Cytogenetic Evaluation of the Physiological Saline Extract of a Newly Developed Dental Material ‘‘ORMO-48''
Keywords:
Chromosomal aberrations, dental material, genotoxicity, micronucleiAbstract
The ORMO-48 is a new indigenous material for dental applications, developed by the Dental Products Laboratory of our Institute. The aim of the present study was to evaluate the genotoxic effect of an indigenously developed dental material in Swiss albino mice. The genotoxic effect was evaluated by micronucleus and chromosomal aberration tests. Two grams of dental material was extracted in 10.0 ml of physiological saline at 70 °C for 24 h. The extract was cooled to room temperature and was used for the experiment. The experimental designed had three groups each (six mice in each group) for micronucleus and chromosomal aberration tests. The first, second, and third groups were given a single exposure of physiological saline alone (control), dental material's extract (test), and cyclophosphamide (positive control) respectively for micronucleus and chromosomal aberration tests. The result of the study indicated that, the percentage of micronucleated PCE (polychromatic erythrocytes) and NCE (normochromatic erythrocytes) induced by the dental material (extract) treated group was well comparable with control group, whereas the positive control induced significantly high (P < 0.001) micronucleated PCE when compared to control. The PCE and NCE ratio of the dental material extract treated group was similar to that of control group. The chromosomal anomalies such as chromatid/chromosomal breaks, centric rings, exchanges, dicentric, and acentric fragments were evaluated. The result showed that the anomalies of the dental material extract treated group were similar to control group, however, significant anomalies were observed in the cyclophosphamide treated group. Hence, the present study concluded that the indigenously developed biocompatible dental material, ORMO-48 is non genotoxic at our laboratory conditions.Downloads
References
Madle S, Korte A, Bass R. Experience with mutagenecity testing of new drugs: viewpoint of a regulatory agency. Mutat Res 1987;182:187-92
Zhu J, Wan X, Zhu Y, Ma X, Zheng Y, Zhang T. Evaluation of salidroside in vitro and in vivo genotoxicity. Drug Chem Toxicol 2010;33:220-6.
Wassom JS. Origins of genetic toxicology and the Environmental Mutagen Society. Environ Mol Mutagen 1989;14:1-6.
Tennant RW, Margolin BH, Shelby MD, Zeiger E, Haseman JK, Spalding J. Prediction of chemical carcinogenecity in rodents from in vitro genetic toxicity assays. Science 1987;236:933-41.
Schmid W. Chemical mutagen testing on in vivo somatic mammalian cells. Agents Actions 1973;3:77-85.
Alghazal MA, Sutiakova I, Kovalkovicova N, Legath J, Falis M, Pistl J, et al. Induction of micronuclei in rat bone marrow after chronic exposure to lead acetate trihydrate. Toxicol Ind Health 2008;24:587-93.
Heddle JA. A rapid in vivo test for chromosomal damage. Mutat Res 1973;18:187-90.
Gurbuz N, Ozkul A, Burgaz S. Effects of vitamin C and N-acetylcysteine against cyclophosphamide-induced genotoxicity in exfoliated bladder cells of mice in vivo. J Buon 2009;14:647-52.
International Organization for Standardization 10993-12, 2002. Biological evaluation of medical devices: Sample preparation and reference materials. Geneva: ISO; 2002. p. 10993-12.
International Organization for Standardization 10993-3, 2003. Biological evaluation of medical devices: Tests for genotoxicity, carcinogenicity and reproductive toxicity. Geneva: ISO; 2003.p. 10993-3.
Organization for Economic Co-operation and Development. Guideline for Testing of Chemicals, 474. Mammalian erythrocyte micronucleus test. Paris: OECD Publications; 1997.
Organization for Economic Co-operation and Development. Guideline for Testing of Chemicals, 475. Mammalian bone marrow chromosomal aberration test. Paris: OECD Publications; 1997
Chaubey RC, Kavi BR, Chauhan PS, Sundaram K. Evaluation of the effect of ethanol on the frequency of micronuclei in the bone marrow of swiss mice. Mutat Res 1977;43:441-4.
Mohanan PV, Rathinam K. Effect on bone wax extract on the frequency of bone marrow erythrocyte micronuclei in mice. Vet Hum Toxicol 1996;38:427-8.
Sobti RC, Bhardwaj DK, Gupta BD. Spontaneous chromosomal aberrations in the peripheral blood lymphocytes of patients with cancer. Med Sci Res1991;19:23-5.
David EA, Stephanie TD. Biological Evaluation of Medical Devices: The Role of Chemical and Material Characterization, Materials/Biomaterials, Business Briefing Medical Device Manufacturing and Technology; 2004. p. 48-51.
Yalcin E, Oruc E, Cavusoglu K, Yapar K Protective role of grape seed extract against doxorubicin-induced cardiotoxicity and genotoxicity in albino mice. J Med Food 2010;13:17-25.
Haveric A, Haveric S, Ibrulj S. Micronuclei frequencies in peripheral blood and buccal exfoliated cells of young smokers and non-smokers. Toxicol Mech Methods 2010;20:260-6.
Al-Zubairi AS, Abdul AB, Syam MM. Evaluation of the genotoxicity of zerumbone in cultured human peripheral blood lymphocytes. Toxicol In Vitro 2010;24:707-12.