Nontamart Naiyana, Posridee Kakanang, Suwannaprapha Parin, Srisawat Rungrudee, Oonsivilai Ratchadaporn
School of Preclinical Science, Institute of Science, Suranaree University of Technology, Nakhon Ratchasima 30000, Thailand.
Health and Wellness Research Unit, School of Food Technology, Institute of Agricultural Technology, Suranaree University of Technology, Nakhon Ratchasima 30000, Thailand.
Toxics. 2025 Jun 3;13(6):473. doi: 10.3390/toxics13060473.
This study rigorously evaluated the safety profile of dietary fiber extracted from cassava pulp, a promising functional food ingredient, through acute and 28-day sub-acute oral toxicity assessments in Wistar rats. This research hypothesized that cassava pulp fiber would exhibit minimal toxicity across a range of doses. In the acute study, rats received single oral doses of 175, 550, or 2000 mg/kg, while the sub-acute toxicity study involved daily doses of 250, 500, or 1000 mg/kg, with satellite groups included for reversibility assessment. Comprehensive monitoring encompassed clinical signs, mortality, body weight, food intake, hematological and biochemical parameters, relative organ weights, and detailed histopathological examination. Remarkably, no treatment-related mortality or overt clinical signs of toxicity were observed in either study. The LD was higher than 2000 mg/kg for the acute study and the no-observed-adverse-effect level (NOAEL) was determined to be 2000 mg/kg for the acute study and 1000 mg/kg for the sub-acute toxicity study, indicating a high margin of safety. While statistically significant alterations were noted in some hematological, biochemical, and relative organ weight parameters, these changes were not considered toxicologically relevant. Notably, histopathological changes in the lungs were observed across all groups, including controls, warranting further investigation. These findings suggest that cassava pulp fiber is well tolerated at high oral doses, supporting its potential for safe application in food and nutraceutical formulations. However, the observed lung alterations necessitate further research to elucidate their etiology and clinical significance.
本研究通过对Wistar大鼠进行急性和28天亚急性经口毒性评估，严格评估了木薯渣中提取的膳食纤维（一种有前景的功能性食品成分）的安全性。本研究假设木薯渣纤维在一系列剂量下毒性极小。在急性研究中，大鼠单次经口给予175、550或2000 mg/kg的剂量，而亚急性毒性研究涉及每日给予250、500或1000 mg/kg的剂量，并设有卫星组进行可逆性评估。全面监测包括临床症状、死亡率、体重、食物摄入量、血液学和生化参数、相对器官重量以及详细的组织病理学检查。值得注意的是，两项研究均未观察到与治疗相关的死亡或明显的毒性临床症状。急性研究的半数致死量高于2000 mg/kg，急性研究的未观察到有害作用水平（NOAEL）确定为2000 mg/kg，亚急性毒性研究的NOAEL为1000 mg/kg，表明安全性很高。虽然在一些血液学、生化和相对器官重量参数中发现了具有统计学意义的变化，但这些变化在毒理学上不被认为具有相关性。值得注意的是，在所有组（包括对照组）中均观察到肺部的组织病理学变化，需要进一步研究。这些结果表明木薯渣纤维在高经口剂量下耐受性良好，支持其在食品和营养保健品配方中安全应用的潜力。然而，观察到的肺部变化需要进一步研究以阐明其病因和临床意义。
