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      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

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          Abstract

          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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          Acute and chronic toxicity of the aqueous extract of Artemisia afra in rodents.

          J Mukinda, J A Syce (2007)
          Artemisia afra (Jacq. Ex. Willd), "African Wormwood" is widely used traditionally in South Africa with no literature evidence substantiating its safety. The aim of this study was to investigate the safety of the aqueous extract of Artemisia afra by determining its pharmaco-toxicological effects after acute and chronic administration in mice and rats, respectively. The aqueous extract mimicked the traditional decoction dosage form of Artemisia afra. In mice, single intraperitoneal injections of Artemisia afra-extract (1.5-5.5g/kg) induced a regular dose-dependent increase in the death rate and incidence of general behaviour adverse effects, while with single oral doses (2-24g/kg) the increases in incidence of general behaviour adverse effects and mortality rate were dose-independent. The LD(50s) after acute intraperitoneal and oral doses were 2.45 and 8.96g/kg, respectively. Rats given oral doses of Artemisia afra-extract (0.1 or 1g/kg/day) survived the 3 months of dosing (i.e. LD(50) much higher than 1g/kg), experienced no significant changes in general behaviour and haematological and biochemical parameters, except for transient decrease in AST activity. No significant changes were observed in organ weights, and histopathological results showed normal profile suggesting no morphological alterations. Collectively, the results indicate that Artemisia afra-extract is non-toxic when given acutely, has low chronic toxicity potential and, in high doses, may have a hepatoprotective effect.
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            Toxicity potentials of the nutraceutical Moringa oleifera at supra-supplementation levels.

            George Awuku Asare, Ben Gyan, Kwasi Bugyei … (2012)
            Moringa oleifera Lam. (order -Moringales, family -Moringaceae and genus -Moringa) is a well known nutraceutical used in the treatment of hypercholesterolemia and hyperglycemia, and also, as a nutritional supplementation. Its popularity use raises the question of possible toxicity at supra-supplementation levels. The objective of the study was to ascertain possible acute toxicity with supra-supplementation using Sprague-Dawley (S-D) rats. In experiment 1, human peripheral blood mononuclear cells were given graded doses of Moringa oleifera aqueous leaf extract to induce cytotoxicity. In experiment 2, two groups of rats received low and high dose (LD and HD, respectively) levels (1,000 and 3,000 mg/kgb.wt, respectively) per o.s. alongside negative and positive control rats (0.9% saline and 10mg/mL N-ethyl-N-nitrosourea - administered i.m., respectively). Each group consisted of five rats. Rats were killed after 48 h and the femur bone marrow aspirate examined for polychromatic micronucleated erythrocytes (PCEMN)/normochromatic micronucleated erythrocytes (NCEMN) ratios after Giemsa/Leishman staining. In experiment 3, control, LD and HD groups were established. The LD and HD extracts were administered per o.s. to the respective groups and observed for 14 days. Each group consisted of five rats. Blood was sampled after 48 h and 14 days and examined biochemically and haematologically for acute toxicity. Experiment 1 showed that Moringa oleifera was cytotoxic at 20mg/mL. In experiment 2, PCEMN/NCEMN ratios were: negative control=2.087; LD=1.849; HD=1.397; positive control=1.257. Statistically, LD and HD ratios were significant (p=0.020). Experiment 3 showed that hepatonephro-toxicity was nil with no abnormal haematology results. Genotoxicity results have hitherto not been shown. Moringa oleifera is genotoxic at supra-supplementation levels of 3,000 mg/kg b.wt. However, intake is safe at levels ≤ 1,000 mg/kg b.wt.
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              Preliminary toxicity and phytochemical studies of the stem bark aqueous extract of Musanga cecropioides in rats.

              Adejuwon Adeneye, S Adeleke, Ibrahim Bello … (2006)
              These studies were designed to determine the preliminary oral toxicity profile of the crude aqueous stem bark extract of Musanga cecropioides (MCW) in adult Sprague-Dawley rats and its active chemical constituents by way of phytochemistry. The acute oral toxicity study was conducted using limit dose test of Up and Down Procedure according to the OECD/OCDE Test Guidelines on Acute Oral Toxicity (AOT425statPgm, version: 1.0) at a limit dose of 3,000 mg/kg body weight/oral route. Repeat dose oral toxicity studies were conducted by daily oral dosing of 750 mg/kg body weight of MCW dissolved in 1 ml of 0.9% saline and 1 ml of 0.9% saline to rats in the test and control groups, respectively, for 28 days. On day 29, blood samples for bioassays were collected by cardiac puncture under diethyl ether anesthesia. The phytochemical analysis was conducted using standard procedures. The LD(50) estimate of the extract was calculated to be greater than 3,000 mg/kg body weight/oral route. The extract caused a significant (P<0.05) decrease in weight gain, differential eosinophil count and increase in serum creatinine but did not affect the organ weights, other serum electrolytes (Na(+), K(+), HCO(3)(-)), liver enzymes and other hematological indices in test rats. Its phytochemical analysis showed it contains saponins, flavonoids, alkaloids, tannins, phlobatannins, glycosides, reducing sugars and anthraquinones. These results show that the aqueous extract of Musanga cecropioides is relatively safe toxicologically when administered orally. Thus, its use in folkloric medicine as an oral antihypertensive is relatively safe when used over the tested period.
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                Author and article information

                Contributors
                Retno Murwanti:
                ORCID: https://orcid.org/0000-0002-4320-8210
                Journal
                Journal ID (nlm-ta): J Toxicol
                Journal ID (iso-abbrev): J Toxicol
                Journal ID (publisher-id): jt
                Title: Journal of Toxicology
                Publisher: Hindawi
                ISSN (Print): 1687-8191
                ISSN (Electronic): 1687-8205
                Publication date Collection: 2023
                Publication date (Electronic): 3 January 2023
                Volume: 2023
                Electronic Location Identifier: 7511397
                Affiliations
                1Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta, Indonesia
                2Medicinal Plants and Natural Products Research Center, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta, Indonesia
                3Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta, Indonesia
                4Department of Pharmaceutical Biology, Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta, Indonesia
                Author notes

                Academic Editor: Mohd. Salman

                Author information
                https://orcid.org/0000-0002-4320-8210
                Article
                DOI: 10.1155/2023/7511397
                PMC ID: 9831695
                PubMed ID: 36636256
                SO-VID: 64eefec7-9e46-4e45-8cb2-f90acc623982
                Copyright © Copyright © 2023 Retno Murwanti et al.
                License:

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 11 October 2022
                Date revision received : 14 December 2022
                Date accepted : 21 December 2022
                Funding
                Funded by: Kementerian Riset Teknologi Dan Pendidikan Tinggi Republik Indonesia
                Award ID: 025/SP2H/PLDit.Litabmas/II/2015 and 206/LPPM/2015
                Categories
                Subject: Research Article

                ScienceOpen disciplines: Toxicology
                Data availability:
                ScienceOpen disciplines: Toxicology

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