Suresh Swathi, Vellapandian Chitra
Department of Pharmacology, SRM College of Pharmacy, SRM Institute of Science & Technology, Kattankulathur, Chengalpattu, Tamil Nadu, 603203, India.
Dean, SRM College of Pharmacy, SRM Institute of Science & Technology, Kattankulathur, Chengalpattu,Tamil Nadu, 603203, India.
Future Sci OA. 2024 May 20;10(1):FSO982. doi: 10.2144/fsoa-2023-0322. eCollection 2024.
Purified anthocyanins lack a detailed safety profile, prompting the need for comprehensive oral toxicity research. Sprague-Dawley rats aged 8 weeks received 300 mg/kg cyanidin orally for 14 days in acute toxicity (OECD 423). In the subacute study (OECD 407), adult SD rats were administered 7.5, 15 and 30 mg/kg/day cyanidin orally for 28 days. Acute toxicity indicated an LD50 exceeding 300 mg/kg/day without adverse effects. Subacute toxicity at 7.5-30 mg/kg/day showed well-tolerated responses in both genders. No significant alterations in organ weights, hematological parameters, liver/kidney functions or adverse histopathological findings were observed. Oral cyanidin administration demonstrated high safety and tolerance in rats, establishing a NOAEL at 30 mg/kg/day, affirming cyanidin's safety for oral use.
纯化的花青素缺乏详细的安全性资料,因此需要开展全面的口服毒性研究。8周龄的斯普拉格-道利大鼠在急性毒性试验(经合组织423号试验)中口服300毫克/千克的花青素,持续14天。在亚急性研究(经合组织407号试验)中,成年SD大鼠口服7.5、15和30毫克/千克/天的花青素,持续28天。急性毒性试验表明,半数致死剂量超过300毫克/千克/天,且无不良反应。7.5至30毫克/千克/天的亚急性毒性试验表明,两种性别均表现出良好的耐受性。未观察到器官重量、血液学参数、肝/肾功能有显著变化,也未发现不良组织病理学结果。大鼠口服花青素显示出高安全性和耐受性,确定无观察到有害作用水平为30毫克/千克/天,证实了花青素口服使用的安全性。