Pronamide: Human relevance of liver-mediated rat leydig cell tumors

Regulatory Toxicology and Pharmacology - Tập 72 - Trang 394-404 - 2015
Reza J. Rasoulpour1, Amanda K. Andrus1, M. Sue Marty1, Fagen Zhang1, Johnson Thomas1, Matthew J. LeBaron1, Sabitha Papineni2, Lynn H. Pottenger1, David L. Eisenbrandt2
1The Dow Chemical Company, Midland, MI, USA
2Dow AgroSciences LLC, Indianapolis, IN, USA

Tài liệu tham khảo

Amador, 1985, Testicular LH receptors during aging in Fischer 344 rats, J. Androl., 6, 61, 10.1002/j.1939-4640.1985.tb00816.x Bailey, D.E., 1990a. Kerb® Herbicide (Technical, no clay): 24-Month Dietary Chronic Toxicity/Oncogenicity Study in Rats. 12-Month Chronic Toxicity Phase. Unpublished report of Rohm and Haas Company (REPORT 87RC-062E), a subsidiary of The Dow Chemical Company, Midland, Michigan. Bailey, D.E., 1990b. Kerb ® Herbicide (Technical, no clay): 24-Month Dietary Chronic Toxicity/Oncogenicity Study in Rats. 24-Month Oncogenicity Phase. Unpublished report of Rohm and Haas Company (REPORT 87RC-062), a subsidiary of The Dow Chemical Company, Midland, Michigan. Boobis, A.R., Cohen, S.M., Dellarco, V., McGregor, D., Meek, M.E., Vickers, C., Willcocks, D., Farland, W., 2007. IPCS Framework for Analysing the Relevance of a Cancer Mode of Action For Humans. Harmonization Project Document No. 4, World Health Organization, Geneva, pp. 10–29. Boorman, 1987, Focal interstitial cell hyperplasia testes, rat, 201, 10.1007/978-3-642-72550-0_31 Boorman, 1990, Testis and epididymis, 405 Clegg, 1997, Leydig cell hyperplasia and adenoma formation: mechanisms and relevance to humans, Reprod. Toxicol., 11, 101, 10.1016/S0890-6238(96)00203-1 Cohen, 2003, The human relevance of information on carcinogenic modes of action: overview. Invited review, Crit. Rev. Toxicol., 33, 581, 10.1080/713608371 Cook, 1999, Rodent Leydig cell tumorigenesis: a review of the physiology, pathology, mechanisms, and relevance to humans, Crit. Rev. Toxicol., 29, 169, 10.1080/10408449991349203 Coulson, 2003, Lansoprazole increases testosterone metabolism and clearance in male Sprague–Dawley rats: implications for Leydig cell carcinogenesis, Toxicol. Appl. Pharmacol., 192, 154, 10.1016/S0041-008X(03)00275-8 Deguchi, 2009, Mode of action analysis of the synthetic pyrethroid metofluthrin-induced rat liver tumors: evidence for hepatic Cyp2b induction and hepatocyte proliferation, Toxicol. Sci., 108, 69, 10.1093/toxsci/kfp006 Ellis, 1982, Male rats secrete luteinising hormone and testosterone episodically, Endocrinology, 110, 1618, 10.1210/endo-110-5-1618 Fan, 2004, PPARalpha activators down-regulate CYP2C7, a retinoic acid and testosterone hydroxylase, Toxicology, 203, 41, 10.1016/j.tox.2004.05.013 Feldman, 2001, The development of androgen-independent prostate cancer, Nat. Rev. Cancer, 1, 34, 10.1038/35094009 Gardi, 2008, The proportionator: unbiased stereological estimation using biased automatic image analysis and non-uniform probability proportional to size sampling, Comput. Biol. Med., 38, 313, 10.1016/j.compbiomed.2007.11.002 Grubbs, 1969, Procedures for detecting outlying observations in samples, Technometrics, 11, 1, 10.1080/00401706.1969.10490657 Guengerich, 1982, Microsomal enzymes involved in toxicology – analysis and separation, 609 Hazelton, G.A., DiDonato, L.J., Kaminski, E.J., Lomax, L.G., 1993. Pronamide (Kerb®Herbicide): Effect of Endocrine Regulation on Rat Testes. Unpublished report of Rohm & Haas Company (REPORT 92R-053), a subsidiary of The Dow Chemical Company, Midland, Michigan, MRID 42987501. Hollander, 1973 Huhtaniemi, 1983, Gonadotrophin receptors: correlates with normal and pathological functions of the human ovary and testis Katzung, 1995 Klaunig, 2003, PPARalpha agonist-induced rodent tumors: modes of action and human relevance, Crit. Rev. Toxicol., 33, 655, 10.1080/713608372 Kocarek, 1992, Expression of multiple forms of cytochrome P450 mRNAs in primary cultures of rat hepatocytes maintained on matrigel, Toxicol. Appl. Pharmacol., 43, 328 Kocarek, 1993, Regulation of phenobarbital inducible cytochrome P450 mRNAs by lovastatin and oxysterols in primary cultures of rat hepatocytes, Toxicol. Appl. Pharmacol., 120, 298, 10.1006/taap.1993.1115 Kolenda-Roberts, H.M., 2010. Pronamide: Immunohistochemistry (IHC) for LH of the Pituitary Gland from Rats. Experimental Pathology Laboratories (EPL PROJECT NO.: 731-005). Unpublished report of Dow AgroSciences, LLC, a wholly owned subsidiary of The Dow Chemical Company, Midland, Michigan. Li, 2002, A high-performance-liquid-chromatography-based method for the determination of hydroxylated testosterone metabolites formed in vitro in liver microsomes from gray seal (Halichoerus grypus), J. Chromatogr. Sci., 40, 397, 10.1093/chromsci/40.7.397 Marty, M.S., Papineni, S., Coady, K.K., Rasoulpour, R.J., Pottenger, L.H., Eisenbrandt, D.L., 2015. Pronamide: Weight of Evidence of Potential Estrogen, Androgen or Thyroid Effects. http://dx.doi.org/10.1016/j.yrtph.2015.03.016. Mati, 2002, Leydig cell tumour – a rare testicular tumour, Int. Urol. Nephrol., 33, 103, 10.1023/A:1014481609336 Meek, 2003, A framework for human relevance analysis of information on carcinogenic modes of action, Crit. Rev. Toxicol., 33, 591, 10.1080/713608373 Miller, 1966 Peffer, 2007, Mouse liver effects of cyproconazole, a triazole fungicide: role of the constitutive androstane receptor, Toxicol. Sci., 99, 315, 10.1093/toxsci/kfm154 Prentice, 1995, A review of drug-induced leydig cell hyperplasia and neoplasia in the rat and some comparisons with man, Hum. Exp. Toxicol., 14, 562, 10.1177/096032719501400703 Rasoulpour, R.J., Andrus, A.K., 2013. Pronamide: Leydig Cell Tumor GnRH Agonism Mode of Action Study in NTac:SD Rats. Unpublished report of Toxicology & Environmental Research and Consulting, The Dow Chemical Company, Midland, Michigan. Study 101111. Scheer, 2008, A novel panel of mouse models to evaluate the role of human pregnane X receptor and constitutive androstane receptor in drug response, J. Clin. Invest., 118, 3228, 10.1172/JCI35483 Sonich-Mullin, 2001, IPCS conceptual framework for evaluating a mode of action for chemical carcinogenesis, Regul. Toxicol. Pharmacol., 34, 146, 10.1006/rtph.2001.1493 Steel, 1960 Steers, 2001, 5alpha-reductase activity in the prostate, Urology, 58, 17, 10.1016/S0090-4295(01)01299-7 Turner, 2000, Effect of chronic administration of an aromatase inhibitor to adult male rats on pituitary and testicular function and fertility, J. Endocrinol., 164, 225, 10.1677/joe.0.1640225 US EPA, 2005. Guidelines for carcinogen risk assessment. EPA/630/P-03/001B. US EPA TRED, 2002. Pronamide Tolerance Reassessment Eligibility Decision (TRED), Chemical ID No. 101701, DP Barcode No. D275194, U.S. Environmental Protection Agency, Office of Prevention, Pesticides, and Toxic Substances, March 8, 2002 (<http://www.epa.gov/oppsrrd1/REDs/pronamide_tred.pdf>). Wang, 2007, Rapid quantitation of testosterone hydroxyl metabolites by ultra-performance liquid chromatography and mass spectrometry. J, Chromatogr. B Analyt. Technol. Biomed. Life Sci., 855, 290, 10.1016/j.jchromb.2007.05.022 Waxman, 1988, Interactions of hepatic cytochromes P-450 with steroid hormones: regioselectivity and stereoselectivity of steroid metabolism and hormonal regulation of rat P-450 enzyme expression, Biochem. Pharmacol., 37, 71, 10.1016/0006-2952(88)90756-3 Williams, 2000, Induction of testosterone biotransformation enzymes following oral administration of methyl tert-butyl ether to male Sprague-Dawley rats, Toxicol. Sci., 57, 147, 10.1093/toxsci/57.1.147 Winer, 1971 Zhang, F., McClymont, E.L., Kan, L., 2012. Metabolite Quantitation (Study 101010; Pronamide). Unpublished report of Toxicology & Environmental Research and Consulting, The Dow Chemical Company, Midland, Michigan, Study 101010.