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Int J Toxicol. 2013 May-Jun;32(3):198-208. doi: 10.1177/1091581813484069. Epub 2013 Apr 24.
Forty male and 40 female Crl:SD® CD® IGS rats were fed diets containing 0, 40,000, 80,000, or 120,000 ppm tamarind seed polysaccharide (equivalent to 3450.8, 6738.9, or 10 597.1 mg/kg bw/day and 3602.1, 7190.1, or 10,690.7 mg/kg bw/day for males and females, respectively) for 28 days. Animals were observed for adverse clinical signs, body weight, feed consumption, hematology and clinical chemistry parameters, urinalysis values were recorded, and at the end of the study the rats underwent a full necropsy. Functional Observational Battery (FOB) and Motor Activity (MA) tests were performed on all animals. There were no mortalities, no clinical or ophthalmologic signs, body weight, body weight gain, food consumption and food efficiency, FOB or MA findings associated with the administration of tamarind seed polysaccharide. Initial statistically significant decreases in body weight gain and food consumption resolved after the first week and were considered the result of reduced palatability. There were no adverse changes in hematology, coagulation, clinical chemistry or urinalysis parameters in male or female rats considered the result of test substance administration. At necropsy, there were no macroscopic, histopathological findings, estrus cycle, or organ weight changes deemed related to administration of the test substance. Under the conditions of this study and based on the toxicological endpoints evaluated, the no-observed-adverse-effect level (NOAEL) for tamarind seed polysaccharide in the diet was the highest concentration tested of 120,000 ppm (equivalent to 10,597 mg/kg bw/day and 10,691 mg/kg bw/day for male and female rats, respectively).
40 只雄性和 40 只雌性 Crl:SD® CD® IGS 大鼠喂食含有 0、40000、80000 或 120000ppm罗望子多糖的饮食(相当于 3450.8、6738.9 或 10597.1mg/kg bw/day 和 3602.1、7190.1 或 10690.7mg/kg bw/day,分别用于雄性和雌性),为期 28 天。观察动物的不良临床症状、体重、饲料消耗、血液学和临床化学参数,记录尿液分析值,并在研究结束时对大鼠进行全面尸检。对所有动物进行功能观察电池(FOB)和运动活动(MA)测试。没有死亡,没有临床或眼科迹象,体重,体重增加,食物消耗和食物效率,FOB 或 MA 发现与罗望子多糖的给药有关。最初的体重增加和食物消耗的统计学显著下降在第一周后得到解决,被认为是适口性降低的结果。雄性或雌性大鼠的血液学、凝血、临床化学或尿液分析参数没有不良变化,被认为是测试物质给药的结果。在尸检中,没有与给予测试物质有关的宏观、组织病理学发现、发情周期或器官重量变化。在本研究的条件下,并基于评估的毒理学终点,罗望子多糖在饮食中的无观察到不良效应水平(NOAEL)为最高测试浓度 120000ppm(相当于 10597mg/kg bw/day 和 10691mg/kg bw/day,分别用于雄性和雌性大鼠)。