A 90-day oral (dietary) toxicity and mass balance study of corn starch fiber in Sprague Dawley rats.

Citation data:

Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association, ISSN: 1873-6351, Vol: 97, Page: 57-69

Publication Year:
2016
Usage 43
Abstract Views 39
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PMID:
27580979
DOI:
10.1016/j.fct.2016.08.030
Author(s):
Crincoli, Christine M, Nikiforov, Andrey I, Rihner, Marisa O, Lambert, Elizabeth A, Greeley, Melanie A, Godsey, Justin, Eapen, Alex K, van de Ligt, Jennifer L G
Publisher(s):
Elsevier BV
Tags:
Agricultural and Biological Sciences, Pharmacology, Toxicology and Pharmaceutics
article description
The potential toxicity of corn starch fiber was assessed and compared to polydextrose, a commonly used bulking agent with a long history of safe use in the food supply. Groups of male and female Crl:CD(SD) rats were fed 0 (control), 1,000, 3,000, or 10,000 mg/kg-bw/day corn starch fiber in the diet for 90 days. The polydextrose reference article was offered on a comparable regimen at 10,000 mg/kg-bw/day. Following a single gavage dose of [C]-corn starch fiber on study day 13 or 90, the mass balance of the test article was assessed by analysis of excreta samples collected from 0 to 168 h post-dose. There were no toxicologically or biologically relevant findings in any of the test article-treated groups. The few minor differences observed between the corn starch fiber and polydextrose exposed groups were considered to be due to normal biological variation. Following [C]-corn starch fiber dosing, nearly complete excretion of the administered dose occurred over 168 h post-dosing, with the majority excreted in the feces. The dietary no-observed-adverse-effect level of corn starch fiber after 90 days was 10,000 mg/kg-bw/day. Similar toxicity profiles for corn starch fiber and polydextrose were observed due to the structural and compositional similarities of these materials.

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