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

• Published in: Food and chemical toxicology 2016-11, Vol.97, p.57-69
• Main Authors: 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.
• Format: Article
• Language: English
• Subjects: Administration, Oral; Animals; Carbon Radioisotopes - analysis; Dietary Fiber - administration & dosage; Dietary Fiber - toxicity; Dose-Response Relationship, Drug; Feces - chemistry; Female; Fiber; Food Additives - administration & dosage; Food Additives - toxicity; Glucans - administration & dosage; Glucans - toxicity; Male; No-Observed-Adverse-Effect Level; Oral; Rat; Rats; Rats, Sprague-Dawley; Starch - administration & dosage; Starch - toxicity; Subchronic toxicity
• ISSN: 0278-6915; 1873-6351
• DOI: 10.1016/j.fct.2016.08.030

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. •Subchronic dietary administration of up to 10,000 mg corn starch fiber/kg-bw/day to rats resulted in no adverse effects.•The toxicity profile of corn starch fiber was comparable to polydextrose at an equivalent dose level.•After [14C]-corn starch fiber dosing, nearly complete excretion of the administered dose occurred over 168 h post-dosing.