Department of Biotechnology, The Catholic University of Korea, 43 Jibongro, Bucheon, 14662, Republic of Korea.
Department of Experimental Animal Research, Biomedical Research Institute, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea.
BMC Complement Altern Med. 2018 Sep 12;18(1):251. doi: 10.1186/s12906-018-2315-5.
Seed of mature Croton tiglium Linne, also known as Tiglium seed (TS), has been widely used as a natural product due to its several health beneficial properties including anti-tumor and antifungal activities. Despite its ethnomedicinal beneficial properties, toxicological information regarding TS extract, especially its long-term toxicity, is currently limited. Therefore, the objective of the present study was to evaluate acute and subchronic toxicity of TS extract in rats after oral administration following test guidelines of the Organization for Economic Cooperation and Development (OECD).
Toxicological properties of TS extract were evaluated by toxicity assays to determine its single-dose acute toxicity (125, 250, 500, 1000, or 2000 mg/kg), 14-day repeated-dose toxicity (125, 250, 500, 1000, or 2000 mg/kg) and 13-week repeated-dose toxicity (31.25, 62.5, 125, 250, and 500 mg/kg) in Sprague-Dawley rats and F344 rats. Hematological, serum biochemical, and histopathological parameters were analyzed to determine its median lethal dose (LD) and no-observed-adverse-effect-level (NOAEL).
Oral single dose up to 2000 mg/kg of TS extract resulted in no mortalities or abnormal clinical signs. In 13-week toxicity study, TS extract exhibited no dose-related changes (mortality, body weight, food/water consumption, hematology, clinical biochemistry, organ weight, or histopathology) at dose up to 500 mg/kg, the highest dosage level suggested based on 14-day repeat-dose oral toxicity study.
Acute oral LD of TS extract in rats was estimated to be greater than 2000 mg/kg. NOAEL of TS extract administered orally was determined to be 500 mg/kg/day in both male and female rats. Results from these acute and subchronic toxicity assessments of TS extract under Good Laboratory Practice regulations indicate that TS extract appears to be safe for human consumption.
成熟巴豆的种子，也称为巴豆种子（TS），由于其具有多种健康益处，包括抗肿瘤和抗真菌活性，已被广泛用作天然产物。尽管具有民间医学的有益特性，但关于 TS 提取物的毒理学信息，特别是其长期毒性，目前还很有限。因此，本研究的目的是按照经济合作与发展组织（OECD）的测试指南，评估 TS 提取物在大鼠口服后的急性和亚慢性毒性。
通过毒性测定评估 TS 提取物的毒理学特性，以确定其单次口服急性毒性（125、250、500、1000 或 2000mg/kg）、14 天重复剂量毒性（125、250、500、1000 或 2000mg/kg）和 13 周重复剂量毒性（31.25、62.5、125、250 和 500mg/kg）在 Sprague-Dawley 大鼠和 F344 大鼠中。分析血液学、血清生化和组织病理学参数，以确定其半数致死剂量（LD）和无观察到不良效应水平（NOAEL）。
口服 TS 提取物高达 2000mg/kg 不会导致死亡或出现异常临床症状。在 13 周毒性研究中，TS 提取物在高达 500mg/kg 的剂量下没有表现出剂量相关的变化（死亡率、体重、食物/水消耗、血液学、临床生物化学、器官重量或组织病理学），这是根据 14 天重复口服毒性研究建议的最高剂量水平。
大鼠口服 TS 提取物的急性 LD 估计大于 2000mg/kg。TS 提取物的口服 NOAEL 在雄性和雌性大鼠中均为 500mg/kg/天。根据良好实验室规范对 TS 提取物进行的这些急性和亚慢性毒性评估的结果表明，TS 提取物似乎可安全供人类食用。
