GST对Sprague-Dawley大鼠90天重复剂量口服毒性研究。

Environmental analysis, health and toxicology Pub Date : 2022-06-01 Epub Date: 2022-05-11 DOI:10.5620/eaht.2022013
Sang Ho Kim, Myeong Kyu Park, Ja Kyung Seol, Jae Min Im, Heung Sik Seo, Hee Ju Park, Sung Soon Nah
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摘要

由于材料的使用特性(化妆品、油漆和其他产品),已经对二氧化钛的吸入和皮肤暴露进行了研究,而用于潜在风险评估的其他摄入途径的额外安全信息有限。因此,本研究的目的是根据OECD测试指南(TG 408),通过对Sprague-Dawley (SD)大鼠进行重复剂量毒性试验,获得污水处理厂污泥回收产生的新型TiO2粉末GST的安全性数据。根据剂量范围研究(28天重复毒性)的结果,GST以0、500、1000和2000 mg/kg体重/天的剂量口服给药大鼠90天,并在4周后评估2000 mg/kg体重/天的效果可逆性。在临床症状方面,治疗组(低:14或15天,中:8天,高:8天)所有动物均出现复合色大便,并持续观察至给药结束或恢复期第1天(高剂量组)。同时,治疗组所有动物尸检大体发现胃肠道中均有试验物质残留,这些器官(胃、十二指肠、回肠、盲肠、结肠、直肠)的管腔中均有异物,可能提示组织病理学检查中有试验物质存在。此外,在详细的临床观察、感觉反应性/功能评估、体重、饮食、尿液分析、眼科检查、血液学/生化参数、器官重量、组织病理学结果中未发现与试验物质相关的不良反应。因此,本研究结果表明,在本研究条件下,新TiO2粉末的NOAEL(未观察到不良反应水平),GST为2000 mg/kg B.W/day,在本研究条件下重复口服90天,未发现靶器官。
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Repeated-dose 90-day oral toxicity study of GST in Sprague-Dawley rats.

TiO2 have been studied on inhalation and skin exposure due to the properties of the materials' use (cosmetics, paints and other products) and the additional safety information on other intake routes for the potential risk assessment is limited. Therefore, the aim of this study was to obtain safety data for new TiO2 powder, GST produced through sludge recycling of the sewage treatment plant through repeated-dose toxicity in Sprague-Dawley (SD) rats in according to the OECD test guideline (TG 408). Based on the results of the dose-range finding study (28-day repeated toxicity), GST was orally administered to rats at doses of 0, 500, 1000, and 2000 mg/kg B.W/day for 90-day and reversibility of effects of 2000 mg/kg bw/day was assessed after 4 weeks. In clinical signs, compound-colored stool was observed in all animals of treatment group (low: day 14 or 15, middle: day 8, high: day 8) and continuously observed up to the end of administration or day 1 of recovery period (high dose group). Also, the test substance retention in gastro-intestinal tract was observed in all animals of treatment group in gross finding at necropsy and foreign materials in lumen of these organs (stomach, duodenum, ileum, cecum, colon, rectum) likely indicative for the presence of test material in histopathological examination. In addition, no test substance-related adverse effects were noted in the detailed clinical observations, sensory reactivity/ functional assessments, body weight, food consumption, urinary analysis, ophthalmological examination, hematological / biochemical parameters, organ weights, histopathological findings. Therefore, the present results show that the NOAEL (no observed adverse effect level) of new TiO2 powder, GST was considered to be 2000 mg/kg B.W/day in rats after repeated oral administration for 90-day under the present study conditions and no target organs were identified.

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