Relevance of maximum tolerated dose to human carcinogenic risk

Regulatory Toxicology and Pharmacology - Tập 11 - Trang 68-80 - 1990
Alexander Apostolou1
1Center for Veterinary Medicine, Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20857 USA

Tài liệu tham khảo

Bonser, 1952, The carcinogenic properties of 2-amino-1-naphthol hydrochloride and its parent amine 2-naphthylamine, Brit. J. Cancer, 6, 412, 10.1038/bjc.1952.47 Boot, 1956, The mammary tumour incidence in the C3H mouse strain with and without the agent (C3H, C3Hf, C3He), Acta Unio Int. Cancrum, 12, 569 Boyland, 1954, The induction of carcinoma of the bladder in rats with acetaminofluorene, Brit. J. Cancer, 8, 647, 10.1038/bjc.1954.70 Epstein, 1969, Renal epithelial neoplasms induced in male Wistar rats by oral aflatoxin B1, Cancer Res., 29, 1045 Farber, T. M. (no date). Selection of a Maximum Tolerated Dose (MTD) in Oncogenicity Studies. A Position Document of the U.S. Environmental Protection Agency, Office of Pesticide Programs. pp. 8–9. (Unpublished) Gass, 1964, Carcinogenic dose-response curve to oral diethylstilbestrol, J. Natl. Cancer Inst., 33, 971 Gibel, 1976, Tierexperimentelle Untersuchngen uber eine kanzerogene wirkung von Asbesfiltermaterial nach oraler Aufnahme, Arch. Geschwulstforsch., 46, 437 Griswold, 1968, The carcinogenicity of multiple intragastric doses of aromatic and heterocyclic nitro or amino derivatives in young female Sprague-Dawley rats, Cancer Res., 28, 924 Haseman, 1985, Issues in carcinogenicity testing: Dose selection, Fundam. Appl. Toxicol., 5, 66, 10.1016/0272-0590(85)90050-8 Huseby, 1953, The effects of testicular function upon stilbestrol-induced mammary and pituitary tumors in mice, 1, 25 International Agency for Research on Cancer (IARC), 1980, Long-Term and Short-Term Screening Assays for Carcinogens: A Critical Appraisal, IARC Monographs Suppl. 2, 36 Isaka, 1979, Tumors of Sprague-Dawley rats induced by long-term feeding of phenacetin, Gam, 70, 29 Maltoni, 1977, Vinyl chloride carcinogenicity: An experimental model for carcinogenesis studies, 119 Maltoni, 1974, Le potenzialita dei saggi spermimentali nella predizione dei rischi oncogeni ambientali. Un esempio: Il chloruro di vinile, Rend. Sci. Tis. Mat. Nat. (Lincei), 66, 1 Maltoni, 1979, First experimental demonstration of the carcinogenic effects of benzene. Long-term bioassays on Sprague-Dawley rats by oral administration, Med. Lav., 70, 352 National Academy of Sciences/National Research Council (NAS/NRC), 1975, Pest Control: An Assessment of Present and Alternative Technologies National Toxicology Program (NTP), 1986, Toxicology and Carcinogenesis Studies of Benzene (CAS No. 71-43-2) in F344 Rats and B6C3F1 Mice (Gavage Studies) Organization for Economic Cooperation and Development (OECD), 1981, Guidelines for Testing of Chemicals, 9 Okey, 1968, Continuous versus cyclic estrogen administration: Mammary carcinoma in C3H Mice, J. Natl. Cancer Inst., 40, 225 Poel, 1966, Pituitary tumors in mice after prolonged feeding of synthetic progestins, Science, 154, 402, 10.1126/science.154.3747.402 Rudali, 1972, Mammary carcinogenesis in female and male mice receiving contraceptives or gestagens, J. Natl. Cancer Inst., 49, 813 Rudali, 1971, Susceptibility of mice of different strains to the mammary carcinogenic action of natural and synthetic oestrogens, Rev. Eur. Etud. Clin. Biol., 16, 425 Schmahl, 1979, Carcinogenic action of low-dose cyclophosphamide given orally to Sprague-Dawley rats in a lifetime experiment, Int. J. Cancer, 23, 706, 10.1002/ijc.2910230518 Shimkin, 1941, Toxic and carcinogenic effects of stilbestrol in strain C3H male mice, J. Natl. Cancer Inst., 2, 55 Shimkin, 1966, Bioassay of 29 alkylating chemicals by the pulmonary-tumour response in strain A mice, J. Natl. Cancer Inst., 36, 915 U.S. Department of Health, 1976, DHEW Publ. (NIH) 76–801, NCI-CG-TR-1, 18 U.S. Department of Health and Human Services (USDHHS), 1985, Fourth Annual Report on Carcinogens U.S. Environmental Protection Agency (USEPA), 1984, Pesticide Assessment Guidelines, Subdivision F Hazard Evaluation, Human & Domestic Animals, 120 U.S. Food and Drug Administration (USFDA), 1982, Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food, 141 Vesselinovitch, 1975, Factors modulating benzidine carcinogenicity bioassay, Cancer Res., 35, 2814 Williams, 1962, Induction of hepatomas in rats and mice following the administration of auramine, Brit. J. Cancer, 16, 87, 10.1038/bjc.1962.8 Wogan, 1976, The induction of liver cell cancer by chemicals, 127 Wogan, 1974, Carcinogenic effects of low dietary levels of aflatoxin B1 in rats, Food Cosmet. Toxicol., 12, 681, 10.1016/0015-6264(74)90239-9