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Letters to the Editor

Response to Letter to the Editor from Drs. van Kesteren, Pronk, Heusinkveld, Luijten and Hakkert concerning Yamada et al. (2021): Critical evaluation of the human relevance of the mode of action for rodent liver tumor formation by activators of the constitutive androstane receptor (CAR). Crit. Rev. Toxicol. Vol. 51: 373-394.

ORCID Icon, ORCID Icon &
Pages 399-402 | Received 01 Jul 2022, Accepted 07 Jul 2022, Published online: 16 Aug 2022

References

  • 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(10):781–792.
  • Corton JC, Cunningham ML, Hummer BT, Lau C, Meek B, Peters JM, Popp JA, Rhomberg L, Seed J, Klaunig JE. 2014. Mode of action framework analysis for receptor-mediated toxicity: the peroxisome proliferator-activated receptor alpha (PPARalpha) as a case study. Crit Rev Toxicol. 44(1):1–49.
  • Corton JC, Peters JM, Klaunig JE. 2018. The PPARalpha-dependent rodent liver tumor response is not relevant to humans: addressing misconceptions. Arch Toxicol. 92(1):83–119.
  • ECHA. 2017. Guidance on the application of the CLP criteria, Guidance to regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, version 5.0. <https://echa.europa.eu/documents/10162/23036412/clp_en.pdf/58b5dc6d-ac2a-4910-9702-e9e1f5051cc5.> (accessed 6/22/2022).
  • Eguchi A, Fukunaga S, Ogata K, Kushida M, Asano H, Cohen SM, Sukata T. 2021. Chimeric mouse with humanized liver is an appropriate animal model to investigate mode of action for porphyria-mediated hepatocytotoxicity. Toxicol Pathol. 49(7):1243–1254.
  • Elcombe CR, Peffer RC, Wolf DC, Bailey J, Bars R, Bell D, Cattley RC, Ferguson SS, Geter D, Goetz A, et al. 2014. Mode of action and human relevance analysis for nuclear receptor-mediated liver toxicity: a case study with phenobarbital as a model constitutive androstane receptor (CAR) activator. Crit Rev Toxicol. 44(1):64–82.
  • Haines C, Elcombe BM, Chatham LR, Vardy A, Higgins LG, Elcombe CR, Lake BG. 2018. Comparison of the effects of sodium phenobarbital in wild type and humanized constitutive androstane receptor (CAR)/pregnane X receptor (PXR) mice and in cultured mouse, rat and human hepatocytes. Toxicology. 396–397:23–32.
  • IARC. 2001. IARC monographs on the evaluation of carcinogenic risks to humans. Vol. 79, some thyrotropic agents: phenobarbital and its sodium salt. Lyon, IARC Press, 161–288.
  • La Vecchia C, Negri E. 2014. A review of epidemiological data on epilepsy, phenobarbital, and risk of liver cancer. Eur J Cancer Prev. 23(1):1–7.
  • Lake BG. 2018. Human relevance of rodent liver tumour formation by constitutive androstane receptor (CAR) activators. Toxicol Res (Camb). 7(4):697–717.
  • Monro A. 1993. The paradoxical lack of interspecies correlation between plasma concentrations and chemical carcinogenicity. Regul Toxicol Pharmacol. 18(1):115–135.
  • Nihira K, Nan-Ya KI, Kakuni M, Ono Y, Yoshikawa Y, Ota T, Hiura M, Yoshinari K. 2019. Chimeric mice with humanized livers demonstrate human-specific hepatotoxicity caused by a therapeutic antibody against TRAIL-receptor 2/death receptor 5. Toxicol Sci. 167(1):190–201.
  • Ohara A, Takahashi Y, Kondo M, Okuda Y, Takeda S, Kushida M, Kobayashi K, Sumida K, Yamada T. 2017. Candidate genes responsible for early key events of phenobarbital-promoted mouse hepatocellular tumorigenesis based on differentiation of regulating genes between wild type mice and humanized chimeric mice. Toxicol Res (Camb). 6(6):795–813.
  • Okuda Y, Kushida M, Kikumoto H, Nakamura Y, Higuchi H, Kawamura S, Cohen SM, Lake BG, Yamada T. 2017. Evaluation of the human relevance of the constitutive androstane receptor-mediated mode of action for rat hepatocellular tumor formation by the synthetic pyrethroid momfluorothrin. J Toxicol Sci. 42(6):773–788.
  • Parzefall W, Erber E, Sedivy R, Schulte-Hermann R. 1991. Testing for induction of DNA synthesis in human hepatocyte primary cultures by rat liver tumor promoters. Cancer Res. 51(4):1143–1147.
  • Soldatow V, Peffer RC, Trask OJ, Cowie DE, Andersen ME, LeCluyse E, Deisenroth C. 2016. Development of an in vitro high content imaging assay for quantitative assessment of CAR-dependent mouse, rat, and human primary hepatocyte proliferation. Toxicol in Vitro. 36:224–237.
  • Sprenger H, Rasinger JD, Hammer H, Naboulsi W, Zabinsky E, Planatscher H, Schwarz M, Poetz O, Braeuning A. 2022. Proteomic analysis of hepatic effects of phenobarbital in mice with humanized liver. Archives of Toxicology. https://doi.org/10.1007/s00204-022-03338-7.
  • Stritzelberger J, Lang JD, Mueller TM, Reindl C, Westermayer V, Kostev K, Hamer HM. 2021. Anti-seizure medication is not associated with an increased risk to develop cancer in epilepsy patients. J Neurol. 286(6):2185–2191.
  • Tateno C, Yamamoto T, Utoh R, Yamasaki C, Ishida Y, Myoken Y, Oofusa K, Okada M, Tsutsui N, Yoshizato K. 2015. Chimeric mice with hepatocyte-humanized liver as an appropriate model to study human peroxisome proliferator–activated receptor-α. Toxicol Pathol. 43(2):233–248.
  • Tateno C, Kojima Y. 2020. Characterization and applications of chimeric mice with humanized livers for preclinical drug development. Lab Anim Res. 36(2). https://doi.org/10.1186/s42826-019-0032-y
  • Terry C, Yan Z, Corvaro M, Gehen SC. 2021. A retrospective study on EU harmonised classifications for carcinogenicity to guide future research. Regul Toxicol Pharmacol. 119:104800.
  • Whysner J, Ross PM, Williams GM. 1996. Phenobarbital mechanistic data and risk assessment: enzyme induction, enhanced cell proliferation, and tumor promotion. Pharmacol Ther. 71(1–2):153–191.
  • Yamada T, Okuda Y, Kushida M, Sumida K, Takeuchi H, Nagahori H, Fukuda T, Lake BG, Cohen SM, Kawamura S. 2014. Human hepatocytes support the hypertrophic but not the hyperplastic response to the murine nongenotoxic hepatocarcinogen sodium phenobarbital in an in vivo study using a chimeric mouse with humanized liver. Toxicol Sci. 142(1):137–157.
  • Yamada T. 2018. Case examples of an evaluation of the human relevance of the pyrethroids/pyrethrins-induced liver tumours in rodents based on the mode of action. Toxicol Res (Camb). 7(4):681–696.
  • Yamada T, Ohara A, Ozawa N, Maeda K, Kondo M, Okuda Y, Abe J, Cohen SM, Lake BG. 2020. Comparison of the hepatic effects of phenobarbital in chimeric mice containing either rat or human hepatocytes with humanized constitutive androstane receptor and pregnane X receptor mice. Toxicol Sci. 177(2):362–376.
  • Yamada T. 2021. Application of humanized mice to toxicology studies: evaluation of the human relevance of the mode of action for rodent liver tumor formation by activators of the constitutive androstane receptor (CAR). J Toxicol Pathol. 34(4):283–297.
  • Yamada T, Cohen SM, Lake BG. 2021. Critical evaluation of the human relevance of the mode of action for rodent liver tumor formation by activators of the constitutive androstane receptor (CAR). Crit Rev Toxicol. 51(5):373–394.

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