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REVIEW ARTICLE

Human health screening level risk assessments of tertiary-butyl acetate (TBAC): Calculated acute and chronic reference concentration (RfC) and Hazard Quotient (HQ) values based on toxicity and exposure scenario evaluations

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Pages 142-171 | Received 05 Aug 2014, Accepted 22 Oct 2014, Published online: 28 Jan 2015

References

  • Baker RC, Sorensen SM, Deitrich RA. (1982). The in vivo metabolism of tertiary butanol by adult rats. Alcohol Clin Exp. Res, 6, 247–51.
  • Belpoggi F, Soffritti M, Filippini F, Maltoni C (1997). Results of long-term experimental studies on the carcinogenicity of methyl tert-butyl ether. Annals NY Acad Sci, 837, 77–95.
  • Bernauer U, Amberg A, Scheutzow D, 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, 651–58.
  • Blanck O, Fowles J, Schorsch F, Pallen C, Espinasse-Lormeau H, Schulte-Koerne E, et al. (2010). Tertiary butyl alcohol in drinking water induces phase I and II liver enzymes with consequent effects on thyroid hormone homeostasis in the B6C3F1 female mouse. J Appl Toxicol, 30, 125–32.
  • Bird MG, Burleigh-Flayer HD, Chun JS, Douglas JF, Kneiss J J, Andrews LS. (1997). Oncogenicity studies of inhaled methyl tertiary-butyl ether (MTBE) in CD-1 mice and F-344 rats. J Appl Tox, 17, S45–S55.
  • Boas M, Feldt-Rasmussen U, Skakkebaek NE, Main KM. (2006). Environmental chemicals and thyroid function. Eur J Endocrinol, 154, 599–611.
  • Boobis AR, Cohen SM, Dellarco V, McGregor D, Meek ME, Vickers C, et al (2006). IPCS framework for analyzing the relevance of a cancer mode of action for humans. Crit Rev Toxicol, 27, 781–792.
  • Borghoff SJ, Prescott JS, Janszen DB, Wong BA, Everitt JI. (2001). α2u-Globulin nephropathy, renal cell proliferation, and dosimetry of inhaled tert-butyl alcohol in male and female F-344 rats. Toxicol Sci, 61, 176–86.
  • Budroe JD, Brown JP, Salmon AG, Marty MA. (2004). Acute toxicity and cancer risk assessment values for tert-butyl acetate. Regul Toxicol Pharmacol, 40, 168–176. Erratum (2005): Regul Toxicol Pharmacol, 42: 148. Corrigendum (2006): Regul Toxicol Pharmacol, 46: 243.
  • Cain WS, Schmidt R. (2009). Can we trust odor databases? Example of t- and n-butyl acetate. Atmospheric Environment, 43, 2591–2601.
  • Capen CC. (1997). Mechanistic data and risk assessment of selected toxic endpoints of the thyroid gland. Toxicol Path, 25, 39–48.
  • CARB (2006). Environmental impact assessment of tertiary butyl acetate. Available at: http://www.arb.ca.gov/research/reactivity/tbacf.pdf
  • Cirvello JD, Radovsky A, Heath JE, Farnell DR, Lindamood C. (1995). Toxicity and carcinogenicity of t-butyl alcohol in rats and mice following chronic exposure in drinking water. Toxicol Ind Health, 11, 151–165.
  • Cometto-Muñiz JE, Cain WS. (1995). Relative sensitivity of the ocular trigeminal, nasal trigeminal, and olfactory systems to airborne chemicals. Chem Senses, 20, 191–198.
  • Cruzan G, Kirkpatrick D. (2006). Tertiary-butyl Acetate Metabolism, Toxicity, and Human Health Considerations. Toxicological Environmental Chem July-Sept. 88(3), 405–421.
  • Dellarco V.L, McGregor D, Berry SC, Cohen SM, Boobis AR. (2006). Thiazopyr and thyroid disruption: Case study within the context of the 2006 IPCS Human Relevance Framework for analysis of a cancer mode of action. Crit Rev Toxicol, 36, 793–801.
  • Dodd DE, Wilson G, Parkinson H, Bermudez E. (2013). Two-year drinking water carcinogenicity study of methyl tertiary-butyl ether (MTBE) in Wistar rats. J Appl Toxicol, 33, 693–606.
  • European Chemicals Agency (ECHA). (2014a). REACH Dossier summary IUCLID file for tert-butyl acetate. Exp Key Acute toxicity: oral. 001. Available from: http://apps.echa.europa.eu/registered/data/dossiers
  • European Chemicals Agency (ECHA). (2014b). REACH Dossier summary IUCLID file for tert-butyl acetate. Exp Key Acute toxicity: dermal. 001. Available from: http://apps.echa.europa.eu/registered/data/dossiers
  • European Chemicals Agency (ECHA). (2014c). REACH Dossier summary IUCLID file for tert-butyl acetate. Exp Supporting Acute toxicity: inhalation. 003. Available from: http://apps.echa.europa.eu/registered/data/dossiers
  • European Chemicals Agency (ECHA). (2014d). REACH Dossier summary IUCLID file for tert-butyl acetate. Exp Supporting Acute toxicity: inhalation. 002. Available from: http://apps.echa.europa.eu/registered/data/dossiers
  • European Chemicals Agency (ECHA). (2014e). REACH Dossier summary IUCLID file for tert-butyl acetate. Exp Key Acute toxicity: inhalation. 001. Available from: http://apps.echa.europa.eu/registered/data/dossiers
  • European Chemicals Agency (ECHA). (2014f). REACH Dossier summary IUCLID file for tert-butyl acetate. Exp Key Skin irritation/corrosion. 001. Available from: http://apps.echa.europa.eu/registered/data/dossiers
  • European Chemicals Agency (ECHA). (2014g). REACH Dossier summary IUCLID file for tert-butyl acetate. Exp Key Eye irritation. 001. Available from: http://apps.echa.europa.eu/registered/data/dossiers
  • European Chemicals Agency (ECHA). (2014h). REACH Dossier summary IUCLID file for tert-butyl acetate. Exp Key Skin sensitisation. 001. Available from: http://apps.echa.europa.eu/registered/data/dossiers
  • E-FAST's CEM (2008). Available at: http://www.epa.gov/opptintr/exposure/pubs/efastdl.htm
  • Elema JD, Arends A. (1975). Focal and segmental glomerular hyalinosis and sclerosis in the rat. Lab Invest, 33, 554–561.
  • EPA (1994). Methods for derivation of inhalation reference concentrations and application of inhalation dosimetry, EPA/600/ 8–90/066F.
  • EPA (1998). Health effects test guidelines OPPTS 870.7800 immunotoxicity. EPA 712–C–98–351. August 1998. Available at; http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/870_Health_Effects_TestGuidelines/Series/870–7800.pdf
  • EPA (2005). Guidelines for carcinogen risk assessment. EPA/630/P-03/001F, March, 2005.
  • EPA (2007). Exposure and fate assessment screening tool (e-fast) version 2.0 documentation manual. EPA Contract No. EP-W-04–035. March, 2007.
  • Faber W, Kirkpatrick D, Coder P, Li A, Borghoff S, Banton M. (2014). Subchronic, reproductive, and maternal toxicity studies with tertiary butyl acetate (TBAC). Regul Toxicol Pharmacol, 68, 332–342.
  • Faulkner TP, Hussain AS. (1989). The pharmacokinetics of tertiary butanol in C57BL/6 J mice. Res Commun Chem Pathol Pharmacol 64, 31–39.
  • Frocht A, Fillit H. (1984). Renal disease in the geriatric patient. J Am Geriatr Soc, 32, 28–43
  • Germolec DR, Nyska A, Kashon M, Kuper CF, Portier C, Kommineni C, Johnson KA, Luster MI. (2004). Extended histopathology in immunotoxicity testing: interlaboratory validation studies. Toxicol Sci, 78(1), 107–115.
  • Groth G, Freundt KJ. (1994). Inhaled tert-butyl acetate and its metabolite tert-butyl alcohol accumulate in the blood during exposure. Hum Exp Toxicol, 13, 478–480.
  • Hard GC, Rodgers IS, Baetcke KP, Richards WL, McGaughy RE, Valcovic LR. (1993). Hazard evaluation of chemicals that cause accumulation of α2u-globulin, hyaline droplet nephropathy, and tubule neoplasia in the kidneys of male rats. Environ Health Perspect, 99, 313–349.
  • Hard GC, Alden CL, Stula EF, Trump BF. (1995). Proliferative lesions of the kidney in rats. In Guides for Toxicol Pathol pp 1–19. STP/ARP/AFIP, Washington, DC.
  • Hard GC, Khan KN. (2004)A contemporary overview of chronic progressive nephropathy in the laboratory rat, and its significance for human risk assessment. Toxicol Pathol, 32, 171–180
  • Hard GC, Seely JC. (2005). Recommendations for the interpretation of renal tubule prolerative lesions occurring in rat kidneys with advanced chronic progressive nephropathy (CPN) Toxicol Pathol 33, 641–649
  • Hard GC, Seely JC. (2006) Histological investigation of diagnostically challenging tubule profiles in advanced chronic progressive nephropathy (CPN) in the Fischer 344 rat Toxicol Pathol, 34, 941–948
  • Hard GC, Johnson KJ, Cohen SM. (2009)A comparison of rat nephropathy (CPN) with human renal disease – Implications for human risk assessment. Crit Rev Toxicol, 39, 332–346.
  • Hard GC, Banton MI, Bretzlaff RS, Dekant W, Fowes J, Mallett AK, et al. (2013). Consideration of rat chronic progressive nephropathy in regulatory evaluations for carcinogenicity. Toxicol Sci, 132, 268–275.
  • Haley P, Perry R, Ennulat D, Frame S, Johnson C, Lapointe JM, et al. (2005). STP position paper: best practice guideline for the routine pathology evaluation of the immune system. Toxicol Pathol, 33(3), 404–7; discussion 408.
  • Hill RN, Erdreich LS, Paynter OE, Roberts PA, Rosenthal SL, Wilkinson CF. (1989). Thyroid follicular cell carcinogenesis. Fundam Appl Toxicol, 12, 629–697.
  • Hoshino H, Chihara G, Fukuoka F. (1970)Detection of potential weak carcinogens and procarcinogens. II. Tertiary butyl hydroperoxide. Gann, 61, 121–124.
  • Hosokawa M, Endo T, Fujihawa M, Hara S, Iwata N, Sato Y, Satoh, T. (1995). Interindividual variation in carboxylesterase levels in human liver microsomes. Drug Metab Dispos, 23, 1022–1027.
  • Hosokawa et al. as follows: IARC (1992). In, U. Mohr (ed-in-chief) International classification of rodent tumors . Part 1. The Rat. 3. Urinary system. IARC Sci. Pub. No. 122. Lyon. pp. 46.
  • IPCS - International Program for Chemical Safety, Concise International Chemical Assessment Document 64 (IPCS CICAD 64). (2005). “Butyl Acetates”. World Health Organization (WHO).
  • Janer G, Hakkert BC, Slob W, Vermeire T, Piersma AH. (2007). A retrospective analysis of the two-generation study: What is the added value of the second generation? Reproduct Toxicol, 24, 97–102.
  • Jahnke GD, Choksi NY, Moore JA, Shelby MD. (2004). Thyroid toxicants. Assessing reproductive health effects. Env. Hlth. Perspect, 112, 363–368.
  • Kaneko T, Wang PY, Sato A. (1994). Partition coefficients of some acetate esters and alcohols in water, blood, olive oil, and rat tissues. Occup Environ Med, 51, 68–72.
  • Leavens TL, Borghoff SJ. (2009). Physiologically based pharmacokinetic mode of methyl tertiary butyl ether and tertiary butyl alcohol dosimetry in male rats based on binding to α-2u-globulin. Toxicol Sci, 109, 321–335.
  • Lindamood C, III, Farnell DR, Giles HD, Prejean JD, Collins JJ, Takahashi K, Maronpot RR. (1992). Subchronic toxicity studies of t-butyl alcohol in rats and mice. Fund Appl Toxicol, 19, 91–100.
  • Lock EA, Hard GC. (2004). Chemically induced renal tubule tumors in the laboratory rat and mouse: Review of the NCI/NTP database and categorization of renal carcinogens based on mechanistic information. Crit Rev Toxicol, 34, 211–299.
  • McGregor DB, Martin R, Cattanach P, Edwards I, McBride D, Caspary, WJ. (1988). Responses of the L5178Y tk + tk- mouse lymphoma cell forward mutation assay. II: 18 Chemicals. Environ Mol Mutagen 11, 91–118.
  • McGregor DB, Cruzan G, Callander RD, May K, Banton M. (2005). The mutagenicity testing of tertiary-butyl alcohol, tertiary-butyl acetate and methyl tertiary- butyl ether in Salmonella typhimurium. Mutat Res, 565, 181–189.
  • McGregor DB. (2006). Methyl tertiary-Butyl Ether: Studies for Potential Human Health Hazards. Crit Rev Toxicol, 36, 319–358
  • McGregor DG. (2010). Tertiary-Butanol: A toxicological review. Crit Rev Toxicol, 40, 697–727.
  • McClain RM. (1989). The significance of hepatic microsomal enzyme induction and altered thyroid function in rats: Implications for thyroid gland neoplasia. Toxicol Pathol, 17, 294–306.
  • Meek ME, Bucher JR, Cohen SM, Dellarco V, Hill RN, Lehman-McKeeman LD, et al. (2003). A framework for human relevance analysis of information on carcinogenic modes of action. Crit Rev Toxicol, 33, 591–653.
  • Mennear J. (1997). Carcinogenicity studies on MTBE: critical review and interpretation. Risk Anal, 17, 673–681.
  • Muskhelishvili L, Latendresse JR, Kodel RL, Henderson EB. (2003). Evaluation of cell proliferation in rat tissues with BrdU, PCNA, Ki-67(MIB-5) immunohistochemistry and in situ hybridization for histone mRNA. J Histochem Cytochem, 51, 1681–1688.
  • Nagata Y. (2003). Odor intensity and odor threshold value. J Jap Air Cleaning Assoc, 41, 17–25.
  • National Toxicology Program (NTP) (1995). NTP Technical Report on the Toxicology and Carcinogenesis Studies of T-Butyl Alcohol (CAS No. 75–65-0) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP TR-436 (NIH Publication No. 95–3167).
  • National Toxicology Program (NTP) (1997). NTP Technical Report on Toxicity Studies of T-Butyl Alcohol (CAS No. 75–65-0) Administered by Inhalation to F344/N Rats and B6C3F1 Mice. NTP TR-53 (NIH Publication No. 97–3942).
  • Piersma AH, Rorije E, Beekhuijzen MEW, Cooper R, Dix D, Heinrich-Hirsch B, et al. (2011). Combined retrospective analysis of 498 rat multi-generation reproductive toxicity studies: On the impact of parameters related to F1 mating and F2 offspring. Reproduct Toxicol, 31, 392–401.
  • Plunkett LM, Kaplan AM, Becker RA. (2010). An enhanced tiered toxicity testing framework with triggers for assessing hazards and risks of commodity chemicals. Regul Toxicol Pharmacol, 58, 382–394.
  • Poet TS, Valentine JL, Borghoff SJ. (1997). Pharmacokinetics of tertiary butyl alcohol in male and female Fischer 344 rats. Toxicol Lett, 92, 179–186.
  • Rorije E, Muller A, Beekhuijzen MEW, Hass U, Heinrich-Hirsch B, Paparella M, et al. (2011). On the impact of second generation mating and offspring in multi-generation reproductive toxicity studies on classification and labelling of substances in Europe. Regul Toxicol Pharmacol, 61, 251–260.
  • SCAQMD (2005). PAR 1151 EA document appendix B. Available at: http://www.aqmd.gov/ceqa/documents/2005/aqmd/finalEA/FEA_1151.doc
  • SCAQMD (2006). PAR 1113 EA document appendix D. Available at: http://www.aqmd.gov/ceqa/documents/2006/aqmd/finalEA/1113/FEA.doc
  • Sonnich-Mullins C, Fielder R, Wiltse J, Baetcke K, Dempsey J, Fenner-Crisp P, et al. (2001). IPCS conceptual framework for evaluating a mode of action for chemical carcinogenesis. Regul Toxicol Pharmacol, 34, 146–152.
  • Seely JC, Haseman JK, Nyska A, Wolf DC, Everitt JI, Hailey JR. (2002). The effect of chronic progressive nephropathy on the incidence of renal tubule cell neoplasms in control male F344 rats. Toxicol Pathol, 30, 681–686.
  • SJVUAPCD (2006)- Draft rule 4612 appendix C.
  • Swenberg JA, Lehman-McKeeman LD. (1999). α2urinary-globulin-associated nephropathy as a mechanism of renal tubule cell carcinogenesis in male rats. In: Capen CC, Dybing E, Rice JM, Wilbourn JD, eds. Species Differences in Thyroid, Kidney and Urinary Bladder Carcinogenesis. IARC Sci Pub No 147. Lyon: International Agency for Research on Cancer, 95–118.
  • Tang G, Wang J, Zhuang Z. (1997). Cytotoxicity and genotoxicity of methyl tert-butyl ether and its metabolite to human leukemia cells. Chin J Prev Med, 31, 334–337.
  • Wilbourn JD, Partensky C, Rice JM. (1999). Agents that induce epithelial neoplasms of the urinary bladder, renal cortex and thyroid follicular lining in experimental animals and humans: summary of data from IARC Monographs Volumes 1–69. In: Capen CC, Dybing E, Rice JM, Wilbourne JD, eds. Species Differences in Thyroid, Kidney and Urinary Bladder Carcinogenesis. IARC Sci. Pub. No. 147. Lyon: International Agency for Research on Cancer, pp 191–209.
  • Williams TM, Borghoff SJ. (2001)Characterization of tert-butyl alcohol binding to α2u-globulin in F-344 rats. Toxicol Sci, 62, 228–235.
  • William-Hills D, Spears CP, Prakash S, Olah GA, Shamma T, Moin T, et al. (1999). Mutagenicity studies of methyl-tert-butylether using the Ames tester strain TAl02. Mutat Res, 446, 15–21
  • Yang YS, Ahn TH, Lee JC, Moon CJ, Kim SH, Park SC, et al. (2007). Effects of tert-butyl acetate on maternal toxicity and embryo-fetal development in Sprague-Dawley rats. Birth Def Res, Part B, 80, 374–382.
  • Zeiger E, Anderson B, Haworth S, Lawlor T, Mortelmans K, Speck W. (1987). Salmonella mutagenicity tests: III. Results from the testing of 255 chemicals. Environ Mutagen 9 (Suppl. 9):1–110.

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