Six months chronic toxicological evaluation of naringin in Sprague-Dawley rats.
Naringin is a flavonoid showing variable pharmacological properties and is distributed ubiquitously in plant foods. There is a paucity of reported data regarding its safety profile. In the present study, chronic toxicity studies of naringin was designed and conducted by oral gavage at doses of 0, 50, 250 and 1250 mg/kg in Sprague-Dawley (SD) rats for six months followed by 1-month recovery period. During the 6-month treatment period and one month recovery period, no mortality and toxicologically significant changes in clinical signs, opthalmoscopic examination, hematology, clinical biochemistry, serumsexhormone, macroscopic findings, organ weights and histopathological examination were noted and attributed to naringin administration. Although consecutive and/or isolated periods of significant body weights and food consumption decreases were relevant to naringin administration, they were not considered toxicologically significant. In addition, slight, non-pathological and reversible hair loss was noted during the 6-month treatment period and considered as a kind of change possibly relevant to naringin administration; however, it was not considered adverse change and to be of toxicological significance. Based on the results of this study, the no-observed-adverse-effect-level (NOAEL) of naringin in rats is greater than 1250 mg/kg/day when administered orally for 6 consecutive months.
Guangdong Key Laboratory of Plant Resources, Guangzhou Quality R&D Center of Traditional Chinese Medicine, School of Life Sciences, Sun Yat-sen University, Guangzhou 510275, PR China.
Peibo
P
Li
Guangdong Key Laboratory of Plant Resources, Guangzhou Quality R&D Center of Traditional Chinese Medicine, School of Life Sciences, Sun Yat-sen University, Guangzhou 510275, PR China.
Sheng
S
Wang
National Chengdu Center for Safety Evaluation of Drugs, Chengdu 610041, PR China.
Xiaolin
X
Guan
National Chengdu Center for Safety Evaluation of Drugs, Chengdu 610041, PR China.
Xiaobo
X
Cen
National Chengdu Center for Safety Evaluation of Drugs, Chengdu 610041, PR China.
Chunyan
C
Hu
Guangdong Key Laboratory of Plant Resources, Guangzhou Quality R&D Center of Traditional Chinese Medicine, School of Life Sciences, Sun Yat-sen University, Guangzhou 510275, PR China.
Wei
W
Peng
Guangdong Key Laboratory of Plant Resources, Guangzhou Quality R&D Center of Traditional Chinese Medicine, School of Life Sciences, Sun Yat-sen University, Guangzhou 510275, PR China. Electronic address: kforest@163.com.
Yonggang
Y
Wang
Guangdong Key Laboratory of Plant Resources, Guangzhou Quality R&D Center of Traditional Chinese Medicine, School of Life Sciences, Sun Yat-sen University, Guangzhou 510275, PR China. Electronic address: lsssww@126.com.
Weiwei
W
Su
D000284:Administration, Oral; D000818:Animals; D001835:Body Weight / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D005247:Feeding Behavior / Q000187:drug effects; D005260:Female; D044950:Flavanones / Q000008:administration & dosage / Q000633:toxicity*; D012739:Gonadal Steroid Hormones / Q000097:blood; D008297:Male; D009929:Organ Size / Q000187:drug effects; D051381:Rats; D017207:Rats, Sprague-Dawley; D036401:Toxicity Tests, Chronic
D044950:Flavanones; D012739:Gonadal Steroid Hormones; C005274:naringin
Chronic toxicological evaluation; Naringin; Six months; Sprague–Dawley rats