal plants have been used traditionally therapeutic agents, but recently, they have seen more and more as substitutes for chemical agents with side effects or drug resistance [1, 2]. Herbal medicine derived from medicinal plants often has anti-oxidant, anti-microbial, and anti-inflammatory properties so they may provide potential options for the treatment of diseases such as COVID-19 that yet has no approved drug [3,4,5,6,7]. In a Korean traditional medical encyclopedia known as Dongui Bogam, it is described that A. glehni has anti-pyretic and analgesic effects and suppresses phlegm and coughing [17]. It has been reported that ethanolic extract of A. glehni shows antiadipogenic, hypouricemic, and anti-inflammatory effects [18,19,20]
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