1 |
OECD (2009) Guideline for Testing of Chemicals 451. Carcinogenicity Studies.
|
2 |
Cruzan, G., Borghoff, S.J., de Peyster, A., Hard, G.C., McClain, M., McGregor, D.B. and Thomas, M.G. (2007) Methyl tertiary-butyl ether mode of action for cancer endpoints in rodents. Regul. Toxicol. Pharmacol., 47, 156-165.
DOI
|
3 |
Roberts, L.G., Gray, T.M., Marr, M.C., Tyl, R.W., Trimmer, G.W., Hoffman, G.M., Murray, F.J., Clark, C.R. and Schreiner C.A. (2014) Health assessment of gasoline and fuel oxygenate vapors: developmental toxicity in rats. Regul. Toxicol. Pharmacol., 70, S69-S79.
DOI
|
4 |
Amberg, A., Rosner, E. and Dekant, W. (2001) Toxicokinetics of methyl tert-butyl ether and its metabolites in humans after oral exposure. Toxicol. Sci., 61, 62-67.
DOI
|
5 |
Phillips, S., Palmer, R.B. and Brody, A. (2008) Epidemiology, toxicokinetics, and health effects of methyl tert-butyl ether (MTBE). J. Med. Toxicol., 4, 115-126.
DOI
|
6 |
European Food Safety Authority (EFSA) (2009) Updated opinion on a request from the European Commission related to the 2nd ERF carcinogenicity study on aspartame, taking into consideration study data submitted by the Ramazzini Foundation in February 2009. EFSA J., 7, 1-18.
|
7 |
Hazardous Substances Data Bank (2005) Isopropyl Ether. [cited 2017 Jul 4]. Available from: https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/-4y1FdJ:1/.
|
8 |
Fiserova-Bergerova, V. (1985) Toxicokinetics of organic solvents. Scand. J. Work. Environ. Health, 11, 7-21.
DOI
|
9 |
Lee, M.J. and Kim, H.Y. (2017) A 90-day inhalation toxicity study of ethyl formate in rats. Toxicol. Res., 33, 333-342.
DOI
|
10 |
Gift, J.S., Caldwell, J.C., Jinot, J., Evans, M.V., Cote, I. and Vanderberg, J.J. (2013) Scientific considerations for evaluating cancer bioassays conducted by the Ramazzini institute. Environ. Health Perspect., 121, 1253-1263.
|
11 |
National Toxicology Program (NTP) (2011) Summary Report of the National Toxicology Program and Environmental Protection Agency Sponsored Review of Pathology Materials from Selected Ramazzini Institute Rodent Cancer Bioassays. Available from: https://ntp.niehs.nih.gov/ntp/about_ntp/partnerships/international/summarypwg_report_ri_bioassays.pdf/.
|
12 |
Henley, M., Letinski, D.J., Carr, J., Caro, M.L., Daughtrey, W. and White, R. (2014) Health assessment of gasoline and fuel oxygenate vapors: generation and characterization of test materials. Regul. Toxicol. Pharmacol., 70, S13-S17.
DOI
|
13 |
United States Environmental Protection Agency (1994) Good Laboratory Practice Standards 79.60, CFR vol. 59, No. 122.
|
14 |
OECD (2009) Guideline for Testing of Chemicals 413. Subchronic Inhalation Toxicity: 90-Day Study.
|
15 |
Swenberg, J.A. (1993) Alpha 2u-globulin nephropathy: review of the cellular and molecular mechanisms involved and their implications for human risk assessment. Environ. Health Perspect., 101(Suppl 6), 39-44.
|
16 |
United States Environmental Protection Agency (1991) Alpha2u-Globulin: Association with Chemically Induced Renal Toxicity and Neoplasia in the Male Rat. EPA/625/3-91/019F.
|
17 |
OECD, Environment Directorate (2009) The 2007 OECD List of High Production Volume Chemicals. Available from: http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ENV/JM/MONO(2009)40&doclanguage=en/.
|
18 |
O'Callaghan, J.P. and Sriram, K. (2005) GFAP and other glial proteins as biomarkers of neurotoxicity. Exp. Opin. Drug Saf., 4, 433-442.
DOI
|
19 |
OECD (1997) Guideline for the Testing of Chemicals 424. Neurotoxicity Study in Rodents.
|
20 |
OECD (1983) Guideline for the Testing of Chemicals 415. One-Generation Reproduction Toxicity Study.
|
21 |
Harrington, P.J. (2011) Pharmaceutical Process Chemistry for Synthesis: Rethinking the Routes to Scale-Up. John Wiley & Sons, Hoboken, NJ, USA.
|
22 |
Sittig, M. (2013) Pharmaceutical Manufacturing Encyclopedia (3rd edition), William Andrew Publishing, Norwich, NY, USA.
|
23 |
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (2016) Guideline for Residual Solvents Q3C (R6), 2016.
|
24 |
Klimisch, H.J., Andreae, M. and Tillmann, U. (1997) A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data. Regul. Toxicol. Pharmacol., 25, 1-5.
DOI
|
25 |
Clark, C.R., Schreiner, C.A., Parker, C.M., Gray, T.M. and Hoffman, G.M. (2014) Health assessment of gasoline and fuel oxygenate vapors: subchronic inhalation toxicity. Regul. Toxicol. Pharmacol., 70, S18-S28.
DOI
|
26 |
Dalbey, W. and Feuston, M. (1996) Subchronic and developmental toxicity studies of vaporized diisopropyl ether in rats. J. Toxicol. Environ. Health, 49, 29-43.
DOI
|
27 |
Gray, T.M., Steup, D., Roberts, L.G., O'Callaghan, J.P., Hoffman, G., Schreiner, C.A. and Clark, C.R. (2014) Health assessment of gasoline and fuel oxygenate vapors: reproductive toxicity assessment. Regul. Toxicol. Pharmacol., 70, S48-S57.
DOI
|
28 |
White, K.L., Jr., Peachee, V.L., Armstrong, S.R., Twerdok, L.E., Clark, C.R. and Schreiner, C.A. (2014) Health assessment of gasoline and fuel oxygenate vapors: immunotoxicity evaluation. Regul. Toxicol. Pharmacol., 70, S43-S47.
DOI
|
29 |
Schreiner, C.A., Hoffman, G.M., Gudi, R. and Clark, C.R. (2014) Health assessment of gasoline and fuel oxygenate vapors: micronucleus and sister chromatid exchange evaluations. Regul. Toxicol. Pharmacol., 70, S29-S34.
DOI
|
30 |
United States Environmental Protection Agency (1998) Health Effects Test Guidelines OPPTS 870.3465 90-Day Inhalation Toxicity. EPA 712-C-98-204.
|
31 |
Chernoff, N. and Rogers, J.M. (2004) Supernumerary ribs in developmental toxicity bioassays and in human populations: incidence and biological significance. J. Toxicol. Environ. Health B Crit. Rev., 7, 437-449.
DOI
|
32 |
OECD (2001) Guideline for the Testing of Chemicals 414. Prenatal Developmental Toxicity Study.
|
33 |
O'Callaghan, J.P., Daughtrey, W.C., Clark, C.R,. Schreiner, C.A. and White, R. (2014) Health assessment of gasoline and fuel oxygenate vapors: neurotoxicity evaluation. Regul. Toxicol. Pharmacol., 70, S35-S42.
DOI
|
34 |
Brooks, T., Meyer, A. and Hutson, D. (1988) The genetic toxicology of some hydrocarbon and oxygenated solvents. Mutagenesis, 3, 227-232.
DOI
|
35 |
United States Environmental Protection Agency (1998) Health Effects Test Guidelines OPPTS 870.3700 Prenatal Developmental Toxicity Studies. EPA 712-C-98-207.
|
36 |
Rodriguez, S.C. and Dalbey, W. (1997) Subchronic neurotoxicity of vaporized diisopropyl ether in rats. Int. J. Toxicol., 16, 599-610.
DOI
|
37 |
United States Environmental Protection Agency (1996) Health Effects Test Guidelines OPPTS 870.6200 Neurotoxicity Screening Battery. EPA-712-C-96-238.
|
38 |
OECD (1997) Guideline for the Testing of Chemicals 471. Bacterial Reverse Mutation Test.
|
39 |
OECD (1986) Guideline for the Testing of Chemicals 481. Genetic Toxicology: Saccharomyces cerevisiae Mitotic Recombinant Assay.
|
40 |
OECD (1983) Guideline for the Testing of Chemicals 473. Genetic Toxicology: In Vitro Mammalian Cytogenetic Test.
|
41 |
International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (2011) Guideline S2 (R1) on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use.
|
42 |
Belpoggi, F., Soffritti, M., Minardi, F., Bua, L., Cattin, E. and Maltoni, C. (2002) Results of long-term carcinogenicity bioassays on tert-amyl-methyl-ether (TAME) and di-isopropyl-ether (DIPE) in rats. Ann. N.Y. Acad. Sci., 982, 70-86.
|
43 |
United States Environmental Protection Agency (1998) Health Effects Test Guidelines OPPTS 870.5915 In vivo sister chromatid exchange. EPA 712-C-98-235.
|
44 |
United States Environmental Protection Agency (1998) Health Effects Test Guidelines OPPTS 870.3800 Reproduction and Fertility Effects. EPA 712-C-98-208.
|
45 |
United States Environmental Protection Agency (1998) Health Effects Test Guidelines 870.7800, Immunotoxicity. EPA 712-C-98-351.
|
46 |
United States Environmental Protection Agency (1998) Health Effects Test Guidelines 870.5395 Mammalian Erythrocyte Micronucleus Test. EPA 712-C-98-226.
|
47 |
Bernauer, U., Amberg, A., Scheutzow, D. and Dekant, W. (1998) Biotransformation of 12C- and 2-13C-labeled methyl tert-butyl ether, ethyl tert-butyl ether, and tert-butyl alcohol in rats: identification of metabolites in urine by 13C nuclear magnetic resonance and gas chromatography/mass spectrometry. Chem. Res. Toxicol., 11, 651-658.
DOI
|
48 |
Amberg, A., Rosner, E. and Dekant, W. (2000) Biotransformation and kinetics of excretion of ethyl tert-butyl ether in rats and humans. Toxicol. Sci., 53, 194-201.
DOI
|
49 |
Shamsipur, M., MiranBeigi, A.A., Teymouri, M., Poursaberi, T., Mostafavi, S.M., Soleimani, P., Chitsazian, F. and Tash, S.A. (2012) Biotransformation of methyl tert-butyl ether by human cytochrome P450 2A6. Biodegradation, 23, 311-318.
DOI
|
50 |
Casazza, J.P., Felver, M.E. and Veech, R.L. (1984) The metabolism of acetone in rat. J. Biol. Chem., 259, 231-236.
|