Extending the threshold of regulation concept: de minimis limits for carcinogens and mutagens.

作者: Janice M. Fiori , Roger D. Meyerhoff

DOI: 10.1006/RTPH.2002.1534

关键词: Risk assessmentMutagenDe minimisRisk factor (computing)Audit riskRisk managementRisk analysis (engineering)Risk analysisCarcinogenMedicine

摘要: Risk assessment processes for carcinogens are highly developed but risk mutagens not well established. In the pharmaceutical industry, associated with exposure to is tightly controlled. It desirable control also, in spite of greater uncertainty risk. this paper, a published cancer potency database used frame and support management decisions. A de minimis proposed decision matrix presented align available data approaches mutagens.

参考文章(18)
Errol Zeiger, Lois Swirsky Gold, Handbook of Carcinogenic Potency and Genotoxicity Databases CRC Press. ,(1996) , 10.1201/9781439810644
L S Gold, T H Slone, L Bernstein, Summary of carcinogenic potency and positivity for 492 rodent carcinogens in the carcinogenic potency database. Environmental Health Perspectives. ,vol. 79, pp. 259- 272 ,(1989) , 10.1289/EHP.8979259
Lois Swirsky Gold, Charles B. Sawyer, Renae Magaw, Georganne M. Backman, Margarita De Veciana, Robert Levinson, N. Kim Hooper, William R. Havender, Leslie Bernstein, Richard Peto, Malcolm C. Pike, Bruce N. Ames, A carcinogenic potency database of the standardized results of animal bioassays Environmental Health Perspectives. ,vol. 58, pp. 9- 319 ,(1984) , 10.1289/EHP.84589
Joyce McCann, Lois Swirsky Gold, Laura Horn, R. McGill, T.E. Graedel, John Kaldor, Statistical analysis of Salmonella test data and comparison to results of animal cancer tests. Mutation Research\/genetic Toxicology. ,vol. 205, pp. 183- 195 ,(1988) , 10.1016/0165-1218(88)90017-1
J D Hackney, W S Linn, E L Avol, Acid fog: effects on respiratory function and symptoms in healthy and asthmatic volunteers. Environmental Health Perspectives. ,vol. 79, pp. 159- 162 ,(1989) , 10.1289/EHP.8979159
D.W. Gaylor, L.S. Gold, Quick Estimate of the Regulatory Virtually Safe Dose Based on the Maximum Tolerated Dose for Rodent Bioassays Regulatory Toxicology and Pharmacology. ,vol. 22, pp. 57- 63 ,(1995) , 10.1006/RTPH.1995.1069
D. Krewski, M. Szyszkowicz, H. Rosenkranz, Quantitative factors in chemical carcinogenesis: Variation in carcinogenic potency Regulatory Toxicology and Pharmacology. ,vol. 12, pp. 13- 29 ,(1990) , 10.1016/S0273-2300(05)80043-1
R Peto, M C Pike, L Bernstein, L S Gold, B N Ames, The TD50: a proposed general convention for the numerical description of the carcinogenic potency of chemicals in chronic-exposure animal experiments. Environmental Health Perspectives. ,vol. 58, pp. 1- 8 ,(1984) , 10.1289/EHP.84581
I.C Munro, E Kennepohl, R Kroes, A procedure for the safety evaluation of flavouring substances Food and Chemical Toxicology. ,vol. 37, pp. 207- 232 ,(1999) , 10.1016/S0278-6915(98)00112-4
Frederick T. Hatch, Mark G. Knize, Dan H. Moore, James S. Felton, Quantitative correlation of mutagenic and carcinogenic potencies for heterocyclic amines from cooked foods and additional aromatic amines. Mutation Research\/environmental Mutagenesis and Related Subjects. ,vol. 271, pp. 269- 287 ,(1992) , 10.1016/0165-1161(92)90022-E