---
title: "Toxicity Evaluation of Urtica dioica Leaf Extract Granules: Acute and 90-Day Oral Studies in Roden"
id: "biorxiv-21-acute-and-90-day-repeated-dose-oral-toxicity-of-urtica-dioica-l-leaf-extract"
canonical_url: "https://medichelpline.com/clinical-feed/biorxiv-21-acute-and-90-day-repeated-dose-oral-toxicity-of-urtica-dioica-l-leaf-extract"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "bioRxiv (Biomedical Preprints)"
source_url: "https://www.biorxiv.org/content/10.64898/2026.10.20.760560v1?rss=1"
published_at: "2026-10-23T12:00:00.000Z"
evidence_level: "Verified Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Toxicity Evaluation of Urtica dioica Leaf Extract Granules: Acute and 90-Day Oral Studies in Roden
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/biorxiv-21-acute-and-90-day-repeated-dose-oral-toxicity-of-urtica-dioica-l-leaf-extract
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** bioRxiv (Biomedical Preprints)
- **Source URL:** [Original Journal Publication](https://www.biorxiv.org/content/10.64898/2026.10.20.760560v1?rss=1)
- **Published At:** 2026-10-23T12:00:00.000Z
- **Evidence Rating:** Verified Feed
## Executive GIST (TL;DR)
- Investigators tested granules made from an ethanolic extract of **Urtica dioica** leaves in standard rodent models to assess acute and subchronic oral toxicity under Indonesian BPOM Regulation No. 10 of 2022. - Female Swiss Webster mice received a single oral dose at 5, 50, 500, or 5000 mg/kg; no mortality occurred up to 5000 mg/kg, indicating an **LD50** greater than that highest dose. - Sprague–Dawley rats (both sexes, five per sex per group) were dosed daily for 13 weeks at 77.5, 155, or 310 mg/kg/day, with satellite groups observed through a 30-day recovery period. - Clinical signs, body weight trajectories, and rectal temperature showed no clear dose-related adverse pattern during acute testing. - After 90 days, erythrocyte indices, blood urea nitrogen and creatinine were unchanged in both sexes, suggesting no overt hemolytic or renal toxicity in measured parameters. - High-dose females showed a statistically significant leukocyte count increase (p < 0.05); this change was not present in the high-dose recovery group. - Liver weight differed among female groups, but the differences did not follow a dose-response pattern reported by the authors. - Weight gain at the highest dose differed from control in both sexes, but the direction of change was opposite between males and females. - Control group values were outside the strain reference range and there was a baseline body-weight imbalance across groups; these issues prevented the study team from establishing a definitive no-observed-adverse-effect level (NOAEL). - The report is a preprint and has not undergone peer review; the authors declared no competing interests.
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Leaf Extract Granules in Rodents [ View ORCID Profile](http://orcid.org/0000-0002-2295-5698)Nitya Nurul Fadilah, Srie Rezeki Nur Endah, Sri Adi Sumiwi, Widya Nurul Aini, Muhammad Ilham doi: https://doi.org/10.64898/2026.10.20.760560 This article is a preprint and has not been certified by peer review [[what does this mean?](https://www.biorxiv.org/about/FAQ#unrefereed)]. Nitya Nurul Fadilah 1 Universitas Perjuangan Tasikmalaya; * [Find this author on Google Scholar](https://www.biorxiv.org/lookup/google-scholar?link_type=googlescholar&gs_type=author&author%5B0%5D=Nitya%2B%2BNurul%2BFadilah%2B "Open in new tab") * [Find this author on PubMed](https://www.biorxiv.org/lookup/external-ref?access_num=Fadilah%20N&link_type=AUTHORSEARCH "Open in new tab") * [Search for this author on this site](https://www.biorxiv.org/search/author1%3ANitya%2B%2BNurul%2BFadilah%2B) * [ORCID record for Nitya Nurul Fadilah](http://orcid.org/0000-0002-2295-5698 "Open in new tab") * For correspondence: nityanurul@gmail.com Srie Rezeki Nur Endah 1 Universitas Perjuangan Tasikmalaya; * [Find this author on Google Scholar](https://www.biorxiv.org/lookup/google-scholar?link_type=googlescholar&gs_type=author&author%5B0%5D=Srie%2B%2BRezeki%2BNur%2BEndah%2B "Open in new tab") * [Find this author on PubMed](https://www.biorxiv.org/lookup/external-ref?access_num=Nur%20Endah%20S&link_type=AUTHORSEARCH "Open in new tab") * [Search for this author on this site](https://www.biorxiv.org/search/author1%3ASrie%2B%2BRezeki%2BNur%2BEndah%2B) Sri Adi Sumiwi 2 Universitas Padjadjaran * [Find this author on Google Scholar](https://www.biorxiv.org/lookup/google-scholar?link_type=googlescholar&gs_type=author&author%5B0%5D=Sri%2B%2BAdi%2BSumiwi%2B "Open in new tab") * [Find this author on PubMed](https://www.biorxiv.org/lookup/external-ref?access_num=Sumiwi%20S&link_type=AUTHORSEARCH "Open in new tab") * [Search for this author on this site](https://www.biorxiv.org/search/author1%3ASri%2B%2BAdi%2BSumiwi%2B) Widya Nurul Aini 1 Universitas Perjuangan Tasikmalaya; * [Find this author on Google Scholar](https://www.biorxiv.org/lookup/google-scholar?link_type=googlescholar&gs_type=author&author%5B0%5D=Widya%2B%2BNurul%2BAini%2B "Open in new tab") * [Find this author on PubMed](https://www.biorxiv.org/lookup/external-ref?access_num=Aini%20W&link_type=AUTHORSEARCH "Open in new tab") * [Search for this author on this site](https://www.biorxiv.org/search/author1%3AWidya%2B%2BNurul%2BAini%2B) Muhammad Ilham 1 Universitas Perjuangan Tasikmalaya; * [Find this author on Google Scholar](https://www.biorxiv.org/lookup/google-scholar?link_type=googlescholar&gs_type=author&author%5B0%5D=Muhammad%2BIlham%2B "Open in new tab") * [Find this author on PubMed](https://www.biorxiv.org/lookup/external-ref?access_num=Ilham%20M&link_type=AUTHORSEARCH "Open in new tab") * [Search for this author on this site](https://www.biorxiv.org/search/author1%3AMuhammad%2BIlham%2B) * [Abstract](https://www.biorxiv.org/content/10.64898/2026.10.20.760560v1)[](https://www.biorxiv.org/panels_ajax_tab/biorxiv_tab_art/node:5897916/1) * [Info/History](https://www.biorxiv.org/content/10.64898/2026.10.20.760560v1.article-info)[](https://www.biorxiv.org/panels_ajax_tab/biorxiv_tab_info/node:5897916/1) * [Metrics](https://www.biorxiv.org/content/10.64898/2026.10.20.760560v1.article-metrics)[](https://www.biorxiv.org/panels_ajax_tab/article_tab_metrics/node:5897916/1) * [ Preview PDF](https://www.biorxiv.org/content/10.64898/2026.10.20.760560v1.full.pdf+html)[](https://www.biorxiv.org/panels_ajax_tab/biorxiv_tab_pdf/node:5897916/1) ![Loading](https://www.biorxiv.org/sites/all/modules/contrib/panels_ajax_tab/images/loading.gif) ## 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 The Chan Zuckerberg Initiative, Cold Spring Harbor Laboratory, the Sergey Brin Family Foundation, California Institute of Technology, Centre National de la Recherche Scientifique, Fred Hutchinson Cancer Center, Imperial College London, Massachusetts Institute of Technology, Stanford University, The University of Edinburgh, University of Washington, and Vrije Universiteit Amsterdam. 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