Inhalation toxicology and carcinogenesis studies of propylene glycol mono-t-butyl ether in rats and mice

Toxicology

Volumn 199, Issue 1, 2004, Pages 1-22

  Doi, Adriana M ^a   Roycroft, Joseph H ^a   Herbert, Ronald A ^a   Haseman, Joseph K ^a   Hailey, James R ^a   Chou, Billy J ^b   Dill, Jeffrey A ^b   Grumbein, Sondra L ^b   Miller, Rodney A ^b   Renne, Roger A ^b   Bucher, John R ^a  

^a NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES   (United States)

^b BATTELLE MEMORIAL INSTITUTE   (United States)

Author keywords

2u Globulin; Hepatoblastoma; Hepatocellular adenoma; Hepatocellular carcinoma; Renal tubular neoplasm; Solvent

Indexed keywords

ALPHA GLOBULIN; ETHER; GLYCOL; PROPYLENE; TERT BUTYL ETHER; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; CARCINOGENESIS; CHEMICAL ENVIRONMENT; CONTROLLED STUDY; FEMALE; HEPATOBLASTOMA; INCIDENCE; KIDNEY INJURY; KIDNEY TUMOR; LIVER CELL CARCINOMA; LIVER HYPERTROPHY; LIVER TOXICITY; LIVER TUMOR; LIVER WEIGHT; MALE; NEPHROTOXICITY; NONHUMAN; PRIORITY JOURNAL; RAT; SEX DIFFERENCE; STATISTICAL SIGNIFICANCE;

ADENOMA, LIVER CELL; ADMINISTRATION, INHALATION; ALPHA-GLOBULINS; ANIMALS; CARCINOGENICITY TESTS; CARCINOGENS; CARCINOMA, HEPATOCELLULAR; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HEPATOBLASTOMA; KIDNEY NEOPLASMS; KIDNEY TUBULES; LIVER NEOPLASMS; MALE; MICE; MICE, INBRED STRAINS; MUTAGENS; PROPYLENE GLYCOLS; RATS; RATS, INBRED F344; SALMONELLA TYPHIMURIUM; SOLVENTS;

EID: 2342451268     PISSN: 0300483X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.tox.2003.12.020     Document Type: Article

References (50)

1. American Ink Maker, 1985. PTB Solvent from ARCO. American Ink Maker, December, p. 153.
2. Bailer A.J., Portier C.J. Effects of treatment-induced mortality and tumor-induced mortality on tests for carcinogenicity in small samples. Biometrics. 44:1988;417-431
3. Bannasch, P., Griesemer, R., Andens, F., Becker, R., Cabral, J., Della Porta, G., Feron, V., Henschler, D., Ito, N., Kroes, R., Magee, P., Montesano, R., Napalkov, N., Nesnoro, S., Rao, G., Wilbourn, J., 1986. Early preneoplastic lesions. In: Montesano, R., Vainio, H., Yamasaki, H. (Eds.). Long-term and short-term assays for carcinogens. IARC Scientific Publications No. 83, Lyon, France, pp. 85-101.
4. Begley, R., 1986. Solvent Makers Eye Compliance Deadline. Chemical Marketing Reporter, November, p. 34, 40.
5. Boatman, R.J., 2001. Glycol ethers: Ethers of propylene, butylene glycols, and other glycol derivatives. In: Bingham, E., Cohrseen, B., Powell, C.H. (Eds.), Patty, s Toxicology. Wiley, New York, pp. 271-395.
6. 2u-globulin nephropathy and renal cell proliferation. Toxicol. Lett. 63:1992;21-33
7. Brecher G., Schneiderman M. A time-saving device for the counting of reticulocytes. Am. J. Clin. Pathol. 20:1950;2079-2084
8. Bus J.S., Crissman J.W., Fox T.R., Redmond J.M., Cieszlak F.S., Corley R.A., Stott W.T. Rat and mouse liver and kidney response to inhaled propylene glycol monomethy ether (PGME). The Toxicologist. 12:1992;234
9. Chapin R.E., Sloane R.A. Reproductive assessment by continuous breeding: evolving study design and summaries of ninety studies. Environ. Health Perspect. 105(Suppl. 1):1997;199-395
10. 2u-globulin gene family in the liver of NIH black rats. Endocrinology. 125:1989;1385-1388
11. Cox D. Regression models and life-tables. J. R. Stat. Soc. B34:1972;187-220
12. Davis B.J., Almekinder J.L., Flagler N., Travlos G., Wilson R., Maronpot R.R. Ovarian luteal cell toxicity of ethylene glycol monomethyl ether and methoxy acetic acid in vivo and in vitro. Toxicol. Appl. Pharmacol. 142:1997;328-337
13. Dill, J.A., Lee, K.M., Fuciarelli, A.F., Renne, R.A., Rowe, S.E., Weigel, R.J., Westerberg, R.B., Young, J.Y., 2000. Two-year chronic inhalation toxicity and carcinogenicity study of propylene glycol mono-t-butyl ether in rats. Final report prepared for the National Toxicology Program, Research Triangle Park, NC. Battelle, Toxicology Northwest, Richland, WA.
14. 2u-Globulin nephropathy and carcinogenicity following exposure to decalin (decahydronaphthalene) in F344/N rats. Toxicol. Sci. 72:2003;223-234
15. Dixon, W., Massey Jr., F., 1951. Introduction to Statistical Analysis. McGraw-Hill, New York.
16. Dodd D.E., Snellings W.M., Maronpot R.R., Ballantyne B. Ethylene glycol monobutyl ether: acute, 9-day, and 90-day vapor inhalation studies in Fischer 344 Rats. Toxicol. Appl. Pharmacol. 68:1983;405-414
17. Dunn O. Multiple comparisons using rank sums. Technometrics. 6:1964;241-252
18. Dunnett C. A multiple comparison procedure for comparing several treatments with a control. J. Am. Stat. Assoc. 50:1955;1096-1121
19. Galloway S.M., Armstrong M.J., Reuben C., Colman S., Brown B., Cannon C., Bloom A.D., Nakamura F., Ahmed M., Duk S., Rimpo J., Margolin B.H., Resnick M.A., Anderson B., Zeiger E. Chromosome aberrations and sister chromatid exchanges in Chinese hamster ovary cells: evaluations of 108 chemicals. Environ. Mol. Mutagen. 10(Suppl. 10):1987;1-175
20. Gupta, V.P., 1987. Recovery of Propylene Glycol Mono t-Butoxy Ether. United States Patent No. 4, 675, 082.
21. Harada, T., Enomoto, A., Boorman, G.A., Maronpot, R.R., 1999. Liver and gallbladder. In: Maronpot, R.R., Boorman, G.A., Gaul, B.W. (Eds.), Pathology of the Mouse. Cahe River Press, Vienna, pp. 119-183.
22. Haseman J.K., Hailey J.R., Morris R.W. Spontaneous neoplasm incidences in Fischer 344 rats and B6C3F1 mice in two-year carcinogenicity studies: a National Toxicology Program update. Toxicol. Pathol. 26:1998;428-441
23. Heckman R.A. Using P-Series glycol ethers in water-reducible coatings. Modern Paint and Coat. 76:1986;36-42
24. Hollander, M., Wolfe, D., 1973. Nonparametric statistical methods. Wiley, New York.
25. Integrated Laboratory System (ILS), 1990. Micronucleus Data Management and Statistical Analysis Software, version 1.4. ILS, Research Triangle Park.
26. Jonckheere A. A distribution-free k-sample test against ordered alternatives. Biometrika. 41:1954;133-145
27. Kaplan E., Meier P. Nonparametric estimation from incomplete observations. J. Am. Stat. Assoc. 53:1958;457-481
28. Kessler, D.G., 1989. Regulations Bring New Products and Services. CPI Purchasing, October, pp. 46-53.
29. MacGregor J.T., Wehr C.M., Henika P.R., Shelby M.D. The in vivo erythrocyte micronucleus test: measurement at steady state increases assay efficiency and permits integration with toxicity studies. Fundam. Appl. Toxicol. 14:1990;513-522
30. 2u globulin gene family. Mol. Cell Biol. 6:1986;3563-3567
31. Morrison, D., 1976. Multivariate Statistical Methods. McGraw-Hill, New York.
32. NTP, 1983. Toxicology and carcinogenesis studies of Pentachloroethane (CAS No. 76-01-7) in F344/N rats and B6C3F1 mice (Gavage studies). Technical Report Series No. 232. National Toxicology Program, Research Triangle Park, NC.
33. NTP, 1986. NTP Toxicology and carcinogenesis studies of Tetrachloroethylene (Perchloroethylene) (CAS No. 127-18-4) in F344/N rats and B6C3F1 mice (Inhalation Studies). Technical Report Series No. 311. National Toxicology Program, Research Triangle Park, NC.
34. NTP, 1987. NTP Toxicology and carcinogenesis studies of 1, 4-Dichlorobenzene (CAS No. 106-46-7) in F344/N rats and B6C3F1 mice (Gavage Studies). Technical Report Series No. 319. National Toxicology Program, Research Triangle Park, NC.
35. NTP, 1990. Toxicology and carcinogenesis studies of d-Limonene (CAS No. 5989-27-5) in F344/N rats and B6C3F1 mice (Gavage Studies). Technical Report Series No. 347. National Toxicology Program, Research Triangle Park, NC.
36. NTP, 2000. Toxicology and carcinogenesis studies of 2-butoxyethanol (CAS No. 111-76-2) in F344/N rats and B6C3F1 mice (Inhalation Studies). Technical Report Series No. 484. National Toxicology Program, Research Triangle Park, NC.
37. NTP, in progress [a]. Toxicology and carcinogenesis studies of Propylene glycol mono-t-butyl ether (CAS No. 57018-52-7) in F344/N rats and B6C3F1 mice and a toxicology study of propylene glycol mono-t-butyl ether in male NBR rats (Inhalation studies). Draft Technical Report Series No. 515. National Toxicology Program, Research Triangle Park, NC.
38. NTP, in progress [b]. Toxicology and carcinogenesis studies of Decalin (CAS No. 91-17-8) in F344/N rats and B6C3F1 mice and a toxicology study of Decalin in male NBR rats (Inhalation Studies). Draft Technical Report Series No. 513. National Toxicology Program, Research Triangle Park, NC.
39. Nudy, L.R., Johnston, W.A., 1990. PTB: A safe, effective solvent for hard surface cleaners. Household and Personal Products Industry, April, pp. 90-92.
40. Piegorsch, W., Bailer, A.J., 1997. Statistics for Environmental Biology and Toxicology, Section 6.3.2. Chapman and Hall, London.
41. Portier C.J., Bailer A.J. Testing for increased carcinogenicity using a survival-adjusted quantal response test. Fundam. Appl. Toxicol. 12:1989;731-737
42. 2u-globulin. J. Biol. Chem. 262:1987;12821-12825
43. 2u-globulin. J. Biol. Chem. 258:1983;10123-10127
44. Shirley E. A non-parametric equivalent of Williams' test for contrasting increasing dose levels of a treatment. Biometrics. 33:1977;386-389
45. 2-Urinary globulin-associated nephropathy as a mechanism of renal tubule cell carcinogenesis in male rats. IARC Scientific Publications. 147:1999;95-118
46. Tarone R. Tests for trend in life table analysis. Biometrika. 62:1975;679-682
47. Williams D.A. A test for differences between treatment means when several dose levels are compared with a zero dose control. Biometrics. 27:1971;103-117
48. Williams D.A. The comparison of several dose levels with a zero dose control. Biometrics. 28:1972;519-531
49. Zeiger E., Haworth S., Mortelmans K., Speck W. Mutagenicity testing of di(2-ethylhexyl)phthalate and related chemicals in Salmonella. Environ. Mutagen. 7:1985;213-232
50. Zeiger E., Anderson B., Haworth S., Lawlor T., Mortelmans K., Results from the testing of 311 chemicals V. Environ. Mol. Mutagen. 19(Suppl. 21):1992;2-141