title: A 90-day oral (dietary) toxicity and mass balance study of corn starch fiber in Sprague Dawley rats.
abstract: 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.
authors: Cargill, Inc., 15407 McGinty Road West, Wayzata, MN 55391, USA. Electronic address: christine_crincoli@cargill.com.
authors: Christine M
authors: CM
authors: Crincoli
authors: Toxicology Regulatory Services, Charlottesville, VA, USA.
authors: Andrey I
authors: AI
authors: Nikiforov
authors: Toxicology Regulatory Services, Charlottesville, VA, USA.
authors: Marisa O
authors: MO
authors: Rihner
authors: Charles River Laboratories Ashland, LLC, Ashland, OH, USA.
authors: Elizabeth A
authors: EA
authors: Lambert
authors: Charles River Laboratories Ashland, LLC, Ashland, OH, USA.
authors: Melanie A
authors: MA
authors: Greeley
authors: Charles River Laboratories Ashland, LLC, Ashland, OH, USA.
authors: Justin
authors: J
authors: Godsey
authors: Cargill, Inc., 15407 McGinty Road West, Wayzata, MN 55391, USA.
authors: Alex K
authors: AK
authors: Eapen
authors: Food Protection and Defense Institute, University of Minnesota, Saint Paul, MN, USA.
authors: Jennifer L G
authors: JL
authors: van de Ligt
mesh_terms: D000284:Administration, Oral; D000818:Animals; D002250:Carbon Radioisotopes / Q000032:analysis*; D004043:Dietary Fiber / Q000008:administration & dosage / Q000633:toxicity*; D004305:Dose-Response Relationship, Drug; D005243:Feces / Q000737:chemistry*; D005260:Female; D005503:Food Additives / Q000008:administration & dosage / Q000633:toxicity; D005936:Glucans / Q000008:administration & dosage / Q000633:toxicity; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D051381:Rats; D017207:Rats, Sprague-Dawley; D013213:Starch / Q000008:administration & dosage / Q000633:toxicity*
chemical_list: D002250:Carbon Radioisotopes; D004043:Dietary Fiber; D005503:Food Additives; D005936:Glucans; D013213:Starch; C033375:polydextrose
keywords: Fiber; Oral; Rat; Subchronic toxicity