Acute and 90-Day Repeated-Dose Oral Toxicity of Urtica dioica L. Leaf Extract Granules in Rodents
- 1Universitas Perjuangan Tasikmalaya
Abstract
Urtica dioica L. leaves are traditionally used in Indonesia for gout-related complaints, and granules formulated from their ethanolic leaf extract have shown xanthine oxidase inhibitory and uric acid-lowering activity; the safety of the finished formulation, however, remains uncharacterised. This study evaluated acute and repeated-dose oral toxicity under Indonesian National Agency of Drug and Food Control (BPOM) Regulation No. 10 of 2022. Female Swiss Webster mice received a single dose of 5, 50, 500, or 5000 mg/kg granules, and Sprague-Dawley rats of both sexes (five per sex per group) received 77.5, 155, or 310 mg/kg/day for 13 weeks (90 days), with satellite groups observed through a 30-day recovery period. No mortality occurred at 5000 mg/kg, giving an LD50 above that limit; clinical signs, body weight, and rectal temperature showed no dose-related change. After repeated dosing, erythrocyte indices, blood urea nitrogen, and creatinine were unchanged in both sexes. Leukocyte count rose in high-dose females (p < 0.05) but was not observed in the high-dose recovery group, and liver weight differed among female groups without a dose-response pattern. Weight gain at the highest dose differed from control in both sexes but in opposite directions. Control values outside the strain reference range and baseline body-weight imbalance preclude establishing a no-observed-adverse-effect level.
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BibTeX
@misc{fadilah2026acute,
title = {{Acute and 90-Day Repeated-Dose Oral Toxicity of Urtica dioica L. Leaf Extract Granules in Rodents}},
author = {N. N. Fadilah and S. R. Nur Endah and S. A. Sumiwi and W. N. Aini and M. Ilham},
howpublished = {bioRxiv},
year = {2026},
month = oct,
doi = {10.64898/2026.10.20.760560},
url = {https://www.biorxiv.org/content/10.64898/2026.10.20.760560v1},
note = {CC BY},
}
RIS
TY - UNPB
TI - Acute and 90-Day Repeated-Dose Oral Toxicity of Urtica dioica L. Leaf Extract Granules in Rodents
AU - N. N. Fadilah
AU - S. R. Nur Endah
AU - S. A. Sumiwi
AU - W. N. Aini
AU - M. Ilham
PY - 2026
DA - 2026/10/20
PB - bioRxiv
DO - 10.64898/2026.10.20.760560
UR - https://www.biorxiv.org/content/10.64898/2026.10.20.760560v1
AB - Urtica dioica L. leaves are traditionally used in Indonesia for gout-related complaints, and granules formulated from their ethanolic leaf extract have shown xanthine oxidase inhibitory and uric acid-lowering activity; the safety of the finished formulation, however, remains uncharacterised. This study evaluated acute and repeated-dose oral toxicity under Indonesian National Agency of Drug and Food Control (BPOM) Regulation No. 10 of 2022. Female Swiss Webster mice received a single dose of 5, 50, 500, or 5000 mg/kg granules, and Sprague-Dawley rats of both sexes (five per sex per group) received 77.5, 155, or 310 mg/kg/day for 13 weeks (90 days), with satellite groups observed through a 30-day recovery period. No mortality occurred at 5000 mg/kg, giving an LD50 above that limit; clinical signs, body weight, and rectal temperature showed no dose-related change. After repeated dosing, erythrocyte indices, blood urea nitrogen, and creatinine were unchanged in both sexes. Leukocyte count rose in high-dose females (p < 0.05) but was not observed in the high-dose recovery group, and liver weight differed among female groups without a dose-response pattern. Weight gain at the highest dose differed from control in both sexes but in opposite directions. Control values outside the strain reference range and baseline body-weight imbalance preclude establishing a no-observed-adverse-effect level.
ER -