A 90-day subchronic toxicity study of 5-methyl-2-phenyl-2-hexenal in F344 rats
Kenji Nakamura1, Yuji Ishii2, Shinji Takasu2
1Division of Pathology, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa, 210-9501, Japan; Laboratory of Veterinary Pathology, Tokyo University of Agriculture and Technology, 3-5-8 Saiwai-cho, Fuchu-shi, Tokyo, 183-8509, Japan.
Abstract:
5-Methyl-2-phenyl-2-hexenal (MPH) has been used as a flavoring agent. In the present study, we performed a subchronic toxicity study in male and female F344 rats with oral administration of MPH by gavage at 0, 8, 24 and 70 mg/kg body weight (BW)/day for 90 days. No mortality or clinical signs were observed during the experimental period. Body weight and food consumption for all treated groups of both sexes were essentially the same as for the respective control groups. Hematologic examination demonstrated significant decreases in monocyte counts for females given 24 and 70 mg/kg BW/day. However, these changes were not substantial and no related histopathological changes were observed, suggesting that these changes were not toxicologically significant. Among organ weights, the absolute and/or relative weights of testes and liver were significantly increased in the 70 mg/kg BW/day groups of males and females, respectively, but no related histopathological changes were observed, suggesting that these changes did not reflect adverse effects. In addition, no treatment-related histopathological changes were observed for any of the tissues examined. Based on the overall data, the no-observed-adverse-effect level (NOAEL) for MPH was determined to be 70 mg/kg BW/day, the highest dose tested, in both male and female rats.
Insights
The flavoring agent 5-Methyl-2-phenyl-2-hexenal (MPH) showed no adverse effects in a 90-day rat toxicity study. The highest dose tested (70 mg/kg BW/day) was determined to be the no-observed-adverse-effect level (NOAEL) for both male and female rats.
Area of Science:
- Toxicology
- Food Science
- Chemical Safety
Background:
- 5-Methyl-2-phenyl-2-hexenal (MPH) is utilized as a flavoring agent in various products.
- Understanding the safety profile of food additives like MPH is crucial for consumer protection.
Purpose of the Study:
- To evaluate the subchronic toxicity of 5-Methyl-2-phenyl-2-hexenal (MPH) following oral administration in rats.
- To determine the no-observed-adverse-effect level (NOAEL) for MPH in a 90-day feeding study.
Main Methods:
- Male and female F344 rats were administered MPH orally via gavage at doses of 0, 8, 24, and 70 mg/kg body weight/day for 90 days.
- Comprehensive toxicological assessments included monitoring clinical signs, body weight, food consumption, hematology, serum biochemistry, organ weights, and histopathology.
Main Results:
- No mortality or treatment-related clinical signs were observed. Body weight and food consumption remained comparable between treated and control groups.
- Minor, non-adverse hematological changes (decreased monocyte counts in females) and increased organ weights (testes in males, liver in females) at the highest dose lacked histopathological correlation.
- No treatment-related histopathological findings were identified in any examined tissues.
Conclusions:
- 5-Methyl-2-phenyl-2-hexenal (MPH) did not induce significant toxicity in rats during a 90-day subchronic study.
- The no-observed-adverse-effect level (NOAEL) for MPH was established at 70 mg/kg body weight/day, the highest dose tested, for both sexes.
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