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 Styrene TDI oral Organisation Description Target organ/Critical Effect Reference Web link Health Protection Agency (HPA) Toxic by inhalation, ingestion and skin contact. Possible human carcinogen and cause of CNS depression. Irritation to any tissues contacted. Limited evidence from animal studies that styrene will cause adverse effects on reproduction. HPA Compendium of Chemical Hazards, Styrene. JC Wakefield, HPA 2008 http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1202115635291 Rats - increased liver and kidney weights, growth depression Health and Safety Executive (HSE) HSE 2 CNS depression, skin, eye and respiratory tract irritation, repeated dose toxicity CNS depression, skin, eye and respiratory tract irritation, repeated dose toxicity Scientific Committee on Food (SCF) pre 2002 See WHO guidelines for DW See WHO guidelines for DW WHO (1993). Guidelines for drinking water guidelines, 2 nd edition, vol. 1. Health criteria and other supporting information. World Health Organization, Geneva. http://ec.europa.eu/food/fs/sc/scf/out24_en.html International Programme on Chemical Safety (IPCS) 2 year oral study rats received 0, 125mg/l and 250mg/l in drinking water. At 250mg/l females showed lower terminal body weight than lower dose groups. 125mg/l identified as an NOAEL equating to 7.7mg/kg (males) and 12mg/kg (females) Reduced body weight Styrene in Drinking Water. Background Document for the development of WHO http://www.who.int/water_sanitation_health/dwq/chemicals/styrene.pdf Guidelines for Drinking-water Quality. World Health Organisation 2003 Primary (Study) Reference given as: Chemical Manufacturers Association (1980) Toxicological study on styrene incorporated in drinking water of rats for two years in conjunction with three generation reproduction study. Litton Bionetic IPCS INCHEM As above As Above Primary Reference given as: Chemical Manufacturers Association (1980) http://www.inchem.org/documents/jecfa/jecmono/v19je15.htm Toxicological study on styrene incorporated in drinking water of rats for two years in conjunction with three generation reproduction study. Litton Bionetics WHO Guidelines for drinking water Quality 2 year oral study rats received 0, 125mg/l and 250mg/l in drinking water. At 250mg/l females showed lower terminal body weight than lower dose groups. 125mg/l identified as an NOAEL equating to 7.7mg/kg (males) and 12mg/kg (females) Reduced body weight Guidelines for Drinking-water Quality. First Addendum to the Third Edition. http://www.who.int/water_sanitation_health/dwq/gdwq0506.pdf Volume 1, Recommendations. World Health Organisation 2006 Principal Reference: Styrene in Drinking Water. Background Document for the development of WHO Guidelines for Drinking-water Quality. World Health Organisation 2003 Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels 2 year oral study rats received 0, 125mg/l and 250mg/l in drinking water. At 250mg/l females showed lower terminal body weight than lower dose groups. 125mg/l identified as an NOAEL for females. Males showed no effects at 250mg/l (NOAEL). i.e.. This is the same study but different interpretation of the results from the WHO approach above Reduced body weight in females 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 (Primary Reference given as Van Apeldorn et al. 1986) http://www.rivm.nl/bibliotheek/rapporten/711701025.pdf Health Canada Toxicological Values US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk levels USEPA Acute Guideline Levels (AEGLs) USEPA Health Advisors Dose groups of 125mg/l and 250 mg/l in drinking Reproductive effects in three generation rat Primary (Study) Reference: Beliles et al. 1985 water. Over three generations. 125mg/l identified study as NOAEL. 250mg/l as LOAEL http://www.hc-sc.gc.ca/ewh-semt/pubs/contaminants/psl1- lsp1/stryene/styrene_3-eng.php http://www.atsdr.cdc.gov/mrls/pdfs/atsdr_mrls_december_2008.pdf / USEPA Integrated Risk Information System (IRIS) Toxicology Data Network (Toxnet) Four beagle dogs/sex were gavaged with doses of 0, 200, 400, or 600 mg styrene/kg bw/day in peanut oil for 560 days. No adverse effects were observed for dogs administered styrene at 200 mg/kg-day. Red blood cell and liver effects Quast, J.F., C.G. Humiston, R.Y. Kalnins, et al. 1979. Results of a toxicity study of monomeric styrene administered to beagle dogs by oral intubation for 19 months. Toxicology Research Laboratory, Health and Environmental Sciences, DOW Chemical Co., Midland, MI. Final Report. as above as above as above as above http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f./temp/~wxAHsQ:1 Page2 of 4 EIC Proforma styrene.xls28/08/2009]
www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Styrene CAS Number: 100-42-5 Assessor A: Nick Brown, Grontmij Assessor B: Catherine Helm WD Final Review: Panel/SF Date 26/05/2009 Date 01/06/2009 Date 28/08/2009 TDI inhal Recommended TDIinhal Units 240 ug.kg-1.d-1 Justification ATSDR value has been selected because of relevance and quality of study but primary reference is still draft. However the second best source (RIVM) used the original ATSDR Toxicological Profile (1993) which is slightly less conservative. i.e. More conservative draft value has been selected Organisation Last Updated Health criteria type Value Units CLEA Units ug.kg-1.d-1 Confidence rating Health Protection Agency (HPA) http://www.hpa.org.uk/ 05/05/2009 WHO Air Quality 0.26 (weekly average) mg/m3 74 Guideline Basis Value Units UF UF description Study type Health Protection Agency (HPA) 25/03/2009 31/03/2009 4 hour LC50 2700 mg/m3 Rats Health Protection Agency (HPA) 25/03/2009 31/03/2009 2 hour LC50 2160 mg/m3 Mice Dutch National Institute for Public Health and http://www.rivm.nl/en/ 05/05/2009 TCA 900 ug/m3 257 NOAEC 26 (107) mg/m3 30 x 3 for LOAEC to NOAEC x Occupational the Environment (RIVM) Maximum Permissible Risk (MPR) levels 10 for intra human variation exposure assessment Health Canada Toxicological Values http://www.hc-sc.gc.ca/index_e.html 05/05/2009 TDI 41 ug/kg bw/day 41 LOAEL 260 mg/m3 500 x 5 for LOEL, x 10 for interspecies variation, x 10 for intraspecies Kishi Study: Wistar Rats US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk levels http://www.atsdr.cdc.gov/ 05/05/2009 MRL 0.2 ppm (1ppm = 4.25mg/m3) 240 LOAEL from Metanalysis of data 20 ppm 100 10 LOAEL and 10 Intra Species Variation Occupational Exposure studies USEPA Integrated Risk Information System (IRIS) http://epa.gov/iris/ 05/05/2009 RFC 1 mg/m3 285 NOAEL 30 mg/m3 30 x 3 database inadequacies X10 intra-species variation Mutti et al. (1984) Toxicology Data Network (Toxnet) http://toxnet.nlm.nih.gov/ as IRIS as IRIS as IRIS as IRIS as IRIS as IRIS as IRIS as IRIS as IRIS Page3 of 4 EIC Proforma styrene.xls28/08/2009]
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