Pre Clinical Safety Assessment of AYUSH Carctol S through Acute and Sub Chronic Oral Toxicity Study: Safety Assessment of AYUSH Carctol S
Keywords:
Acute Toxicity, AYUSH Carctol S, LD50, NOAEL, Subchronic Oral ToxicityAbstract
AYUSH Carctol S is a coded Ayurvedic compound formulation developed for treatment of cancer. The safety of the test drug was not established in the experimental animals yet, hence the present study was highlighted the same through acute and sub-chronic toxicity studies. The acute oral toxicity study of the test drug was performed in swiss albino mice with a dose of 2600 mg/kg. Similarly, the sub-chronic oral toxicity study was carried out in wistar rats with three different test doses i.e., 180 mg/kg, 900 mg/kg, and 1800 mg/kg. Cage side observations, feed intake, body weight, gross morphology, and necropsy findings of the animals of test drug-treated animals were normal and no mortality was reported in both either study. During the sub-chronic toxicity study, the hematological and biochemical parameters of AYUSH Carctol S-treated animals were found to be non-significant when compared to the control animals. Further, the histopathological analysis of major organs of AYUSH Carctol S 1800 mg/kg treated animals showed no major lesions and treatment-related changes. The test drug was considered to be nontoxic during the acute and sub-chronic oral toxicity studies. The LD50 of AYUSH Carctol S estimated during the acute toxicity was found as 2600 mg/kg and the sub-chronic safety dose i.e., NOAEL is up to 1800 mg/kg.
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Copyright (c) 2024 Sudesh N. Gaidhani, G. Dayanand Reddy, R. Ganesan, Pawan Tiwari, N. Srikanth, M. M. Padhi, Viswanth Reddy, Srikanth Ala
This work is licensed under a Creative Commons Attribution 4.0 International License.
Accepted 2024-06-20
Published 2024-10-24
References
Patwardhan B. Historical future of Ayurveda. J Ayurveda Integr Med. 2013; 4(4): 189–192. https://doi. org/10.4103/0975-9476.123671
Mukherjee PK, Harwansh RK, Bahadur S, Banerjee S, Kar A, Chanda J, et al. Development of Ayurveda – Tradition to trend. J Ethnopharmacol. 2017; 197:10–24. https://doi. org/10.1016/j.jep.2016.09.024
Sperling F. Introduction to toxicity evaluation session. Environ Health Perspect. 1979; 32:259. https://doi.org/10.1289/ehp.7932259
Walum E. Acute oral toxicity. Environ Health Perspect. 1998; 106(2):497–503. https://doi.org/10.1289/ehp.98106497
Kroes R,Walker R. Safety issues of botanicals and botanical preparations in functional foods. Toxicology. 2004; 198(1- 3): 213–220. https://doi.org/10.1016/j.tox.2004.01.028
Andrade EL, Bento AF, Cavalli J, Oliveira SK, Schwanke RC, Siqueira JM, Freitas CS, Marcon R, Calixto JB. Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies. Braz J Med Biol Res. 2016; 49(12):e5646. https://doi.org/10.1590/1414- 431x20165646
Pieters MN, Kramer HJ, Slob W. Evaluation of the uncertainty factor for subchronic-to-chronic extrapolation: Statistical analysis of toxicity data. Regul Toxicol Pharmacol. 1998; 27(2):108-111. https://doi.org/10.1006/ rtph.1997.1196
Dorato MA, Engelhardt JA. The no-observed-adverseeffect- level in drug safety evaluations: Use, issues, and definition(s). Regul Toxicol Pharmacol. 2005; 42(3):265- 274. https://doi.org/10.1016/j.yrtph.2005.05.004
Moussaoui A. E., Bourhia M., Jawhari F. Z., et al. Withania frutescens. L extract: Phytochemical characterization and acute and repeated dose 28-day oral toxicity studies in mice. BioMed Research International. 2020. https://doi. org/10.1155/2020/1976298
Wakkumbura HP, Wickramaarachchi WMD, Arawwawala LDAM, Liyanage JA, Rajapakse RPVJ. Assessment of the quality and evaluation of the antioxidant potential of a novel Sri Lankan ayurvedic polyherbal formulation. Evidence- Based Complementary and Alternative Medicine. 2020. https://doi.org/10.1155/2020/2319315
Sindete M, Gbankoto A, Ganfon H, Osseni R, Yemoa A, Laleye A. Safety assessment of the ethanol of Caesalpinia bonduc (L.) Roxb. Root in wistar rats: Acute and subacute (28-day) oral toxicity studies. National Journal of Physiology, Pharmacy and Pharmacology. 2019; 9(12):1– 11. https://doi.org/10.5455/njppp.2019.9.1034131102019
Wang M, Qiu H, Zhang R, Long F, Mao D. Subchronic toxicity of herbal compound ‘Jiedu huayu’ granules in rats. BMC Complementary and Alternative Medicine. 2017; 17(450):1–8. https://doi.org/10.1186/s12906-017-1960-4
Miaffo D, Wansi SL, Ntchapda F, Kamanyi A. Chronic oral safety study of the aqueous of Combretum molle twigs on biochemical, haematological and antioxidant parameters of wistar rats. BMC Complementary Medicine and Therapies. 2020; 20(106):1-9. https://doi.org/10.1186/ s12906-020-02896-6
Deyno S, Abebe A, Tola MA, et al. Acute and sub-acute toxicity of Echinops kebericho decoction in rats. BMC Complementary Medicine and Therapies. 2020; 20(2):1– 11. https://doi.org/10.1186/s12906-019-2794-z
Ugwah-Oguejiofor CJ, Okoli CO, Oguejiofor-Ugwah M, et al. Acute and sub-acute toxicity of aqueous extract of aerial parts of Caralluma dalzielii N. E. Brown in mice and rats. Heliyon. 2019; 5:1–20. https://doi.org/10.1016/j. heliyon.2019.e01179
Lim HS, Seo YS, Ryu SM, Moon BC, Choi G, Kim JS. Two-week repeated oral dose toxicity study of Mantidis ootheca water extract in C57BL/6 mice. Evidence-Based Complementary and Alternative Medicine. 2019 ; 6. https:// doi.org/10.1155/2019/6180236
Ikechukwu GC, Egba SI, Ibeh RC, Helal EG, Ejiofor EU, Okafor PN. Assessment of sub-chronic effect of two artificial food additives on selected biochemical parameters in wistar rats. Journal of Pharmacology and Toxicology. 2017; 12(4):180–190. https://doi.org/10.3923/ jpt.2017.180.190
Al-Afifi N. A., Alabsi A. M., Bakri M. M., Ramanathan A. Acute and sub-acute oral toxicity of Dracaena cinnabari resin methanol extractin rats. BMC Complementary and Alternative Medicine. 2018; 18(50):1–14. https://doi.org/10.1186/s12906-018-2110-3