Soil Generic Assessment Criteria for Human Health Risk ... - ESdat

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www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Assessor A: Cheryl Davies, Delta- Simons Assessor B: Jennifer Stothert, Entec UK Ltd Final Review: Panel/SF Methyl tert-butyl ether CAS Number: 1634-04-4 Date 01/03/2009 Date 27/04/2009 date: 26/08/2009 TDI inhal Recommended TDIinhal Units Justification 722 ug.kg-1.d-1 Organisation Web Link Last Updated Date Web Checked Health criteria type Value Initial Units CLEA units ug.kg- Confidence 1.d-1 rating Committee on the Medical http://www.advisorybodies.doh. Sep-00 27/04/2009 Low - is a Effects of Air Pollutants gov.uk/comeap/index.htm high value. (COMEAP) No NOAEL European Chemicals Bureau (ECB) IPCS Environmental Health Criteria (EHC) Monographs http://ecb.jrc.it/ 2002 27/04/2009 Various repeated toxicity animal studies and occupational human studies available but no TDI derived. http://inchem.org/pages/ehc.ht ml General consistency amongst RIVM, ATSDR and IRIS values, most conservative value chosen (ATSDR). All available values based on same tox study. Conversion using ATSDR MRL; 0.7ppm x 3610μg.m-3.ppm-1 x 20m3.day-1 / 70kg). Basis Value Units UF UF description Study type NOAEL 3142 mg.m-3 Inhalation 300 mg.kg bw-1.d- 1 1998 27/04/2009 NOAEL 1440 mg.m-3 Mid length inhalation exposure study Unknown Inhalation. Repeat dose toxicity WHO Guidelines for drinking water Quality http://www.who.int/water_sanit ation_health/dwq/guidelines/en 2005 27/04/2009 NOAEL 210 mg. Kg bw-1.d- 1 Neurotoxicity study inhalation Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk levels USEPA Integrated Risk Information System (IRIS) http://www.rivm.nl/en/ 2004 25/03/2009 TCA 2.6 mg.m-3 742 NOAEL 1440 mg.m-3 Uses correction factor for exposure duration and UF of 100 and rounding off http://www.atsdr.cdc.gov/ 1996 27/04/2009 MRL (Conversion 1ppm=3.61mg/m³) 0.7 ppm (1ppm = 3.61mg/m3) Subchronic inhalation 722 NOAEL 400 (1444) ppm (mg/m³) 100 Intermediate Inhalation http://epa.gov/iris/ 01/09/1993 26/03/2009 Inhal RfC 3 mg.m-3 857 NOAEL 1453 mg.m-3 100 An uncertainty factor of 10 is applied to account for extrapolation to sensitive human subpopulations. An additional factor of 3 is used to account for interspecies extrapolation. A full 10-fold adjustment for interspecies extrapolation is not deemed necessary. Chronic ID oral Recommended IDoral Units Organisation Web Link Last Updated Date Web Checked Non threshold effects Basis Health criteria type European Chemicals Bureau http://ecb.jrc.it/ 2002 27/04/2009 MTBE is not a LOAEL (ECB) genotoxic substance International Agency for http://inchem.org/pages/iarc.ht Sep-99 27/04/2009 Research on Cancer (IARC) ml The data indicate that methyl tert-butyl ether is not genotoxic IPCS Environmental Health Criteria (EHC) Monographs http://inchem.org/pages/ehc.ht ml 1998 27/04/2009 The weight of evidence indicates that MTBE is not genotoxic. Justification Consensus that MTBE not genotoxic Value Units Confidence rating Basis Study type 250 mg/kg bw- 1.d-1 Not very high Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels http://www.rivm.nl/en/ 2004 27/04/2009 The weight of evidence indicates that MTBE is not genotoxic. 3 of 6 C:\Firth Consultants\projects\eic\EIC GAC\3rd phase\Final Proformas\EIC Proforma MTBE.xls26/08/2009
www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Methyl tert-butyl ether TDI inhal Organisation Description Response Reference Web link Committee on the Medical Effects of Air Pollutants (COMEAP) European Chemicals Bureau (ECB) Rat study Motor activity affected Health Effects Institute: The Potential Health Effects of Oxygenates added to Gasoline (1996). An inhalation NOAEC of 800 ppm has been used based on a) inhalation exposure in a 13 week rat study b) 2 year rat study a) mild liver effects at 4000 ppm b) mild liver effects at 3000 ppm a) Lington AW, Dodd DE, Ridlon SA, Douglas JF, Kneiss JJ & Andrews LS (1997). Evaluation of 13-week inhalation toxicity study on methyl t-butyl ether (MTBE) in Fischer 344 rats. Journal of Applied Toxicology, 17. b) Bird MG, Burleigh-Flayer HD, Chun JS, Dou http://www.advisorybodies.doh.gov.uk/comeap/pdfs/comeap-99-00.pdf http://ecb.jrc.ec.europa.eu/Documents/Existing- Chemicals/RISK_ASSESSMENT/REPORT/mtbereport313.pdf IPCS Environmental Health Criteria (EHC) Monographs An oncogenicity study was also carried out on Effects on the liver CD-1 mice exposed to MTBE (99% pure) vapour in inhalation chambers (Burleigh-Flayer et al., 1992; Bird et al., 1997). Groups of 50 male and 50 female mice were exposed to target concentrations of 0, 1430, 10 7 Burleigh-Flayer HD, Chun JS, & Kintigh WJ (1992) Methyl tertiary butyl ether: vapor inhalation oncogenicity study in CD-1 mice (Laboratory project ID 91N0013A). Export, Pennsylvania, Bushy Run Research Center, 1068 pp (Report to the Methyl Tertiary Butyl http://inchem.org/documents/ehc/ehc/ehc206.htm#SubSectionNumber:7 .4.2 WHO Guidelines for drinking water Quality Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk levels USEPA Integrated Risk Information System (IRIS) Daily exposure of male and female rats to MTBE at 2900 mg.m-3 for 13 weeks 28 day inhalation study of rat. Exposure of 6 hrs/day, 5 days/week 24 month inhalation rat study. Exposure of 6 hr/day, 5 d/week. 24 month inhalation rat study. Exposure of 6 hr/day, 5 d/week. Absolute but not relative decrease in brain weight Miller MJ et al. (1997) Pharmacokinetics and disposition of methyl t-butyl ether in Fischer-344 rats. Journal of Applied Toxicology, 17(Suppl. 1): S3–S12. Increased liver and kidney weight TCA from ECB (2002) based on Chun et al. 1993. ECB (2002). European Union Risk Assessment Report t-butyl methyl ether. European Chemicals Bureau, 3rd Priority list, volume 19; Office for Official Publications of the EC, Luxembourg. Increased liver and kidney weight Increased absolute and relative liver and kidney weights and increased severity of spontaneous renal lesions (females), increased prostration (females), and swollen periocular tissue (males and females) http://www.who.int/water_sanitation_health/dwq/chemicals/MTBE2006 05.pdf http://www.rivm.nl/bibliotheek/rapporten/711701039.pdf RFC from IRIS 1996 based on Chun JS, Burleigh-Flayer HD, Kintigh WJ. http://www.atsdr.cdc.gov/toxprofiles/tp91.pdf 1992. Methyl tertiary butyl ether: Vapor inhalation oncogenicity study in Fischer 344 rats. Bushy Run Research Center, Export, PA. Project No. 91N0013B. Chun, J.S., H.D. Burleigh-Flayer, and W.J. Kintigh. 1992. Methyl tertiary butyl ether: vapor inhalation oncogenicity study in Fischer 344 rats (unpublished material). Prepared for the MTBE Committee by Bushy Run Research Center, Union Carbide Chemicals. http://www.epa.gov/ncea/iris/subst/0545.htm ID oral Organisation European Chemicals Bureau (ECB) International Agency for Research on Cancer (IARC) Description Response Reference Web link Tumours have been reported in rats at doses 250 mg.kg-1 IPCS Environmental Health Criteria (EHC) Monographs Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels 4 of 6 C:\Firth Consultants\projects\eic\EIC GAC\3rd phase\Final Proformas\EIC Proforma MTBE.xls26/08/2009
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