A Tiered Approach to Systemic Toxicity Testing for Agricultural Chemical Safety Assessment

REFERENCES

• Barton H. A., Pastoor T. P., Baetcke K., Chambers J. E., Diliberto J., Doerrer N. G., Driver J. H., Hastings C. E., Iyengar S., Krieger R., Stahl B., Timchalk C. The acquisition and application of absorption, distribution, metabolism, and excretion (ADME) data in agricultural chemical safety assessments. Crit. Rev. Toxicol. 2006; 36: 9–35, [CSA]
   PubMed Web of Science ®Google Scholar
• Basketter D. A., Bremmer J. N., Buckley P., Kammuller M. E., Kawabata T., Kimber I., Loveless S. E., Magda S., Stringer D. A., Vohr H.-W. Pathology considerations for, and subsequent risk assessment of, chemicals identified as immunosuppressive in routine toxicology. Food Chem. Toxicol. 1995; 33: 239–243, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Battershill J. M., Fielder R. J. Mouse-specific carcinogens: an assessment of hazard and significance for validation of short-term carcinogenicity bioassays in transgenic mice. Hum. Exp. Toxicol. 1998; 17: 193–205, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Carmichael N. G., Barton H. A., Boobis A. R., Cooper R. L., Dellarco V. L., Doerrer N. G., Fenner-Crisp P. A., Doe J. E., Lamb J. C., Pastoor T. P. Agricultural chemical safety assessment: A multi-sector approach to the modernization of human safety requirements. Crit. Rev. Toxicol. 2006; 36: 1–7, [CSA]
   PubMed Web of Science ®Google Scholar
• Cohen S. M. Alternative models for carcinogenicity testing: Weight of evidence evaluations across models. Toxicol. Pathol. 2001; 29(Suppl.)183–190, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
   PubMedGoogle Scholar
• Cohen S. M. Human carcinogenic risk evaluation: An alternative approach to the two-year rodent bioassay. Toxicol. Sci. 2004; 80: 225–229, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Cohen S. M., Robinson D., MacDonald J. Alternative models for carcinogenicity testing. Toxicol. Sci. 2001; 64: 14–19, [PUBMED], [INFOTRIEVE], [CSA]
   PubMed Web of Science ®Google Scholar
• Cooper R. L., Lamb J. C., Barlow S. M., Bentley K., Brady A. M., Doerrer N. G., Eisenbrandt D. L., Fenner-Crisp P. A., Hines R. N., Irvine L., Kimmel C. A., Koeter H., Li A. A., Makris S. L., Sheets L., Speijers G. J.A., Whitby K. A tiered approach to life stages testing for agricultural chemical safety assessment. Crit. Rev. Toxicol. 2006; 36: 69–98, [CSA]
   PubMed Web of Science ®Google Scholar
• Counts J. L., Goodman J. I. Principles underlying dose selection for, and extrapolation from, the carcinogen bioassay: Dose influences mechanism. Regul. Toxicol. Pharmacol. 1995; 21: 418–421, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Dourson M. L., Andersen M. E., Erdreich L. S., MacGregor J. A. Using human data to protect the public's health. Regul. Toxicol. Pharmacol. 2001; 33: 234–256, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
   PubMed Web of Science ®Google Scholar
• European Crop Protection Association. Relationship between no effect levels and low effect levels in rat 28 day and 90 day studies. 1999, Unpublished report
   Google Scholar
• Gaylor D. W. Are tumor incidence rates telling us what we need to know about carcinogens?. Regul. Toxicol. Pharmacol 2005; 41: 128–133, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Goodman J. I. A perspective on current and future uses of alternative models for carcinogenicity testing. Toxicol. Pathol. 2001; 29(Suppl.)173–176, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Holsapple M. P. The plaque-forming cell (PFC) response in immunotoxicology: An approach to monitoring the primary effector function of B-lymphocytes. Methods in Immunotoxicology, G. R. Burleson, J. H. Dean, A. E. Munson. Wiley-Liss, New York 1995; Vol. 1: 71–108
   Google Scholar
• Huff J. E., Bucher J. R., Schwetz B. A., Barrett J. C. Optimum exposure levels for chemical carcinogenesis experiments: Concepts, principles, guidelines, and experience. Toxicologist 1994, SOT Abstract 475[CSA]
   Google Scholar
• International Programme on Chemical Safety. Guidance document for the use of data in development of chemical-specific adjustment factors (CSAFs) for interspecies differences and human variability in dose/concentration-response assessment. World Health Organization (WHO), GenevaSwitzerland 2001 http://www.who.int/ipcs/publications/methods/harmonization/en/csafs_guidance_doc.pdf
   Google Scholar
• Luster M. I., Munson A. E., Thomas P. T., Holsapple M. P., Fenters J. D., White K. L., Jr., Lauer L. D., Germolec D. R., Rosenthal G. J., Dean J. H. Development of a testing battery to assess chemical-induced immunotoxicity: National Toxicology Program's guidelines for immunotoxicity evaluation in mice. Fundam. Appl. Toxicol. 1988; 10: 2–19, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
   PubMedGoogle Scholar
• Luster M. I., Pait D. G., Portier C., Rosenthal G. J., Germolec D. R., Comment C. E., Munson A. E., White K., Pollock P. Qualitative and quantitative experimental models to aid in risk assessment for immunotoxicology. Toxicol. Lett. 1992a; 64/65: 71–78, [CSA], [CROSSREF]
   Google Scholar
• Luster M. I., Portier C., Pait D. G., White K. L., Jr., Gennings C., Munson A. E., Rosenthal G. J. Risk assessment in immunotoxicology I: Sensitivity and predictability of immune tests. Fundam. Appl. Toxicol. 1992b; 18: 200–210, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
   PubMedGoogle Scholar
• Luster M. I., Portier C., Pait D. G., Rosenthal G. J., Germolec D. R., Corsini E., Blaylock B. L., Pollock P., Kouchi Y., Craig W., White D. L., Munson A. E., Comment C. E. Risk assessment in immunotoxicology II: Relationships between immune and host resistance tests. Fundam. Appl. Toxicol. 1993; 21: 71–82, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
   PubMedGoogle Scholar
• McClain R. M. Mechanistic considerations in the regulation and classification of chemical carcinogens. Nutritional Toxicology, F. N. Kotsonis, M. Mackey, J. Hjelle. Raven Press, New York 1994; 273–304
   Google Scholar
• McConnell E. The maximum tolerated dose: The debate. J. Am. Coll. Toxicol. 1989; 8: 1115–1120, [CSA]
   Google Scholar
• McConnell E. Historical review of the rodent bioassay and future directions. Regul. Toxicol. Pharmacol. 1995; 21: 38–43, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Mead R. The Design of Experiments. Cambridge University Press, Cambridge, UK 1988
   Google Scholar
• Monro A. How useful are chronic (life-span) toxicology studies in rodents in identifying pharmaceuticals that pose a carcinogenic risk to humans?. Adverse Drug React. Toxicol. Rev. 1993; 12: 5–34, [PUBMED], [INFOTRIEVE], [CSA]
   PubMedGoogle Scholar
• Moser V. C., MacPhail R. C. Comparative sensitivity of neurobehavioural tests for chemical screening. Neurotoxicology 1990; 11: 335–344, [PUBMED], [INFOTRIEVE], [CSA]
   PubMed Web of Science ®Google Scholar
• National Research Council. Use of the maximum tolerated dose in animal bioassays for carcinogenicity. Issues in Risk Assessment, B. Goldstein, et al. National Academies Press, Washington, DC 1993; 15–83
   Google Scholar
• National Research Council. Committee on the Use of Third Party Toxicity Research with Human Research Participants, National Research Council of the National Academies. National Academies Press, Washington, DC. 2004
   Google Scholar
• National Toxicology Program. Report of the NTP Ad Hoc Panel on Chemical Carcinogenesis Testing and Evaluation. National Institute of Environmental Health Sciences, Research Triangle Park, NC. 1984
   Google Scholar
• National Toxicology Program. Final report of the advisory review by the NTP Board of Scientific Councilors. Fed. Reg. 1992; 57: 31721–31730, [CSA]
   Google Scholar
• Organisation for Economic Cooperation and Development. Health effects test guideline 453. Combined chronic toxicity/carcinogenicity studies. Environment Directorate, ParisFrance 1981
   Google Scholar
• Organisation for Economic Cooperation and Development. Health effects test guideline 407. Repeated dose 28-day oral toxicity study in rodents. Environment Directorate, ParisFrance 1995
   Google Scholar
• Organisation for Economic Cooperation and Development. Health effects test guideline 409. Repeated dose 90-day oral toxicity study in non-rodents, Environment Directorate, ParisFrance 1998
   Google Scholar
• Organisation for Economic Cooperation and Development. Protocol for investigating the efficacy of the Enhanced 407 Test Guideline (phase 2). Rationale for the investigation, and description of the protocol. Environment Directorate, ParisFrance 2000
   Google Scholar
• Organisation for Economic Cooperation and Development. Health effects test guideline 416. Two-generation reproduction toxicity study. Environment Directorate, ParisFrance 2001
   Google Scholar
• Popp J. A. Criteria for the evaluation of studies in transgenic models. Toxicol. Pathol. 2001; 29(Suppl.)20–23, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
   PubMedGoogle Scholar
• Pritchard J. B., French J. E., Davis B. J., Haseman J. K. Transgenic mouse models: Their role in carcinogen identification. Environ. Health Perspect. 2003; 111: 444–454, [PUBMED], [INFOTRIEVE], [CSA]
   PubMed Web of Science ®Google Scholar
• Robinson D. E., MacDonald J. S. Background and framework for ILSI's collaborative evaluation program on alternative models for carcinogenicity assessment. Toxicol. Pathol. 2001; 29(Suppl.)13–19, [PUBMED], [INFOTRIEVE], [CSA]
   PubMedGoogle Scholar
• Rozman K. K., Doull J. Dose and time as a variable of toxicity. Toxicology 2000; 144: 169–178, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Solecki R. Pesticide residues in food—2000. Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group. Annex 5: Proposed test guidelines for studies with single oral doses (for use in establishing acute reference doses for chemical residues in food and drinking water). FAO Plant Production and Protection Paper 163, FAO, RomeItaly 2001, http://www.fao.org/ag/agp/agpp/pesticid/jmpr/Download/2000_rep/cont.pdf
   Google Scholar
• Sontag J. M., Page N. P., Safiotti U. Guidelines for carcinogen bioassay in small rodents. DHHS Publication (NIH) 76-801, National Cancer Institute, Bethesda, MD. 1976
   Google Scholar
• Spielmann H., Gerbracht U. The use of dogs as second species in regulatory testing of pesticides. Part II: Subacute, subchronic and chronic studies in the dog. Arch. Toxicol. 2001; 75: 1–21, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Storer R. D., French J. E., Haseman J., Hajian G., LeGrand E. K., Long G. G., Mixson L. A., Ochoa R., Sagartz J. E., Soper K. A. P53 +/− hemizygous knockout mouse: overview of available data. Toxicol. Pathol. 2001; 29(Suppl.)30–50, [PUBMED], [INFOTRIEVE], [CSA]
   PubMedGoogle Scholar
• U.S. Environmental Protection Agency. Health Effects Test Guideline OPPTS 870.3100. 90-Day oral toxicity in rodents. EPA 712-C-98-199, Office of Prevention, Pesticides and Toxic Substances, Washington, DC. 1998a
   Google Scholar
• U.S. Environmental Protection Agency. Health Effects Test Guideline OPPTS 870.3150. 90-Day oral toxicity in nonrodents. EPA 712-C-98-200, Office of Prevention, Pesticides and Toxic Substances, Washington, DC. 1998b
   Google Scholar
• U.S. Environmental Protection Agency. Health Effects Test Guideline OPPTS 870.3800. Reproduction and fertility effects. EPA 712-C-98-208, Office of Prevention, Pesticides and Toxic Substances, Washington, DC 1998c
   Google Scholar
• U.S. Environmental Protection Agency. Health Effects Test Guideline OPPTS 870.4300. Combined chronic toxicity/carcinogenicity. EPA 712-C-98-212, Office of Prevention, Pesticides and Toxic Substances, Washington, DC 1998d
   Google Scholar
• U.S. Environmental Protection Agency. Health Effects Test Guideline OPPTS 870.3050. Repeated dose 28-day oral toxicity study in rodents. EPA 712-C-00-366, Office of Prevention, Pesticides and Toxic Substances, Washington, DC. 2000
   Google Scholar
• U.S. Environmental Protection Agency. Draft final guidelines for carcinogen risk assessment. Fed. Reg. 2003a; 68: 10012, [CSA]
   Google Scholar
• U.S. Environmental Protection Agency. Rodent carcinogenesis studies: dose selection and evaluation. Interim Guidance Document No. G2003.02, Office of Pesticide Programs, Health Effects Division, Washington, DC. 2003b
   Google Scholar
• U.S. Environmental Protection Agency. Human Testing; Proposed plan and description of review process. Fed. Reg. 2005; 70: 6661, [CSA]
   Google Scholar
• Usui T., Griffiths S. A., Lumley C. E. (1996) Industry viewpoint: The utility of the mouse for the assessment of the carcinogenic potential of pharmaceuticals. Proceedings, Third International Conference on Harmonisation, Yokohama, 1995, F. D'Arcy, D. W.G. Harron. Greystone Books, Antrim, N. Ireland, 279–284
   Google Scholar
• Usui T., Mutai M., Hisada S., Takoaka M., Soper K. A., McCullough B., Alden C. CB6F1-rasH2 mouse: Overview of available data. Toxicol Pathol. 2001; 29(Suppl.)90–108, [PUBMED], [INFOTRIEVE], [CSA]
   PubMedGoogle Scholar
• Van Oosterhout J. P., Van der Laan J. W., De Waal E. J., Olejniczak K., Hilgenfeld M., Schmidt V., Bass R. The utility of two rodent species in carcinogenic risk assessment of pharmaceuticals in Europe. Regul Toxicol. Pharmacol. 1997; 25: 6–17, [PUBMED], [INFOTRIEVE], [CSA], [CROSSREF]
   PubMed Web of Science ®Google Scholar
• Ware G. W. The Pesticide Book, 5th ed. Thomson, Fresno, CA. 2000
   Google Scholar
• Yamamoto S., Urano K., Koizumi H., Wakana S., Hioki K., Mitsumori K., Kurokawa Y., Hayashi Y., Nomura T. Validation of transgenic mice carrying the human prototype c-Ha-ras gene as a bioassay model for rapid carcinogenicity testing. Environ. Health Perspect. 1998; 106(Suppl. 1)57–69, [PUBMED], [INFOTRIEVE], [CSA]
   PubMedGoogle Scholar