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Single-dose oral toxicity of fermented rice extracts (FREs): a 14-day observation
Jae-Suk Choi1, Joo-Wan Kim2, Ki-Young Kim2
1RIS Center,IACF, Silla University, Gwaebup-dong, Sasang-gu, Busan, Republic of Korea.
Abstract:
The aim of present research was to determine the acute oral toxicity of fermented rice extracts (FREs), in female and male ICR mice. To investigate the toxicity and identify target organs, FREs were orally administered once to male and female ICR mice at doses of 0 (vehicle control), 500, 1000, or 2000 mg/kg body weight (BW). Effects on mortality, BW, and clinical signs were monitored over 14 days, including changes in the weights and histopathological characteristics of 14 organs, as described in the Korea Food and Drug Administration (KFDA) Guidelines (2009-116, 2009). No treatment-related mortality was observed during the 14-day observation period in either gender. In addition, no FRE-related change was observed in BW or organ weight (OW), clinical indicators, or histopathological findings in this study. Our results suggest that the FRE is non-toxic in mice and is therefore likely to be safe for clinical use. The approximate LD and LD50 in mice after single oral dose of FRE are greater than 2000 mg/kg in female and male ICR mice. Additionally, no specific target organ or negative clinical indicator was detected in this study.
Insights
Fermented rice extracts (FREs) demonstrated no toxicity in male and female ICR mice during a 14-day study. These findings suggest fermented rice extracts are safe for potential clinical applications.
Area of Science:
- Toxicology
- Pharmacology
- Food Science
Background:
- Fermented rice extracts (FREs) are utilized in various applications.
- Assessing the safety profile of FREs is crucial for their clinical use.
Purpose of the Study:
- To determine the acute oral toxicity of fermented rice extracts (FREs) in female and male ICR mice.
- To identify potential target organs and adverse effects following single oral administration of FREs.
Main Methods:
- Mice (female and male ICR) were administered FREs orally at doses of 0, 500, 1000, or 2000 mg/kg body weight.
- Monitoring included mortality, body weight, clinical signs, organ weights, and histopathological examination of 14 organs over 14 days.
- Study protocols followed Korea Food and Drug Administration (KFDA) guidelines.
Main Results:
- No treatment-related mortality was observed in any group.
- No significant changes were noted in body weight, organ weight, clinical indicators, or histopathological findings.
- The median lethal dose (LD50) was determined to be greater than 2000 mg/kg for both genders.
Conclusions:
- Fermented rice extracts (FREs) exhibit a non-toxic profile in mice following acute oral administration.
- The study suggests FREs are likely safe for clinical use.
- No specific target organs or adverse clinical indicators were identified.
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