ГОСТ 32647-2014 Методы испытания по воздействию химической продукции на организм человека. Комбинированные исследования хронической токсичности и канцерогенности (Переиздание)

[1]

Руководящий документ ОЕСD Test N 453 "Combined Chronic Toxicity/Carcinogenicity Studies".

[2]

OECD (1995), Report of the Consultation Meeting on Sub-chronic and Chronic Toxicity/Carcinogenicity Testing (Rome, 1995), internal working document, Environment Directorate, OECD, Paris.

[3]

EPA (2005). Guidelines for Carcinogen Risk Assessment Risk Assessment Forum U.S. Environmental Protection Agency Washington, DC.

[4]

Combes RD, Gaunt, I, Balls M (2004). A Scientific and Animal Welfare Assessment of the OECD Health Effects Test Guidelines for the Safety Testing of Chemicals under the European Union REACH System. ATLA 32, 163-208.

[5]

Barlow S.M., Greig J.B., Bridges J.W. et al (2002). Hazard identification by methods of animalbased toxicology. Food. Chem. Toxicol. 40, 145-191.

[6]

Chhabra R.S., Bucher J.R., Wolfe M., Portier С. (2003). Toxicity characterization of environmental chemicals by the US National Toxicology Programme: an overview. Int. J. Hyg.Environ. Health 206, 437-445.

[7]

OECD (1998), Repeat Dose 90-day Oral Toxicity Study in Non-Rodents. Test Guideline N. 409, OECD Guidelines for the Testing of Chemicals, OECD, Paris.

[8]

OECD (2009), Draft Guidance Document on the Design and Conduct of Chronic Toxicity and Carcinogenicity Studies, Series on Testing and Assessment No. 116, available on the OECD public website for Test Guidelines.

[9]

OECD (2009), Guidance Document on Acute Inhalation Toxicity Testing. Series on Testing and Assessment N 39, ENV/JM/MONO (2009) 28, OECD, Paris.

[10]

OECD (2009), Subacute Inhalation Toxicity: 28-Day Study, Test Guideline N. 412, OECD Guidelines for the Testing of Chemicals, OECD, Paris.

[11]

OECD (2009), Subchronic Inhalation Toxicity: 90-Day Study, Test Guideline No. 413, OECD, Guidelines for the Testing of Chemicals, OECD, Paris.

[12]

OECD (1981), Repeated Dose Dermal Toxicity: 21/28-day Study, Test Guideline No. 410, OECD Guidelines for the Testing of Chemicals, OECD, Paris.

[13]

Boobis, A.R., Cohen, S.M., Dellarco, V., McGregor, D., Meek, M.E., Vickers, C, Wllcocks, D. &Farland, W. IPCS Framework for analyzing the Relevance of a Cancer Mode of Action for Humans. Crit. Rev. in Toxicol, (2006) 36:793-801.

[14]

Cohen, S.M., Meek, M.E., Klaunig, J.E., Patton, D.E., and Fenner-Crisp, P.A. (2003) The human relevance of information on carcinogenic Modes of Action: An Overview. Crit. Rev. Toxicol. 33:581-589.

[15]

Holsapple, M.P., Pitot, H.C., Cohen, S.N., Boobis, A.R., Klaunig, J.E., Pastoor, Т., Dellarco, V.L. &Dragan, Y.P. (2006) Mode of Action in Relevance of Rodent Liver Tumors to Human Cancer Risk. Toxicol. Sci. 89:51-56.

[16]

Meek, E.M., Bucher, J.R., Cohen, S.M., Dellarco, V., Hill, R.N., Lehman-McKemmon, L.D., Longfellow, D.G., Pastoor, Т., Seed, J. & Patton, D.E. (2003) A Framework for Human Relevance analysis of Information on Carcinogenic Modes of Action. Crit. Rev. Toxicol. 33:591-653.

[17]

Carmichael N.G., Barton H.A., Boobis A.R. et al (2006). Agricultural Chemical Safety Assessment: A Multisector Approach to the Modernization of Human Safety Requirements. Crit. Rev. Toxicol. 36, 1-7.

[18]

Barton H.A., Pastoor T..P, Baetcke T. et al (2006). The Acquisition and Application of Absorption, Distribution, Metabolism, and Excretion (ADME) Data in Agricultural Chemical Safety Assessments. Crit. Rev. Toxicol. 36, 9-35.

[19]

Doe J.E., Boobis A.R., Blacker A. et al (2006). A Tiered Approach to Systemic Toxicity Testing for Agricultural Chemical Safety Assessment. Crit. Rev. Toxicol. 36, 37-68.

[20]

Cooper R.L., Lamb J.S., Barlow S.M. et al (2006). A Tiered Approach to Life Stages Testing for Agricultural Chemical Safety Assessment. Crit. Rev. Toxicol. 36, 69-98.

[21]

OECD (2002), Guidance Notes for Analysis and Evaluation of Chronic Toxicity and Carcinogenicity Studies, Series on Testing and Assessment No. 35 and Series on Pesticides N 14, ENV/JM/MONO (2002) 19, OECD, Paris.

[22]

OECD (2000), Guidance Document on the recognition, assessment, and use of clinical signs as humane endpoints for experimental animals used in safety evaluation, Series on Testing and Assessment No. 19, ENV/JM/MONO (2000) 7, OECD, Paris.

[23]

Rhomberg, L.R., Baetcke, K., Blancato, J., Bus, J., Cohen, S., Conolly, R., Dixit R., Doe, J., Ekelman, K., Fenner-Crisp, P., Harvey, P., Hattis, D., Jacobs, A., Jacobson-Kram, D., Lewandowski, T., Liteplo, R., Pelkonen, O., Rice, J., Somers, D., Turturro, A., West, W., Olin, S. Issues in the Design and Interpretation of Chronic Toxicity and Carcinogenicity Studies in Rodents: Approaches to Dose Selection Crit Rev. Toxicol. 37 (9) 729-837 (2007).

[24]

ILSI (International Life Sciences Institute) (1997). Principles for the Selection of Doses in Chronic Rodent Bioassays. Foran JA (Ed.). ILSI Press, Washington, DC.

[25]

Griffiths S.A., Parkinson C., McAuslane J.A.N. and Lumley C.E. (1994) The utility of the second rodent species in the carcinogenicity testing of pharmaceuticals. The Toxicologist 14(1):214.

[26]

Usui T., Griffiths S.A. and Lumley C.E. (1996). The utility of the mouse for the assessment of the carcinogenic potential of pharmaceuticals. In D'Arcy POF &Harron DWG (eds). Proceedings of the Third International Conference on Harmonisation. Queen's University Press, Belfast, pp 279-284.

[27]

Carmichael N.G., Enzmann H., Pate I., Waechter, F. (1997). The Significance of Mouse Liver Tumor Formation for Carcinogenic Risk Assessment: Results and Conclusions from a Survey of Ten Years of Testing by the Agrochemical Industry. Environ Health Perspect 105:1196-1203.

[28]

EEC Council Directive 86/609/EEC on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. Official Journal, 29, L358, 18th December 1986.

[29]

National Research Council, 1985. Guide for the care and use of laboratory animals. NIHPublication No. 86-23. Washington D.C., US. Dept. of Health and Human Services.

[30]

GV-SOLAS (Society for Laboratory Animal Science, , December, 1989). Publication on the Planning and Structure of Animal Facilities for Institutes Performing Animal Experiments. ISBN 3-906255-06-9.

[31]

GV-SOLAS (Society for Laboratory Animal Science, , 2006). Microbiological monitoring of laboratory animals in various housing systems.

[32]

Diehl K-H, Hull R., Morton D., Pfister R., Rabemampianina Y., Smith D., Vidal J-M., van deVorstenbosch С. 2001. A good practice guide to the administration of substances and removal of blood, including routes and volumes. Journal of Applied Toxicology, 21:15-23.

[33]

IPCS (1986). Principles and Methods for the Assessment of Neurotoxicity Associated with Exposure to Chemicals. Environmental Health Criteria Document N 60.

[34]

Tupper, D.E., Wallace, R.B. (1980). Utility of the Neurologic Examination in Rats. ActaNeurobiol. Exp., 40, 999-1003.

[35]

Gad, S.C. (1982). A Neuromuscular Screen for Use in Industrial Toxicology. J.Toxicol. Environ. Health, 9, 691-704.

[36]

Moser, V.C., McDaniel, K.M., Phillips, P.M. (1991). Rat Strain and Stock Comparisons Usinga Functional Observational Battery: Baseline Values and Effects of Amitraz. Toxicol. Appl. Pharmacol., 108, 267-283.

[37]

Meyer O.A., Tilson H.A., Byrd W.C., Riley M.T. (1979). A Method for the Routine Assessment of Fore- and Hind-limb Grip Strength of Rats and Mice. Neurobehav. Toxicol., 1, 233-236.

[38]

Crofton K.M., Howard J.L., Moser V.C., Gill M.W., Reiter L.W., Tilson H.A., MacPhail R.C. (1991). Interlaboratory Comparison of Motor Activity Experiments: Implication for Neurotoxicological Assessments. Neurotoxicol. Teratol., 13, 599-609.

[39]

Weingand K., Brown G., Hall R. et al. (1996). Harmonisation of Animal Clinical Pathology Testing in Toxicity and Safety Studies. Fundam. & Appl. Toxicol., 29: 198-201.

[40]

EMEA (draft) document 'Non-clinical guideline on drug-induced hepatotoxicity' (Doc. Ref. EMEA/CHMP/SWP/a50115/2006).

[41]

Crissman J.W., Goodman D.G., Hildebrandt P.K. et al. (2004). Best Practices Guideline: Toxicological Histopathology. Toxicologic Pathology 32, 126-131.

УДК 661:615.099

МКС 13.020.01

Ключевые слова: химическая продукция, воздействие на организм человека, метод испытаний, комбинированные исследования, хроническая токсичность, канцерогенность.