Toxicological evaluation and preliminary exposure assessment on glycerol monocaprylate

Jin Fang; Yongquan Feng; Haibo Liu; Yuan Zhi; Xiaodan Wang; Huiling Wang; Jiyue Zhang; Huali Wang; Zhou Yu; Jianbo Zhang; Xudong Jia

doi:10.1016/j.fct.2024.114715

Toxicological evaluation and preliminary exposure assessment on glycerol monocaprylate

Food Chem Toxicol. 2024 May 9:189:114715. doi: 10.1016/j.fct.2024.114715. Online ahead of print.

Authors

Jin Fang¹, Yongquan Feng¹, Haibo Liu¹, Yuan Zhi¹, Xiaodan Wang¹, Huiling Wang¹, Jiyue Zhang¹, Huali Wang¹, Zhou Yu¹, Jianbo Zhang², Xudong Jia³

Affiliations

¹ NHC Key Laboratory of Food Safety Risk Assessment, Chinese Academy of Medical Science Research Unit (2019RU014), China National Center for Food Safety Risk Assessment, Beijing, 100021, China.
² NHC Key Laboratory of Food Safety Risk Assessment, Chinese Academy of Medical Science Research Unit (2019RU014), China National Center for Food Safety Risk Assessment, Beijing, 100021, China. Electronic address: zhangjianbo@cfsa.net.cn.
³ NHC Key Laboratory of Food Safety Risk Assessment, Chinese Academy of Medical Science Research Unit (2019RU014), China National Center for Food Safety Risk Assessment, Beijing, 100021, China. Electronic address: jiaxudong@cfsa.net.cn.

PMID: 38729342
DOI: 10.1016/j.fct.2024.114715

Abstract

As a commonly used food preservative, glycerol monocaprylate (GMC) has limited information and lacked a comprehensive risk assessment. In this study, we conducted in vitro genotoxicity tests, a 90-day subchronic toxicity study, and dietary exposure assessment in China. Rats (n = 10/sex/group) were orally administered GMC at doses of 1.02, 2.04, and 4.08 g/kg BW/day along with a water and corn oil for 90 days, including satellite groups (n = 5/sex/group) in the control groups and 4.08 g/kg BW dose group for observation after 90 days. Body weight, food consumption, hematology, serum biochemistry, urinalysis, endocrine hormone level and other metrics were examined. GMC did not exhibit genotoxicity based on the genotoxicity tests results, and an acceptable daily intake (ADI) of 40.8 mg/kg BW/day was established based on the 90-day subchronic toxicity study. Estimated daily intake of GMC for general population and consumer population in China were 0.99 mg/kg BW/day and 3.19 mg/kg BW/day respectively, which were significantly lower than the ADI. Our findings suggest that GMC does not pose a known health risk to Chinese consumers at the current usage level.

Keywords: Acceptable daily intake; Dietary exposure assessment; Genotoxicity; Glycerol monocaprylate; Risk assessment; Subchronic toxicity.