Safety evaluation of kaempferol glycosides-rich standardized roasted goji berry leaf extract

• Published in: Regulatory toxicology and pharmacology 2023-05, Vol.140, p.105382-105382, Article 105382
• Main Authors: Lee, Hyun Jeong, Lee, Somin, Ryu, Hyeon Yeol, Shim, Soon-Mi
• Format: Article
• Language: English
• Subjects: Animals; Chromosome Aberrations; Cricetinae; Cricetulus; Genotoxicity; Glucosides - toxicity; Glycosides - toxicity; Goji berry leaf; Kaempferol glycoside; Kaempferols - toxicity; Lycium; Mutagenicity Tests - methods; Oral acute toxicity; Plant Extracts - toxicity; Repeated dose toxicity; Stability
• ISSN: 0273-2300; 1096-0295
• DOI: 10.1016/j.yrtph.2023.105382

Goji berry leaf (GL) has been used for medicinal foods for its pharmacological effects, including anti-oxidative and anti-obesity activities. Nevertheless, toxicological information on GL is limited for developing health functional ingredient. The aim of the research was to evaluate the single dose acute, 14-day repeated oral toxicity, and genotoxicity of standardized roasted GL extract (rGL) rich in kaempferol-3-O-sophoroside-7-O-glucoside. Tested rGL was found to be stable as kaempferol-3-O-sophoroside-7-O-glucoside, showing 0.7–2.1% of analytical standard variance. According to the single dose toxicity for 14 days, the lethal dose of rGL was determined to be ≥ 2000 mg/kg. Repeated doses of 0–1000 mg/kg of rGL per day for 14 days did not show any toxicity signs or gross pathological abnormalities. No genotoxic signs for the rGL treatment appeared via bacterial reverse mutation up to 5000 μg/plate. There was no significant increase in chromosomal aberration of rGL irrespective of metabolic activation by using CHO–K1 cells (p > 0.05). Regarding carcinogenic toxicity, chromosomal aberrations were not induced at 2000 mg of rGL/kg by using the in vivo bone marrow micronucleus test (p > 0.05). Results from the current study suggest that rGL could be used as a functional ingredient to provide various effects with safety assurance. [Display omitted] •Genotoxic potential of rGL intended to use in functional foods was investigated.•rGL does not appear to have any toxicity in acute and repeated toxicity studies.•rGL, up to 5000 μg/plate, did not produce mutagenic in the Ames test.•rGL, up to 1667 μg/mL, did not induce chromosome aberration on CHO–K1 cells.•rGL, up to 2000 mg/kg, did not form micronucleus in the bone marrow.