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www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Cis 1,2 Dichloroethene TDI oral Organisation International Programme on Chemical Safety (IPCS) Study type Description Target organ/Critical Effect Reference Web link Barnes 90 day CD1 mice study using the trans isomer CD1 Mice received trans-1,2-dichloroethene in drinking water. Dose groups of 17, 175 and 387 mg/kg-bw/day. No effects at 17mg/kg-bw/day Increased serum alkaline phosphate levels in males and decreased thymus weight in females. Human effects include CNS depression, neurological effects and trans is estimated to be 2x more potent than cis isomer WHO (2003) 1,2-Dichloroethene in drinking-water. Background document for http://www.who.int/water_sanitation_health/dwq/1,2-Dichloroethene.pdf preparation of WHO Guidelines for drinking-water quality. Geneva, World Health Organization, (WHO/SDE/WSH/03.04/72). Primary study - Barnes DW et al. Toxicology of trans-1,2-dichloroethylene in the mouse. Drug Chemistry and toxicology, 1985, 8:373- 407 Joint Expert Committee on Food Additives (JECFA) Barnes 90 day CD1 mice study using the trans isomer CD1 Mice received trans-1,2-dichloroethene in drinking water. Dose groups of 17, 175 and 387 mg/kg-bw/day. No effects at 17mg/kg-bw/day Increased serum alkaline phosphate levels in males and decreased thymus weight in females. Human effects include CNS depression, neurological effects and trans is estimated to be 2x more potent than cis isomer WHO (2003) 1,2-Dichloroethene in drinking-water. Background document for preparation of WHO Guidelines for drinking-water quality. Geneva, World Health Organization, (WHO/SDE/WSH/03.04/72) Primary study - Barnes DW et al. Toxicology of trans-1,2-dichloroethylene in the mouse. Drug Chemistry and toxicology, 1985, 8:373-407 http://www.who.int/water_sanitation_health/dwq/1,2-Dichloroethene.pdf Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels Macauley 90 day rat study Semi-chronic study on rats. Dose groups included male haematopoietic system effects and females at 97 and 290 mg/kg-bw/day - reductions in haemoglobin and haemocrit recorded at these concentrations. 32mg/kg-bw/day identified as a NOAEL RIVM Report 711701 025. Re-evaluation of human toxicological maximum permissible risk levels A.J. Bars, R.M.C Theelan, P.J.C.M. Janssen, J.M. Hesse, M.E. van Apeldoorn, M.C.M. Meijerink, L.Verdam, M.J.Zeilmaker March 2001 (McCauley PT et al. 1995. The effect of subacute and subchronic oral exposure to cis- 1,2-dichloroethylene in Sprague-Dawley rats. Drug Chem Toxicol 18, 171-184.) http://www.rivm.nl/bibliotheek/rapporten/711701025.pdf US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk levels Macauley 90 day rat study Semi-chronic study on rats. Dose groups included male Haematological ATSDR Minimum Risk Levels December 2008 and Toxicological Profile for 1,2- and females at 97 and 290 mg/kg-bw/day - reductions Dichloroethene, ATSDR, 1996 available at in haemoglobin and haemocrit recorded at these http://www.atsdr.cdc.gov/toxprofiles/tp87.pdf (Primary Reference for the Study: concentrations. 32mg/kg-bw/day identified as a NOAEL Macauley et al. 1990. The effects of subacute and subchronic oral exposure to Cis-1,2- dichloroethylene in Rats. Human Effects Research Laboratory, U.S. EPA, Cincinnati, OH and Air Force Aerospace Medical Research Laboratory, Wright-Patterson AFB, OH) http://www.atsdr.cdc.gov/mrls/pdfs/atsdr_mrls_december_2008.pdf USEPA Acute Guideline Levels (AEGLs) US EPA Provisional Peer Reviewed Toxicity Values (PPRTV) Macauley 90 day rat study Semi-chronic study on rats. Dose groups included male Mild Anemic Changes and females at 97 and 290 mg/kg-bw/day - reductions in haemoglobin and haemocrit recorded at these concentrations. 32mg/kg-bw/day identified as a NOAEL Provisional Peer Reviewed Toxicity Values for cis-1,2-dichloroethylene, Superfund Health Risk Technical Support Centre for Environmental Assessment, 2006. EPA Health Effects Assessment Summary Table (HEAST) cited as source of the RfD. (Primary Reference for the Study: Macauley et al. 1990. The effects of subacute and subchronic oral exposure to Cis-1,2-dichloroethylene in Rats. Human Effects Research Laboratory, U.S. EPA, Cincinnati, OH and Air Force Aerospace Medical Research Laboratory, Wright- Patterson AFB, OH) TDI inhalation Organisation only provisional and therefore more stringent RIVM oral TDI is considered appropriate. Study type Description Target organ/Critical Effect Reference Web link Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels Extrapolation from Extrapolation from ORAL TDI based on 90 day rat study critical effects of oral intake were ORAL TDI based on haematopoietic system effects Macauley 90 day rat study RIVM Report 711701 025. Re-evaluation of human toxicological maximum permissible risk levels A.J. Bars, R.M.C Theelan, P.J.C.M. Janssen, J.M. Hesse, M.E. van Apeldoorn, M.C.M. Meijerink, L.Verdam, M.J.Zeilmaker March 2001 (McCauley PT et al. 1995. The effect of subacute and subchronic oral exposure to cis- 1,2-dichloroethylene in Sprague-Dawley rats. Drug Chem Toxicol 18, 171-184.) http://www.rivm.nl/bibliotheek/rapporten/711701025.pdf Page 1 of 3 EIC Proforma cis 1,2 dichloroethene.xls28/08/2009
www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Cis-1,2-dichloroethene CAS 156-59-2 Assessor A: Nick Brown Grontmij Assessor B: Catherine Helm WD Environmental Final Review Panel/SF Date 29/05/2009 Date 01/06/2009 Date 28/08/2009 MDI Recommended MDIoral Units 4 ug day-1 Justification: Only US Data has been identified. In the majority of cases exposure through drinking water and food is likely to be negligible however sources in drinking water have been identified. A value of 4ug day-1 for background exposure through drinking water is tentatively proposed within the WHO Background document for development of WHO Guidelines for Drinking Water Quality. This value appears to be based on the US study that identified detectable concentrations in 8% of drinking water sources with detectable concentrations ranging between 2-120ug/l. In conjunction with the MDI Inhalation (6ug day-1 see below) this equates to a total of 10ug/day background exposure which conforms reasonably well with the RIVM estimate of total background exposure to the mixed isomers of 0.13ug/kg-bw/day (9.1ug/day for a 70kg adult). The same value has also been selected for the trans isomer since the primary study does not distinguish between the two isomers. Organisation Date Media Value Units Description Reference Web link International Programme on 14/04/2009 See WHO Guidelines for See WHO Guidelines See WHO Guidelines for DWQ Chemical Safety (IPCS) DWQ for DWQ See WHO Guidelines for DWQ WHO (2003) 1,2-Dichloroethene in drinking-water. Background document for preparation of WHO Guidelines for drinking-water quality. Geneva, World Health Organization, (WHO/SDE/WSH/03.04/72) http://www.who.int/water_sanitation_health/dwq/1,2- Dichloroethene.pdf Joint Expert Committee on Food Additives (JECFA) 14/04/2009 See WHO Guidelines for DWQ See WHO Guidelines for DWQ See WHO Guidelines for DWQ See WHO Guidelines for DWQ WHO (2003) 1,2-Dichloroethene in drinking-water. Background document for preparation of WHO Guidelines for drinking-water quality. Geneva, World Health Organization, (WHO/SDE/WSH/03.04/72) http://www.who.int/water_sanitation_health/dwq/1,2- Dichloroethene.pdf WHO Guidelines for Drinking Water Quality 14/04/2009 Drinking water 4 ug/day 1,2 dichloroethene (mixed isomers) detected in 8% of drinking WHO (2003) 1,2-Dichloroethene in drinking-water. Background supplies derived from groundwater, at concentrations between document for preparation of WHO Guidelines for drinking-water quality. 2-120ug/l. The high end value is therefore greatly atypical with Geneva, World Health Organization, (WHO/SDE/WSH/03.04/72) the majority of drinking water containing concentrations less than detection levels. Estimated 4ug/l MDI is based on a concentration of 2ug/l in drinking water. http://www.who.int/water_sanitation_health/dwq/1,2- Dichloroethene.pdf 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 14/04/2009 Drinking water 0-120 ug/l Dutch data not available. 1,2 dichloroethene (mixed isomers) detected in 8% of drinking supplies derived from groundwater, at concentrations between 2-120ug/l.. RIVM estimated background exposure of 0.13ug/kg-bw/day for the mixed isomers via inhalation and oral intake. RIVM Report 711701 025. Re-evaluation of human toxicological maximum permissible risk levels A.J. Bars, R.M.C Theelan, P.J.C.M. Janssen, J.M. Hesse, M.E. van Apeldoorn, M.C.M. Meijerink, L.Verdam, M.J.Zeilmaker March 2001 14/04/2009 Drinking water 0-120 ug/l 1,2 dichloroethene (mixed isomers) detected in 8% of drinking supplies derived from groundwater, at concentrations between 2-120ug/l. The high end value is atypical with the majority of drinking water containing concentrations less than detection levels. Toxicological Profile for 1,2-Dichloroethene, ATSDR, 1996 http://www.rivm.nl/bibliotheek/rapporten/711701025.pdf http://www.atsdr.cdc.gov/toxprofiles/tp87.pdf USEPA Health Advisories 14/04/2009 DW 0.07 mg/l MCLG & MCL www.epa.gov/waterscience/criteria/drinking/ Toxicological Data Network 14/04/2009 ND to 408 ug/l ADI from water in HSDB Database (Cis isomer specific) (3) EPA; National Contaminant Occurrence Database. cis-1,2- http://toxnet.nlm.nih.gov/ (TOXNET) Dichloroethylene. Available from the Database Query page at http://www.epa.gov/safewater/data/ncod.html as of Apr 12, 2001. Justification: Only US Data has been identified. The value of 6ug/day is the maximum value within range that ATSDR suggest that the general US population is likely to be exposed to. In conjunction with MDI Recommended MDIinh Units the MDI Oral (4ug day-1 see above) this equates to a total of 10ug/day background exposure which conforms reasonably well with the RIVM estimate of total background exposure to the mixed isomers of 0.13ug/kg-bw/day (9.1ug/day for a 70kg adult). The same value has also been selected for the trans isomer since ATSDR do not distinguish between the two isomers. 6 ug day-1 Organisation Date Media Value Units Description Reference Web link Joint Expert Committee on Food 14/04/2009 See WHO Guidelines for See WHO Guidelines See WHO See WHO Guidelines for DWQ See WHO Guidelines for DWQ http://www.who.int/water_sanitation_health/dwq/1,2- Additives (JECFA) DWQ for DWQ Guidelines for Dichloroethene.pdf WHO Guidelines for Drinking Water Quality 14/04/2009 Urban and suburban air - Cis isomer 644 (Based on 20m3 x 32.2ug/m3) ug/day 1,2 Dichloroethene (mixed isomers) recorded at mean concentrations of 32.2ug/m3 within indoor air (Data source unclear). Mean concentrations of the Cis isomer recorded in the range 0.04-0.3ug/m3 in urban and industrial areas. WHO (2003) 1,2-Dichloroethene in drinking-water. Background document for preparation of WHO Guidelines for drinking-water quality. Geneva, World Health Organization, (WHO/SDE/WSH/03.04/72) http://www.who.int/water_sanitation_health/dwq/1,2- Dichloroethene.pdf Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) Levels 14/04/2009 Urban and suburban air - Cis isomer 0.27 ug/m3 Dutch data not available. Average air concentration of the Cis isomer of 0.27ug/m3 recorded in urban and suburban air in US study. RIVM estimated background exposure of 0.13ug/kgbw/day for the mixed isomers via inhalation and oral intake. RIVM Report 711701 025. Re-evaluation of human toxicological maximum permissible risk levels A.J. Bars, R.M.C Theelan, P.J.C.M. Janssen, J.M. Hesse, M.E. van Apeldoorn, M.C.M. Meijerink, L.Verdam, M.J.Zeilmaker March 2001 http://www.rivm.nl/bibliotheek/rapporten/711701025.pdf US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk Levels Toxicological Data Network (TOXNET) 14/04/2009 Ambient air 6 ug/day 14/04/2009 Air 0.068-0.326 ppb ADI from air in HSDB Database The general population (USA) estimated to be exposed to low Toxicological Profile for 1,2-Dichloroethene, ATSDR, 1996 levels of 1,2 dichloroethene (mixed isomers) through inhalation in urban air (1-6ug/day) http://www.atsdr.cdc.gov/toxprofiles/tp87.pdf http://toxnet.nlm.nih.gov/ 1) Shah JJ, Singh HB; Environ Sci Technol 22: 1381-1388 (1988) (2) EPA; Volatile organic chemicals in the atmosphere: An assessment of available data. Menlo Park, CA: SRI Int p. 198 (1982) EPA-600/3-83-027A Page 2 of 3 EIC Proforma cis 1,2 dichloroethene.xls28/08/2009
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