Evaluation of acute, subacute toxicity and in vivo impact of aqueous decoction of Flemingia faginea Guill. & Perr. (Barker) leafy stems on NMRI mice and normotensive Wistar rats
Abstract
Introduction: Flemingia faginea, a Fabaceae family medicinal plant, has been used for a long time in Burkina Faso for the treatment of hypertension and excess salt. However, the safety of the preparations derived from this plant has not yet been scientifically documented. This study aimed to evaluate the acute and subacute oral toxicity of the leafy stems aqueous decoction of F. faginea (FAD) in healthy normotensive mice and rats and the impact on their normal blood pressure. Material and Methods: The acute oral toxicity study was conducted according to the toxicity class method of the Economic Cooperation and Development Organization (OECD) guideline 423. Subacute toxicity was carried out according to the OECD Guideline 407 for repeated dose chemical toxicity for 28 days. Hematological and biochemical analyzes of blood were performed after autopsy. An evaluation of the impact of the extract on the blood pressure of rats was performed using the non-invasive method. Results: A single oral dose of 2000 mg/kg bw to mice did not cause mortality or clinical signs or symptoms of toxicity during the 14-day study. The FAD was classified in the fifth category of the Harmonized System of Classification of the United Nations and considered practically safe with an estimated 50% lethal dose of 5000 mg/kg bw. Daily gavage of male and female rats with doses of 100,500 and 1000 mg/kg did not result in mortality or significant adverse effects during the 28days of experimentation. There were no significant differences in body weight gain, food &water consumption or relative vital organ weights in treated animals. Analysis of the hematological and biochemical parameters of blood serum did not show significant differences between treated and control animals in this study. Additionally, no aberrant changes were found in the systolic and diastolic blood pressures of the test animals during the 28 days of inclusion compared to those of the control group. Conclusion: The extract FAD could be considered safe within the doses tested for the results of the toxicological evaluation. However, microscopic, histopathological, and subchronic investigations will have to be carried out to confirm the safety of this extract use.
Keywords:
Flemingia faginea, Lethal Dose 50, Acute toxicity, Subacute toxicity, Hypertension
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References
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30. Amarasiri SS, Attanayake AP, Arawwawala LDAM, Jayatilaka KAPW, Mudduwa LKB. Acute and 28-Day Repeated-Dose Oral Toxicity Assessment of Abelmoschus moschatus Medik. In Healthy Wistar Rats. Evidence-based Complement Altern Med 2020; 2020. https://doi.org/10.1155/2020/1359050
31. Chang CJ, Tzeng TF, Liou SS, Chang YS, Liu IM. Acute and 28-day subchronic oral toxicity of an ethanol extract of Zingiber zerumbet (L.) Smith in rodents. Evidence-based Complement Altern Med 2012; 2012. https://doi.org/10.1155/2012/608284
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34. Diaconu CC, Dediu GN, Iancu MA. Drug-induced arterial hypertension - a frequently ignored cause of secondary hypertension: a review. Acta Cardiol [homepage on the Internet] 2018 [cited 2022 Jul 16]; 73(6):511-517. Available from: https://pubmed.ncbi.nlm.nih.gov/29291681/ https://doi.org/10.1080/00015385.2017.1421445
35. Gyamlani G, Geraci SA. Secondary Hypertension due to Drugs and Toxins. South Med J [homepage on the Internet] 2007 [cited 2022 Jul 16];100(7):692-699. Available from: https://pubmed.ncbi.nlm.nih.gov/17639749/ https://doi.org/10.1097/SMJ.0b013e318063c3e8
2. Organization WH. WHO global report on traditional and complementary medicine 2019 [Homepage on the Internet]. Geneva: World Health Organization, 2019; Available from: https://apps.who.int/iris/handle/10665/312342
3. Stewart MH, Lavie CJ, Ventura HO. Emerging Therapy in Hypertension. Curr Hypertens Rep [homepage on the Internet] 2019; 21(3):1-9. Available from: https://link.springer.com/article/10.1007/s11906-019-0923-1 https://doi.org/10.1007/s11906-019-0923-1
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7. Brito-da-costa AM, Dias-da-silva D, Gomes NGM, Dinis-oliveira RJ, Madureira-carvalho Á. Toxicokinetics and Toxicodynamics of Ayahuasca Alkaloids N, N-Dimethyltryptamine (DMT), Harmine, Harmaline and Tetrahydroharmine: Clinical and Forensic Impact. Pharmaceuticals (Basel) [homepage on the Internet] 2020 [cited 2022 Jul 16]; 13(11):1-39. Available from: https://pubmed.ncbi.nlm.nih.gov/33114119/ https://doi.org/10.3390/ph13110334
8. Cisse A, Gueye M, Ka A, Ndiaye F, Koma S, Akpo L. Ethnobotanique des plantes médicinales chez les bergers peuls de Widou Thiengoly de la commune de Téssékéré ( Ferlo-Nord Sénégal ). J Appl Biosci 2016; 98:9301-9308. https://doi.org/10.4314/jab.v98i1.6
9. Assan G, Raymond N, Djingdia L, Amade O. Ex-situ propagation by cutting of Flemingea faginea (Guill. Perr.) (Burkina Faso, West Africa). J Hortic For 2021; 13(1):15-24. https://doi.org/10.5897/JHF2020.0659
10. Coulibaly B. CONTRIBUTION A L ' ETUDE DES EFFETS HYPOTENSEURS DE FLEMINGIA FAGINEA CHEZ LE RAT NORMOTENDU ( Mus ratus ). 2006;
11. Salas SP, Russo N M. [Analysis of the main ethical conflicts in the 2008 declaration of Helsinki and the proposed changes in the new version]. Rev médica Chile 2014; 142(4):475-480. https://doi.org/10.4067/S0034-98872014000400009
12. OCDE. Toxicité orale aiguë - Méthode par classe de toxicité aiguë [Homepage on the Internet]. OECD, 2001 [cited 2019 May 28]; Available from: https://www.oecd-ilibrary.org/environment/essai-n-423-toxicite-orale-aigue-methode-par-classe-de-toxicite-aigue_9789264071018-fr
13. OCDE. Essai n° 407: Toxicité orale à doses répétées - pendant 28 jours sur les rongeurs [Homepage on the Internet]. OECD, 2008 [cited 2020 Sep 2]; Available from: https://www.oecd-ilibrary.org/environment/essai-n-407-toxicite-orale-a-doses-repetees-pendant-28-jours-sur-les-rongeurs_9789264070691-fr
14. Belemnaba L, Nitiéma M, Ilboudo S, et al. Preclinical Evaluation of the Antihypertensive Effect of an Aqueous Extract of Anogeissus leiocarpa (DC) Guill et Perr. Bark of Trunk in L-NAME-Induced Hypertensive Rat. 2021; Available from: https://doi.org/10.2147/JEP.S319787
15. Zhu F-C, Li Y-H, Guan X-H, et al. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial. Lancet [homepage on the Internet] 2020 [cited 2020 Jun 7]; 395(10240):1845-1854. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0140673620312083
16. United nations Office on Drug and Crime. EXECUTIVE SUMMARY CONCLUSIONS AND POLICY IMPLICATIONS 1 WORLD DRUG REPORT [Homepage on the Internet]. 2017 [cited 2022 Jul 17]; Available from: www.unodc.org/wdr2017 https://doi.org/10.18356/66312961-en
17. OUEDRAOGO GG, ILBOUDO S, OUEDRAOGO S, et al. Acute and Subacute Oral Toxicity Studies and Anti-Sickling Activity Assessment of FACA® Syrup. J Drug Deliv Ther [homepage on the Internet] 2020 [cited 2022 Jul 15]; 10(5-s):40-50. Available from: http://jddtonline.info/index.php/jddt/article/view/4336 https://doi.org/10.22270/jddt.v10i5-s.4336
18. Mathieu N, Sylvain I, Lazare B, et al. ACUTE AND SUB-ACUTE TOXICITY STUDIES OF AQUEOUS DECOCTION OF THE TRUNK BARKS FROM LANNEA MICROCARPA ENGL . AND K . KRAUSE ( ANACARDIACEAE ) IN RODENTS. World J Pharm Pharm Sci 2018; 7(9):30-42.
19. Tran P-NT, Tran TTN. Evaluation of Acute and Subchronic Toxicity Induced by the Crude Ethanol Extract of Plukenetia volubilis Linneo Leaves in Swiss Albino Mice. Biomed Res Int [homepage on the Internet] 2021 [cited 2022 Jul 15]; 2021:1-13. Available from: https://www.hindawi.com/journals/bmri/2021/6524658/ https://doi.org/10.1155/2021/6524658
20. Sylvain I, Hortense S, Geoffroy GO, Félix BK, Sylvin O, Innocent PG. Phytochemical, acute and subacute toxicity studies of Annona senegalensis Pers. (Annonaceae) root wood extracts. African J Biochem Res [homepage on the Internet] 2019; 13(4):44-55. Available from: https://academicjournals.org/journal/AJBR/article-abstract/A1F229D60812 https://doi.org/10.5897/AJBR2019.1030
21. Santos EW, Oliveira DC de, Hastreiter A, et al. Hematological and biochemical reference values for C57BL/6, Swiss Webster and BALB/c mice. Brazilian J Vet Res Anim Sci [homepage on the Internet] 2016 [cited 2022 Jul 16]; 53(2):138-145. Available from: https://www.revistas.usp.br/bjvras/article/view/103850 https://doi.org/10.11606/issn.1678-4456.v53i2p138-145
22. World Health Organization (WHO). WHO Drug Information. 2010;
23. Ouedraogo GG, Ilboudo S, Ouedraogo N, Ouedraogo S, Diallo D, Guissou PI. PHYTOCHEMICAL STUDY AND CARDIOVASCULAR TOXIC EFFECTS INVESTIGATION OF ROOT BARKS POWDER AND EXTRACTS FROM CALOTROPIS PROCERA (AIT.) R.BR. Ouedraogo al World J Pharm Res World J Pharm Res SJIF Impact Factor 6 [homepage on the Internet] 2016 [cited 2022 Jul 15];5(9):299-316. Available from: www.wjpr.net
24. Devaki K, Beulah U, Akila G, Gopalakrishnan VK. Effect of Aqueous Extract of Passiflora edulis on Biochemical and Hematological Parameters of Wistar Albino Rats. Toxicol Int [homepage on the Internet] 2012 [cited 2022 Jul 16]; 19(1):63. Available from: /pmc/articles/PMC3339248/ https://doi.org/10.4103/0971-6580.94508
25. Jacob Filho W, Lima CC, Paunksnis MRR, et al. Reference database of hematological parameters for growing and aging rats. Aging Male 2018; 21(2):145-148. https://doi.org/10.1080/13685538.2017.1350156
26. Belemnaba L, Soubeiga M, Ouédraogo GG, et al. Antioxidant properties and subchronic toxicity of the standardized extract of LAMIC, a phytomedicine prototype based on aqueous extracts from trunk bark of Lannea microcarpa Engl and K. Krause. J Drug Deliv Ther 2019; 9(5):1-8. https://doi.org/10.22270/jddt.v9i5.3285
27. Akhmadeeva K, Belova A, Karimova R. Biochemical parameters of rat blood in the models of chronic heart failure and chronic kidney disease at the administration of nitric oxide donor. BIO Web Conf [homepage on the Internet] 2020 [cited 2022 May 19]; 27:00071. Available from: https://www.bio-conferences.org/articles/bioconf/full_html/2020/11/bioconf_fies-20_00071/bioconf_fies-20_00071.html https://doi.org/10.1051/bioconf/20202700071
28. Gupta RC (Ramesh C. Biomarkers in toxicology. 2e ed. 2019;
29. Parvez MK, Rishi V. Herb-Drug Interactions and Hepatotoxicity. Curr Drug Metab [homepage on the Internet] 2019 [cited 2022 Jul 16]; 20(4):275-282. Available from: https://pubmed.ncbi.nlm.nih.gov/30914020/ https://doi.org/10.2174/1389200220666190325141422
30. Amarasiri SS, Attanayake AP, Arawwawala LDAM, Jayatilaka KAPW, Mudduwa LKB. Acute and 28-Day Repeated-Dose Oral Toxicity Assessment of Abelmoschus moschatus Medik. In Healthy Wistar Rats. Evidence-based Complement Altern Med 2020; 2020. https://doi.org/10.1155/2020/1359050
31. Chang CJ, Tzeng TF, Liou SS, Chang YS, Liu IM. Acute and 28-day subchronic oral toxicity of an ethanol extract of Zingiber zerumbet (L.) Smith in rodents. Evidence-based Complement Altern Med 2012; 2012. https://doi.org/10.1155/2012/608284
32. Vlad CE, Foia L, Florea L, et al. Evaluation of cardiovascular risk factors in patients with familial hypercholesterolemia from the North-Eastern area of Romania. Lipids Health Dis [homepage on the Internet] 2021 [cited 2022 Jul 16]; 20(1):1-16. Available from: https://lipidworld.biomedcentral.com/articles/10.1186/s12944-020-01428-y https://doi.org/10.1186/s12944-020-01428-y
33. Watts GF, Catapano AL, Masana L, Zambon A, Pirillo A, Tokgözoglu L. Hypercholesterolemia and cardiovascular disease: Focus on high cardiovascular risk patients. Atheroscler Suppl 2020; 42:e30-e34. https://doi.org/10.1016/j.atherosclerosissup.2021.01.006
34. Diaconu CC, Dediu GN, Iancu MA. Drug-induced arterial hypertension - a frequently ignored cause of secondary hypertension: a review. Acta Cardiol [homepage on the Internet] 2018 [cited 2022 Jul 16]; 73(6):511-517. Available from: https://pubmed.ncbi.nlm.nih.gov/29291681/ https://doi.org/10.1080/00015385.2017.1421445
35. Gyamlani G, Geraci SA. Secondary Hypertension due to Drugs and Toxins. South Med J [homepage on the Internet] 2007 [cited 2022 Jul 16];100(7):692-699. Available from: https://pubmed.ncbi.nlm.nih.gov/17639749/ https://doi.org/10.1097/SMJ.0b013e318063c3e8
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OUEDRAOGO WRC, BELEMNABA L, NITIEMA M, KABORE B, COMPAORE S, KOALA M, SEMDE R, OUEDRAOGO S. Evaluation of acute, subacute toxicity and in vivo impact of aqueous decoction of Flemingia faginea Guill. & Perr. (Barker) leafy stems on NMRI mice and normotensive Wistar rats. JDDT [Internet]. 15Jan.2023 [cited 1May2024];13(1):1-0. Available from: https://www.jddtonline.info/index.php/jddt/article/view/5819
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