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104 周毒性研究中 Sprague-Dawley 大鼠自发性肿瘤病变的历史对照背景发生率。

Historical Control Background Incidence of Spontaneous Neoplastic Lesions of Sprague-Dawley Rats in 104-Week Toxicity Studies.

机构信息

Labcorp Early Development Laboratories Inc., Madison, Wisconsin, USA.

Biogen Inc., Cambridge, Massachusetts, USA.

出版信息

Toxicol Pathol. 2023 Aug;51(6):329-356. doi: 10.1177/01926233231224466. Epub 2024 Jan 28.

DOI:10.1177/01926233231224466
PMID:38281147
Abstract

Data collected from approximately 1800 male and 1800 female Sprague-Dawley (SD) rats used in 104-week carcinogenicity studies were archived in a historical control database at Labcorp Early Development, Inc, and the neoplastic microscopic observation data from these rats were retrospectively evaluated. Historical control data can provide useful information on the range and incidence of spontaneously occurring background neoplasms in the species and strain of the test animal used in different types of toxicity studies, including studies of differing lengths, delivery of test article, and test animal. Some of the most common malignant findings noted included fibrosarcoma of skin/subcutis and thyroid C-cell carcinoma in males (2.1% each) while mammary gland carcinoma and pituitary carcinoma (25% and 2.6%) were most common in females. Pituitary adenoma of pars distalis was found to be the most prevalent benign neoplasm in both males and females (56.4% and 77.1%). Fibroadenoma of mammary gland (35.6%) and thyroid C-cell adenoma (8.5%) were the second and third most common benign tumors in female SD rats. In males, the thyroid C-cell adenoma (10.9%) and benign pheochromocytoma (8.9%) were the second and third most common tumors.

摘要

从用于 104 周致癌性研究的大约 1800 只雄性和 1800 只雌性 Sprague-Dawley(SD)大鼠中收集的数据被存档在 Labcorp Early Development, Inc. 的历史对照数据库中,这些大鼠的肿瘤显微镜观察数据被回顾性评估。历史对照数据可以为用于不同类型毒性研究的试验动物物种和品系中自发性背景肿瘤的范围和发生率提供有用信息,包括不同长度的研究、试验物质的给药和试验动物。在雄性中最常见的恶性发现包括皮肤/皮下纤维肉瘤和甲状腺 C 细胞癌(各占 2.1%),而在雌性中最常见的是乳腺腺癌和垂体腺癌(各占 25%和 2.6%)。在雄性和雌性中,垂体远侧部腺瘤被发现是最常见的良性肿瘤(分别为 56.4%和 77.1%)。乳腺纤维腺瘤(35.6%)和甲状腺 C 细胞腺瘤(8.5%)是雌性 SD 大鼠中第二和第三常见的良性肿瘤。在雄性中,甲状腺 C 细胞腺瘤(10.9%)和良性嗜铬细胞瘤(8.9%)是第二和第三常见的肿瘤。

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