Derivation of a No-significant-risk-level (NSRL) for dermal exposures to diethanolamine

Regulatory Toxicology and Pharmacology

Volumn 76, Issue , 2016, Pages 137-151

  Kirman, C R ^a   Hughes, B ^b   Becker, R A ^c   Hays, S M ^a  

^a LLP   (United States)

^b DOW CHEMICAL COMPANY   (United States)

^c AMERICAN CHEMISTRY COUNCIL   (United States)

Author keywords

Dose response assessment; Mode of action; Species differences

Indexed keywords

ALCOHOL; BETAINE; CHOLINE; DIETHANOLAMINE; ETHANOLAMINE DERIVATIVE;

AMINE TRANSPORT; ARTICLE; CHEMICAL CARCINOGENESIS; CONCENTRATION RESPONSE; DNA METHYLATION; HUMAN; KIDNEY TUMOR; LIVER TUMOR; NO SIGNIFICANT RISK LEVEL; NO-OBSERVED-ADVERSE-EFFECT LEVEL; NONHUMAN; PHOSPHOLIPID SYNTHESIS; PRIORITY JOURNAL; SKIN ABSORPTION; SPECIES DIFFERENCE; TOXICITY TESTING; TOXICOKINETICS; TOXICOLOGICAL PARAMETERS; ANIMAL; BIOLOGICAL MODEL; CARCINOGEN TESTING; CHEMICALLY INDUCED; CUTANEOUS DRUG ADMINISTRATION; DOSE RESPONSE; DRUG EFFECTS; GENETIC EPIGENESIS; GENETICS; METABOLISM; MOUSE; RISK ASSESSMENT; SKIN;

ADMINISTRATION, CUTANEOUS; ANIMALS; CARCINOGENICITY TESTS; DOSE-RESPONSE RELATIONSHIP, DRUG; EPIGENESIS, GENETIC; ETHANOLAMINES; HUMANS; KIDNEY NEOPLASMS; LIVER NEOPLASMS; MICE; MODELS, BIOLOGICAL; NO-OBSERVED-ADVERSE-EFFECT LEVEL; RISK ASSESSMENT; SKIN; SKIN ABSORPTION; SPECIES SPECIFICITY;

EID: 84958168706     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2016.01.020     Document Type: Article

References (62)

1. ADD Obeid, 2013.
2. Bachman A.N., Kamendulis L.M., Goodman J.I. Diethanolamine and phenobarbital produce an altered pattern of methylation in GC-rich regions of DNA in B6C3F1 mouse hepatocytes similar to that resulting from choline deficiency. Toxicol. Sci. 2006, 90(2):317-325.
3. Barak A.J., Tuma D.J., Sorrell M.F. Relationship of ethanol to choline metabolism in the liver: a review. Am. J. Clin. Nutr. 1973, 26(11):1234-1241.
4. Boobis A.R., Doe J.E., Heinrich-Hirsch B., Meek M.E., Munn S., Ruchirawat M., Schlatter J., Seed J., Vickers C. IPCS framework for analyzing the relevance of a noncancer mode of action for humans. Crit. Rev. Toxicol. 2008, 38(2):87-96.
5. Borgert C.J., Wise K., Becker R.A. Modernizing problem formulation for risk assessment necessitates articulation of mode of action. Regul. Toxicol. Pharmacol. 2015, 72(3):538-551.
6. Chen R.Z., Pettersson U., Beard C., Jackson-Grusby L., Jaenisch R. DNA hypomethylation leads to elevated mutation rates. Nature 1998, 395(6697):89-93. 1998 Sep 3.
7. Chester D.N., Goldman J.D., Ahuja J.K., Moshfegh A.J. Dietary Intakes of Choline what We Eat in America, NHANES 2007-2008 2011, Food Surveys Research Group Dietary Data Brief No. 9.
8. Christman J.K., Chen M.-L., Sheiknejad G., Dizik M., Abileah S., Wainfan E. Methyl deficiency, DNA methylation and cancer: studies on the reversibility of the effects of a Iipotrope-deficient diet. Biochem. 1993, 4:672-680.
9. CIR Cosmetic Ingredient Review. Amended Final Safety Assessment: Diethanolamine and its Salts as Used in Cosmetics 2011, http://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/FR575.pdf.
10. Counts J.L., Sarmiento J.I., Harbison M.L., Downing J.C., McClain R.M., Goodman J.L. Cell proliferation and global methylation status changes in mouse liver after phenobarbital and/or choline-devoid, methionine-deficient diet administration. Carcinogenesis 1996, 17(6):1251-1257. 1996 Jun.
11. Craciunescu C.N., Niculescu M.D., Guo Z., et al. Dose response effects of dermally applied diethanolamine on neurogenesis in fetal mouse hippocampus and potential exposure of humans. Toxicol. Sci. 2009, 107:220-226.
12. Ghoshal A.K., Farber E. The induction of liver cancer by dietary deficiency of choline and methionine without added carcinogens. Carcinogenesis 1984, 5(10):1367-1370.
13. Hayashi S.M., Ton T.V., Hong H.H., Irwin R.D., Haseman J.K., Devereux T.R., Sills R.C. Genetic alterations in the Catnb gene but not the H-ras gene in hepatocellular neoplasms and hepatoblastomas of B6C3F(1) mice following exposure to diethanolamine for 2 years. Chem. Biol. Interact. 2003, 146(3):251-261.
14. Heard C.M., Screen C. Probing the permeation enhancement of mefenamic acid by ethanol across full-thickness skin, heat-separated epidermal membrane and heat-separated dermal membrane. Int. J. Pharm. 2008, 349(1-2):323-325. 2008 Feb 12.
15. Hollenbeck C.B. An introduction to the nutrition and metabolism of choline. Cent. Nerv. Syst. Agents Med. Chem. 2012, 12(2):100-113.
16. IARC. Monograph 101 2012, International Agency for Research on Cancer.
17. ICRP. Basic Anatomical and Physiological Data or Use in Radiological Protection: Reference Values 2002, ICRP Publication, 89.
18. Kamendulis L.M., Klaunig J.E. Species differences in the induction of hepatocellular DNA synthesis by diethanolamine. Toxicol. Sci. 2005, 87:328-336.
19. Kamendulis L.M., Smith D.J., Klaunig J.E. Species differences in the inhibition of gap junctional intercellular communication (GJIC) by diethanolamine. Toxicologist 2004, Abstract 1091.
20. Kraeling M.E., Yourick J.J., Bronaugh R.L. In vitro human skin penetration of diethanolamine. Food Chem. Toxicol. 2004, 42:1553-1561.
21. Lehman-McKeeman L.D., Gamsky E.A. Diethanolamine inhibits choline uptake and phosphatidylcholine synthesis in Chinese hamster ovary cells. Biochem. Biophys. Res. Commun. 1999, 262(3):600-604. 1999 Sep. 7.
22. Lehman-McKeeman L.D., Gamsky E.A. Choline supplementation inhibits diethanolamine-induced morphological transformation in syrian hamster embryo cells: evidence for a carcinogenic mechanism. Toxicol. Sci. 2000, 55(2):303-310.
23. Lehman-McKeeman L.D., Gamsky E.A., Hicks S.M., Vassallo J.D., Mar M.H., Zeisel S.H. Diethanolamine induces hepatic choline deficiency in mice. Toxicol. Sci. 2002, 67(1):38-45.
24. Leibold E., van Ravenzwaay B. 14C-Ethanol - Bioavailability after a Single Dermal Application in Mice 2003, Final Report. BASF. lb0308026001.
25. Leung H.-W., Kamendulis L.M., Stott W.T. Review of the carcinogenic activity of diethanolamine and evidence of choline deficiency as a plausible mode of action. Regul. Toxicol. Pharmacol. 2005, 43:260-271.
26. Li Z., Agellon L.B., Vance D.E. A role for high density lipoproteins in hepatic phosphatidylcholine homeostasis. Biochim. Biophys. Acta 2007, 1771(7):893-900.
27. Locker J., Reddy T.V., Lombardi B. DNA methylation and hepatocarcinogenesis in rats fed a choline-devoid diet. Carcinogenesis 1986, 7(8):1309-1312.
28. Matthews J.M., Garner C.E., Matthews H.B. Metabolism, bioaccumulation, and incorporation of diethanolamine into phospholipids. Chem. Res. Toxicol. 1995, 8(5):625-633.
29. Matthews J.M., Garner C.E., Black S.L., Matthews H.B. Diethanolamine absorption, metabolism and disposition in rat and mouse following oral, intravenous and dermal administration. Xenobiotica 1997, 27:733-746.
30. Meek M.E., Palermo C.M., Bachman A.N., North C.M., 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. 2014, 34(6):595-606.
31. Mellert W., Bahnemann R. Diethanolamine (DEA) - sustained increase in cell proliferation is restricted to target cells in liver and kidney. Toxicologist 2001, Abstract 1365.
32. Mellert W., Kaufmann W., Rossbacher R., van Ravenzwaay B. Investigations on cell proliferation in B6C3F(1) mouse liver by diethanolamine. Food Chem. Toxicol. 2004, 42(1):127-134. 2004 Jan.
33. Mendrala A.L., Waechter J.M., Bormett G.A., Bartels M.J., Stott W.T. The pharmacokinetics of diethanolamine in Sprague-Dawley rats following intravenous administration. Food Chem. Toxicol. 2001, 39(9):931-939. 2001 Sep.
34. Michael U.F., Cookson S.L., Chavez R., Pardo V. Renal function in the choline deficient rat. Proc. Soc. Exp. Biol. Med. 1975, 150(3):672-676. 1975 Dec.
35. Monserrat A.J., Ghoshal A.K., Hartroft W.S., Porta E.A. Lipoperoxidation in the pathogenesis of renal necrosis in choline-deficient rats. Am. J. Pathol. 1969, 55(2):163-190.
36. Monserrat A.J., Hamilton F., Ghoshal A.K., Porta E.A., Hartroft W.S. Lysosomes in the pathogenesis of the renal necrosis of choline-deficient rats. Am. J. Pathol. 1972, 68(1):113-146.
37. Monteiro-Riviere N.A., Bristol D.G., Manning T.O., Rogers R.A., Riviere J.E. Interspecies and interregional analysis of the comparative histologic thickness and laser Doppler blood flow measurements at five cutaneous sites in nine species. J. Invest. Dermatol. 1990, 95(5):582-586.
38. Newberne P.M., Rogers A.E., Wogan G.N. Hepatorenal lesions in rats fed a low lipotrope diet and exposed to Aflatoxin. J. Nutr. 1968, 94(3):331-343.
39. Newberne P.M., De Camargo J.L.V., Clark A.J. Choline deficiency, partial hepatectomy, and liver tumors in rats and mice. Toxicol. Path 1982, 10(2):95-106.
40. NTP Toxicology and carcinogenesis studies of diethanolamine (cas no. 111-42-2) in f344/n rats and b6c3f1 mice (dermal studies). Natl. Toxicol. Program Tech. Rep. Ser. 1999, 478. 1-212.
41. NTP NTP toxicology and carcinogenesis studies of lauric acid diethanolamine condensate (CAS NO. 120-40-1) in F344/N rats and B6C3F1 mice (Dermal studies). Natl. Toxicol. Program Tech. Rep. Ser. 1999, 480. 1-200.
42. NTP NTP toxicology and carcinogenesis studies of oleic acid diethanolamine condensate (CAS No. 93-83-4) in F344/N rats and B6C3F1 mice (Dermal studies). Natl. Toxicol. Program Tech. Rep. Ser. 1999, 481. 1-198.
43. NTP Toxicology and carcinogenesis studies of coconut oil acid diethanolamine condensate (CAS No. 68603-42-9) in F344/N rats and B6C3F1 mice (dermal studies). Natl. Toxicol. Program Tech. Rep. Ser. 2001, 479. 5-226.
44. OEHHA. Title 27, California Code of Regulations 2012, Article 7. No Significant Risk Levels § 257.
45. Park H.S., Jeon B.H., Woo S.H., Leem J., Jang J.E., Cho M.S., Park I.S., Lee K.U., Koh E.H. Time-dependent changes in lipid metabolism in mice with methionine choline deficiency-induced fatty liver disease. Mol. Cells 2011, 32(6):571-577.
46. Simon T.W., Simons S.S., Preston R.J., Boobis A.R., Cohen S.M., Doerrer N.G., Fenner-Crisp P.A., McMullin T.S., McQueen C.A., Rowlands J.C., RISK21 Dose-Response Subteam 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. 2014, 2014 Aug;44 Suppl 3:17-43.Stott et al. 2000.
47. Stott W.T., Bartels M.J., Brzak K.A., Mar M., Markham D.A., Thornton C.M., Zeisel S.H. Potential mechanisms of tumorigenic action of diethanolamine in mice. Toxicol. Lett. 2000, 114(1-3):67-75.
48. Sun J.D., Beskitt J.L., Tallant M.J., Frantz S.W. In vitro skin penetration of monoethanolamine and diethanolamine using excised skin from rats, mice, rabbits, and humans. J. Toxicol. Cutan. Ocul. Toxicol. 1996, 15:131-146.
49. Thompson J.A., Reitz R.C. A possible mechanism for the increased oxidation of choline after chronic ethanol ingestion. Biochim. Biophys. Acta 1979, 545(3):381-397.
50. USEPA. Memo from LL Brunsman to R Gardner 2001, Dated September 26, 2001.
51. USEPA. Memo from S Reilly to R Gardner 2002, Dated April 25, 2002.
52. USEPA. Guidelines for Carcinogen Risk Assessment 2005, EPA/630/P-03/001B.
53. 3/4 as the Default Method in Derivation of the Oral Reference Dose 2011, EPA/100/R11/0001.
54. USEPA. Benchmark Dose Technical Guidance Document 2012, EPA/100/R-12/001.
55. Wainfan E., Lionel A., Poirier L.A. Methyl groups in carcinogenesis: effects on DNA methylation and gene expression. Cancer Res. 1992, 2071s-2077s. (Suppl.) 52.
56. Wang B., Amacher D.E., Whittaker M.H. Derivation of a no-significant-risk-level (NSRL) for diethanolamine (DEA). Regul. Toxicol. Pharmacol. 2014, 68(1):76-84.
57. Zeisel S.H. Choline. A nutrient that is involved in the regulation of cell proliferation, cell death, and cell transformation. Adv. Exp. Med. Biol. 1996, 399:131-141.
58. Zeisel S.H. Genetic polymorphisms in methyl-group metabolism and epigenetics: lessons from humans and mouse models. Brain Res. 2008, 1237:5-11.
59. Zeisel S.H. Metabolic crosstalk between choline/1-carbon metabolism and energy homeostasis. Clin. Chem. Lab. Med. 2012, 0518:1-9.
60. Zeisel S.H., Blusztajn J.K. Choline and human nutrition. Annu. Rev. Nutr. 1994, 14:269-296.
61. Zeisel S.H., da Costa K.A. Choline: an essential nutrient for public health. Nutr. Rev. 2009, 67(11):615-623.
62. Zeisel S.H., da Costa K.A., Albright C.D., Shin O.H. Choline and hepatocarcinogenesis in the rat. Adv. Exp. Med. Biol. 1995, 1995(375):65-74.