Abstract
A subchronic toxicity study was conducted to evaluate the potential toxicological effects associated with intestinal translocation of a special fine particle size (median particle size 6 microns) microcrystalline cellulose (MCC). Four groups of Sprague-Dawley rats (20/sex/group) received either 0 (control), 500, 2500 or 5000 mg/kg/day MCC (25% w/v in tap water) daily by oral gavage for 90 d. At study termination, organs and tissues from high-dose and control animals, including multiple sections of intestine with gut-associated lymphoid tissue, were processed for light microscopy with subsequent examination under polarised light for the presence of birefringent MCC particles. None were observed in any tissue examined. No toxicologically significant effects or lesions were found in any other parameter or organ evaluated. The 'no observed adverse effect level' (NOAEL) for toxicological effects was greater than 5000 mg/kg/day MCC, which was the highest dosage tested. These results further verify the safety of commercial MCC products for use in food and pharmaceutical applications.
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- Hodges G. M., Carr E. A., Hazzard R. A., Carr K. E. Uptake and translocation of microparticles in small intestine. Morphology and quantification of particle distribution. Dig Dis Sci. 1995 May;40(5):967–975. doi: 10.1007/BF02064184. [DOI] [PubMed] [Google Scholar]
- Kringsholm B., Christoffersen P. The nature and the occurrence of birefringent material in different organs in fatal drug addiction. Forensic Sci Int. 1987 May-Jun;34(1-2):53–62. doi: 10.1016/0379-0738(87)90083-1. [DOI] [PubMed] [Google Scholar]
- LeFevre M. E., Boccio A. M., Joel D. D. Intestinal uptake of fluorescent microspheres in young and aged mice. Proc Soc Exp Biol Med. 1989 Jan;190(1):23–27. doi: 10.3181/00379727-190-42825. [DOI] [PubMed] [Google Scholar]
- Pahlke G., Friedrich R. Persorption von mikrokristalliner Cellulose. Naturwissenschaften. 1974 Jan;61(1):35–35. doi: 10.1007/BF00602897. [DOI] [PubMed] [Google Scholar]
- Simon L., Shine G., Dayan A. D. Effect of animal age on the uptake of large particulates across the epithelium of the rat small intestine. Int J Exp Pathol. 1994 Oct;75(5):369–373. [PMC free article] [PubMed] [Google Scholar]