低聚木糖的毒理学安全性研究

Toxicological safety study of xylooligosaccharides

中文关键词:  低聚木糖  急性毒性  遗传毒性  亚急性毒性  安全评价

英文关键词:xylooligosaccharides  acute toxicity  genotoxicity  subacute toxicity  safety evaluation

中文摘要:

      目的 评价低聚木糖的毒理学安全性。方法 依据食品安全国家标准, 通过小鼠急性经口毒性试验、哺乳动物骨髓红细胞微核试验、精母细胞染色体畸变试验、细菌回复突变(Ames)试验、28 d经口毒性试验对其进行安全性评价。结果 低聚木糖对雌雄小鼠急性经口最大耐受剂量(maximum tolerated dose, MTD)均大于10000 mg/(kg·bw), 属实际无毒级; 哺乳动物骨髓红细胞微核试验、精母细胞染色体畸变试验和细菌回复突变试验试验均为阴性; 设0(基础饲料对照)、4167、8333、16667 mg/(kg·bw) 3个剂量组(相当于最大推荐摄入量的25倍、50倍和100倍), 每日经口灌胃一次, 连续28 d。高剂量组动物出现与受试样品相关的总增重降低, 丙氨酸氨基转移酶、碱性磷酸酶、血糖及尿素氮等生化指标改变, 雄性大鼠部分脏器重量及脏体比减少等变化, 而中、低剂量组(相当于最大推荐摄入量的50倍和25倍)以及卫星组未见相应变化。结论 低聚木糖未显示急性毒性、遗传毒性; 该样品对雌、雄大鼠28 d经口毒性未观察到有害作用剂量(no observed adverse effect level, NOAEL)为8333 mg/(kg·bw)。

英文摘要:

      Objective To evaluate the toxicological safety of xylooligosaccharides. Methods According to the national food safety standards, the safety of xylooligosaccharides was evaluated through acute oral toxicity test in mice, micronucleus tests in mammalian bone marrow red blood cells, chromosomal aberration tests in spermatocytes, Bacterial reverse mutation (Ames) test, and 28 day oral toxicity test. Results The acute maximum tolerated dose (MTD) of xylooligosaccharides in male and female mice was greater than 10000 mg/(kg·bw), which was classified as practically non-toxic; the micronucleus test of mammalian bone marrow red blood cells, chromosome aberration test of spermatocytes, and Ames test were all negative; set up 3 dose groups: 0 (basic feed control), 4167, 8333 and 16667 mg/(kg·bw) (equivalent to 25 times, 50 times and 100 times the maximum recommended intake), orally administered once a day for 28 consecutive days. The high-dose group of animals showed a decrease in total weight gain related to the test sample, changes in biochemical indicators such as alanine aminotransferase, alkaline phosphatase, glucose and urea nitrogen, and a decrease in organ weight and visceral to body ratio in male rats. However, there were no corresponding changes observed in the medium and low-dose groups (equivalent to 50 times and 25 times the maximum recommended intake) and the Weixing group. Conclusion Xylooligosaccharides do not show acute toxicity or genetic toxicity; the no observed adverse effect level (NOAEL) of the sample for 28 days of oral toxicity in female and male rats is 8333 mg/(kg·bw).