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Safety studies conducted on pecan shell fiber, a food ingredient produced from ground pecan shells

机译:关于山核桃壳纤维的安全性研究,山核桃壳纤维是由山核桃壳制成的食品成分

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Use of pecan shell fiber in human food is presently limited, but could increase pending demonstration of safety. In a 91-day rat study, pecan shell fiber was administered at dietary concentrations of 0 (control), 50000, 100000 or 150000ppm. There was no effect of the ingredient on body weight of males or females or food consumption of females. Statistically significant increases in food consumption were observed throughout the study in 100000 and 150000ppm males, resulting in intermittent decreases in food efficiency (150000ppm males only) that were not biologically relevant. All animals survived and no adverse clinical signs or functional changes were attributable to the test material. There were no toxicologically relevant changes in hematology, clinical chemistry or urinalysis parameters or organ weights in rats ingesting pecan shell fiber. Any macroscopic or microscopic findings were incidental, of normal variation and/or of minimal magnitude for test substance association. Pecan shell fiber was non-mutagenic in a bacterial reverse mutation test and non-clastogenic in a mouse peripheral blood micronucleus test. Based on these results, pecan shell fiber has an oral subchronic (13-week) no observable adverse effect level (NOAEL) of 150000ppm in rats and is not genotoxic at the doses analyzed.
机译:目前山核桃壳纤维在人类食品中的使用受到限制,但可能会增加其安全性。在一项为期91天的大鼠研究中,山核桃壳纤维的饮食浓度为0(对照组),50000、100000或150000ppm。该成分对雄性或雌性体重或雌性食物食用没有影响。整个研究期间,在100000和150000ppm的男性中观察到食物消耗的统计显着增加,导致食品效率的间歇性下降(仅150000ppm的男性)与生物学无关。所有动物均存活,并且没有不良临床症状或功能变化可归因于测试材料。摄入山核桃壳纤维的大鼠的血液学,临床化学或尿液分析参数或器官重量均无毒理学相关变化。对于测试物质的结合,任何宏观或微观发现都是偶然的,正常变化的和/或最小的。山核桃壳纤维在细菌反向突变试验中无致突变性,在小鼠外周血微核试验中无致伤性。根据这些结果,山核桃壳纤维对大鼠的口腔亚慢性(13周)无可观察到的不良反应水平(NOAEL)为150000ppm,并且在所分析的剂量下没有遗传毒性。

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