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 Dichloromethane TDI oral Organisation Study type Description Target organ/Critical Effect Reference Web link Health and Safety Laboratory (HSL) International Programme on Chemical Safety (IPCS) Fischer 344 Rat study 2-year drinking water study in rats Liver/ Hepatic histological alterations and exposed to 0, 5, 50, 125 and 250mg/kgbw/day for 104 weeks fatty changes. LOAEL recorded at 52mg/kgbw/day NCA 1982. Dichloromethane in Drinking Water. Background to the Development of WHO Guidelines for Drinking Water Quality. WHO 2003 (First Published 1996) (Serota D, Thakur AK, Ulland BM, et al. 1986. A Two Year water study of dichloromethane in rodents. I. Rats. Food Chem Toxicol 24:951-958) http://www.who.int/water_sanitation_health/dwq/chemicals/dichloromethanesum.pdf Joint Expert Committee on Food Additives (JECFA) Fischer 344 Rat study 2-year drinking water study in rats Liver/ Hepatic histological alterations and exposed to 0, 5, 50, 125 and 250mg/kgbw/day for 104 weeks fatty changes. LOAEL recorded at 52mg/kgbw/day NCA 1982. Dichloromethane in Drinking Water. Background to the Development of WHO Guidelines for Drinking Water Quality. WHO 2003 (First Published 1996) (Serota D, Thakur AK, Ulland BM, et al. 1986. A Two Year water study of dichloromethane in rodents. I. Rats. Food Chem Toxicol 24:951-958) http://www.who.int/water_sanitation_health/dwq/chemicals/dichloromethan e.pdf WHO Guidelines for drinking water Quality Fischer 344 Rat study 2-year drinking water study in rats Liver/ Hepatic histological alterations and exposed to 0, 5, 50, 125 and 250mg/kgbw/day for 104 weeks fatty changes. LOAEL recorded at 52mg/kgbw/day NCA 1982. Dichloromethane in Drinking Water. Background to the Development of WHO Guidelines for Drinking Water Quality. WHO 2003 (First Published 1996) (Serota D, Thakur AK, Ulland BM, et al. 1986. A Two Year water study of dichloromethane in rodents. I. Rats. Food Chem Toxicol 24:951-958) http://www.who.int/water_sanitation_health/dwq/chemicals/dichloromethan e.pdf Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels 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 (ATDSR) Toxicological Profiles and Minimal Risk levels Fischer 344 Rat study 85 rats/ sex at each of four nominal Liver dose groups (i.e., 5, 50, 125 and 250 mg/kg/day) for 2 years. Many effects were monitored. Treatment related histological alterations of the liver were evident at nominal doses of 50 mg/kg/day or higher. The low nominal dose of 5 mg/kg/day was a NOAEL. Same study as WHO Guidelines for Drinking Water Quality (Serota D, Thakur AK, Ulland BM, et al. 1986. A Two Year water study of dichloromethane in rodents. I. Rats. Food Chem Toxicol 24:951-958) http://www.atsdr.cdc.gov/toxprofiles/tp14-a.pdf USEPA Acute Guideline Levels (AEGLs) USEPA Health Advisors USEPA Integrated Risk Information System (IRIS) Fischer 344 Rat study 85 rats/ sex at each of four nominal Liver dose groups (i.e., 5, 50, 125 and 250 mg/kg/day) for 2 years. Many effects were monitored. Treatment related histological alterations of the liver were evident at nominal doses of 50 mg/kg/day or higher. The low nominal dose of 5 mg/kg/day was a NOAEL. Same study as WHO Guidelines for Drinking Water Quality National Coffee Association. 1982. 24-Month chronic toxicity and oncogenicity study of methylene chloride in rats. Final Report. Prepared by Hazleton Laboratories America, Inc., Vienna, VA. (Unpublished) (Serota D, Thakur AK, Ulland BM, et al. 1986. A Two Year water study of dichloromethane in rodents. I. Rats. Food Chem Toxicol 24:951-958) http://www.epa.gov/NCEA/iris/subst/0070.htm Toxicology Data Network (Toxnet) See IRIS above See IRIS above See IRIS above See IRIS above See IRIS above Page 2 of 6 EIC Proforma dichloromethane.xls 28/08/2009
www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Dichloromethane CAS Number: 75-09-2 Assessor A: Nick Brown, Grontmij Assessor B Catherine Helm, WD Final Review: Panel/SF Environmental Date 26/05/2009 Date 01-Jun-09 Date 28/08/2009 TDI inhal Recommended TDIinhal Units 134.3 ug.kg-1.d-1 Justification Derived from WHO weekly average. WHO based on human study, most conservative value. Organisation Last Updated Date Web Checked Health criteria type Value Initial Units CLEA units ug.kg-1.d-1 Confidence rating Basis Value Units UF UF description International Programme on Chemical Safety (IPCS) Joint Expert Committee on Food Additives (JECFA) WHO Air Quality guidelines for Europe http://www.euro.who.int/air/activities/20050 222_2 http://www.who.int/ipcs/en/ 01/04/2009 As WHO As WHO As WHO As WHO As WHO As WHO As WHO As WHO As WHO As WHO http://who.int/ipcs/food/jecfa/en/ 02/04/2009 As WHO As WHO As WHO As WHO As WHO As WHO As WHO As WHO As WHO As WHO 02/04/2009 Air Quality Guideline 3 (0.47 - weekly average) mg/m3 857 (134.3) Predicted to cause 1% increase in COHb NA NA Dutch National Institute for Public Health and http://www.rivm.nl/en/ Published 2001 02/04/2009 TCA 3000 ug/m3 857 WHO value adopted NA NA the Environment (RIVM) Maximum Permissible Risk (MPR) levels US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk levels http://www.atsdr.cdc.gov/ 05/05/2009 MRL 0.3 (1.05) ppm (mg/m3) 300 NOAEL 30 x 3 interspecies and x 10 intraspecies ATSDR 2 http://www.atsdr.cdc.gov/ 05/05/2009 Maximum concentration associated with acute exposure and irreversible harm 750 ppm ID oral Recommended IDoral Units Justification N/A ug.kg-1.d-1 Human studies are considered generally inadequate to demonstrate whether or not DCM is carcinogenic, however, carcinogenicity has been demonstrated in mice and to a lesser extent in female rats. IRIS provides the carcinogenic Classification —B2; probable human carcinogen. IARC classified dichloromethane as possibly carcinogenic to humans (Group 2B), based on inadequate evidence for the carcinogenicity of dichloromethane in humans and sufficient evidence for the carcinogenicity of dichloromethane in experimental animals. Health Canada classified dichloromethane as "probably carcinogenic to humans" (Group II) and has generated PBEK modified TD05 values (5% incidence of tumours). IRIS has also quantified carcinogenic risk by predicting concentrations equivalent to increased cancer risk of E-5. In relation to the tendency for tumor development in mice through exposure to DCM by inhalation, TERA comment that; "there are clear species differences in the putatively carcinogenic pathway of metabolism of dichloromethane which are consistent with the hypothesis that humans are likely to be less sensitive than some species of experimental animals in this regard". RIVM determined that dichloromethane is not considered to be genotoxic to humans, and therefore, derived risk values based on a threshold approach. Threshold based HCVs are also provided by ATSDR and WHO. In view of the uncertainty remaining in relation to the actual carcinogenicity of DCM to humans and uncertainty relating to the methods of quantification of nonthreshold risk, particularly in view of the guidance provided within SR2, the selection of conservative TDIs is considered more appropriate at this stage than the derivation Index Doses. Organisation Web Link Last Updated Date Web Checked Non threshold effects USEPA Integrated Risk Information System http://epa.gov/iris/ 02/04/2009 (IRIS) Basis Health criteria type Carcinogenic risk level of E-5 Value Units Confidence rating 50 ug/l 1.42 Extrapolation Method — Linearized multistage procedure, extra risk Basis Yes Toxicology Data Network (Toxnet) http://toxnet.nlm.nih.gov/ 02/04/2009 Yes See IRIS data See IRIS data See IRIS data See IRIS data See IRIS data See IRIS data Page 3 of 6 EIC Proforma dichloromethane.xls 28/08/2009
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