Oral toxicity evaluation of freeze-dried honeybee pupa powder (HDPp) in ICR mice: single-dose and 4-week repeated-dose studies

Abstract

Drone pupae of honeybees (Apis mellifera L.) are rich in proteins, carbohydrates, fats, minerals, and vitamins, making them a valuable food ingredient in various regions including Korea, Japan, China, the United States, and parts of Europe. In this study, we investigated the safety of freeze-dried honeybee drone pupae (HDPp) as a potential functional food ingredient using single- and repeated-dose oral toxicity assessments. In the single-dose oral toxicity study, both male and female control groups were evaluated along with three test groups, each consisting of five animals, totaling 40 mice. The administered doses for the test groups were set at 2000, 1000, and 500 mg/kg body weight. The subjects were monitored over a period of 2 weeks following a single administration. Following the guidelines provided by the Korean Ministry of Food and Drug Safety, observations included mortality, changes in body weight, clinical symptoms, and post-mortem examinations of major organs for visual inspection and weight measurement. The repeated-dose oral toxicity study was extended over four weeks, employing the same dosages and methodology as the single-dose study. Additionally, this study incorporated blood and serological evaluations. The results demonstrated no toxicity-related effects in either single-dose or repeated-dose studies, suggesting that HDPp is a safe food ingredient with a lethal dose-50 exceeding 2000 mg/kg.