TY - JOUR
T1 - A 90-day oral (dietary) toxicity and mass balance study of corn starch fiber in Sprague Dawley rats
AU - Crincoli, Christine M.
AU - Nikiforov, Andrey I.
AU - Rihner, Marisa O.
AU - Lambert, Elizabeth A.
AU - Greeley, Melanie A.
AU - Godsey, Justin
AU - Eapen, Alex K.
AU - van de Ligt, Jennifer L.G.
N1 - Funding Information:
Work was supported by Cargill, Inc.
Publisher Copyright:
© 2016
PY - 2016/11/1
Y1 - 2016/11/1
N2 - 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 [14C]-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 [14C]-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.
AB - 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 [14C]-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 [14C]-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.
KW - Fiber
KW - Oral
KW - Rat
KW - Subchronic toxicity
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U2 - 10.1016/j.fct.2016.08.030
DO - 10.1016/j.fct.2016.08.030
M3 - Article
C2 - 27580979
AN - SCOPUS:84989311611
SN - 0278-6915
VL - 97
SP - 57
EP - 69
JO - Food and Chemical Toxicology
JF - Food and Chemical Toxicology
ER -