Shara Michael, Yasmin Taharat, Kincaid Anthony E, Limpach Aimee L, Bartz Jason, Brenneman Karrie A, Chatterjee Archana, Bagchi Manashi, Stohs Sidney J, Bagchi Debasis
Creighton University Medical Center, Omaha, NE, USA.
J Inorg Biochem. 2005 Nov;99(11):2161-83. doi: 10.1016/j.jinorgbio.2005.07.017. Epub 2005 Sep 19.
Chromium is an essential trace element required for normal protein, fat and carbohydrate metabolism. It also helps in energy production and increasing lean body mass. Niacin-bound chromium (NBC) is a unique form of bioavailable chromium that promotes healthy lipid profile. This study was focused on determining the broad spectrum safety of NBC. Acute oral, acute dermal, primary dermal irritation and primary eye irritation toxicities of NBC were evaluated. Ames bacterial reverse mutation assay, mouse lymphoma test and a dose-dependent 90-day subchronic toxicity were also conducted. In safety studies, the acute oral LD(50) of NBC was found to be greater then 5000 mg/kg in both male and female Sprague-Dawley rats. No changes in body weight or adverse effects were observed following necropsy. The acute dermal LD(50) of NBC was found to be >2000 mg/kg. The primary skin irritation test was conducted with NBC on New Zealand Albino rabbits. NBC was classified as slightly irritating. The primary eye irritation test was conducted with NBC on rabbits. NBC was classified as practically non-irritating to the eye. NBC did not induce mutagenic effects in the bacterial reverse mutation test in five Salmonella typhimurium strains (TA1535, TA98, TA100, TA97a and TA102), either with or without metabolic activation. Similarly, NBC did not induce mutagenic effects in the mammalian cell gene mutation test in L5178Y mouse lymphoma cells TK (+/-), either with or without metabolic activation. A dose-dependent 90-day subchronic toxicity study demonstrated no significant changes in selected organ weights individually and as percentages of body and brain weights. NBC supplementation did not cause changes in hepatic lipid peroxidation or DNA fragmentation after 30, 60 or 90 days of treatment. Hematology, clinical chemistry and histopathological evaluations did not show any adverse effects in all organs tested. Taken together, the above results indicate a broad spectrum of safety for NBC.
铬是正常蛋白质、脂肪和碳水化合物代谢所需的必需微量元素。它还有助于能量产生并增加瘦体重。烟酸结合铬（NBC）是一种独特的生物可利用铬形式，可促进健康的血脂水平。本研究的重点是确定NBC的广谱安全性。评估了NBC的急性口服、急性皮肤、原发性皮肤刺激性和原发性眼刺激性毒性。还进行了艾姆斯细菌回复突变试验、小鼠淋巴瘤试验和剂量依赖性90天亚慢性毒性试验。在安全性研究中，发现NBC对雄性和雌性Sprague-Dawley大鼠的急性口服半数致死量（LD50）均大于5000mg/kg。尸检后未观察到体重变化或不良反应。发现NBC的急性皮肤LD50大于2000mg/kg。用NBC对新西兰白化兔进行了原发性皮肤刺激性试验。NBC被分类为轻度刺激性。用NBC对兔子进行了原发性眼刺激性试验。NBC被分类为对眼睛实际无刺激性。在有或无代谢活化的情况下，NBC在五种鼠伤寒沙门氏菌菌株（TA1535、TA98、TA100、TA97a和TA102）的细菌回复突变试验中均未诱导致突变作用。同样，在有或无代谢活化的情况下，NBC在L5178Y小鼠淋巴瘤细胞TK（+/-）的哺乳动物细胞基因突变试验中也未诱导致突变作用。一项剂量依赖性90天亚慢性毒性研究表明，所选器官重量单独以及作为体重和脑重的百分比均无显著变化。治疗30、60或90天后，补充NBC未引起肝脏脂质过氧化或DNA片段化的变化。血液学、临床化学和组织病理学评估在所有测试器官中均未显示任何不良反应。综上所述，上述结果表明NBC具有广谱安全性。
