Acute and Subchronic Oral Toxicity Evaluation of Herbal Formulation: Piper crocatum Ruiz and Pav., Typhonium flagelliforme (Lodd.) Blume, and Phyllanthus niruri L. in Sprague–Dawley Rats

Background. The product combination of Piper crocatum Ruiz. and Pav., Phyllanthus niruri Linn., and Typhonium flagelliforme (Lodd.) BL ethanolic extract (SKM) exerts immunomodulatory activity. However, the toxicity profile of the combination has never been investigated. Objective. This study aimed t...

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Main Authors: Retno Murwanti, A. Nurrochmad, Andayana P. Gani, Ediati Sasmito, Angela E. Edwina, Mayang K. Chandra, F. H. Suryawan, A. R. Wardana, null Natalia, Jelita L. S. R. Budiningsih
Format: Article
Language:English
Published: Wiley 2023-01-01
Series:Journal of Toxicology
Online Access:http://dx.doi.org/10.1155/2023/7511397
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author Retno Murwanti
A. Nurrochmad
Andayana P. Gani
Ediati Sasmito
Angela E. Edwina
Mayang K. Chandra
F. H. Suryawan
A. R. Wardana
null Natalia
Jelita L. S. R. Budiningsih
author_facet Retno Murwanti
A. Nurrochmad
Andayana P. Gani
Ediati Sasmito
Angela E. Edwina
Mayang K. Chandra
F. H. Suryawan
A. R. Wardana
null Natalia
Jelita L. S. R. Budiningsih
author_sort Retno Murwanti
collection DOAJ
description Background. The product combination of Piper crocatum Ruiz. and Pav., Phyllanthus niruri Linn., and Typhonium flagelliforme (Lodd.) BL ethanolic extract (SKM) exerts immunomodulatory activity. However, the toxicity profile of the combination has never been investigated. Objective. This study aimed to establish the acute toxicity profile of the SKM product on Sprague–Dawley (SD) rats and its subchronic toxicity profile on female SD rats. Method. The acute and subchronic toxicity tests were conducted in accordance with OECD 423 and OECD 408, respectively. Result. The SKM product was safe up to 5000 mg/kg b.w. in male and female SD rats. In repeated doses of SKM for 90 days, the administration of 22.5, 45, and 90 mg/kg b.w. per day of the SKM product to female SD rats did not affect clinical signs, body weight, food and water consumption, hematological parameters, clinical chemical parameters, urinalysis, relative organ weights, and gross pathological and histopathological features compared with the control group. Conclusion. Analyses of these results suggest that the long-term oral administration of the SKM product for 90 days does not cause subchronic toxicity.
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publishDate 2023-01-01
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spelling doaj-art-b0dd694c24764d3f8d8e08f55fbba8e02025-02-03T05:57:24ZengWileyJournal of Toxicology1687-82052023-01-01202310.1155/2023/7511397Acute and Subchronic Oral Toxicity Evaluation of Herbal Formulation: Piper crocatum Ruiz and Pav., Typhonium flagelliforme (Lodd.) Blume, and Phyllanthus niruri L. in Sprague–Dawley RatsRetno Murwanti0A. Nurrochmad1Andayana P. Gani2Ediati Sasmito3Angela E. Edwina4Mayang K. Chandra5F. H. Suryawan6A. R. Wardana7null Natalia8Jelita L. S. R. Budiningsih9Department of Pharmacology and Clinical PharmacyDepartment of Pharmacology and Clinical PharmacyMedicinal Plants and Natural Products Research CenterDepartment of Pharmaceutical ChemistryDepartment of Pharmacology and Clinical PharmacyDepartment of Pharmacology and Clinical PharmacyDepartment of Pharmacology and Clinical PharmacyDepartment of Pharmacology and Clinical PharmacyDepartment of Pharmacology and Clinical PharmacyDepartment of Pharmacology and Clinical PharmacyBackground. The product combination of Piper crocatum Ruiz. and Pav., Phyllanthus niruri Linn., and Typhonium flagelliforme (Lodd.) BL ethanolic extract (SKM) exerts immunomodulatory activity. However, the toxicity profile of the combination has never been investigated. Objective. This study aimed to establish the acute toxicity profile of the SKM product on Sprague–Dawley (SD) rats and its subchronic toxicity profile on female SD rats. Method. The acute and subchronic toxicity tests were conducted in accordance with OECD 423 and OECD 408, respectively. Result. The SKM product was safe up to 5000 mg/kg b.w. in male and female SD rats. In repeated doses of SKM for 90 days, the administration of 22.5, 45, and 90 mg/kg b.w. per day of the SKM product to female SD rats did not affect clinical signs, body weight, food and water consumption, hematological parameters, clinical chemical parameters, urinalysis, relative organ weights, and gross pathological and histopathological features compared with the control group. Conclusion. Analyses of these results suggest that the long-term oral administration of the SKM product for 90 days does not cause subchronic toxicity.http://dx.doi.org/10.1155/2023/7511397
spellingShingle Retno Murwanti
A. Nurrochmad
Andayana P. Gani
Ediati Sasmito
Angela E. Edwina
Mayang K. Chandra
F. H. Suryawan
A. R. Wardana
null Natalia
Jelita L. S. R. Budiningsih
Acute and Subchronic Oral Toxicity Evaluation of Herbal Formulation: Piper crocatum Ruiz and Pav., Typhonium flagelliforme (Lodd.) Blume, and Phyllanthus niruri L. in Sprague–Dawley Rats
Journal of Toxicology
title Acute and Subchronic Oral Toxicity Evaluation of Herbal Formulation: Piper crocatum Ruiz and Pav., Typhonium flagelliforme (Lodd.) Blume, and Phyllanthus niruri L. in Sprague–Dawley Rats
title_full Acute and Subchronic Oral Toxicity Evaluation of Herbal Formulation: Piper crocatum Ruiz and Pav., Typhonium flagelliforme (Lodd.) Blume, and Phyllanthus niruri L. in Sprague–Dawley Rats
title_fullStr Acute and Subchronic Oral Toxicity Evaluation of Herbal Formulation: Piper crocatum Ruiz and Pav., Typhonium flagelliforme (Lodd.) Blume, and Phyllanthus niruri L. in Sprague–Dawley Rats
title_full_unstemmed Acute and Subchronic Oral Toxicity Evaluation of Herbal Formulation: Piper crocatum Ruiz and Pav., Typhonium flagelliforme (Lodd.) Blume, and Phyllanthus niruri L. in Sprague–Dawley Rats
title_short Acute and Subchronic Oral Toxicity Evaluation of Herbal Formulation: Piper crocatum Ruiz and Pav., Typhonium flagelliforme (Lodd.) Blume, and Phyllanthus niruri L. in Sprague–Dawley Rats
title_sort acute and subchronic oral toxicity evaluation of herbal formulation piper crocatum ruiz and pav typhonium flagelliforme lodd blume and phyllanthus niruri l in sprague dawley rats
url http://dx.doi.org/10.1155/2023/7511397
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