Abstract:
The impact of oral administration of mechanically fibrillated cellulose nanofibers (fib-CNF), a commonly used nanofiber, on toxicity and health remains unclear, despite reports of the safety and beneficial effects of chitin-based nanofibers. Thus, evaluating the oral toxicity of fib-CNF in accordance with OECD Test Guideline 407 (TG407) is essential. This study aimed to assess the safety of orally administered fib-CNF through an acute toxicity study in rats, following the OECD TG407 guidelines for 4 weeks. CNF \"BiNFi-s\" FMa-10005, derived from mechanically fibrillated pulp cellulose, was administered via gavage to male and female Crl:CD(SD) rats at doses of 50, 150, 500, and 1000 mg/kg/day for 28 days, with a control group receiving water for injection. The study evaluated the toxic effects of repeated administration, and the rats were monitored for an additional 14 days post-administration to assess recovery from any toxic effects. The results showed no mortality in either sex during the administration period, and no toxicological effects related to the test substance were observed in various assessments, including general condition and behavioral function observations, urinalysis, hematological examination, blood biochemical examination, necropsy findings, organ weights, and histopathological examination. Notably, only female rats treated with 1000 mg/kg/day of CNF exhibited a consistent reduction in body weight during the 14-day recovery period after the end of treatment. They also showed a slight decrease in pituitary and liver weights. However, hematological and blood biochemical tests did not reveal significant differences, suggesting a potential weight-suppressive effect of CNF ingestion.
摘要:
口服机械原纤化纤维素纳米纤维(fib-CNF)的影响,一种常用的纳米纤维,对毒性和健康仍不清楚,尽管有关于几丁质基纳米纤维的安全性和有益效果的报道。因此,根据OECD测试指南407(TG407)评估fib-CNF的口服毒性至关重要。本研究旨在通过大鼠急性毒性研究评估口服fib-CNF的安全性,遵循OECDTG407指南4周。CNF“BiNFi-s”FMa-10005,源自机械原纤化纸浆纤维素,通过管饲法对雄性和雌性Crl:CD(SD)大鼠以50、150、500和1000mg/kg/天的剂量施用28天,对照组接受注射用水。该研究评估了重复给药的毒性作用,并在给药后对大鼠进行额外14天的监测,以评估从任何毒性作用中恢复的情况。结果显示,在给药期间,两种性别都没有死亡,在各种评估中没有观察到与测试物质相关的毒理学作用,包括一般状况和行为功能观察,尿液分析,血液学检查,血液生化检查,尸检结果,器官重量,和组织病理学检查。值得注意的是,在治疗结束后的14天恢复期,只有接受1000mg/kg/天CNF治疗的雌性大鼠表现出持续的体重减轻.他们还显示垂体和肝脏重量略有下降。然而,血液学和血液生化检查没有发现显著差异,提示摄入CNF的潜在体重抑制作用。