A 13-week subchronic toxicity study of vanillin propylene glycol acetal in F344 rats. (October 2019)

• Record Type: Journal Article
• Authors: Matsushita, Kohei; Toyoda, Takeshi; Morikawa, Tomomi; Ogawa, Kumiko
• Is Part Of: Food and chemical toxicology. Volume 132(2019)
• Publication Date: 2019-10
• Subjects: Vanillin propylene glycol acetal -- Flavoring agent -- Subchronic toxicity -- F344 rats -- Hepatocellular hypertrophy; Toxicology -- Periodicals; Food poisoning -- Periodicals; Food Poisoning -- Periodicals; Toxicology -- Periodicals; Toxicologie -- Périodiques; Intoxications alimentaires -- Périodiques; Food poisoning; Toxicology; Periodicals; Electronic journals; 615.9
• DOI: 10.1016/j.fct.2019.110643
• Languages: English
• ISSNs: 0278-6915

Abstract

Abstract: Vanillin propylene glycol acetal (VPGA) has been used as a flavoring agent. Here, we performed a 13-week subchronic toxicity study of VPGA in F344 rats with oral administration by gavage at doses of 0, 100, 300, and 1000 mg/kg body weight (BW)/day. In the 1000 mg/kg BW group, loss of vigorous activity and listlessness immediately after administration were observed for both sexes throughout the experimental period. Reduction of body weight gain was noted in both sexes at 1000 mg/kg BW. Serum biochemistry demonstrated significant increases in total protein, albumin, total cholesterol, calcium, inorganic phosphorus, and γ-glutamyl transpeptidase in both sexes at 1000 mg/kg BW and increases in the albumin/globulin ratio and urea nitrogen in the male 1000 mg/kg BW group. A significant increase in relative liver weight was detected in both sexes at 1000 mg/kg BW. Histopathologically, centrilobular hepatocellular hypertrophy in the liver was observed in both sexes at 1000 mg/kg BW. In addition, the incidence of fatty changes in hepatocytes in the male 1000 mg/kg BW group was decreased compared with that in the control. Based on these results, the no-observed-adverse-effect level for VPGA was evaluated to be 300 mg/kg BW/day for both sexes in the current study. Highlights: Vanillin propylene glycol acetal was assessed for 13-week subchronic toxicity. Loss of vigorous activity and listlessness were noted in both sexes at 1000 mg/kg. Reduction of body weight gain was observed in both sexes at 1000 mg/kg. Hepatocellular hypertrophy was detected in both sexes at 1000 mg/kg. The no-observed-adverse-effect level was 300 mg/kg for both sexes.