Carcinogenic mode of action of folpet in mice and evaluation of its relevance to humans

References

• Adams TB, Gavin CL, Taylor SV, Waddell WJ, Cohen SM, Feron VJ, Goodman J, Rietjens IM, Marnett LJ, Portoghese PS, Smith RL. (2008). The FEMA GRAS assessment of alpha beta-unsaturated aldehydes and related substances used as flavor ingredients. Food Chem Toxicol 46:2935–2967.
   PubMed Web of Science ®Google Scholar
• Andersen ME, Meek ME, Boorman GA, Brusick DJ, Cohen SM, Dragan YP, Frederick CB, Goodman JI, Hard GC, O’Flaherty EJ, Robinson DE. (2000). Lessons learned in applying the U.S. EPA proposed cancer guidelines to specific compounds. Toxicol Sci 53:159–172.
   PubMed Web of Science ®Google Scholar
• Arce GT, Gordon EB, Cohen SM, Singh P. (2009). Genetic toxicology of folpet and captan. Crit Rev Toxicol (In press. Companion article to this one).
   Google Scholar
• Arndt T, Dohn D. (2004). Measurement of the Half-Life of Thiophosgene in Human Blood. CRO: PTRL West, Inc., Hercules, CA Report No. 1146W-1. MRID 46296101. Captan Task Force, 82 pages, June 3, 2004.
   Google Scholar
• Bernard BK, Gordon EB. (2000). An evaluation of the common mechanism approach to the Food Quality Protection Act: Captan and four related fungicides, a practical example. Int J Toxicol 19:43–61.
   Google Scholar
• Boobis AR, Cohen SM, Dellarco V, McGregor D, Meek ME, Vickers C, Willcocks D, Farland W. (2006). IPCS framework for analyzing the relevance of a cancer mode of action for humans. Crit Rev Toxicol 36:781–792.
   PubMed Web of Science ®Google Scholar
• Boobis AR, Doe JE, Heinrich-Hirsch B, Meek ME, Munn S, Ruchirawat M, Schlatter J, Seed J, Vickers C. (2008). IPCS framework for analyzing the relevance of a noncancer mode of action for humans. Crit Rev Toxicol 38:87–96.
   PubMed Web of Science ®Google Scholar
• Bullock CH, Cisson CM, Wong ZA. (1982). The eye irritation potential of Phaltan Technical (PN 2623). Richmond, CA: Environmental Health & Toxicology, The Chevron Chemical Company, Ortho Division. Report no. SOCAL 1907 (S-2074); (FLP 178). August 3 1982. MRID 00160444.
   Google Scholar
• Chasseaud LF. (1991). Comparative metabolic fate and biochemical effects of folpet in male rats and mice. Cambridgeshire, England: Huntingdon Research Centre Ltd. Sponsor: New York: Makhteshim-Agan (America) Inc. Report no. NRC/MBS 32/90110 (Volume I: rats); NRC/MBS 33/90110 (Volume II, mice). March 5, 1991. MRID 42122016.
   Google Scholar
• Chidiac P, Goldberg M.T. (1987). Lack of induction of nuclear aberrations by captan in mouse duodenum. Environ Mutagen. 9:297–306. MRID 43405103.
   PubMedGoogle Scholar
• Clayson DB, Iverson F, Nera EA, Lok E. (1990). The significance of induced forestomach tumors. Annu Rev Pharmacol Toxicol. 30:441–463.
   PubMed Web of Science ®Google Scholar
• Cohen SM, Ellwein LB. 1990. Cell proliferation in carcinogenesis. Science 249:1007–1011.
   PubMed Web of Science ®Google Scholar
• Cohen SM, Ellwein LB. 1991. Genetic errors cell proliferation and carcinogenesis. Cancer Res 51:6493–6505.
   PubMed Web of Science ®Google Scholar
• Couch R, Siegel MR. 1972. Reactions of the trichloromethyl sulfenyl fungicides with histones. Phytopathology 62:802.
   Google Scholar
• Couch RC, Siegel MR. 1977. Interaction of captan and folpet with mammalian DNA and histones. Pestic Biochem Physiol 7:531–546.
   Google Scholar
• Couch RC, Siegel MR, Dorough HW. 1977. Fate of captan and folpet in rats and their effects on isolated liver nuclei. Pestic Biochem Physiol 7:547–558.
   Google Scholar
• Cox RH, Marshall PM, Voelker RW, Vargas KJ, Alsaker RD, Dudeck LE. (1985). Combined chronic oral toxicity/oncogenicity study in rats with Chevron Folpet Technical (SX-1388). Vienna, VA: Hazleton Labs America Inc. Project no. 2107-109. September 9, 1985. MRID 00151560.
   Google Scholar
• Cracknell S. (1993). Folpet technical (micronized): Acute inhalation toxicity study in the rat. Suffolk, England: Pharmaco-LSR Ltd. Sponsor: Beer Sheva, Israel: Makhteshim Chemical Works. Report no. 93/MAK139B/0507 (FLP 564). October 15, 1993. MRID 44286301.
   Google Scholar
• Crown S, Nyska A, Waner T. (1985). Folpan carcinogenicity study in the rat. Ness Ziona: Israel Life Science Research Israel, Ltd. Report no. MAK/022/FOL. December 1, 1985. MRID 00157493.
   Google Scholar
• Crown S, Nyska A, Waner T, Kenan G. (1989). Folpan: Toxicity by dietary administration to rats for two years. Ness Ziona: Israel Life Science Research Israel. Report no. MAK/053/FOL. January 10, 1989. MRID 43640201, 00124023.
   Google Scholar
• East P. (1994). Folpet: Oncogenicity study by dietary administration to CD-1 mice for 104 weeks. CRO Pharmaco LSR, Ltd., Suffolk, England. Report no. 94/MAK117/0403. MRID 44316501, 1422 pages, July 12, 1994.
   Google Scholar
• EFSA. 2009a. Conclusions on Pesticide Peer Review. Peer review of the pesticide risk assessment the active substance captan (Question No. EFA-Q-2009-604). EFSA. Scientific Report (2009) 296, 1–90. Conclusion on the peer review of captan. Parma, Italy: EFSA.
   Google Scholar
• EFSA. 2009b. Conclusions on Pesticide Peer Review. Peer review of the pesticide risk assessment the active substance folpet (Question No. EFA-Q-2009-605). EFSA. Scientific Report (2009) 297, 1–80. Conclusion on the peer review of folpet. Parma, Italy: EFSA.
   Google Scholar
• FAO/WHO (1996). Pesticide Residues in Food—1995 (Captan; Folpet). Geneva: WHO.
   Google Scholar
• Ghanayem BI, Sanchez IM, Matthews HB, Elwell MR. (1994). Demonstration of a temporal relationship between ethyl acrylate-induced forestomach cell proliferation and carcinogenicity. Toxicol Pathol 22:497–509.
   PubMedGoogle Scholar
• Gordon E. (2007). Captan: Transition from ‘B2′ to ‘not likely’. How pesticide registrants affected the EPA Cancer Classification Update. J App Toxicol 27:519–526.
   PubMed Web of Science ®Google Scholar
• Gordon EB. (2010). Captan and folpet. In: Krieger RI, ed. Hayes Handbook of Pesticide Toxicoklogy. 3rd ed. Vol. 2. NewYork: Elsevier, 1915–1949.
   Google Scholar
• Gordon EB, Mobley SC, Ehrlich T, Williams M. (2001). Measurement of the reaction between the fungicides captan or folpet and blood thiols. Toxicol Methods 11:209–223.
   Google Scholar
• Greaves P. (2007). Histopathology of Preclinical Toxicity Studies. London: Elsevier-Academic Press, 386–392, 397–407.
   Google Scholar
• Greenfield RE, Ellwein LB, Cohen SM. (1984). A general probabilistic model of carcinogenesis: Analysis of experimental urinary bladder cancer. Carcinogenesis 5:437–445.
   PubMed Web of Science ®Google Scholar
• Grice HC. (1988). Safety evaluation of butylated hydroxyanisole from the perspective of effects on forestomach and oesophageal squamous epithelium. Food Chem Toxicol 26:717–723.
   PubMed Web of Science ®Google Scholar
• Gudi R, Krsmanovic L. (2001). Nuclear aberration test in the mouse duodenum (folpet) and photomicrographs. Rockville, MD: BioReliance Corporation. Report no. AA31SK.123005.BTL. March 15, 2001. MRID 45745105.
   Google Scholar
• Haseman JK. (1983) A reexamination of false-positive rates for carcinogenesis studies. Fundam App Toxicol 3:334–339.
   PubMedGoogle Scholar
• Haseman JK, Hailey JR, Morris RW. (1998). Spontaneous neoplasm incidences in Fischer 344 rats and B6C3F1 mice in two-year carcinogenicity studies: A National Toxicology Program update. Toxicol Pathol 26:428–441.
   PubMed Web of Science ®Google Scholar
• Hill BA. (1965). The environment and disease: Association or causation? Proc R Soc Med 58:295–300.
   PubMed Web of Science ®Google Scholar
• Ito N, Hirose M. (1989). Antioxidants—Carcinogenic and chemopreventive properties. Adv Cancer Res 53:247–302.
   PubMed Web of Science ®Google Scholar
• Jernstrom B, Morgenstern R, Moldeus P. (1993). Protective role of glutathione thiols and analogues in mutagenesis and carcinogenesis. Basic Life Sci 61:137–47.
   PubMedGoogle Scholar
• Knudson AG Jr. (1971). Mutation and cancer: Statistical study of retinoblastoma. Proc Natl Acad Sci USA 68:820–823.
   Google Scholar
• Lee KS. (1989). [Trichloromethyl-14C]—Captan; Hydrolysis at 25°C. Richmond, CA: ICI Americas Inc. Report no. WRC 89-44. May 26 1989.
   Google Scholar
• Lin KK. (1998). Formats for submission of animal carcinogenicity study data. Drug Inf J. 32:43–52.
   Google Scholar
• Liu MK, Fishbein L. (1967). Reactions of captan and folpet with thiols. Experientia 23:81–82.
   PubMedGoogle Scholar
• Lukens RJ. (1966). The fungitoxicity of compounds containing a trichloromethylthio- group. J Agric Food Chem 14:365–367.
   Web of Science ®Google Scholar
• Lukens RJ, Rich S, Horsfall JG. (1965). Role of the R-group in the fungitoxicity of R-SCCI3 compounds. Phytopathology 55:658–662.
   PubMedGoogle Scholar
• McConnell EL, Basit AW, Murdan S. (2009). Measurements of rat and mouse gastrointestinal pH, fluid and lymphoid tissue, and implications for in-vivo experiments. J Pharm Pharmacol 60:63–70.
   Google Scholar
• Meek ME, Bucher JR, Cohen SM, Dellarco V, Hill RN, Lehman-McKeeman LD, Longfellow DG, Pastoor T, Seed J, Patton DE. (2003). A framework for human relevance analysis of information on carcinogenic modes of action. Crit Rev Toxicol 33:591–653.
   PubMed Web of Science ®Google Scholar
• Milburn GM. (1997). Folpet: Study of hyperplasia in the mouse duodenum. CRO: Central Toxicology Laboratory, Alderley Park Macelesfield, Cheshire, UK. Report no. CTL/p/5577. R-9688. 56 pages, December 17, 1997. MRID 44866402.
   Google Scholar
• Moolgavkar SH, Knudson AG, Jr, . (1981). Mutation and cancer: A model for human carcinogenesis. J Natl Cancer Inst 66:1037–1052.
   PubMed Web of Science ®Google Scholar
• Moriya M, Kato K, Shirasu Y. (1978). Effects of cysteine and a liver metabolic activation system on the activities of mutagenic pesticides. Mutat Res. 57:259–263.
   PubMedGoogle Scholar
• Noffsinger A, Waxman I. (2007). Preinvasive neoplasia in the stomach: Diagnosis and treatment. Clin Gastroenterol Hepatol 5:1018–1023.
   PubMedGoogle Scholar
• NTP (2000). Report on Carcinogens (RoC), Ninth Edition. U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program Pursuant to Section 301(b) (4) of the Public Health Service Act as Amended by Section 262, PL 95-622. Available at: http://niehs.nih.gov/. Current report: 11th RoC.
   Google Scholar
• Nyska A, Waner T, Paster Z, Bracha P, Gordon EB, Klein B. (1990). Induction of gastrointestinal tumors in mice fed the fungicide folpet: Possible mechanisms. Jpn J Cancer Res 81:545–549.
   PubMedGoogle Scholar
• Potten CS, Loeffler M. (1990). Stem cells: Attributes, cycles, spirals, pitfalls and uncertainties. Lessons for and from the crypt. Development 110:1001–1020.
   PubMed Web of Science ®Google Scholar
• Potten CS, Owen G, Roberts SA. (1990). The temporal and spatial changes in cell proliferation within the irradiated crypts of the murine small intestine. Int J Radiat Biol 57:185–199.
   PubMed Web of Science ®Google Scholar
• Proctor DM, Gatto NM, Hong SJ, Allamneni KP. (2007). Mode-of-action framework for evaluating the relevance of rodent forestomach tumors in cancer risk assessment. Toxicol Sci 98:313–326.
   PubMed Web of Science ®Google Scholar
• Provan WM, Eyton-Jones H, Lappin G, Pritchard D, Moore RB, Green T. (1995). The incorporation of radiolabelled sulphur from captan into protein and its impact on a DNA binding study. Chem Biol Interact 96:173–184.
   PubMedGoogle Scholar
• Quest JA, Fenner-Crisp PA, Burnam W, Copley M, Dearfield KL, Hamernik KL, Saunders DS, Whiting RJ, Engler R. (1993). Evaluation of the carcinogenic potential of pesticides. 4. Chloroalkylthiodicarboximide compounds with fungicidal activity. Regul Toxicol Pharmacol 17:19–34.
   PubMed Web of Science ®Google Scholar
• Reno FE, Burdock G, Serota D. (1981). Subchronic toxicity study in rats: Phaltan (folpet). Vienna, VA: Hazleton Laboratories America, Inc. Report no. 2107-100; R-6118. MRID 00115269.
   Google Scholar
• Riddell RH, Petras RE, Sobin LH, Williams GT. (2003). Epithelial neoplasia of the intestines. Published by Armed Forces Institute of Pathology, Washington, DC. In: Tumors of the Intestines. AFIP Atlas of Tumor Pathology, Third Series, Vol. 32. 85–240.
   Google Scholar
• Rosen PP, Oberman HA. (1993). Fibroepithelial neoplasms. In: Tumors of the Mammary Gland. Published by Armed Forces Institute of Pathology, Washington, DC. AFIP Atlas of Tumor Pathology, Third Series, Vol. 7. 191–114.
   Google Scholar
• Rubin Y, Nyska A. (1985). Folpan: Oncogenicity study in the mouse. Life Science Research Israel. Sponsor: Beer Sheva, Israel: Makhteshim Chemical Works, Ltd. Report no. MAK/015/FOL. September 9, 1985. MRID 00151075.
   Google Scholar
• Russo J, Russo I. H. (1987). Biological and molecular bases of mammary carcinogenesis. Lab Invest 57:112–137.
   PubMed Web of Science ®Google Scholar
• Russo J, Gusterson BA, Rogers AE, Russo IH, Wellings SR, van Zwieten MJ. (1990). Biology of disease—Comparative study of human and rat mammary tumorigenesis. Lab Invest 62:244–278.
   PubMed Web of Science ®Google Scholar
• Ruzo LO, Ewing AD. (1988). Hydrolysis of [14C]-folpet. Richmond, CA: PTRL West, Inc. Report no. PTRL 124. August 4, 1988. MRID 40818801.
   Google Scholar
• Schnaubelt LJ. (1995). Reregistration of phosmet; literature review of the metabolite phthalimide. Washington, DC: Reregistration Branch, Section II, Special Review and Reregistration Division. May 24, 1995.
   Google Scholar
• Seed J, Carney EW, Corley RA, Crofton KM, DeSesso JM, Foster PM, Kavlock R, Kimmel G, Klaunig J, Meek ME, Preston RJ, Slikker W Jr, Tabacova S, Williams GM, Wiltse J, Zoeller RT, Fenner-Crisp P, Patton DE. (2005). Overview: Using mode of action and life stage information to evaluate the human relevance of animal toxicity data. Crit Rev Toxicol 35:664–672.
   PubMed Web of Science ®Google Scholar
• Siegel MR. (1971a) Reactions fo the fungicide folpet (n-trichloromethylthio) phthalimide with a nonthiol protein. Pestic Biochem Physiol 1:234–240.
   Google Scholar
• Siegel MR. (1971b) Reaction of the fungicide folpet (N-trichloromethylthio phthalimide) with a thiol protein. Pestic Biochem Physiol 1:225–233.
   Google Scholar
• Sonich-Mullen C, Fielder R, Wiltse J, Baetcke K, Dempsey J, Fenner-Crisp P, Grant D, Hartley M, Knaap A, Kroese D, Mangelsdorf I, Meek E, Rice JM, Younes M. (2001). IPCS conceptual framework for evaluating a mode of action for chemical carcinogenesis. Regul Toxicol Pharmacol 34:146–152.
   PubMedGoogle Scholar
• TERA. (2003). Report of Peer Review Meeting Cancer Assessment for Captan September 3–4, 2003. Cincinnati, OH: Toxicology Excellence for Risk Assessment (TERA). November 21, 2003. Available at: http://www.TERA.org/peer/CAPTAN/Captan%20final%20meeting%20report.pdf.
   Google Scholar
• US EPA. (1999a). Captan: Reregistration Eligibility Decision (RED). Washington, DC: Prevention, Pesticides and Toxic Substances (7508C). Report no. EPA 738-R-99-015. November 1999.
   Google Scholar
• US EPA. (1999b). Folpet: Reregistration Eligibility Decision (RED). Washington, DC: Prevention, Pesticides and Toxic Substances (7508C). Report no. EPA 738-R-99-011. November 1999.
   Google Scholar
• US EPA. (1999c). Guidelines for Carcinogen Risk Assessment (Review Draft). Washington, DC: Risk Assessment Forum. US Environmental Protection Agency. Report no. NCEA-F-0644. July 1999. Available at: http://www.epa.gov/ncea/raf/cancer.htm.
   Google Scholar
• US EPA. (2003). Folpet; pesticide tolerance. Federal Register 68:10377–10388.
   Google Scholar
• US EPA. (2004a). Captan: Cancer Reclassification; Amendment of Reregistration Eligibility Decision; Notice of Availability. Federal Register 69:68357–68360.
   Google Scholar
• US EPA. (2004b). Folpet; pesticide tolerance. Federal Register 69:52182–52192.
   Google Scholar
• US EPA. (2005). Guidelines for Carcinogen Risk Assessment. Washington, DC: Risk Assessment Forum, US Environmental Protection Agency. Report no. EPA/630/P-03/001F. March 2005.
   Google Scholar
• Waner T. (1985). Folpan chronic oral study in beagle dogs for 52 weeks. Life Science Research Israel. Report no. LSRI MAK/062/FOL. October 28, 1985.
   Google Scholar
• Waterson LA. (1995). Folpet: Investigation of the effect on the duodenum of male mice after dietary administration for 28 days with recovery. Cambridgeshire, England: Huntingdon Research Centre Ltd. Sponsor: Beer Sheva, Israel: Maktheshim Chemical Works, Ltd. Report no. MBS 45/943003. R-7794; April 11 1995. MRID 44286303.
   Google Scholar
• Wester PW, Kroes R. (1988). Forestomach carcinogens: Pathology and relevance to man. Toxicol Pathol 16:165–171.
   PubMed Web of Science ®Google Scholar
• Wilkinson CF, Arce G, Gordon EB. (2004). Analysis of the appropriate cancer classification of captan under EPA’s current guidelines. Captan Task Force: San Francisco, CA: Arvesta Corporation, and New York: Makhteshim Agan of North America, Inc. Report no. CTF 0304. 82 Pages, April 9, 2004. MRID 46247701.
   Google Scholar
• Wong ZA. (1985). Lifetime oncogenic feeding study of Phaltan Technical (SX-946) in CD-1 mice (ICR derived). Richmond, CA: Chevron Environmental Health Center, Chevron Chemical Company. Report no. Socal 1331. July 26, 1985. MRID 00125718.
   Google Scholar