TOXICOLOGY AND CARCINOGENESIS STUDIES OF DECALIN (CAS NO. 91-17-8) IN F344/N RATS AND B6C3F1MICE AND A TOXICOLOGY STUDY OF DECALIN IN MALE NBR RATS (INHALATION STUDIES)

NTP Technical Report on the Toxicology and Carcinogenesis Studies Series

Volumn TR-513, Issue , 2005, Pages 1-321

  Chan, P C ^a   Bristol, D W ^a   Bucher, J R ^a   Haseman, J K ^a   Herbert, R A ^a   Maronpot, R R ^a   Peckham, J C ^a   Rao, G N ^a   Roycroft, J H ^a   Smith, C S ^a   Travlos, G S ^a   Witt, K L ^a   Chou, B J ^a   Decker, J R ^a   Dill, J A ^a   Fuciarelli, A F ^a   Grumbein, S L ^a   Miller, R A ^a   Ragan, H A ^a   Westerberg, R B ^a   Hardisty, J F ^a   Brecher, S ^a   Stedham, M A ^b   Flake, G P ^c   Hailey, J R ^c   Nyska, A ^c   Pearse, G ^c   Renne, R A ^d   Shackelford, C C ^e   Wall, H G ^f,i   White, H J ^a   Willson, G ^e   Wolf, D ^g   Long, P ^b   Brix, A E ^e   Houle, C ^h   Tomlinson, L ^h   Crockett, P W ^a   Betz, L J ^a   Easterling, M R ^a   McGowan, K P ^a   Scott, J T ^a   Gunnels, S R ^a   Barker, M P ^a   Harper, L M ^a   Paal, E S ^a   Serbus, D C ^a   Willis, R A ^a   more..

^a ILS Inc ^*

^b Pathology Associates International

^c National Toxicology Program

^d BATTELLE MEMORIAL INSTITUTE   (United States)

^e EXPERIMENTAL PATHOLOGY LABORATORIES INC   (United States)

^f GLAXOSMITHKLINE   (United Kingdom)

^g Environmental Protection Agency

^h NORTH CAROLINA STATE UNIVERSITY   (United States)

ⁱ Glaxo Wellcome

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85045454862     PISSN: 23788917     EISSN: 23788925     Source Type: Book Series    
DOI: None     Document Type: Review

References (85)

1. American Conference of Governmental Industrial Hygienists (ACGIH) (2002). 2002 TLVs and BEIs. Threshold Limit Values for Chemical Substances & Physical Agents and Biological Exposure Indices, p. 43. Cincinnati, OH.
2. Ashby, J., and Tennant, R.W. (1991). Definitive relationships among chemical structure, carcinogenicity and mutagenicity for 301 chemicals tested by the U.S. NTP. Mutat. Res. 257, 229-306.
3. Bailer, A.J., and Portier, C.J. (1988). Effects of treatment-induced mortality and tumor-induced mortality on tests for carcinogenicity in small samples. Biometrics 44, 417-431.
4. Bieler, G.S., and Williams, R.L. (1993). Ratio estimates, the delta method, and quantal response tests for increased carcinogenicity. Biometrics 49, 793-801.
5. Bingham, E., and Falk, H.L. (1969). Environmental carcinogens. The modifying effect of cocarcinogens on the threshold response. Arch. Environ. Health 19, 779-783.
6. Boorman, G.A., Montgomery, C.A., Jr., Eustis, S.L., Wolfe, M.J., McConnell, E.E., and Hardisty, J.F. (1985). Quality assurance in pathology for rodent carcinogenicity studies. In Handbook of Carcinogen Testing (H.A. Milman and E.K. Weisburger, Eds.), pp. 345-357. Noyes Publications, Park Ridge, NJ.
7. Brecher, G., and Schneiderman, M. (1950). Time saving device for the counting of reticulocytes. Am. J. Clin. Pathol. 20, 2079-2084.
8. Bucher, J.R., Portier, C.J., Goodman, J.I., Faustman, E.M., and Lucier, G.W. (1996). National Toxicology Program Studies: Principles of dose selection and applications to mechanistic based risk assessment. Fundam. Appl. Toxicol. 31, 1-8.
9. Chatterjee, B., Demyan, W.F., Song, C.S., Garg, B.D., and Roy, A.K. (1989). Loss of androgenic induction of alpha 2u-globulin gene family in the liver of NIH black rats. Endocrinology 125, 1385-1388.
10. Code of Federal Regulations (CFR) 21, Part 58.
11. Cox, D.R. (1972). Regression models and life-tables. J. R. Stat. Soc. B34, 187-220.
12. Crawford, B.D. (1985). Perspectives on the somatic mutation model of carcinogenesis. In Advances in Modern Environmental Toxicology. Mechanisms and Toxicity of Chemical Carcinogens and Mutagens (M.A. Mehlman, W.G. Flamm, and R.J. Lorentzen, Eds.), pp. 13-59. Princeton Scientific Publishing Co., Inc., Princeton, NJ.
13. CRCS, Inc. (1984). 1, 2, 3, 4-Tetrahydronaphthalene. Draft Information Review prepared for the EPA and the TSCA Interagency Testing Committee
14. Dixon, W.J., and Massey, F.J., Jr. (1951). Introduction to Statistical Analysis, 1st ed., pp. 145-147. McGraw-Hill Book Company, Inc., New York.
15. Dunn, O.J. (1964). Multiple comparisons using rank sums. Technometrics 6, 241-252.
16. Dunnett, C.W. (1955). A multiple comparison procedure for comparing several treatments with a control. J. Am. Stat. Assoc. 50, 1096-1121.
17. DuPont (1990a). Material Safety Data Sheet for Decalin. Wilmington, DE.
18. DuPont (1990b). Material Safety Data Sheet for Tetralin. Wilmington, DE.
19. Elliott, T.H., Robertson, J.S., and Williams, R.T. (1966). The metabolism of cis- and trans-decalin. Biochem. J. 100, 403-406.
20. Eurell, T.E., Eurell, J.A., Schaeffer, D.J., Mattie, D.R., and Alden, C.L. (1990). Lysosomal changes in renal proximal tubular epithelial cells of male Sprague Dawley rats following decalin exposure. Toxicol. Pathol. 18, 637-642.
21. Gaworski, C.L., Leahy, H.F., and Bruner, R.H. (1980). Subchronic inhalation toxicity of decalin. In Proceedings of the 10th Conference on Environmental Toxicology, pp. 226-282. AMRLTR-121 (ADA086341). Aerospace Medical Research Laboratory, Wright-Patterson Air Force Base, OH.
22. Gaworski, C.L., Haun, C.C., MacEwen, J.D., Vernot, C.H., Bruner, R.H., Amster, R.L., and Cowan, M.J., Jr. (1985). A 90-day vapor inhalation toxicity study of decalin. Fundam. Appl. Toxicol. 5, 785-793.
23. Hampton, C.V., Pierson, W.R., Harvey, T.M., Updegrove, W.S., and Marano, R.S. (1982). Hydrocarbon gases emitted from vehicles on the road. 1. A qualitative gas chromatography/mass spectrometry survey. Environ. Sci. Technol. 16, 287-298.
24. Hardin, B.D., Schuler, R.L., Burg, J.R., Booth, G.M., Hazelden, K.P., MacKenzie, K.M., Piccirillo, V.J., and Smith, K.N. (1987). Evaluation of 60 chemicals in a preliminary developmental toxicity test. Teratog. Carcinog. Mutagen. 7, 29-48.
25. Hazardous Substances Data Bank (HSDB) (2002). National Institute for Occupational Safety and Health, HSDB database available through the National Library of Medicine MEDLARS System.
26. Hollander, M., and Wolfe, D.A. (1973). Nonparametric Statistical Methods, pp. 120-123. John Wiley and Sons, New York.
27. Horton, A.W., and Christian, G.M. (1974). Cocarcinogenic versus incomplete carcinogenic activity among aromatic hydrocarbons: Contrast between chrysene and benzo(b)triphenylene. J. Natl. Cancer Inst. 53, 1017-1020.
28. Inman, R.C., Yu, K.O., and Serve, M.P. (1982). JP-10 metabolism in male Fischer rats. Proceedings of the 13th Annual Conference of Environmental Toxicology, pp. 350-363. AFAMRL-TR-82-101. Wright-Patterson Air Force Base, Dayton, OH.
29. Integrated Laboratory Systems (ILS) (1990). Micronucleus Data Management and Statistical Analysis Software, Version 1.4. ILS, P.O. Box 13501, Research Triangle Park, NC 27707.
30. Jonckheere, A.R. (1954). A distribution-free k-sample test against ordered alternatives. Biometrika 41, 133-145.
31. Kanerva, R.L., McCracken, M.S., Alden, C.L., and Stone, L.C. (1987). Morphogenesis of decalin-induced renal alterations in the male rat. Food Chem. Toxicol. 25, 53-61.
32. Kaplan, E.L., and Meier, P. (1958). Nonparametric estimation from incomplete observations. J. Am. Stat. Assoc. 53, 457-481.
33. Kohn, M.C., and Melnick, R.L. (1999). A physiological model for ligand-induced accumulation of alpha 2u-globulin in male rat kidney: Roles of protein synthesis and lysosomal degradation in the renal dosimetry of 2, 4, 4-trimethyl-2-pentanol. Toxicology 136, 89-105.
34. Krotoszynski, B.K., and O'Neill, H.J. (1982). Involuntary bioaccumulation of environmental pollutants in nonsmoking heterogeneous human population. J. Environ. Sci. Health 17, 855-883.
35. Lehman-McKeeman, L.D. (1993). Male rat-specific light hydrocarbon nephropathy. In: Toxicology of the Kidney, 2nd ed. (J.B. Hook and R.S. Goldstein, Eds.), pp. 477-494. Raven Press, Ltd., New York.
36. Longacre, S.L. (1987). Tetralin. In Ethel Browning's Toxicity and Metabolism of Industrial Solvents, 2nd ed. (R. Snyder, Ed.), Vol. 1, pp. 143-152. Elsevier, New York.
37. McConnell, E.E., Solleveld, H.A., Swenberg, J.A., and Boorman, G.A. (1986). Guidelines for combining neoplasms for evaluation of rodent carcinogenesis studies. J. Natl. Cancer Inst. 76, 283-289.
38. MacEwen, J.D., and Vernot, E.H. (1978). Toxic Hazards Research Unit Annual Technical Report: 1978. University of California, Irvine, under Contract F33615-76-C-5005, Aerospace Medical Research Laboratory. National Technical Information Service Publication AD-A062-138.
39. MacGregor, J.T., Wehr, C.M., Henika, P.R., and Shelby, M.D. (1990). The in vivo erythrocyte micronucleus test: Measurement at steady state increases assay efficiency and permits integration with toxicity studies. Fundam. Appl. Toxicol. 14, 513-522.
40. Maronpot, R.R., and Boorman, G.A. (1982). Interpretation of rodent hepatocellular proliferative alterations and hepatocellular tumors in chemical safety assessment. Toxicol. Pathol. 10, 71-80.
41. Melnick, R.L. (1992). An alternative hypothesis on the role of chemically induced protein droplet ("2u-globulin) nephropathy in renal cacrinogenesis. Regul. Toxicol. Pharmacol. 16, 111-125.
42. The Merck Index (1989). 11th ed. (S. Budavari, Ed.), pp. 447-448, 1453. Merck and Company, Rahway, NJ.
43. Middleditch, B.S. (1982). Volatile constituents of the produced water effluent from the Buccaneer gas and oil field. J. Chromatogr. 239, 159-172.
44. Miller, J.A., and Miller, E.C. (1977). Ultimate chemical carcinogens as reactive mutagenic electrophiles. In Origins of Human Cancer (H.H. Hiatt, J.D. Watson, and J.A. Winsten, Eds.), pp. 605-627. Cold Spring Harbor Laboratory, Cold Spring Harbor, NY.
45. Montgomery, C.A., Jr., and Seely, J.C. (1990). Kidney. In Pathology of the Fischer Rat. Reference and Atlas (G.A. Boorman, S.L. Eustis, M.R. Elwell, C.A. Montgomery, Jr., and W.F. MacKenzie, Eds.), p. 129. Academic Press, Inc., San Diego.
46. Morrison, D.F. (1976). Multivariate Statistical Methods, 2nd ed., pp. 170-179. McGraw-Hill Book Company, New York.
47. Murty, C.V., Olson, M.J., Garg, B.D., and Roy, A.K. (1988). Hydrocarbon-induced hyaline droplet nephropathy in male rats during senescence. Toxicol. Appl. Pharmacol. 96, 380-392.
48. National Institute for Occupational Safety and Health (NIOSH) (1978). National Occupational Hazard Survey (1972-1974). Cincinnati, OH.
49. National Institute for Occupational Safety and Health (NIOSH) (1990). National Occupational Exposure Survey (1981-1983), unpublished provisional data as of July 1, 1990. NIOSH, Cincinnati, OH.
50. National Toxicology Program (NTP) (1988). Toxicology and Carcinogenesis Studies of Trichloroethylene (CAS No. 79-01-6) in Four Strains of Rats (ACI, August, Marshall, Osborne-Mendel) (Gavage Studies). Technical Report Series No. 273. NIH Publication No. 88-2529. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, Research Triangle Park, NC.
51. National Toxicology Program (NTP) (1992). Toxicology and Carcinogenesis Studies of Naphthalene (CAS No. 91-20-3) in B6C3F1 Mice (Inhalation Studies). Technical Report Series No. 410. NIH Publication No. 92-3141. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, Research Triangle Park, NC.
52. National Toxicology Program (NTP) (2000). Toxicology and Carcinogenesis Studies of Naphthalene (CAS No. 91-20-3) in F344/N Rats (Inhalation Studies). Technical Report Series No. 500. NIH Publication No. 01-4434. U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, Research Triangle Park, NC.
53. Nyska, A., Haseman, J.K., Hailey, J.R., Smetana, S., and Maronpot, R.R. (1999). The association between severe nephropathy and pheochromocytoma in the male F344 rat - The National Toxicology Program experience. Toxicol. Pathol. 27, 456-462.
54. Olson, C.T., Yu, K.O., and Serve, M.P. (1986). Metabolism of nephrotoxic cis- and trans-decalin in Fischer-344 rats. J. Toxicol. Environ. Health 18, 285-292.
55. Piegorsch, W.W., and Bailer, A.J. (1997). Statistics for Environmental Biology and Toxicology, Section 6.3.2. Chapman and Hall, London.
56. Portier, C.J., and Bailer, A.J. (1989). Testing for increased carcinogenicity using a survival-adjusted quantal response test. Fundam. Appl. Toxicol. 12, 731-737.
57. Portier, C.J., Hedges, J.C., and Hoel, D.G. (1986). Age-specific models of mortality and tumor onset for historical control animals in the National Toxicology Program's carcinogenicity experiments. Cancer Res. 46, 4372-4378.
58. Rao, G.N. (1996). New diet (NTP-2000) for rats in the National Toxicology Program toxicity and carcinogenicity studies. Fundam. Appl. Toxicol. 32, 102-108.
59. Rao, G.N. (1997). New nonpurified diet (NTP-2000) for rodents in the National Toxicology Program's toxicology and carcinogenesis studies. J. Nutr. 127, 842s-846s.
60. Read, N.G., Astbury P.J., Morgan, R.J., Parsons, D.N., and Port, C.J. (1988). Induction and exacerbation of hyaline droplet formation in the proximal tubular cells of the kidneys from male rats receiving a variety of pharmacological agents. Toxicology 52, 81-101.
61. Sadtler Standard Spectra. IR No. 24406K; NMR No. 11964M. Sadtler Research Laboratories, Philadelphia
62. Saito, K., Kaneko, H., Isobe, N., Nakatsuka, I., Yoshitake, A., and Yamada, H. (1992). Differences in alpha 2u-globulins increased in male rat kidneys following treatment with several alpha 2u-globulin accumulating agents: Cystein protease(s) play(s) an important role in production of kidney-type-alpha 2u-globulin. Toxicology 76, 177-186.
63. Sandmeyer, E.E. (1981). Alicyclic hydrocarbons. In Patty's Industrial Hygiene and Toxicology (G.D. Clayton and F.E. Clayton, Eds.), 3rd revised ed., Vol. 2B, pp. 3221-3251. John Wiley and Sons, New York.
64. Sax, N.I., and Lewis, R.J., Sr. (1989). Dangerous Properties of Industrial Materials, 7th ed., pp. 1033, 3211. Van Nostrand Reinhold, New York.
65. Serve, M.P. (1989). A Study of the Nephrotoxicity and Metabolism of Tetralin and Indan in Fischer 344 Rats. Report for U.S. Air Force Grant No. AFOSR-87-0108.
66. Serve, M.P., Llewelyn, B.M., Yu, K.O., McDonald, G.M., Olson, C.T., and Hobson, D.W. (1989). Metabolism and nephrotoxicity of tetralin in male Fischer 344 rats. J. Toxicol. Environ. Health 26, 267-275.
67. Shelby, M.D. (1988). The genetic toxicity of human carcinogens and its implications. Mutat. Res. 204, 3-15.
68. Shelby, M.D., and Witt, K.L. (1995). Comparison of results from mouse bone marrow chromosome aberration and micronucleus tests. Environ. Mol. Mutagen. 25, 302-313.
69. Shelby, M.D., and Zeiger, E. (1990). Activity of human carcinogens in the Salmonella and rodent bone-marrow cytogenetics tests. Mutat. Res. 234, 257-261.
70. Shelby, M.D., Erexson, G.L., Hook, G.J., and Tice, R.R. (1993). Evaluation of a three-exposure mouse bone marrow micronucleus protocol: Results with 49 chemicals. Environ. Mol. Mutagen. 21, 160-179.
71. Shirley, E. (1977). A non-parametric equivalent of Williams' test for contrasting increasing dose levels of a treatment. Biometrics 33, 386-389.
72. Stone, L.C., McCracken, M.S., Kanerva, R.L., and Alden, C.L. (1987a). Development of a short-term model of decalin inhalation nephrotoxicity in the male rat. Food Chem. Toxicol. 25, 35-41.
73. Stone, L.C., Kanerva, R.L., Burns, J.L., and Alden, C.L. (1987b). Decalin-induced nephrotoxicity: Light and electron microscopic examination of the effects of oral dosing on the development of kidney lesions in the rat. Food Chem. Toxicol. 25, 43-52.
74. Straus, D.S. (1981). Somatic mutation, cellular differentiation, and cancer causation. JNCI 67, 233-241.
75. Swenberg, J.A., and Lehman-McKeeman, L.D. (1999). Alpha 2-urinary globulin-associated nephropathy as a mechanism of renal tubule cell carcinogenesis in male rats. IARC Sci. Publ. 147, 95-118.
76. Swenberg, J.A., Short, B., Borghoff, S., Strasser, J., and Charbonneau, M. (1989). The comparative pathobiology of "2u-globulin nephropathy. Toxicol. Appl. Pharmacol. 97, 35-46.
77. Tarone, R.E. (1975). Tests for trend in life table analysis. Biometrika 62, 679-682.
78. Tennant, R.W., Margolin, B.H., Shelby, M.D., Zeiger, E., Haseman, J.K., Spalding, J., Caspary, W., Resnick, M., Stasiewicz, S., Anderson, B., and Minor, R. (1987). Prediction of chemical carcinogenicity in rodents from in vitro genetic toxicity assays. Science 236, 933-941.
79. U.S. Environmental Protection Agency (USEPA) (1991). Alpha2u-globulin: Association with Chemically Induced Renal Toxicity and Neoplasia in the Male Rat. EPA/625/3-91/019F. Risk Assessment Forum, U.S. Environmental Protection Agency, Washington, DC.
80. Williams, D.A. (1971). A test for differences between treatment means when several dose levels are compared with a zero dose control. Biometrics 27, 103-117.
81. Williams, D.A. (1972). The comparison of several dose levels with a zero dose control. Biometrics 28, 519-531.
82. Witt, K.L., Knapton, A., Wehr, C.M., Hook, G.J., Mirsalis, J., Shelby, M.D., and MacGregor, J.T. (2000). Micronucleated erythrocyte frequency in peripheral blood of B6C3F1 mice from short-term, prechronic, and chronic studies of the NTP Carcinogenesis Bioassay Program. Environ. Mol. Mutagen. 36, 163-194.
83. Zeiger, E., Anderson, B., Haworth, S., Lawlor, T., Mortelmans, K., and Speck, W. (1987). Salmonella mutagenicity tests: III. Results from the testing of 255 chemicals. Environ. Mutagen. 9 (Suppl. 9), 1-110.
84. Zeiger, E., Haseman, J.K., Shelby, M.D., Margolin, B.H., and Tennant, R.W. (1990). Evaluation of four in vitro genetic toxicity tests for predicting rodent carcinogenicity: Confirmation of earlier results with 41 additional chemicals. Environ. Mol. Mutagen. 16 (Suppl. 18), 1-14.
85. Ziegenfus, R.C. (1987). Air quality and health. In Public Health and the Environment: The United States Experience (M.R. Greenberg, Ed.), pp. 139-172. The Guilford Press, New York.