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Toxicological evaluation of naringin: Acute, subchronic, and chronic toxicity in Beagle dogs.
Regulatory Toxicology and Pharmacology ( IF 3.4 ) Pub Date : 2020-01-16 , DOI: 10.1016/j.yrtph.2020.104580
Peibo Li 1 , Hao Wu 1 , Yonggang Wang 1 , Wei Peng 1 , Weiwei Su 1
Affiliation  

Naringin is a type of bioflavonoid widely found in a lot of dietary products. Our previous studies revealed that naringin was practically non-toxic for SD rats in an oral acute toxicity study and the no-observed-adverse-effect-level (NOAEL) in SD rats was greater than 1250 mg/kg/day when administered by oral gavage for 13 consecutive weeks or 6 consecutive months. Herein we assessed the safety of naringin in Beagle dogs. Acute oral administration of naringin was done as a single bolus dose up to 5 g/kg. Subchronic toxicity study for 3 months and chronic toxicity study for 6 months were done by oral administration at doses of 0 (control), 20, 100, and 500 mg/kg. The LD50 dosage level for dogs was determined to be > 5 g/kg body weight. In the repeated-dose 3-month and 6-month oral toxicity studies, no morbidity, mortality, and toxicologically relevant events were observed either during dosing or the post-dosing recovery period. It was concluded that the NOAEL of naringin in Beagle dogs is at least 500 mg/kg body weight per day when administered orally for 3 and 6 consecutive months. These results, combined with the previous toxicological studies in rats, demonstrate a good safety profile of naringin.

中文翻译:

柚皮苷的毒理学评估:比格犬的急性,亚慢性和慢性毒性。

柚皮苷是一种广泛存在于许多饮食产品中的生物类黄酮。我们以前的研究表明,在口服急性毒性研究中,柚皮苷对SD大鼠几乎无毒,口服时SD大鼠的未观察到的不良作用水平(NOAEL)大于1250 mg / kg /天连续13周或连续6个月进行管饲。在此,我们评估了柚皮素在比格犬中的安全性。柚皮素的急性口服给药单次推注剂量最大为5 g / kg。通过口服给药0(对照),20、100和500 mg / kg的剂量进行3个月的慢性毒性研究和6个月的慢性毒性研究。确定狗的LD 50剂量水平> 5 g / kg体重。在重复剂量的3个月和6个月口服毒性研究中,没有发病率,死亡率,在给药期间或给药后恢复期间观察到毒理学相关事件。结论是,连续3个月和6个月口服比格犬中柚皮苷的NOAEL为每天至少500 mg / kg体重。这些结果与先前在大鼠中的毒理学研究相结合,证明柚皮苷具有良好的安全性。
更新日期:2020-01-17
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