Safety Evaluation of Scutellaria baicalensis: Acute and 26-Week Repeated-Dose Oral Toxicity Studies in Rats.
- 1Department of Herbal Pharmacology, College of Korean Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Republic of Korea.
Abstract
Scutellaria baicalensis root is widely used in traditional medicine and functional foods, but information on its long-term toxicity remains limited. This study evaluated the acute and 26-week repeated-dose oral toxicity of S. baicalensis root extract (SBE) in male and female Sprague-Dawley rats under Good Laboratory Practice conditions. In the acute study, SBE was administered once at 2500 or 5000 mg/kg, followed by 14 days of observation. In the repeated-dose study, SBE was administered at 500, 1000, or 2000 mg/kg/day for 26 weeks, followed by a 4-week recovery period. No mortality occurred in either study. Acute administration caused only transient, non-adverse clinical signs, and the minimum lethal dose was >5000 mg/kg. Repeated administration at 2000 mg/kg/day increased relative liver weight and urinary ketone grades in both sexes, while absolute liver weight and serum triglycerides increased in females. These findings were considered treatment-related but non-adverse, without corroborating clinical, serum biochemical, or histopathological evidence of organ injury. The no-observed-effect level and no-observed-adverse-effect level were 1000 and 2000 mg/kg/day, respectively, and no target organ of toxicity was identified. These findings provide preclinical safety information for acute and long-term oral exposure to SBE.
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BibTeX
@article{song2026safety,
title = {{Safety Evaluation of Scutellaria baicalensis: Acute and 26-Week Repeated-Dose Oral Toxicity Studies in Rats.}},
author = {Jungbin Song and Hocheol Kim},
journal = {Toxics},
year = {2026},
month = oct,
doi = {10.3390/toxics14100919},
url = {https://europepmc.org/article/MED/42931707},
note = {CC BY},
}
RIS
TY - JOUR
TI - Safety Evaluation of Scutellaria baicalensis: Acute and 26-Week Repeated-Dose Oral Toxicity Studies in Rats.
AU - Jungbin Song
AU - Hocheol Kim
PY - 2026
DA - 2026/10/17
JO - Toxics
DO - 10.3390/toxics14100919
UR - https://europepmc.org/article/MED/42931707
AB - Scutellaria baicalensis root is widely used in traditional medicine and functional foods, but information on its long-term toxicity remains limited. This study evaluated the acute and 26-week repeated-dose oral toxicity of S. baicalensis root extract (SBE) in male and female Sprague-Dawley rats under Good Laboratory Practice conditions. In the acute study, SBE was administered once at 2500 or 5000 mg/kg, followed by 14 days of observation. In the repeated-dose study, SBE was administered at 500, 1000, or 2000 mg/kg/day for 26 weeks, followed by a 4-week recovery period. No mortality occurred in either study. Acute administration caused only transient, non-adverse clinical signs, and the minimum lethal dose was >5000 mg/kg. Repeated administration at 2000 mg/kg/day increased relative liver weight and urinary ketone grades in both sexes, while absolute liver weight and serum triglycerides increased in females. These findings were considered treatment-related but non-adverse, without corroborating clinical, serum biochemical, or histopathological evidence of organ injury. The no-observed-effect level and no-observed-adverse-effect level were 1000 and 2000 mg/kg/day, respectively, and no target organ of toxicity was identified. These findings provide preclinical safety information for acute and long-term oral exposure to SBE.
SN - 2305-6304
ER -