Single-dose intravenous toxicity study of IRDye 800CW in Sprague-Dawley rats.
Single-dose intravenous toxicity study of IRDye 800CW in Sprague-Dawley rats.
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DOI：
10.1007/s11307-010-0317-x
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发表时间：
2010-12
影响因子：
3.1
通讯作者：
Olive, D. Michael
中科院分区：
文献类型：
--
作者：
Marshall, Milton V.;Draney, Daniel;Sevick-Muraca, Eva M.;Olive, D. Michael
荧光团标记的造影剂正朝着临床应用的方向发展。近红外染料IRDye 800CW经常以其n -羟基琥珀胺（NHS）酯形式用于标记这些药物。随着标记配体的结合或分解，过量的NHS酯转化为羧酸盐形式。为了制备临床近红外荧光团，对IRDye 800CW羧酸盐进行了毒性研究。雄性和雌性Sprague-Dawley大鼠单次静脉注射或皮内注射IRDye 800CW羧酸酯；以吲哚菁绿作为对照。给动物注射不同剂量的试验品和对照品，并观察长达14天。对动物亚组进行临床化学、血液学和药代动力学分析。对器官进行了分析，以确定试样的含量。显微镜下观察组织病理变化。根据血液学、临床化学和组织病理学评估，单次静脉注射1、5、20 mg/kg或20 mg/kg皮下注射IRDye 800CW羧酸盐没有产生毒性的病理证据。在静脉或内源性给药IRDye 800CW后，20 mg/kg的剂量被确定为未观察到的不良反应水平。本文的在线版本（doi:10.1007/ s1107 -010-0317-x）包含补充材料，仅供授权用户使用。
Fluorophore-labeled contrast imaging agents are moving toward clinical use for a number of applications. The near-infrared dye IRDye 800CW is frequently used in its N-hydroxysuccinamide (NHS) ester form for labeling these agents. Following conjugation or breakdown of a labeled ligand, excess NHS ester is converted to the carboxylate form. To prepare for clinical use as a near-infrared fluorophore, a toxicity study was conducted on IRDye 800CW carboxylate. Male and female Sprague–Dawley rats were given a single intravenous or intradermal administration of IRDye 800CW carboxylate; Indocyanine Green was used as a comparative control. Animals were injected with varying doses of the test and control articles and observed for up to 14 days. Clinical chemistry, hematological, and pharmacokinetic analyses were performed on subgroups of animals. Organs were analyzed for content of the test article. Tissues were analyzed microscopically for pathological changes. Based on hematologic, clinical chemistry, and histopathologic evaluation, single administration of IRDye 800CW carboxylate intravenously at dose levels of 1, 5, and 20 mg/kg or 20 mg/kg intradermally produced no pathological evidence of toxicity. A dose of 20 mg/kg was identified as the no observed adverse effect level following IV or ID routes of administration of IRDye 800CW. The online version of this article (doi:10.1007/s11307-010-0317-x) contains supplementary material, which is available to authorized users.
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