Novel forms of fibrillated cellulose offer improved attributes for use in foods. Conventional cellulose and many of its derivatives are already widely used as food additives and are authorized as safe for use in foods in many countries. However, novel forms have not yet been thoroughly investigated using standardized testing methods. This study assesses the 90-day dietary toxicity of fibrillated cellulose, as compared to a conventional cellulose, Solka Floc. Sprague Dawley rats were fed 2 %, 3 %, or 4 % fibrillated cellulose for 90 consecutive days, and parallel Solka Floc groups were used as controls. Survival, clinical observations, body weight, food consumption, ophthalmologic evaluations, hematology, serum chemistry, urinalysis, post-mortem anatomic pathology, and histopathology were monitored and performed. No adverse observations were noted in relation to the administration of fibrillated cellulose. Under the conditions of this study and based on the toxicological endpoints evaluated, the no-observed-adverse-effect level (NOAEL) for fibrillated cellulose was 2194.2 mg/kg/day (males) and 2666.6 mg/kg/day (females), corresponding to the highest dose tested (4 %) for male and female Sprague Dawley rats. These results demonstrate that fibrillated cellulose behaves similarly to conventional cellulose and raises no safety concerns when used as a food ingredient at these concentrations.
Keywords: % RET, percent reticulocyte; 90-day subchronic study; ABAS, absolute basophil; AEOS, absolute eosinophil; ALB, albumin; ALKP, alkaline phosphatase; ALT, alanine aminotransferase; ALUC, absolute large unstained cell; ALYM, absolute lymphocyte; AMON, absolute monocyte; ANEU, absolute neutrophil; ANOVA, one-way analysis of variance; ARET, absolute reticulocyte; AST, aspartate aminotransferase; BUN, urea nitrogen; CAS, Chemical Abstracts Service; CHOL, cholesterol; CREAT, creatinine; Cellulose; DLS, dynamic light scattering; EDXS, energy-dispersive X-ray spectroscopy; EFSA, European Food Safety Authority; FDA, U.S. Food and Drug Administration; Fibrillated cellulose; GLOB, globulin; GLP, good laboratory practice; GLU, glucose; GRAS, generally recognized as safe; HBG, hemoglobin; HCT, hematocrit; MCH, mean corpuscular cell hemoglobin; MCHC, mean corpuscular cell hemoglobin concentration; MCV, mean corpuscular cell volume; NOAEL; NOAEL, no-observed-adverse-effect level; OECD 408; OECD, Organisation for Economic Co-operation and Development; Oral exposure; PLT, platelet count; RBC, red blood cell count; RDW, red cell distribution width; SCOGS, Select Committee on GRAS Substances; SDH, sorbitol dehydrogenase; SEM, scanning electron microscopy; TBA, total bile acids; TBIL, total bilirubin; TEM, transmission electron microscopy; TEMPO, 2,2,6,6-tetramethyl-piperidinyloxyl; TP, total protein; TRIG, triglycerides; WBC, white blood cell count.
© 2020 The Authors.