University of Wyoming, School of Pharmacy, Laramie, WY, USA.
Toxicol Mech Methods. 2010 Jul;20(6):321-33. doi: 10.3109/15376516.2010.487880.
Chromium(III) is an essential trace element required for normal protein, fat and carbohydrate metabolism. It also helps in energy production and increasing lean body mass. Chromium(III) dinicocysteinate (CDNC) is a unique form of bioavailable chromium(III). This study was focused on determining the broad spectrum safety of CDNC. Acute oral, acute dermal, primary dermal and eye irritation studies, Ames' bacterial reverse mutation assay, mammalian erythrocyte micronucleus test, and a 90-day dose-dependent oral toxicity study were conducted. Acute oral and dermal LD(50) of CDNC was found to be greater than 2000 mg/kg in Sprague-Dawley rats. A primary skin irritation study in New Zealand Albino rabbits demonstrated CDNC as slightly irritating. An eye irritation study exhibited that CDNC is moderately irritating. Ames' bacterial reverse mutation assay and mammalian erythrocyte micronucleus test demonstrated CDNC as non-mutagenic. A dose-dependent 90-day oral toxicity study demonstrated no significant toxicity of CDNC. Body weight, food and water consumption, selected organ weights (expressed as percentages of body or brain weights), ocular health, hematology, blood chemistry, and histopathology showed no abnormal changes. Clinical and histopathological evaluation of CDNC identified a dose level of 5.7 mg/kg/day as the no observed adverse effect level (NOAEL). Overall, these results demonstrate the broad spectrum safety of CDNC.
铬(III)是一种必需的微量元素，对于正常的蛋白质、脂肪和碳水化合物代谢是必需的。它还有助于能量产生和增加瘦体重。二价铬(III) 二亚氨基二琥珀酸（CDNC）是一种独特的生物可利用铬(III)形式。本研究专注于确定 CDNC 的广泛安全性。进行了急性口服、急性皮肤、原发性皮肤和眼睛刺激研究、Ames 细菌回复突变试验、哺乳动物红细胞微核试验和 90 天剂量依赖性口服毒性研究。在 Sprague-Dawley 大鼠中发现 CDNC 的急性口服和皮肤 LD50 大于 2000mg/kg。新西兰白兔的原发性皮肤刺激研究表明 CDNC 具有轻微刺激性。眼睛刺激研究表明 CDNC 具有中度刺激性。Ames 细菌回复突变试验和哺乳动物红细胞微核试验表明 CDNC 是非致突变的。90 天剂量依赖性口服毒性研究表明 CDNC 无明显毒性。体重、食物和水的消耗、选定的器官重量（表示为体重或脑重的百分比）、眼部健康、血液学、血液化学和组织病理学均未显示异常变化。对 CDNC 的临床和组织病理学评估确定 5.7mg/kg/天的剂量水平为无观察到不良效应水平（NOAEL）。总体而言，这些结果表明 CDNC 的广谱安全性。
