Problems in consideration of rodent hepatocarcinogenesis for regulatory purposes

Toxicologic Pathology

Volumn 24, Issue 1, 1996, Pages 138-146

  Moch, Ronald W ^a   Dua, Prem N ^a   Hines, Fred A ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Hepatocellular foci; Hepatoproliferative lesions; Regulatory evaluation; Rodents

Indexed keywords

RODENTIA;

CARCINOGENICITY; CONFERENCE PAPER; HISTOPATHOLOGY; LIVER CANCER; LIVER CARCINOGENESIS; LIVER TOXICITY; NONHUMAN; PRIORITY JOURNAL; RODENT;

ANIMALS; CARCINOGENS; FEMALE; FOOD ADDITIVES; LIVER NEOPLASMS, EXPERIMENTAL; MALE; MICE; PATHOLOGY; RATS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0030043493     PISSN: 01926233     EISSN: None     Source Type: Journal    
DOI: 10.1177/019262339602400118     Document Type: Article

References (28)

1. Bannasch P, Griesemer RA, Anders F, Becker R, Cabral JR, Della Porta G, Feron VJ, Henschler D, Ito N, Kroes R, Magee PN, Montesano R, Napalkov NP, Nesnow S, Rao GN, and Witbourn J (1986). Early preneoplastic lesions. In: Long-Term and Short-Term Assays for Carcinogens: A Critical Appraisal, IARC Scientific Publications No. 83, R Montesano, H Bartsch, H Vainio, J Wilbourn, and H Yamasaki (eds). International Agency for Research on Cancer, Lyon, pp. 85-101.
2. Chu KC, Cueto C, and Ward JM (1981). Factors in the evaluation of 200 National Cancer Institute carcinogen bioassays. J. Toxicol. Environ. Health 8: 251-280.
3. Dua PN and Jackson BJ (1988). Review of pathology data for regulatory purposes. Toxicol. Pathol. 16: 443-450.
4. Frith CH and Ward JM (1979). A morphologic classification of proliferative and neoplastic hepatic lesions in mice. J. Environ. Pathol. Toxicol. 3: 329-351.
5. Harada T, Maronpot RR, Morris RW, Sitzel KA, and Boorman GA (1989). Morphological and stereological characterization of hepatic foci of cellular alteration in control Fischer 344 rats. Toxicol. Pathol 17: 579-593.
6. Hayashi Y (1989). Pathological implications of rat liver foci and relevance to regulatory decision-making: Current status and future perspective. Toxicol. Pathol. 17: 716-720.
7. Interagency Regulatory Liaison Group. Working Group on Risk Assessment (1979). Scientific basis for identification of potential carcinogens and estimation of risks. J. Natl. Cancer Inst. 63: 241-268.
8. Interdisciplinary Panel on Carcinogenicity (1984). Criteria for evidence of chemical carcinogenicity. Science 225: 682-687.
9. Mahon DC (1989). Altered hepatic foci in rat liver as weight of evidence of carcinogenicity: The Canadian perspective. Toxicol. Pathol. 17: 709-715.
10. Maronpot RR, Harada T, Murthy ASK, and Boorman GA (1989). Documenting foci and hepatocellular alteration in two-year carcinogenicity studies: Current practices of the National Toxicology Program. Toxicol. Pathol. 17: 675-684.
11. Maronpot RR, Haseman JK, Boorman GA, Eustis SE, Rao GN, and Huff JE (1987). Liver lesions in B6C3F1 mice: The National Toxicology Program, experience and position. In: Mouse Liver Tumors, PL Chambers, D Henschler, and F Oesch (eds). Springer-Verlag, New York, pp. 10-26.
12. Maronpot RR, Montgomery CA Jr, Boorman GA, and McConnell EE (1986). National Toxicology Program nomenclature for hepatoproliferative lesions of rats. Toxicol. Pathol. 14: 263-273.
13. Moch RW and O'Neill TP (1989). Hepatocellular foci - A regulator's Gordian knot. Toxicol. Pathol. 17: 724-728.
14. Moore JA (1989). Discussion relative to regulatory issues. Toxicol. Pathol. 17: 729-735.
15. National Institute of Environmental Health Sciences (1989). Symposium on Significance of Foci of Cellular Alteration in the Rat Liver. NIEHS, Research Triangle Park, North Carolina, May 22 and 23.
16. Office of Science and Technology Policy (1985). Chemical carcinogens: A review of the science and its associated principles. Part II. Fed. Regist. Thursday, March 14, 1985: 10371-10442.
17. Richter-Reichhalm H-B (1989). View of the regulatory use of rat liver foci data in the Federal Republic of Germany. Toxicol. Pathol. 17: 721-723.
18. Saffiotti U (1980). Identification and definition of chemical carcinogens: Review of criteria and research needs. J. Toxicol. Environ. Health 6: 1029-1057.
19. Shubik P, Baker WO, Burger EJ Jr, London IM, and Powers WE (1977). General criteria for assessing the evidence of carcinogenicity of chemical substances: Report of the Subcommittee on Environmental Carcinogenesis. J. Natl. Cancer Inst. 58: 461-465.
20. Society of Toxicologic Pathologists (1990). Guides for Toxicologic Pathology: Standardized System of Nomenclature and Diagnostic Criteria. Armed Forces Institute of Pathology, Washington, D.C.
21. Squire RA (1989). The interpretation of equivocal or marginal animal carcinogenicity tests. Cell Biol. Toxicol. 5: 371-375.
22. 1) mice. Toxicol. Pathol. 16: 321-326.
23. 1) mice J. Natl. Cancer. Inst. 66: 1175-1181.
24. Turusov VS and Takayama S (1979). Tumours of the liver. In: Pathology of Tumours in Laboratory Animals, Vol. II, Tumours of the Mouse, IARC Scientific Publication No. 23, VS Turusov (ed). International Agency for Research on Cancer, Lyon, pp. 193-233.
25. U.S. Interagency Staff Group on Carcinogens (1986). Chemical carcinogens: A review of the science and its associated principles. Environ. Health Perspect. 67: 201-282.
26. Ward JM (1980). Morphology of hepatocellular neoplasms in B6C3F1 mice. Cancer Lett. 9: 319-325.
27. Ward JM (1981) Morphology of foci of altered hepatocytes and naturally occurring hepatocellular tumors in F344 rats. Virchow. Arch. (Pathol. Anat.) 390: 339-345.
28. Ward JM, Tamano S, and Nii A (1994). The significance of preneoplastic lesions in rodent bioassays. In: Handbook of Carcinogen Testing, 2nd ed., HA Milman and EK Weisburger (eds). Noyes Publications, Park Ridge, New Jersey, pp. 448-465.