{
  "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.",
  "abstract_shown": true,
  "affiliations": [
    "Universitas Perjuangan Tasikmalaya"
  ],
  "article_type": "New results",
  "arxiv": null,
  "author_total": 5,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "N. N. Fadilah"
    },
    {
      "name": "S. R. Nur Endah"
    },
    {
      "name": "S. A. Sumiwi"
    },
    {
      "name": "W. N. Aini"
    },
    {
      "name": "M. Ilham"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/2sqwtxr5fxhje.bib",
  "cited_by": 0,
  "doi": "10.64898/2026.10.20.760560",
  "fulltext_url": "https://www.biorxiv.org/content/10.64898/2026.10.20.760560v1.full",
  "id": "2sqwtxr5fxhje",
  "issns": [],
  "landing_url": "https://www.biorxiv.org/content/10.64898/2026.10.20.760560v1",
  "language": null,
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "biorxiv",
      "pharmacology and toxicology"
    ],
    [
      "openalex",
      "1110|Phytochemistry Medicinal Plant Applications"
    ]
  ],
  "openalex": "W7223330321",
  "pdf_url": "https://www.biorxiv.org/content/10.64898/2026.10.20.760560v1.full.pdf",
  "pmcid": null,
  "pmid": null,
  "published": "2026-10-20",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/2sqwtxr5fxhje.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:29:21Z",
      "native_id": "10.64898/2026.10.20.760560",
      "source": "biorxiv",
      "url": "https://www.biorxiv.org/content/10.64898/2026.10.20.760560v1"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "biorxiv:pharmacology and toxicology",
      "subfield": "pharmacology-toxicology"
    }
  ],
  "title": "Acute and 90-Day Repeated-Dose Oral Toxicity of Urtica dioica L. Leaf Extract Granules in Rodents",
  "title_text": "Acute and 90-Day Repeated-Dose Oral Toxicity of Urtica dioica L. Leaf Extract Granules in Rodents",
  "type": "preprint",
  "updated_at": "2026-10-30T12:29:21Z",
  "url": "https://research.draconitic.com/paper/2sqwtxr5fxhje",
  "venue": "bioRxiv",
  "versions": []
}