Pradhan Sahar H, Mulenos Marina R, Steele London R, Gibb Matthew, Ede James D, Ong Kimberly J, Shatkin Jo Anne, Sayes Christie M
Department of Environmental Science, Baylor University, One Bear Place #97266, Waco, TX 76798-7266, USA.
Institute of Biomedical Studies, Baylor University, One Bear Place #97266, Waco, TX 76798-7266, USA.
Toxicol Res (Camb). 2020 May 20;9(3):290-301. doi: 10.1093/toxres/tfaa026. eCollection 2020 Jun.
Fibrillated cellulose is a next-generation material in development for a variety of applications, including use in food and food-contact materials. An alternative testing strategy including simulated digestion was developed to compare the physical, chemical, and biological characteristics of seven different types of fibrillated cellulose, following European Food Safety Authority guidance. Fibrillated forms were compared to a conventional form of cellulose which has been used in food for over 85 years and has Generally Recognized as safe regulatory status in the USA. The physical and chemical characterization of fibrillated celluloses demonstrate that these materials are similar physically and chemically, which composed of the same fundamental molecular structure and exhibit similar morphology, size, size distribution, surface charge, and low levels of impurities. Simulated gastrointestinal and lysosomal digestions demonstrate that these physical and chemical similarities remain following exposure to conditions that mimic the gastrointestinal tract or intracellular lysosomes. A toxicological investigation with an advanced intestinal co-culture model found that exposure to each of the fibrillated and conventional forms of cellulose, in either the pristine or digested form at 0.4% by weight, showed no adverse toxicological effects including cytotoxicity, barrier integrity, oxidative stress, or inflammation. The results demonstrate the physical, chemical, and biological similarities of these materials and provide substantive evidence to support their grouping and ability to read-across data as part of a food safety demonstration.
原纤化纤维素是一种正在开发的下一代材料，可用于多种应用，包括食品和食品接触材料。按照欧洲食品安全局的指导方针，开发了一种包括模拟消化在内的替代测试策略，以比较七种不同类型原纤化纤维素的物理、化学和生物学特性。将原纤化形式与一种传统形式的纤维素进行了比较，这种纤维素已在食品中使用了85年以上，在美国具有一般公认安全的监管地位。原纤化纤维素的物理和化学特性表明，这些材料在物理和化学上相似，由相同的基本分子结构组成，具有相似的形态、尺寸、尺寸分布、表面电荷和低水平杂质。模拟胃肠道和溶酶体消化表明，在暴露于模拟胃肠道或细胞内溶酶体的条件后，这些物理和化学相似性仍然存在。一项使用先进肠道共培养模型的毒理学研究发现，以0.4%重量的原始或消化形式暴露于每种原纤化和传统形式的纤维素中，均未显示出包括细胞毒性、屏障完整性、氧化应激或炎症在内的不良毒理学效应。结果证明了这些材料在物理、化学和生物学上的相似性，并提供了实质性证据来支持它们的分组以及作为食品安全论证一部分进行数据类推的能力。
