Toxicological evaluation of a pumpkin-derived pectin preparation: in vitro genotoxicity studies and a 13-week oral toxicity study in Sprague-Dawley rats.

Autor:	Kleijn AF; Laboratory of Food Chemistry, Wageningen University and Research, Bornse Weilanden 9, Wageningen, WG 6708, The Netherlands., Mutter M; G3P Inc., 20 Mall Road Suite 220, Burlington, MA 01803, United States., Akingbasote JA; Intertek Health Sciences Inc., Food and Nutrition Group, 2233 Argentia Road, Suite 201, Mississauga, ON L5N 2X7, Canada., Meetro J; Intertek Health Sciences Inc., Food and Nutrition Group, 2233 Argentia Road, Suite 201, Mississauga, ON L5N 2X7, Canada., Simon RR; Intertek Health Sciences Inc., Food and Nutrition Group, 2233 Argentia Road, Suite 201, Mississauga, ON L5N 2X7, Canada., Muntendam P; G3P Inc., 20 Mall Road Suite 220, Burlington, MA 01803, United States., Frommhagen M; Société des Produits Nestlé SA, Nestlé Research, Route du Jorat 57, CH-1000, Lausanne 26, Switzerland., Schols HA; Laboratory of Food Chemistry, Wageningen University and Research, Bornse Weilanden 9, Wageningen, WG 6708, The Netherlands.
Jazyk:	angličtina
Zdroj:	Toxicology research [Toxicol Res (Camb)] 2024 Jan 23; Vol. 13 (1), pp. tfae004. Date of Electronic Publication: 2024 Jan 23 (Print Publication: 2024).
DOI:	10.1093/toxres/tfae004
Abstrakt:	The safety of a rhamnogalacturonan-I-enriched pectin extract (G3P-01) from pumpkin ( Cucurbita moschata var. Dickinson) was evaluated for use as an ingredient in food and dietary supplements. G3P-01 was tested in a battery of genetic toxicity studies including reverse mutagenicity and in vitro micronucleus assay. In addition, Sprague-Dawley rats were randomized and orally dosed with G3P-01 incorporated in animal diet at concentrations of 0, 9000, 18,000, and 36,000 ppm daily for 13-weeks (n=10/sex/group) in line with OECD guidelines (TG 408). The results of the in vitro bacterial reverse mutation assay and micronucleus assay in TK6 cells demonstrated a lack of genotoxicity. The 13-week oral toxicity study in Sprague-Dawley rats demonstrated that the test article, G3P-01 was well tolerated; there were no mortalities and no adverse effects on clinical, gross pathology, hematology, blood chemistry, and histological evaluation of the essential organs of the animals. The present study demonstrates that G3P-01 is non-genotoxic and is safe when ingested in diet at concentrations up to 36, 000 ppm. The subchronic no-observed-adverse-effect level (NOAEL) for G3P-01 was concluded to be 36,000 ppm, equivalent to 1,899 and 2,361 mg/kg/day for male and female rats respectively. Competing Interests: On behalf of all authors, the corresponding author declares the following financial interest/personal relationships that may be considered as potential competing interests: Authors 1 and 8 are employees of Wageningen University Research and have no competing interests/personal relationships which could have influenced the work reported in this paper. Author 2 is an employee and minor shareholder of G3P Inc. Author 6 is founder and major shareholder of G3P Inc. Authors 3, 4 and 5 are employees of Intertek Health Sciences Inc, and are consultants for G3P-01 Inc. Author 7 is employee of Société des Produits Nestlé SA and mainly contributed to this work without competing interests during his former employment at Wageningen University & Research. (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)
Databáze:	MEDLINE
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