Qualitative investigation of uptake of fine particle size microcrystalline cellulose following oral administration in rats.

AUTOR(ES)

Kotkoskie, L A

RESUMO

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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