Journal
TOXICOLOGY REPORTS
Volume 7, Issue -, Pages 174-182Publisher
ELSEVIER
DOI: 10.1016/j.toxrep.2020.01.003
Keywords
Cellulose; Fibrillated cellulose; 90-day subchronic study; OECD 408; Oral exposure; NOAEL
Categories
Funding
- P3Nano, a public private partnership of the U.S. Endowment for Forestry and Communities
- U.S. Department of Agriculture Forest Service Forest Products Laboratory
- Borregaard AS
- Evergreen Packaging LLC
- Fiberlean Technologies Limited
- Alberta Innovates
- Sappi North America Inc.
- Stora Enso Oyj
- Weidmann Fiber Technology by Weidmann Electrical Technology AG
- Alberta-Pacific Forest Industries Inc.
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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.
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