299
Views
14
CrossRef citations to date
0
Altmetric
Review Articles

Evaluating the MoA/human relevance framework for F-344 rat liver epithelioid granulomas with mineral oil hydrocarbons

, &
Pages 754-770 | Received 30 Nov 2016, Accepted 11 Apr 2017, Published online: 08 Sep 2017

References

  • Albro PW, Fishbein L. 1970. Absorption of aliphatic hydrocarbons by rats. Biochim Biophys Acta. 219:437–446.
  • Baldwin MK, Berry PH, Esdaile DJ, Linnett SL, Martin JG, Peristianis GC, Priston RA, Simpson BJ, Smith JD. 1992. Feeding studies in rats with mineral hydrocarbon food grade white oils. Toxicol Pathol. 20:426–435.
  • Barp L, Kornauth C, Wuerger T, Rudas M, Biedermann M, Reiner A, Concin N, Grob K. 2014. Mineral oil in human tissues. Part I: concentrations and molecular mass distributions. Food Chem Toxicol. 72:312–321.
  • Barp L, Biedermann M, Grob K, Blas-Y-Estrada F, Nygaard UC, Alexander J, Cravedi J-P. 2017. Mineral oil saturated hydrocarbons (MOSH) in female Fischer 344 rats; accumulation of wax components; implications for risk assessment. Sci Total Environ. 583:319–333.
  • Black MM, Epstein WL. 1974. Formation of multinucleate giant cells in organized epithelioid cell granulomas. Am J Pathol. 74:263–274.
  • Blewitt RW, Bradbury K, Greenall MJ, Burrow H. 1977. Hepatic damage associated with mineral oil deposits. Gut. 18:476–479.
  • Boitnott JK, Margolis S. 1970. Saturated hydrocarbons in human tissues. 3. Oil droplets in the liver and spleen. Johns Hopkins Med J. 127:65–78.
  • 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.
  • 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.
  • Boogaard PJ, Goyak KO, Biles RW, van Stee LLP, Miller MS, Miller MJ. 2012. Comparative toxicokinetics of low-viscosity mineral oil in Fischer 344 rats, Sprague–Dawley rats, and humans – implications for an Acceptable Daily Intake (ADI). Regul Toxicol Pharmacol. 63:69–77.
  • Carlton WW, Boitnott JK, Dungworth DL, Ernst H, Hayashi Y, Mohr U, Parodi AL, Pattengale PK, Rittinghausen S, Ward JM. 2001. Assessment of the morphology and significance of the lymph nodal and hepatic lesions produced in rats by the feeding of certain mineral oils and waxes. Proceedings of a pathology workshop held at the Fraunhofer Institute of Toxicology and Aerosol Research Hannover, Germany, May 7–9, 2001. Exp Toxicol Pathol. 53:247–255.
  • Coash M, Forouhar F, Wu CH, Wu GY. 2012. Granulomatous liver diseases: a review. J Formos Med Assoc. 111:3–13.
  • Concin N, Hofstetter G, Plattner B, Tomovski C, Fiselier K, Gerritzen K, Fessler S, Windbichler G, Zeimet A, Ulmer H, et al. 2008. Mineral oil paraffins in human body fat and milk. Food Chem Toxicol. 46:544–552.
  • Concin N, Hofstetter G, Plattner B, Tomovski C, Fiselier K, Gerritzen K, Semsroth S, Zeimet AG, Marth C, Siegl H, et al. 2011. Evidence for cosmetics as a source of mineral oil contamination in women. J Womens Health (Larchmt). 20:1713–1719.
  • Coppock JBM, Cookson MA. 1949. Some aspects of the use of mineral oils in baking practice with particular reference to bread. J Chem Technol Biotechnol. 68:274–277.
  • Cravedi J, Thibaut R, Tulliez J, Perdu E. 2011. Comparative in vitro study of the biotransformation of n-alkanes by liver and small intestine microsomes from different rat strains. Toxicol Lett. 205 Supplement:S188.
  • Cravedi J-P, Perdu E. 2012. In vitro metabolic study on alkanes in hepatic microsomes from humans and rats. EFS3. 9:263E.
  • Cruickshank B, Jane Thomas M. 1984. Mineral oil (follicular) lipidosis: II. Histologic studies of spleen, liver, lymph nodes and bone marrow. Hum Pathol. 15:731–737.
  • Dalbey WE. 2001. Subchronic inhalation exposures to aerosols of three petroleum lubricants. AIHAJ. 62:49–56.
  • Dincsoy HP, Weesner RE, MacGee J. 1982. Lipogranulomas in non-fatty human livers. A mineral oil induced environmental disease. Am J Clin Pathol. 78:35–41.
  • Dourakis SP, Saramadou R, Alexopoulou A, Kafiri G, Deutsch M, Koskinas J, Archimandritis AJ. 2007. Hepatic granulomas: a 6-year experience in a single center in Greece. Eur J Gastroenterol Hepatol. 19:101–104.
  • Duboucher C, Rocchiccioli F, Nègre A, Lageron A, Salvayre R. 1988. Alkane storage disease (very long chain N-alkanes): an original type of lipid storage of dietary origin from plant wax hydrocarbons. In: Lipid storage disorders. USA: Springer; p. 451–456.
  • EFSA. 2012. Scientific opinion on mineral oil hydrocarbons in food. EFSA J. 10:2704.
  • EFSA. 2009. Scientific opinion on the use of high viscosity white mineral oils as a food additive. EFSA J. 7:1387.
  • Firriolo JM, Morris CF, Trimmer GW, Twitty LD, Smith JH, Freeman JJ. 1995. Comparative 90-day feeding study with low-viscosity white mineral oil in Fischer-344 and Sprague-Dawley-derived CRL:CD rats. Toxicol Pathol. 23:26–33.
  • Fleming KA, Zimmerman H, Shubik P. 1998. Granulomas in the livers of humans and Fischer rats associated with the ingestion of mineral hydrocarbons: a comparison. Regul Toxicol Pharmacol: RTP. 27:75–81.
  • Gaya DR, Thorburn D, Oien KA, Morris AJ, Stanley AJ. 2003. Hepatic granulomas: a 10 year single centre experience. J Clin Pathol. 56:850–853.
  • Griffis LC, Twerdok LE, Francke-Carroll S, Biles RW, Schroeder RE, Bolte H, Faust H, Hall WC, Rojko J. 2010. Comparative 90-day dietary study of paraffin wax in Fischer-344 and Sprague-Dawley rats. Food Chem Toxicol. 48:363–372.
  • Halladay JS, Mackerer CR, Twerdok LE, Sipes IG. 2002. Comparative pharmacokinetic and disposition studies of [1-14C]1-eicosanylcyclohexane, a surrogate mineral hydrocarbon, in female Fischer-344 and Sprague-Dawley rats. Drug Metabol Dispos: Biol Fate Chem. 30:1470–1477.
  • Hempenius RA, Lina BA, Haggitt RC. 2000. Evaluation of a subchronic (13-week) oral toxicity study, preceded by an in utero exposure phase, with arachidonic acid oil derived from Mortierella alpina in rats. Food Chem Toxicol. 38:127–139.
  • Hoglen NC, Regan SP, Hensel JL, Younis HS, Sauer JM, Steup DR, Miller MJ, Waterman SJ, Twerdok LE, Sipes IG. 1998. Alteration of Kupffer cell function and morphology by low melt point paraffin wax in female Fischer-344 but not Sprague-Dawley rats. Toxicol Sci. 46:176–184.
  • Ikeda M, Yamakawa K, Saoo K, Matsuda Y, Hosokawa K, Takeuchi H, Li JQ, Zeng Y, Yokohira M, Imaida K. 2008. Induction of multiple granulomas in the liver with severe hepatocyte damage by Montan wax, a natural food additive, in a 90-day toxicity study in F344 rats. Food Chem Toxicol. 46:654–661.
  • Isobe K, Matsunaga S, Nakayama H, Uetsuka K. 2008a. Histopathological characteristics of hepatic lipogranulomas with portosystemic shunt in dogs. J Vet Med Sci. 70:133–138.
  • Isobe K, Nakayama H, Uetsuka K. 2008b. Relation between lipogranuloma formation and fibrosis, and the origin of brown pigments in lipogranuloma of the canine liver. Comp Hepatol. 7:5.
  • JECFA. 1995. Evaluation of certain food additives and contaminants. Forty-fourth report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series 859. Geneva.
  • JECFA. 2002. Evaluation of certain food additives and contaminants. Fifty-ninth report of the Joint FAO/WHO Expert Committee on Food Additives. WHO Technical Report Series 913. Geneva.
  • JECFA. 2012. Joint FAO/WHO expert committee on food additives. Seventy-sixth meeting; Geneva, 5–14 June 2012: Summary and conclusions. Geneva, Switzerland. (JECFA/76/SC).
  • Lagana SM, Moreira RK, Lefkowitch JH. 2010. Hepatic granulomas: pathogenesis and differential diagnosis. Clin Liver Dis. 14:605–617.
  • Lamps LW. 2015. Hepatic granulomas: a review with emphasis on infectious causes. Arch Pathol Lab Med. 139:867–875.
  • Le Bon AM, Cravedi JP, Tulliez JE. 1988. Disposition and metabolism of pristane in rat. Lipids. 23:424–429.
  • McKee RH, Drummond JG, Freeman JJ, Letinski DJ, Miller MJ. 2012. Light white oils exhibit low tissue accumulation potential and minimal toxicity in F344 rats. Int J Toxicol. 31:175–183.
  • Meek ME, Boobis A, Cote I, Dellarco V, Fotakis G, Munn S, Seed J, Vickers C. New developments in the evolution and application of the WHO/IPCS framework on mode of action/species concordance analysis. J Appl Toxicol. 2014a;34:1–18.
  • 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.
  • Meek ME, Palermo CM, Bachman AN, North CM, Jeffrey Lewis R. Mode of action human relevance (species concordance) framework: evolution of the Bradford Hill considerations and comparative analysis of weight of evidence. J Appl Toxicol. 2014b;34:595–606.
  • Miller MJ, Lonardo EC, Greer RD, Bevan C, Edwards DA, Smith JH, Freeman JJ. 1996. Variable responses of species and strains to white mineral oils and paraffin waxes. Regul Toxicol Pharmacol. 23:55–68.
  • Nash JF, Gettings SD, Diembeck W, Chudowski M, Kraus AL. 1996. A toxicological review of topical exposure to white mineral oils. Food Chem Toxicol. 34:213–225.
  • Nochomovitz LE, Uys CJ, Epstein S. 1975. Massive deposition of mineral oil after prolonged ingestion. S Afr Med J. 49:2187–2190.
  • Noti A, Grob K, Biedermann M, Deiss U, Bruschweiler BJ. 2003. Exposure of babies to C15–C45 mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 38:317–325.
  • Oser BL, Oser M, Carson S, Sternberg SS. 1965. Toxicologic studies of petrolatum in mice and rats. Toxicol Appl Pharmacol. 7:382–401.
  • Satoh M, Reeves WH. 1994. Induction of lupus-associated autoantibodies in BALB/c mice by intraperitoneal injection of pristane. J Exp Med. 180:2341–2346.
  • Scotter MJ, Castle L, Massey RC, Brantom PG, Cunninghame ME. 2003. A study of the toxicity of five mineral hydrocarbon waxes and oils in the F344 rat, with histological examination and tissue-specific chemical characterisation of accumulated hydrocarbon material. Food Chem Toxicol. 41:489–521.
  • Seed J, Carney EW, Corley RA, Crofton KM, DeSesso JM, Foster PMD, Kavlock R, Kimmel G, Klaunig J, Meek ME, et al. 2005. Overview: using mode of action and life stage information to evaluate the human relevance of animal toxicity data. Crit Rev Toxicol. 35:663–672.
  • Sharif F, Crushell E, O'Driscoll K, Bourke B. 2001. Liquid paraffin: a reappraisal of its role in the treatment of constipation. Arch Dis Child. 85:121–124.
  • Shoda T, Toyoda K, Uneyama C, Takada K, Takahashi M. 1997. Lack of carcinogenicity of medium-viscosity liquid paraffin given in the diet to F344 rats. Food Chem Toxicol. 35:1181–1190.
  • Shubik P, Saffiotti U, Lijinsky W, Pietra G, Rappaport H, Toth B, Raha CR, Tomatis L, Feldman R, Ramahi H. 1962. Studies on the toxicity of petroleum waxes. Toxicol Appl Pharmacol. 4 Supplement 1:1–62.
  • Smith JH, Bird MG, Lewis SC, Freeman JJ, Hogan GK, Scala RA. 1995. Subchronic feeding study of four white mineral oils in dogs and rats. Drug Chem Toxicol. 18:83–103.
  • Smith JH, Mallett AK, Priston RA, Brantom PG, Worrell NR, Sexsmith C, Simpson BJ. 1996. Ninety-day feeding study in Fischer-344 rats of highly refined petroleum-derived food-grade white oils and waxes. Toxicol Pathol. 24:214–230.
  • Soultati A, Dourakis S. 2007. Liver granulomatosis. Ann Gastroenterol. 2004:17.
  • Stula EF, Kwon BK. 1978. Pulmonary pathology from inhalation of a complex mineral oil mist in dogs, rats, mice and gerbils. Am Ind Hyg Assoc J. 39:393–399.
  • Trimmer GW, Freeman JJ, Priston RA, Urbanus J. 2004. Results of chronic dietary toxicity studies of high viscosity (P70H and P100H) white mineral oils in Fischer 344 rats. Toxicol Pathol. 32:439–447.
  • Wagner WD, Wright PG, Stokinger HE. 1964. Inhalation toxicology of oil mists. I. Chronic effects of white mineral oil. Am Ind Hyg Assoc J. 25:158–168.
  • Wanless IR, Geddie WR. 1985. Mineral oil lipogranulomata in liver and spleen. A study of 465 autopsies. Arch Pathol Lab Med. 109:283–286.
  • Zhang X, Ouyang J, Thung SN. 2013. Histopathologic manifestations of drug-induced hepatotoxicity. Clin Liver Dis. 17:547–564.
  • Zhu HDJ Jr, Bodenheimer HC, Clain DJ, Min AD, Theise ND. 2010. Hepatic lipogranulomas in patients with chronic liver disease: association with hepatitis C and fatty liver disease. WJG. 16:5065–5069.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.