ГОСТ ISO 10993-3-2011 Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 3. Исследования генотоксичности, канцерогенности и токсического действия на репродуктивную функцию

Общая литература

[1]

OECD 474, Mammalian Erythrocyte Micronucleus Test

[2]

OECD 475, Mammalian Bone Marrow Chromosome Aberration Test

[3]

OECD 478, Genetic Toxicology - Rodent Dominant Lethal Test

[4]

OECD 479, Genetic Toxicology - In vitro Sister Chromatid Exchange Assay in Mammalian Cells

[5]

OECD 480, Genetic Toxicology - Saccharomyces cerevisiae - Gene Mutation Assay

[6]

OECD 481, Genetic Toxicology - Saccharomyces cerevisiae - Miotic Recombination Assay

[7]

OECD 482, Genetic Toxicology - DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells in vitro

[8]

OECD 483, Mammalian Spermatogonial Chromosome Aberration Test

[9]

OECD 484, Genetic Toxicology - Mouse Spot Test

[10]

OECD 485, Genetic Toxicology - Mouse Heritable Translocation Assay

[11]

OECD 486, Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo

[12]

Official Journal of the European Communities, L 133/73, May 1988, concerning in vitro cell transformation tests.

Литература по трансгенным животным

[13]

GORELICK, N.J. Overview of mutation assays in transgenic mice for routine testing. Environmental and Molecular Mutagenesis, 1995, 25, pp.218-230

[14]

PROVOST, G.S., ROGERS, B.J., DYCAICO, M.J., and CARR, G. Evaluation of the transgenic Lambda/Lacl mouse model as a short-term predictor of heritable risk. Mutation Research, 1997, 388, pp.129-136

[15]

KRISHNA, G., URDA, G., and THEISS, J. Principles and practice of integrating genotoxicity evaluation into routine toxicology studies: a pharmaceutical industry perspective. Environmental and Molecular Mutagenesis, 1998, 32, pp.115-120

[16]

MACGREGOR, J.T. Transgenic animal models for mutagenesis studies: role in mutagenesis research and regulatory testing. Environmental and Molecular Mutagenesis, 1998, 32, pp.106-109

[17]

KOHLER, S.W., et al. Development of a short-term in vitro mutagenesis assay: The effect of methylation on the recovery of a lambda phage shuttle vector from transgenic mice. Nucleic Acid Research, 1990, 18, pp.3007-3013

[18]

SHORT, J.M., KOHLER, S.W. and PROVOST, G.S. The use of lambda phage shuttle vectors in transgenic mice for development of a short term mutagenicity assay. In Mutation and the environment. Wiley-Liss, New York, 1990, pp.355-367

Литература по анализам клеточной трансформации

[19]

LEBOEUF, R.A., KERCKAERT, K.A., AADEMA, M.J., and ISFORT, R.J. Use of the Syrian hamster embryo and BALB/c 3T3 cell transformation for assessing the carcinogenic potential of chemicals. IARC Science Publications, 1999, 146, pp.409-425

[20]

LEBOEUF, R.A. et al. The pH 6.7 hamster embryo cell transformation assay for assessing the carcinogenic potential of chemicals. Mutation Research, 1996, 356, pp.65-84

[21]

AARDEMA, M.J., ISFORT, R.J., THOMPSON, E.D., and LEBOEUF, R.A. The low pH Syrian hamster embryo (SHE) cell transformation assay: a revitalized role in carcinogenic prediction. Mutation Research, 1996, 356, pp.5-9

[22]

ISFORT, R.J. and LEBOEUF, R.A. The Syrian hamster embryo (SHE) cell transformation system: a biologically relevant in vitro model - with carcinogen predicting capabilities - of in vivo multistage neoplastic transformation. Critical Reviews in Oncology, 1995, 6, pp.251-260

[23]

Advances in Modern Environment Toxicology, Vol. 1. Mammalian Cell Transformation by Chemical Carcinogens. N.Mishra, V.Dunkel, and M.Mehlman (eds). Senate Press: Princeton Junction, NJ, 1981

[24]

Transformation Assays of Established Cell Lines: Mechanisms and Application. T.Kakunaga and H. Yamasaki (eds). Proceedings of a Workshop Organized by IARC in Collaboration with the US National Cancer Institute and the US Environmental Protection Agency, Lyon 15-17 Feb. 1984. IARC Scientific Publication No. 67

[25]

BARRET, J.C., OHSHIMURA, M., TANAKA, N. and TSUTSUI, T. Genetic and Epigenetic Mechanisms of Presumed Nongenotoxic Carcinogens. In Banbury Report 25: Nongenotoxic Mechanisms in Carcinogenesis, 1987, pp.311-324

[26]

OSHIMURA, M., HESTERBERG, TW., TSUTSUI, T. and BARRETT, JC. Correlation of asbestos-induced cytogenetic effects with cell transformation of Syrian hamster embryo cells in culture. Cancer Res., Nov. 1984, 44, pp.5017-5022

[27]

BARRETT, J.C., OSHIMURA, M., TANAKA, N. and TSUTSUI, T. Role of aneuploidy in early and late stages of neoplastic progression of Syrian hamster embryo cells in culture. In Aneuploidy. W.L.Dellargo, P.E.Voytek and A.Hollaender (eds). Plenum Publishing, 1985

[28]

FITZGERALD, D.J. and YAMASAKI, H. Tumor promotion: Models and assay systems. Teratogenesis Carcinog. Mutagen., 1990, 10 (2), pp.89-102

[29]

KUROKI, T. and MATSUSHIMA, T. Performance of short-term tests for detection of human carcinogens. Mutagenesis, 1987, 2 (1), pp.333-337

[30]

RAY, V.A. et al. An approach to identifying specialized batteries of bioassays for specific classes of chemicals: Class analysis using mutagenicity and carcinogenicity relationships and phylogenetic concordance and discordance patterns 1. Composition and analysis of the overall database. A report of phase II of the U.S. Environmental Protection Agency Gene-Tox Program. Mutat Res, 1987, 3, pp.197-241

[31]

DUNKEL, V.D. et al. Interlaboratory evaluation of the C3H/10T1/2 cell transformation assay. Environ. Mol. Mutagen., 1988, 12 (1), pp.12-31

[32]

JONES, C.A. et al. An interlaboratory evaluation of the Syrian hamster embryo cell transformation assay using eighteen coded chemicals. Toxicology in vitro, 1988, 2 (2), pp.103-116

Литература по исследованиям генотоксичности и канцерогенности

[33]

IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans, Vol.19, Some Monomers, Plastics, and Synthetic Elastomers, and Acrolein, p.41, 1979

[34]

IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans, Vol.74, Surgical Implants and Other Foreign Bodies, pp.225-228, 1999

[35]

IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans, Vol.74, Surgical Implants and Other Foreign Bodies, pp.282-297, 1999

[36]

NAKAMURA A. et al. Difference in tumor incidence and other tissue responses to polyetherurethanes and polydimethylsiloxanein long-term subcutaneous implantation into rats, J. Biomed. Mater. Res., 1992, 26, pp.631-650

[37]

TSUCHIYA T. and NAKAMURA A. A new hypothesis of tumorigenesis induced by biomaterials: Inhibitory potentials of intercellular communication play an important role on the tumor-promotion stage, J. Longterm Effects Med. Implants, 1995, 5, pp.232-242

[38]

Department of Health. Guidelines for the testing of chemicals for mutagenicity. London: HMSO, 1989. (Report on Health and Social Security Subjects No. 35)

[39]

Department of Health. Guidelines for the evaluation of chemicals for carcinogenicity. London: HMSO, 1992. (Report on Health and Social Security Subjects No. 42)

[40]

OPPENHEIMER, B.S., OPPENHEIMER, E.T. and STOUT, A.P. Sarcomas induced in rats by implanting cellophane. Proc. Soc. Exp. Biol. Med., 1948, 67 (33)

[41]

BRAND, K.G., JOHNSON, K.H. and BUON, L.C. Foreign Body, Tumorigenesis CRC Crit. Rev. In Toxicology, October 1976, p.353

[42]

BRAND, L. and BRAND, K.G. Testing of Implant Materials for Foreign Body Carcinogenesis. In Biomaterials, 1980, p.819. G.D.Winter, D.F.Gibbons, H.Plenk Jr. (eds). Advances in Biomaterials, Volume 3, New York. J. Wiley, 1982

[43]

Biological Bases for Interspecies Extrapolation of Carcinogenicity Data. Hill ТА., Wands, RC, Leukroth RW. Jr. (eds). (Prepared for the Center for Food Safety and Applied Nutrition, Food and Drug Administration, Department of Health and Human Services, Washington, D.C.) July 1986, Bethesda (MD): Life Science Research Office, Federation of American Societies for Experimental Biology

[44]

National Toxicology Program Report of the BTP Ad Hoc Panel on Chemical Carcinogenesis Testing and Evaluation, August 1984, Board of Scientific Counselors

[45]

ASTM F 1439-39 Standard guide for performance of lifetime bioassay for the tumorgenic potential of implant materials

[46]

CARERE A. et al., Methods and testing strategies for evaluating the genotoxic properties of chemicals, European Commission Report EUR 15945 EN, ISSN 1018-5593, Luxemburg (1995)

[47]

FORAN J.A. (ed.), Principles for the selection of doses in chronic rodent bioassays, ILSI Risk Science Institute, Washington DC, USA, ISBN 0.944398-71-5, 1997

Литература по исследованиям токсического воздействия на развитие и репродуктивную функцию

[48]

Guideline for toxicity studies of drugs, Chapter 4: Reproductive and developmental toxicity studies. First edition. Editorial Supervision by New Drugs Division, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, 1990, Yakuji Nippo Ltd

[49]

GABRIELSON, J.L. and LARSSON, K.S. Proposal for improving risk assessment in reproductive toxicology. Pharmacol. Toxicol., 1990, 66, pp.10-17

[50]

NEUBERT, D. et al. Results of in vivo and in vitro Studies for Assessing Prenatal Toxicity. Environmental Health Perspectives, 1986, 70, pp.89-103

[51]

SADLER, T.W., HORTON, W.E. and WARNER, C.W. Whole Embryo Culture: A Screening Technique for Teratogens? Teratogenesis, Carcinogenesis, and Mutagenesis, 1982, 2, pp.243-253

[52]

In vitro Methods in Developmental Toxicology: Use in Defining Mechanisms and Risk Parameters. G.L.Kimmel and DM.Kochhar (eds.). Boca Raton (Florida): CRC Press, 1990

[53]

In vitro Embryotoxicity and Teratogenicity Tests. F.Homburger and AH.Goldberg (eds.). Concepts in Toxicology, Vol.3. Karger, Basel, 1985

[54]

BRENT, R.L. Predicting Teratogenic and Reproductive Risks in Humans from Exposure to Various Environmental Agents Using In vitro Techniques and in vivo Animal Studies. Congen. Anom., 1988, 28 (Suppl.), S41-S55

[55]

TSUCHIYA, Т., NAKAMURA, A., IIO, T. and TAKAHASI, A. Species Differences between Rats and Mice in the Teratogenic Action of Ethylenethiourea: in vivo/in vitro Tests and Teratogenic Activity of Sera Using an Embryonic Cell Differentiation System. Toxicol. Appl. Pharmacol., 1991, 109, pp.1-6

[56]

TSUCHIYA, Т., et al. Embryo lethality of new herbicides is not detected by the micromass teratogen tests. Arch. Toxicol., 1991, 65, pp.145-149

[57]

KISTLER, A., TSUCHIYA, Т., TSUCHIYA, M. and KLAUS, M. Teratogenicity of arotinoids (retinoids) in vivo and  in vitro. Arch. Toxicol., 1990, 64, pp.616-622

[58]

TSUCHYIA, Т., et al. Comparative Studies of Embryotoxic Action of Ethylenethiourea in Rat Whole Embryo and Embryonic Cell Culture. Teratology, 1991, 43, pp.319-324

[59]

Report of the in vitro teratology task force, Organized by the Division of Toxicology, Office of Toxicological Sciences, Center for Food Safety and Applied Nutrition, Food and Drug Administration. Environmental Health Perspectives, 1987, 72, pp.200-235

[60]

BASS, R., et al. Draft guideline on detection of toxicity to reproduction for medical products. Adverse Drug React. Toxicol. Rev., 1991, 9 (3), pp.127-141

[61]

BROWN et al., Screening chemicals for reproductive toxicity: the current approaches - Report and recommendations of an ECVAM/EST workshop (ECVAM Workshop 12), ATLA, 1995, 23, pp.868-882

[62]

SPIELMANN, H., Reproduction and development, Environmental Health Perspective, 106 (Suppl.2), 1998, pp.571-576

Литература по исследованиям с применением трансгенных животных в качестве альтернативы исследованиям канцерогенности в течение продолжительности жизни

[63]

GULEZIAN, D., et al. Use of transgenic animals for carcinogenicity testing: considerations and implications for risk assessment. Toxicolol. Pathol., 2000, 28, pp.482-499

[64]

STORER, R.D. Current status and use of short/medium term models for carcinogenicity testing of pharmaceuticals - Scientific perspective. Toxicol. Lett., 2000, 112-113, pp.557-566

[65]

DASS, S.B., BUCCI, T.J., HEFLICH, R.H. and CASCIANO, D.A. Evaluation of the transgenic p53+/- mouse for detecting gebotoxic liver carcinogens in a short-term bioassay. Cancer Lett., 1999, 143, pp.81-85

[66]

TENNANT, R.W., et al. Genetically altered mouse models for identifying carcinogens. IARC Science Publications, 1999, 146, pp.123-150

[67]

MAHLER, J.F., et al. Spontaneous and chemically induced proliferative lesions in TG.AC transgenic and p53-heterozygous mice. Toxicol. Pathol., 1998, 26, pp.501-511