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Research Articles

Safety assessment of a novel water-soluble extract of Boswellia serrata gum resin: acute toxicity, 90-day sub-chronic toxicity, Ames’ bacterial reverse mutation, and in vivo micronucleus assays

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Pages 362-372 | Received 19 Aug 2021, Accepted 24 Nov 2021, Published online: 10 Dec 2021

References

  • Abdel-Tawab M, Werz O, Schubert-Zsilavecz M. 2011. Boswellia serrata: an overall assessment of in vitro, preclinical, pharmacokinetic and clinical data. Clin Pharmacokinet. 50(6):349–369.
  • Alluri VK, Dodda S, Kilari EK, Golakoti T, Sengupta K. 2019. Toxicological assessment of a standardized Boswellia serrata gum resin extract. Int J Toxicol. 38(5):423–435.
  • Ames BN, McCann J, Yamasaki E. 1977. Methods for the Salmonella mutagenicity test. In: Kilbey BJ, editor. Handbook of mutagenicity test procedures. Amsterdam: Elsevier; p. 1–17.
  • Ammon HP. 2006. Boswellic acids in chronic inflammatory diseases. Planta Med. 72(12):1100–1116.
  • Aydιn A, Aktay G, Yesilada E. 2016. A guidance manual for the toxicity assessment of traditional herbal medicines. Nat Prod Commun. 11(11):1763–1773.
  • Chatterjee GK, Pal SD. 1984. Anti-inflammatory agents from Indian medicinal plants. Indian Drugs. 21:431.
  • [CFR] Code of Federal Regulations Title 21. 2007. March US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr¼172.510.
  • Davis B, Sengupta K, Alluri VK, Golakoti T. 2019. Plasma concentrations of boswellic acids in fasting healthy humans supplemented with a water-soluble Boswellia extract (78% AKBA) vs. reference boswellia extract (30% AKBA). Curr Dev Nutr. 3(Supp. l):P06-005-19.
  • Dhiman AK. 2006. Ayurvedic drug plants. Delhi: Daya Publishing House.
  • Draize JH, Woodward G, Calvary HO. 1944. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J Pharmacol Exp Ther. 82(3):377–390.
  • Etzel R. 1996. Special extract of Boswellia serrata (H 15) in the treatment of rheumatoid arthritis. Phytomedicine. 3(1):91–94.
  • Gerbeth K, Hüsch J, Fricker G, Werz O, Schubert-Zsilavecz M, Abdel-Tawab M. 2013. In vitro metabolism, permeation, and brain availability of six major boswellic acids from Boswellia serrata gum resins. Fitoterapia. 84:99–106.
  • Giknis MLA, Clifford CB. 2006. Clinical laboratory parameters for Crl:CD(SD) rats. Wilmington (MA): Charles River Laboratories.
  • Hamidpour R, Hamidpour S, Hamidpour M, Shahlari M. 2013. Frankincense (Rǔ Xiāng; Boswellia species): from the selection of traditional applications to the novel phytotherapy for the prevention and treatment of serious diseases. J Tradit Complement Med. 3(4):221–226.
  • Kay JH, Calandra JC. 1962. Interpretation of eye irritation tests. J Soc Cos Chem. 13:281–289.
  • OECD Series on Testing and Assessment, No. 33. 2001. Harmonized integrated classification system for human health and environmental hazards of chemical substances and mixtures. Paris: OECD Publishing.
  • OECD Test No. 402. 1987. Acute dermal toxicity (adopted February 24 1987). Paris: OECD Publishing. https://doi.org/http://dx.doi.org/10.1787/9789264070585-en
  • OECD Test No. 404. 2002. Acute dermal irritation/corrosion. Paris: OECD Publishing. https://doi.org/https://doi.org/10.1787/9789264070622-en
  • OECD Test No. 405. 2002. Acute eye irritation/corrosion. Paris: OECD Publishing.
  • OECD Test No. 425. 2008. Acute oral toxicity: up-and-down procedure, OECD guidelines for the testing of chemicals, section 4. Paris: OECD Publishing.
  • OECD Test No. 474. 2014. Mammalian erythrocyte micronucleus test. Paris: OECD Publishing.
  • OECD Test No. 408. 2018. Repeated dose 90-day oral toxicity study in rodents, OECD guidelines for the testing of chemicals, section 4. Paris: OECD Publishing.
  • Roy NK, Dey P, Banik K, Bordoloi D, Devi AK, Thakur KK, Ganesan P, Mehdi S, Lu F, Sethi G, et al. 2019. An update on pharmacological potential of boswellic acids against chronic diseases. IJMS. 20(17):4101.
  • Roy S, Khanna S, Shah H, Rink C, Phillips C, Preuss H, Subbaraju GV, Golakoti T, Alluri VK, Bagchi M, et al. 2005. Human genome screen to identify the genetic basis of the anti-inflammatory effects of Boswellia in microvascular endothelial cells. DNA Cell Biol. 24(4):244–255.
  • Safayhi H, Mack T, Sabieraj J, Anazodo MI, Subramanian LR, Ammon HP. 1992. Boswellic acids: novel, specific, nonredox inhibitors of 5-lipoxygenase. J Pharmacol Exp Ther. 261(3):1143–1146.
  • Sengupta K, Alluri KV, Satish AR, Mishra S, Golakoti T, Sarma KV, Dey D, Raychaudhuri SP. 2008. A double blind, randomized, placebo controlled study of the efficacy and safety of 5-Loxin for treatment of osteoarthritis of the knee. Arthritis Res Ther. 10(4):R85.
  • Sengupta K, Golakoti T, Marasetti AK, Tummala T, Ravada SR, Alluri KV, Raychaudhuri SP. 2009. Inhibition of TNFα production and blocking of mitogen-activated protein kinase/NFκB activation in lipopolysaccharide-induced THP-1 human monocytes by 3-o-acetyl-11-keto-β-boswellic acid. J Food Lipids. 16(3):325–344.
  • Sengupta K, Kolla JN, Krishnaraju AV, Yalamanchili N, Rao CV, Golakoti T, Raychaudhuri S, Raychaudhuri SP. 2011. Cellular and molecular mechanisms of anti-inflammatory effect of Aflapin: a novel Boswellia serrata extract. Mol Cell Biochem. 354(1–2):189–197..
  • Sengupta K, Krishnaraju AV, Vishal AA, Mishra A, Trimurtulu G, Sarma KV, Raychaudhuri SK, Raychaudhuri SP. 2010. Comparative efficacy and tolerability of 5-Loxin and AflapinAgainst osteoarthritis of the knee: a double blind, randomized, placebo controlled clinical study. Int J Med Sci. 7(6):366–377.
  • Shah SU. 2012. Importance of genotoxicity & S2A guidelines for genotoxicity testing for pharmaceuticals. IOSJPBS. 1(2):43–54.
  • Singh P, Chacko KM, Aggarwal ML, Bhat B, Khandal RK, Sultana S, Kuruvilla BT. 2012. A-90 day gavage safety assessment of Boswellia serrata in rats. Toxicol Int. 19(3):273–278.
  • Syrovets T, Büchele B, Krauss C, Laumonnier Y, Simmet T. 2005. Acetyl-boswellic acids inhibit lipopolysaccharide-mediated TNF-alpha induction in monocytes by direct interaction with IkappaB kinases. J Immunol. 174(1):498–506.
  • Teo S, Stirling D, Thomas S, Hoberman A, Kiorpes A, Khetani V. 2002. A 90 days oral gavage toxicity study of d-methylphenidate and d, l-methylphenidate in Sprague-Dawley rats. Toxicology. 179(3):183–196.
  • Vishal AA, Mishra A, Raychaudhuri SP. 2011. A double blind, randomized, placebo controlled clinical study evaluates the early efficacy of aflapin in subjects with osteoarthritis of knee. Int J Med Sci. 8(7):615–622.
  • Yu G, Xiang W, Zhang T, Zeng L, Yang K, Li J. 2020. Effectiveness of Boswellia and Boswellia extract for osteoarthritis patients: a systematic review and meta-analysis. BMC Complement Med Ther. 20(1):225.

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