Evaluation of the mutagenic potential and acute oral toxicity of standardized extract of Ocimum sanctum (OciBest™)

Human and Experimental Toxicology

Volumn 32, Issue 9, 2013, Pages 992-1004

  Chandrasekaran, C V ^a   Srikanth, H S ^a   Anand, M S ^a   Allan, J Joshua ^a   Viji, M M Hipolith ^a   Amit, A ^a  

^a Natural Remedies Pvt Ltd   (India)

Author keywords

acute oral toxicity; bacterial reverse mutation test; chromosomal aberrations; micronucleus; OciBest ; Ocimum sanctum

Indexed keywords

HISTIDINE; OCIBEST; OCIMUM TENUIFLORUM EXTRACT; PLANT EXTRACT; UNCLASSIFIED DRUG;

ACUTE TOXICITY; ANIMAL CELL; ANIMAL EXPERIMENT; ARTICLE; BACTERIAL MUTATION; BACTERIAL STRAIN; BACTERIUM COLONY; CELL CULTURE; CHROMOSOME ABERRATION; CHROMOSOME BREAKAGE; CHROMOSOME DELETION; CONTROLLED STUDY; DICENTRIC CHROMOSOME; FEMALE; GENOTOXICITY; IN VITRO STUDY; METABOLIC ACTIVATION; MICRONUCLEUS TEST; MUTAGENIC ACTIVITY; NONHUMAN; OCIMUM TENUIFLORUM; PRIORITY JOURNAL; RAT; REVERTANT; RING CHROMOSOME; SALMONELLA TYPHIMURIUM; SINGLE DRUG DOSE; TREATMENT DURATION;

ACUTE ORAL TOXICITY; BACTERIAL REVERSE MUTATION TEST; CHROMOSOMAL ABERRATIONS; MICRONUCLEUS; OCIBEST™; OCIMUM SANCTUM;

ANIMALS; CELL LINE; CHO CELLS; CHROMOSOME ABERRATIONS; CRICETULUS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; MEDICINE, AYURVEDIC; MICRONUCLEI, CHROMOSOME-DEFECTIVE; MUTAGENICITY TESTS; OCIMUM; PLANT EXTRACTS; RATS; RATS, WISTAR; SALMONELLA TYPHIMURIUM; TOXICITY TESTS, ACUTE;

EID: 84883109418     PISSN: 09603271     EISSN: 14770903     Source Type: Journal    
DOI: 10.1177/0960327112472992     Document Type: Article

References (58)

1. Wealth of India, publication and information directorate. New Delhi, India: CSIR ; 1991:
2. Warrier PK. Indian medicinal plants. Longman O, ed. New Delhi, India: Publishing Incorporation ; 1995:
3. Jeba RC, Vaidyanathan R, Rameshkumar G. Immunomodulatory activity of aqueous extract of Ocimum tenuiflorum in rat. Int J Pharm Biomed Res. 2011 ; 2: 33-38
4. Mohan L, Amberkar MV, Kumari M.. Ocimum tenuiflorum Linn. (tulsi): an overview. Int J Pharm Sci Rev Res. 2011 ; 7: 51-53
5. Pattanayak P, Behera P, Das D, Panda SK.. Ocimum sanctum Linn. A reservoir plant for therapeutic applications: an overview. Pharmacog Rev. 2010 ; 4: 95-105
6. Aruna K, Sivaramakrishnan VM. Anticarcinogenic effect of some Indian plant products. Food Chem Toxicol. 1992 ; 30: 953-956
7. Saxena RC, Singh R, Kumar P, Negi MP, Saxena VS, Geetharani P, et al. Efficacy of an extract of Ocimum tenuiflorum (OciBest™) in the management of general stress: a double-blind, placebo-controlled study. Evid Based Complement Alternat Med. 2012 ; 2012: 894509
8. Goel A, Kumar S, Singh DK, Bhatia AK. Wound healing potential of Ocimum tenuiflorum Linn. with induction of tumor necrosis factor-alpha. Indian J Exp Biol. 2010 ; 48: 402-406
9. Kath RK, Gupta RK. Antioxidant activity of hydroalcoholic leaf extract of Ocimum tenuiflorum in animal models of peptic ulcer. Indian J Physiol Pharmacol. 2006 ; 50: 391-396
10. Singh S, Majumdar DK, Rehan HM. Evaluation of anti-inflammatory potential of fixed oil of Ocimum tenuiflorum (holy basil) and its possible mechanism of action. J Ethanopharmacol. 1996 ; 54: 19-26
11. Singh S, Malhotra M, Majumdar DK. Antibacterial activity of Ocimum sanctum L. fixed oil. Indian J Exp Biol. 2005 ; 43: 835-837
12. Eshrat Halim ML, Hussain A, Jamil K, Rao M. Hypoglycemic, hypolipidemic and antioxidant properties of tulsi (Ocimum tenuiflorum) on streptozotocin induced diabetes in rats. Indian J Clin Biochem. 2001 ; 16: 190-194
13. Rodrigues V, Rao MS, Satish N, Rao GM.. Ocimum tenuiflorum prevents stress induced damage to the hippocampal CA-3 neurons in the rats. J Anatomical Soc India. 2001 ; 50: 70
14. Batta SK, Santhakumari G. Antifertility effect of Ocimum tenuiflorum and Hibiscus rosa sinensis. Indian J Med Res. 1971 ; 59: 777-781
15. Ganasoundari A, Devi PU, Rao BSS. Enhancement of bone marrow radioprotection and reduction of WR-2721 toxicity by Ocimum tenuiflorum. Mutat Res. 1998 ; 394: 303-312
16. Rahman S, Islam R, Kamruzzaman M, Alam K, Jamal AHM.. Ocimum tenuiflorum L: a review of phytochemical and pharmacological profile. Am J Drug Discov Dev. 2011 ;: 1-15
17. Prakash P, Gupta N. Therapeutic uses of Ocimum tenuiflorum Linn. (Tulsi) with a note on eugenol and its pharmacological actions: a short review. Indian J Physiol Pharmacol. 2005 ; 49: 125-131
18. Sethi J, Yadav M, Sood S, Dahiya K, Singh V. Effect of tulsi (Ocimum tenuiflorum Linn.) on sperm count and reproductive hormones in male albino rabbits. Int J Ayurveda Res. 2010 ; 1: 208-210
19. OECD guidelines for testing of chemicals. No. 471: bacterial reverse mutation test. Paris, France: Organisation for Economic Co-operation and Development ; 1997:
20. OECD guidelines for testing of chemicals. No. 473. In vitro mammalian chromosomal aberration test. Paris, France: Organisation for Economic Co-operation and Development ; 1997:
21. OECD guidelines for testing of chemicals. No. 487: in vitro micronucleus test. Paris, France: Organisation for Economic Co-operation and Development ; 2004:
22. OECD guidelines for testing of chemicals. No. 420: acute oral toxicity-fixed dose procedure. Paris, France: Organisation for Economic Co-operation and Development ; 2001:
23. ICH Harmonized tripartite guideline. Current step 4 version. Validation of analytical procedures: text and methodology Q2 (R1). ; Geneva, Switzerland, November, 2005 ;..
24. Maron DM, Ames BN. Revised methods of salmonella mutagenicity test. Mut Res. 1983 ; 113: 173-215
25. Fluckiger-Isler S, Baumeister M, Braun K, Gervais V, Hasler-Nguyen N, Reimann R, et al. Assessment of the performance of the Ames II™ assay: a collaborative study with 19 coded compounds. Mut Res. 2004 ; 558: 181-197
26. Chandrasekaran CV, Thiyagarajan P, Sundarajan K, Goudar KS, Deepak M, Murali B, et al. Evaluation of the genotoxic potential and acute oral toxicity of standardized extract of Andrographis paniculata (KalmCold). Food Chem Toxicol. 2009 ; 47: 1892-1902
27. Chandrasekaran CV, Sundarajan K, David K, Agarwal A.. In vitro efficacy and safety of poly-herbal formulations. Toxicol Vitro. 2010 ; 24: 885-897
28. Chandrasekaran CV, Sundarajan K, Gupta A, Srikanth HS, Edwin J, Agarwal A. Evaluation of the genotoxic potential of standardized extract of Glycyrrhiza glabra (GutGard™). Regul Toxicol Pharmacol. 2011 ; 61: 373-380
29. Savage JRK. Classifications and relationships of induced chromosomal structural changes. J Med Genet. 1975 ; 12: 103-122
30. Fenech M. The in vitro micronucleus technique. Mut Res. 2000 ; 455: 81-95
31. Erexson LG, Periago MV, Spicer CS. Differential sensitivity of Chinese hamster V79 and Chinese hamster ovary (CHO) cells in vitro micronucleus screening assay. Mut Res. 2001 ; 495: 75-80
32. Mondal S, Mirdha BR, Mahapatra SC. The science behind sacredness of tulsi (Ocimum sanctum Linn.). Indian J Physiol Pharmacol. 2009 ; 53: 291-306
33. Padilha de Paula J, Gomes-Carneiro MR, Paumgartten FJ. Chemical composition, toxicity and mosquito repellency of Ocimum selloi oil. J Ethnopharmacol. 2003 ; 88: 253-260
34. Stajkovic O, Bjedov TB, Culafic DM, Stankovic S, Gacic BV, Simic D, et al. Antimutagenic properties of basil (Ocimum basilicum L.) in Salmonella typhimurium TA100. Food Technol Biotechnol. 2007 ; 45: 213-217
35. Stanojevic J, Beric T, Opacic B, Gacic BV, Simic D, Vukcevic JK. The effect of essential oil of basil (Ocimum basilicum L.) on UV-induced mutagenesis in Escherichia coli and Saccharomyces cerevisiae. Arch Biol Sci. 2008 ; 60: 93-102
36. Siddique YH, Ara G, Beg T, Afzal M. Anti-genotoxic effect of Ocimum sanctum L. extract against cyproterone acetate induced genotoxic damage in cultured mammalian cells. Acta Biol Hung. 2007 ; 58: 397-409
37. Khumphant E, Darunee BL. Acute toxicity, mutagenicity and antimutagenicity of ethanol Ocimum sanctum leaf extract using rat bone marrow micronucleus assay. Kasetsart J: Nat Sci. 2002 ; 36: 166-174
38. Dutta D, Saravana DS, Krishnamurthi K, Kumar K, Priyanka V, Muthal PL, et al. Modulatory effect of distillate of Ocimum sanctum leaf extract (Tulsi) on human lymphocytes against genotoxicants. Biomed Environ Sci. 2007 ; 20: 226-234
39. Manikandan P, Murugan RS, Abbas H, Abraham SK, Nagini S.. Ocimum sanctum Linn. (Holy Basil) ethanolic leaf extract protects against 7,12-Dimethylbenz[a] Anthracene-induced genotoxicity, oxidative stress, and imbalance in xenobiotic-metabolizing enzymes. J Med Food. 2007 ; 10: 495-502
40. Babu K, Uma Maheswari KC. In vivo studies on the effect of Ocimum sanctum L. leaf extract in modifying the genotoxicity induced by chromium and mercury in allium root meristems. J Environ Biol. 2006 ; 27: 93-95
41. Ganasoundari A, Devi PU, Rao MN. Protection against radiation-induced chromosome damage in mouse bone marrow by Ocimum sanctum. Mutat Res. 1997 ; 373: 271-276
42. Jena GB, Nemmani KV, Kaul CL, Ramarao P. Protective effect of a polyherbal formulation (Immu-21) against cyclophosphamide-induced mutagenicity in mice. Phytother Res. 2003 ; 17: 306-310
43. Padilha de Paula J, Farago PV, Ribas JC, Spinardi GMS, Doll PM, Artoni RF, et al. In vivo evaluation of the mutagenic potential of estragole and eugenol chemotypes of Ocimum selloi Benth. essential oil. Latin Am J Pharm. 2007 ; 26: 846-851
44. Aparecida Resende F, de Andrade Barcala CA, da Silva Faria MC, Kato FH, Cunha WR, Tavares DC. Antimutagenicity of ursolic acid and oleanolic acid against doxorubicin-induced clastogenesis in Balb/c mice. Life Sci. 2006 ; 79: 1268-1273
45. Guidance document on acute oral toxicity testing. OECD environment, health and safety publications series on testing and assessment no. 24. Paris, France: Organisation for Economic Co-operation and Development ; 2001:
46. Devi PU, Ganasoundari A. Radioprotective effect of leaf extract of Indian medicinal plant Ocimum sanctum. Indian J Exp Biol. 1995 ; 33: 205-208
47. Lagarto A, Tillan J, Bueno V, Chavez I, Guerra I, Vega Y, et al. Acute and subchronic oral toxicity in rats of a lyophilized aqueous extract of Ocimum tenuiflorum L. Revista de Toxicologia. 2005 ; 22: 175-179
48. Chanda D, Pal A, Shanker K.. Application of HPLC fingerprints for defining in vivo safety profile of tulsi (Ocimum sanctum). Med Chem Res. 2013 ; 22: 219-224
49. Singh S, Majumdar DK. Toxicological studies of the fixed oil of Ocimum sanctum Linn. (Tulsi). New Botanist. 1994 ; 21: 139-146
50. Tan PV, Mezui C, Enow-Orock G, Njikam N, Dimo T, Bitolog P. Teratogenic effects, acute and sub chronic toxicity of the leaf aqueous extract of Ocimum suave Wild (Lamiaceae) in rats. J Ethnopharmacol. 2008 ; 115: 232-237
51. Reghunandanan R, Sood S, Reghunandanan V, Mehta RM, Singh GP. Effect of Ocimum tenuiflorum Linn. (tulsi) extract on testicular function. Indian J Med Sci. 1995 ; 49: 83-87
52. Akbarsha MA, Palanisamy M, Murugaian P, Lakshmi Latha PN. Ursolic acid generates symplasts in rat spermatogenic clones. Phytother Res. 1998 ; 12: 32-36
53. Rajasekaran M, Bapna JS, Lakshmanan S, Ramachandran Nair AG, Veliath AJ, Panchanadam M. Antifertility effect in male rats of oleanolic acid, a triterpene from Eugenia jambolana flowers. J Ethnopharmacol. 1988 ; 24: 115-121
54. Khanna S, Gupta SK, Grover JK. Effect of long term feeding of Tulsi (Ocimum tenuiflorum) on reproductive performance of adult albino rats. Indian J Exp Biol. 1986 ; 24: 302-304
55. Seth SD, Johri N, Sundaram KR. Antispermatogenic effect of Ocimum sanctum. Indian J Exp Biol. 1981 ; 19: 975-976
56. Sethi J, Sood S, Seth S, Thakur A. A protective effect of tulsi Ocimum tenuiflorum on lipid peroxidation in stress induced by anaemic hypoxia in rabbits. Indian J Physiol Pharmacol. 2003 ; 44: 115-119
57. Narayana DBA.. Letter to Editor. Effect of tulsi (Ocimum tenuiflorum Linn.) on sperm count and reproductive hormones in male albino rabbits. Int J Ayurveda Res. 2011 ; 2: 64
58. Kumar RS, Rao MS, Nayak S, Sareesh NN. Effect of Ocimum sanctum (Linn.) extract on restraint stress induced behavioral deficits in male Wistar rats. Pharmacologyonline. 2007 ; 3: 394-404