Adverse outcome pathway (AOP): α2u-globulin nephropathy and kidney tumors in male rats

References

• Aksu S, Tanrikulu F. 2016. Differentiation of protein species of alpha-2u-globulin according to database entries: a half-theoretical approach. J Proteomics. 134:186–192.
   PubMed Web of Science ®Google Scholar
• Alden CL. 1986. A review of unique male rat hydrocarbon nephropathy. Toxicol Pathol. 14(1):109–111.
   PubMedGoogle Scholar
• Andersen ME, Preston RJ, Maier A, Willis AM, Patterson J. 2014. Dose-response approaches for nuclear receptor-mediated modes of action for liver carcinogenicity: results of a workshop. Crit Rev Toxicol. 44(1):50–63.
   PubMed Web of Science ®Google Scholar
• Bal-Price A, Crofton KM, Leist M, Allen S, Arand M, Buetler T, Delrue N, FitzGerald RE, Hartung T, Heinonen T, et al. 2015. International STakeholder NETwork (ISTNET): creating a developmental neurotoxicity (DNT) testing road map for regulatory purposes. Arch Toxicol. 89(2):269–287.
   PubMed Web of Science ®Google Scholar
• Becker RA, Ankley GT, Edwards SW, Kennedy SW, Linkov I, Meek B, Sachana M, Segner H, Van Der Burg B, Villeneuve DL, et al. 2015. Increasing scientific confidence in adverse outcome pathways: application of tailored bradford-hill considerations for evaluating weight of evidence. Regul Toxicol Pharmacol. 72(3):514–537.
   PubMed Web of Science ®Google Scholar
• Bird MG, Burleigh-Flayer HD, Chun JS, Douglas JF, Kneiss JJ, Andrews LS. 1997. Oncogenicity studies of inhaled methyl tertiary butyl ether in CD-1 mice and F-344 rats. J Appl Toxicol. 17(S1):S45–S55.
   PubMedGoogle Scholar
• Borghoff SJ, Lagarde WH. 1993. Assessment of binding of 2,4,4-trimethyl-2-pentanol to low-molecular-weight proteins isolated from kidneys of male rats and humans. Toxicol Appl Pharmacol. 119(2):228–235.
   PubMed Web of Science ®Google Scholar
• Borghoff SJ, Miller AB, Bowen JP, Swenberg JA. 1991. Characteristics of chemical binding to alpha 2u-globulin in vitro-evaluating structure-activity relationships. Toxicol Appl Pharmacol. 107(2):228–238.
   PubMed Web of Science ®Google Scholar
• Borghoff SJ, Short BG, Swenberg JA. 1990. Biochemical mechanisms and pathobiology of alpha 2u-globulin nephropathy. Annu Rev Pharmacol Toxicol. 30:349–367.
   PubMed Web of Science ®Google Scholar
• Borghoff SJ, Prescott JS, Janszen DB, Wong BA, Everitt JI. 2001. Alpha 2u-globulin nephropathy, renal cell proliferation, and dosimetry of inhaled tert-butyl alcohol in male and female F-344 rats. Toxicol Sci. 61(1):176–186.
   PubMed Web of Science ®Google Scholar
• Borghoff SJ, Hard GC, Berdasco NM, Gingell R, Green SM, Gulledge W. 2009. Methyl isobutyl ketone (MIBK) induction of alpha2u-globulin nephropathy in male, but not female rats. Toxicology. 258(2–3):131–138.
   PubMed Web of Science ®Google Scholar
• Borghoff SJ, Poet T, Green S, Davis J, Hughes B, Mensing T, Sarang SS, Lynch AM, Hard GC. 2015. Methyl isobutyl ketone exposure-related increases in specific measures of α2u-globulin (α2u) nephropathy in male rats along with in vitro evidence of reversible protein binding. Toxicology. 333:1–13.
   PubMed Web of Science ®Google Scholar
• Borghoff SJ, Ring C, Banton MI, Leavens TL. 2017. Physiologically based pharmacokinetic model for ethyl tertiary-butyl ether and tertiary-butyl alcohol in rats: contribution of binding to α2u-globulin in male rats and high-exposure nonlinear kinetics to toxicity and cancer outcomes. J Appl Toxicol. 37(5):621–640.
   PubMed Web of Science ®Google Scholar
• Brooks DE. 1987. The major androgen-regulated secretory proteins of the rat epididymis bear sequence homology with members of the alpha 2u-globulin superfamily. Biochem Int. 14(2):235–240.
   PubMedGoogle Scholar
• Burnett VL, Short BG, Swenberg JA. 1989. Localization of alpha 2u-globulin within protein droplets of male rat kidney: immunohistochemistry using perfusion-fixed, GMA-embedded tissue sections. J Histochem Cytochem. 37(6):813–818.
   PubMed Web of Science ®Google Scholar
• Charbonneau M, Strasser J, Lock EA, Turner MJ, Swenberg JA. 1989. Involvement of reversible binding to alpha 2u-globulin in 1,4-dichlorobenzene-induced nephrotoxicity. Toxicol Appl Pharmacol. 99(1):122–132.
   PubMed Web of Science ®Google Scholar
• Cirvello JD, Radovsky A, Heath JE, Farnell DR, Lindamood C. 1995. Toxicity and carcinogenicity of t-butyl alcohol in rats and mice following chronic exposure in drinking water. Toxicol Ind Health. 11(2):151–165.
   PubMed Web of Science ®Google Scholar
• Dietrich DR, Swenberg JA. 1991. Alpha2u-globulin is necessary for d-limonene promotion of male rat kidney tumors. Cancer Res. 51(13):3512–3521.
   PubMed Web of Science ®Google Scholar
• Dietrich DR, Swenberg JA. 1992a. The presence of alpha2 glоbulin is necessary for d-limonene promotion of male rat kidney tumors. Cancer Res. 51:3512–3521.
   Web of Science ®Google Scholar
• Dietrich DR, Swenberg JA. 1992b. NCI-Black-Reiter (NBR) male rats fail to develop kidney disease following exposure to agents that induce a-2-globulin nephropathy. Fundam Appl Toxicol. 16(4):749–762.
   Google Scholar
• Doi AM, Hill G, Seely J, Hailey JR, Kissling G, Bucher JR. 2007. Alpha 2u-globulin nephropathy and renal tumors in national toxicology program studies. Toxicol Pathol. 35(4):533–540.
   PubMed Web of Science ®Google Scholar
• Edwards SW, Tan Y-M, Villeneuve DL, Meek ME, McQueen CA. 2016. Adverse outcome pathways-organizing toxicological information to improve decision making. J Pharmacol Exp Ther. 356(1):170–181.
   PubMed Web of Science ®Google Scholar
• Eldridge SR, Tilbury LF, Goldsworthy TL, Butterworth BE. 1990. Measurement of chemically induced cell proliferation in rodent liver and kidney: a comparison of 5-bromo-2′-deoxyuridine and [3H]thymidine administered by injection or osmotic pump. Carcinogenesis. 11(12):2245–2251.
   PubMed Web of Science ®Google Scholar
• Hagiwara A, Doi Y, Imai N, Nakashima H, Ono T, Kawabe M, Furukawa F, Tamano S, Nagano K, Fukushima S. 2011. Medium-term multi-organ carcinogenesis bioassay of ethyl tertiary-butyl ether in rats. Toxicology. 289(2–3):160–166.
   PubMed Web of Science ®Google Scholar
• Hard GC, Rodgers IS, Baetcke KP, Richards WI, McGaughy RE, Valcovic LR. 1993. Hazard evaluation of chemicals that cause accumulation of alpha2u-globulin hyaline droplet nephropathy and tubule neoplasia in the kidneys of male rats. Enviro Health Persp. 99:313–349.
   PubMed Web of Science ®Google Scholar
• Hard GC, Banton MI, Bretzlaff RS, Dekant W, Fowles JR, Mallett AK, McGregor DB, Roberts KM, Sielken RL, Valdez-Flores C, et al. 2013. Consideration of rat chronic progressive nephropathy in regulatory evaluations for carcinogenicity. Toxicol Sci. 132(2):268–275.
   PubMed Web of Science ®Google Scholar
• Hard GC, Cohen SM, Ma J, Yu F, Arnold LL, Banton MI. 2019. Histopathology re-examination of the NTP toxicity/carcinogenicity studies of tert-butyl alcohol to identify renal tumor and toxicity modes of action. Regul Toxicol Pharmacol. 102:65–73.
   PubMed Web of Science ®Google Scholar
• [IARC] International Agency for Research on Cancer. 1999. Consensus report. In: Capen CC, Dybing E, Rice JM, Willbourn JD, editors. Species difference in thyroid, kidney, and urinary bladder carcinogenesis. Lyon: IARC Scientific Publication (No. 147).
   Google Scholar
• Kanerva RL, Ridder GM, Lefever FR, Alden CL. 1987. Comparison of short-term renal effects due to oral administration of decalin or d-limonene in young adult male Fischer-344 rats. Food Chem Toxicol. 25(5):335–345.
   Web of Science ®Google Scholar
• Lake BG, Cunninghame ME, Price RJ. 1997. Comparison of the hepatic and renal effects of 1,4-dichlorobenzene in the rat and mouse. Fundam Appl Toxicol. 39(1):67–75.
   PubMedGoogle Scholar
• Lehman-McKeeman LD, Rivera-Torres MI, Caudill D. 1990. Lysosomal degradation of alpha 2u-globulin and alpha 2u-globulin-xenobiotic conjugates. Toxicol Appl Pharmacol. 103(3):539–548.
   PubMed Web of Science ®Google Scholar
• Löbel D, Strotmann J, Jacob M, Breer H. 2001. Identification of a third rat odorant-binding protein (OBP3). Chem Senses. 26(6):673–680.
   PubMed Web of Science ®Google Scholar
• Lock EA, Charbonneau M, Strasser J, Swenberg JA, Bus JB. 1987. 2,4,-Trimethyl-induced nephropathy II. The reversible binding of a TMP metabolite to a kidney protein fraction containing α2u-globulin. Toxicol Appl Pharmacol. 91(2):182–192.
   PubMed Web of Science ®Google Scholar
• Medinsky MA, Wolf DC, Cattley RC, Wong B, Janszen DB, Farris GM, Wright GA, Bond JA. 1999. Effects of a thirteen-week inhalation exposure to ethyl tertiary butyl ether on fischer-344 rats and CD-1 mice. Toxicol Sci. 51(1):108–118.
   PubMed Web of Science ®Google Scholar
• Nemec MD, Pitt JA, Topping DC, Gingell R, Pavkov KL, Rauckman EJ, Harris SB. 2004. Inhalation two-generation reproductive toxicity study of methyl isobutyl ketone in rats. Int J Toxicol. 23(2):127–143.
   PubMed Web of Science ®Google Scholar
• [NTP] National Toxicology Program. 1986. NTP technical report on the toxicology and carcinogenesis studies of isophorone CAS NO. 78-599-1) in F344 rats and B6aC3F1 mice (gavage studies).
   Google Scholar
• [NTP] National Toxicology Program. 1990. NTP technical report on the toxicology and carcinogenesis studies of d-limonene (CAS NO. 5989-27-5) in F344/N rats and B6C3F1 mice (gavage studies).
   Google Scholar
• [NTP] National Toxicology Program. 1995. NTP technical report on the toxicology and carcinogenesis studies of t-butyl alcohol (CAS NO. 75-65-0) in F344/N rats and B6C3F1 mice (drinking water studies).
   Google Scholar
• [NTP] National Toxicology Program. 2005. NTP toxicology and carcinogenesis studies of decalin (CAS No. 91-17-8) in F344/N rats and B6C3F1 mice and a toxicology study of decaline in male NBR rats (inhalation studies). NTP Technical Report 513.
   Google Scholar
• [NTP] National Toxicology Program. 2007. NTP toxicology and carcinogenicity studies of methyl isobutyl ketone (CAS no. 108-10-1) in F344/N rats and B6C3F1 mice inhalation studies. NTP Technical Report Series 538. p. 1–236.
   Google Scholar
• [OECD] Organisation for Economic Co-operation and Development. 2018. User’s handbook supplement to the guidance document for developing and assessing AOPs. ENV/JM/MONO(2016)12.
   Google Scholar
• Perkins EJ, Antczak P, Burgoon L, Falciani F, Garcia-Reyero N, Gutsell S, Hodges G, Kienzler A, Knapen D, McBride M, et al. 2015. Adverse outcome pathways for regulatory applications: examination of four case studies with different degrees of completeness and scientific confidence. Toxicol Sci. 148(1):14–25.
   PubMed Web of Science ®Google Scholar
• Pervaiz S, Brew K. 1987. Homology and structure-function correlations between alpha 1-acid glycoprotein and serum retinol-binding protein and its relatives. FASEB J. 1(3):209–214.
   PubMed Web of Science ®Google Scholar
• Phillips RD, Moran EJ, Dodd DE, Fowler EH, Kary CD, O'Donoghue J. 1987. A 14-week vapor inhalation toxicity study of methyl isobutyl ketone. Fundam Appl Toxicol. 9(3):380–388.
   PubMedGoogle Scholar
• Prescott-Mathews JS, Wolf DC, Wong BA, Borghoff SJ. 1997. Methyl tert-butyl ether causes alpha2u-globulin nephropathy and enhanced renal cell proliferation in male Fischer-344 rats. Toxicol Appl Pharmacol. 143(2):301–314.
   PubMed Web of Science ®Google Scholar
• Prescott-Matthews JS, Poet TS, Borghoff SJ. 1999. Evaluation of the in vivo interaction of methyl tert-butyl ether with alpha2u-globulin in male F-344 rats. Toxicol Appl Pharmacol. 102:524–536.
   Google Scholar
• Rice JM, Baan RA, Blettner M, Genevois-Charmeau C, Grosse Y, McGregor DB, Partensky C, Wilbourn JD. 1999. Rodent tumors of urinary bladder, renal cortex, and thyroid gland in IARC monographs evaluations of carcinogenic risk to humans. Toxicol Sci. 49(2):166–171.
   PubMed Web of Science ®Google Scholar
• Ridder GM, Von Bargen EC, Alden CL, Parker R. 1990. Increased hyaline droplet formation in male rats exposed to decalin is dependent on the presence of alpha2u-globulin. Fundam Appl Toxicol. 15(4):732–743.
   PubMedGoogle Scholar
• Robinson M, Bruner RH, Olson GR. 1990. Fourteen- and ninety-day oral toxicity studies of methyl tertiary-butyl ether in Sprague-Dawley rats. J Am Coll Toxicol. 9(5):525–540.
   Google Scholar
• Roy AK, Raber DL. 1972. Immunofluorescent localization of 2u-globulin in the hepatic and renal tissues of rat. J Histochem Cytochem. 20(2):89–96.
   PubMed Web of Science ®Google Scholar
• Roy AK, Schiop MJ, Dowbenko DJ. 1976. Regulation of the hepatic synthesis of alpha2u-globulin and its corresponding messenger RNA in maturing rats. FEBS Lett. 70(1):137–140.
   PubMed Web of Science ®Google Scholar
• Roy AK, Nath TS, Motwani NM, Chatterjee B. 1983. Age-dependent regulation of the polymorphic forms of alpha2u-globulin. J Biol Chem. 258:10121–10127.
   Web of Science ®Google Scholar
• Saito A, Sasaki T, Kasai T, Katagiri T, Nishizawa T, Noguchi T, Aiso S, Nagano K, Fukushima S. 2013. Hepatotumorigenicity of ethyl tertiary-butyl ether with 2-year inhalation exposure in F344 rats. Arch Toxicol. 87(5):905–914.
   PubMed Web of Science ®Google Scholar
• Saitta B, Jalili MF, Zohoorkari H, Rao R, Hallows KR, Baty CJ, Pastor-Soler NM. 2019. Ex vivo kidney slice preparations as a model system to study signaling cascades in kidney epithelial cells. Methods Cell Biol. 153:185–203.
   PubMed Web of Science ®Google Scholar
• Shaw PH, Held WA, Hastie ND. 1983. The gene family for major urinary proteins: expression in several secretory tissues of the mouse. Cell. 32(3):755–761.
   PubMed Web of Science ®Google Scholar
• Short BG, Burnett VL, Swenberg JA. 1989. Elevated proliferation of proximal tubule cells and localization of accumulated alpha 2u-globulin in F344 rats during chronic exposure to unleaded gasoline or 2,2,4-trimethylpentane. Toxicol Appl Pharmacol. 101(3):414–431.
   PubMed Web of Science ®Google Scholar
• Short BG, Steinhagen WI, Swenberg JA. 1989. Promoting effects of unleaded gasoline and 2,2,4-trimethylpentane on the development of atypical cell foci and renal tubular cell tumors in rats exposed to N-ethyl-N-hydroxyethylnitrosamine. Cancer Res. 49(22):6369–6378.
   PubMed Web of Science ®Google Scholar
• Simon TW, Simons SS Jr., Preston RJ, Boobis AR, Cohen SM, Doerrer NG, Fenner-Crisp PA, McMullin TS, McQueen CA, Rowlands JC. 2014. The use of mode of action information in risk assessment: quantitative key events/dose-response framework for modeling the dose-response for key events. Crit Rev Toxicol. 44 Suppl 3:17–43.
   PubMed Web of Science ®Google Scholar
• Swenberg JA. 1993. Alpha 2u-globulin nephropathy: Review of the cellular and molecular mechanisms involved and their implications for human risk assessment. Environ Health Persp. 101(Suppl 6):39–44.
   PubMedGoogle Scholar
• Swenberg JA, Lehman-McKeeman LK. 1999. Alpha2u-urinary globulin associated nephropathy as a mechanism of renal tubule cell carcinogensis in male rats. In: Capen CC, Dybing E, Rice JM, Wilbourn JD, editors. Species differences in thyroid, kidney and urinary bladder carcinogenesis. IARC Scientific Publications No. 147. Lyon: International Agency for Research on Cancer.
   Google Scholar
• Swenberg JA, Short B, Borghoff S, Strasser J, Charbonneau M. 1989. The comparative pathobiology of alpha 2u-globulin nephropathy. Toxicol Appl Pharmacol. 97(1):35–46.
   PubMed Web of Science ®Google Scholar
• U.S. EPA. 1991. Alpha2u-globulin: association with chemically induced renal toxicity and neoplasia in the male rat (Risk Assessment Forum). Washington, DC: U.S. Environmental Protection Agency. EPA/625/391/019F; NTIS PB92143668.
   Google Scholar
• U.S. EPA. 2019. Memorandum from Andrew R. Wheeler, Administrator to Associate Deputy Administrator. Directive to prioritize efforts to reduce animal testing (2019). Available from: https://www.epa.gov/sites/production/files/2019-09/documents/image2019-09-09-231249.pdf.
   Google Scholar
• U.S. EPA. 2021. Toxicological review of ethyl tertiary butyl ether. EPA/635/R-20/400Fa [accessed 2021 Sep 7]. Available from: https://iris.epa.gov/static/pdfs/1034tr.pdf.
   Google Scholar
• Vandoren G, Mertens B, Heyns W, Van Baelen H, Rombauts W, Verhoeven G. 1983. Different forms of alpha 2u-globulin in male and female rat urine. Eur J Biochem. 134(1):175–181.
   PubMedGoogle Scholar
• Williams TM, Borghoff SJ. 2001. Characterization of tert-butyl alcohol binding to alpha2u-globulin in F-344 rats. Toxicol Sci. 62(2):228–235.
   PubMed Web of Science ®Google Scholar
• Wood C. 2020. Alpha2u-microglobulin cytotoxicity leading to renal tubular adenomas and carcinomas (in male rat) [accessed 2020 Jul 3]. Available from: https://aopwiki.org/aops/105.
   Google Scholar
• Yeung CK, Himmelfarb J. 2019. Kidneys on chips: emerging technology for preclinical drug development. Clin J Am Soc Nephrol. 14(1):144–146.
   PubMed Web of Science ®Google Scholar