Abstract

The present study investigated the potential adverse effects of aluminum chloride (AlCl₃) following a 4-week repeated oral administration in Sprague-Dawley rats. The test article was administered once daily by gavage to male and female rats at dose levels of 0, 100, 300, and 900 mg/kg/day for 4 weeks. After administration of AlCl₃ at 900 mg/kg/day, treatment-related systemic toxicity manifested as significant increases in salivation incidence, neutrophil percentage, reticulocytes, serum triglyceride, adrenal gland and liver weights, and single-hepatocyte necrosis, as well as significant decreases in body weight gain, food intake, hemoglobin, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration (MCHC), lymphocyte percentage, serum total protein and albumin, and thymus weight in male rats; and significant increases in salivation incidence, serum triglyceride, and liver weight, as well as a significant decrease in lymphocyte percentage in female rats. At 300 mg/kg/day, a significant decrease in MCHC was found in male rats, but not in female rats. However, this finding was not toxicologically significant because the reduction was minimal and was not accompanied by changes in any other parameters. No treatment-related effects were observed in the 100 mg/kg/day group of both genders. Under the experimental conditions of this study, the target organs of AlCl₃ were determined to be the blood, liver, and thymus in rats. The no-observed-adverse-effect level was found to be 300 mg/kg/day in rats of both genders.

摘要

本研究调查了Sprague-Dawley 大鼠 4 周重复口服给药后氯化铝 (AlCl ₃ )的潜在副作用。以0、100、300和900mg/kg/天的剂量水平通过管饲法对雄性和雌性大鼠每天一次施用测试制品，持续4周。施用 AlCl _3后在 900 mg/kg/天，治疗相关的全身毒性表现为唾液分泌率、中性粒细胞百分比、网织红细胞、血清甘油三酯、肾上腺和肝脏重量以及单肝细胞坏死的显着增加，以及体重增加的显着降低、雄性大鼠的食物摄入量、血红蛋白、平均红细胞血红蛋白、平均红细胞血红蛋白浓度（MCHC）、淋巴细胞百分比、血清总蛋白和白蛋白以及胸腺重量；雌性大鼠流涎发生率、血清甘油三酯和肝脏重量显着增加，淋巴细胞百分比显着降低。在 300 mg/kg/天时，发现雄性大鼠的 MCHC 显着降低，但雌性大鼠没有。然而，这一发现在毒理学上并不显着，因为减少幅度很小，并且没有伴随任何其他参数的变化。在两性的 100 mg/kg/天组中未观察到与治疗相关的影响。在本研究的实验条件下，AlCl的靶器官₃被确定为大鼠的血液、肝脏和胸腺。在两种性别的大鼠中，未观察到的不良反应水平为 300 mg/kg/天。