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

More documents

Recommendations

Info

www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Di-n-octyl phthalate CAS Number: 117-84-0 US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk levels Assessor A: http://www.atsdr.cdc.gov/ September 1997 16/05/2009 Intermediate duration MRL B Mitcheson, Enviros Assessor B: S Cole, URS Final review: Panel/SF Date 05/05/2009 Date 10/08/2009 Date 09/09/2009 0.4 mg/kg.bw/day 400 Unknown NOAEL 40.8 mg/kg.bw/day 100 Intermediate [X] 10 for extrapolation from animals to humans [X] 10 for human variability Poon et al 1995- 13 week diet study on rats TDI inhal Recommended TDI inhal Units Justification Insufficient information available to recommend a TDI inhal Organisation Last Updated Health criteria type Value Units Confidence rating Drinking Water Inspectorate (DWI) http://www.dwi.gov.uk/ 31-Mar-09 No dose data identified - searched for plasticiser, phthalate, dicarboxylic. Note that tests for plastic pipes must comply with BS 6920 which includes a flavour and odour test Basis Value Units UF UF description Study type Food Standards Agency (FSA) http://www.food.gov.uk/ 31-Mar-09 31/03/2009 Health Protection Agency (HPA) http://www.hpa.org.uk/ Friday 5 August 2005 (On 11-Sep-08 European Chemicals Bureau (ECB) http://ecb.jrc.it/ Date of Last Literature Search : 2005. Review of report by MS Technical Experts finalised: September 2005. Final report: 2008 Not data on inhalation dose. Reference make to endocrine disruptors. Site relates to contact with food 16/05/2009 Page on exposure standards details no drinking water standard, soil standard or air standard 07/04/2009 IPCS Environmental Health Criteria (EHC) Monographs Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels http://inchem.org/pages/ehc.html http://www.rivm.nl/en/ 16/05/2009 07/04/2009 No data in EHC131 Health Canada Toxicological Values http://www.hc-sc.gc.ca/index_e.html 19/04/2007 08/04/2009 No comment on inhalation US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk levels http://www.atsdr.cdc.gov/ 14/01/2009 for MRL page (And report June 2002) 08/04/2009 No inhalation MRLs were derived for DOP due to inadequate data for this route of exposure. ID oral Recommended ID oral n/a Units Justification Weight of evidence indicates unlikely carcinogenic. Organisation Web Link Last Updated Date Web Checked Non threshold effects Basis Health criteria type Value Units Confidence rating Basis Study type Food Standards Agency (FSA) Committee on the Carcinogenicity of Chemicals in Food, Consumer Products and the Environment (COC) http://www.food.gov.uk/ http://www.advisorybodies.doh.gov.uk/coc/index.h tm Friday 5 August 2005 (On 31/03/2009 Site refer to endocrine disruptors not to carcinogenicity 06/04/2009 No dose data indentified. Page 3 of 6 EIC proforma di-n-octylphthalate 09/09/2009
www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Di-n-octyl phthalate US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk levels Groups of 10 male and 10 female Sprague-Dawley rats were maintained on diets containing 0, 5, 50, 500, or 5,000 ppm di-n-octylphthalate (DNOP) in the diet for 13 weeks. The study authors determined that these dietary concentrations corresponded to doses of 0, 0.4, 3.5, 36.8, 350.1 mg/kg/day (males) and 0, 0.4, 4.1, 40.8, 402.9 mg/kg/day (females). The rats were examined daily for clinical signs of toxicity, while food consumption and body weight data were collected weekly. Blood and comprehensive histopathological examinations were performed at the end of the study (although only data on the liver, thyroid, testis, and epididymis were presented). Liver effects observed in rats administered di-n-octylphthalate in the diet at a concentration of 5,000 ppm; the study authors calculated the doses at this concentration to be 350.1 mg/kg/day (males) and 402.9 mg/kg/day (females) (Peon et al. 1995). The hepatic effects consisted of a significant (p < 0.05) increases in ethoxyresorufin-0-deethylase activity (12-fold, males; 3-fold, females); no significant changes were noted in liver aminopyrine-N-demethylase or aniline hydrolase activities. Also, at 5,000 ppm, histopathological changes in hepatic architecture were noted, including moderate accentuation of zonation and mild-to-moderate increases in perivenous cytoplasmic vacuolation. Mild histological changes in the thyroid were also noted at 5,000 ppm that consisted of reduction in the follicle size and decreased colloid density. No effects were observed at 500 ppm (36.8 mg/kg/day for males and 40.8 mg/kg/day for females). TOXICOLOGICAL PROFILE FOR DI-n-OCTYLPHTHALATE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES. Public Health Service Agency for Toxic Substances and Disease Registry, September 1997 http://www.atsdr.cdc.gov/toxprofiles/tp95.pdf (& http://www.atsdr.cdc.gov/mrls/index.html for MRLs) TDI inhal Organisation Drinking Water Inspectorate (DWI) Description Response Reference Web link Food Standards Agency (FSA) http://www.food.gov.uk/foodlabelling/packagingbranch/phthalates/ & http://www.eatwell.gov.uk/healthissues/factsbehindissues/phthalates/lang=en & http://cot.food.gov.uk/pdfs/TOX-2004-14.pdf SCF ( Health Protection Agency (HPA) Phthalates (Diisononylphthalate and Di(2-ethylhexyl)phthalate) Incident management, Health Protection Agency 2008 http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1194947324949 European Chemicals Bureau (ECB) IPCS Environmental Health Criteria (EHC) Monographs Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels Re-evaluation of maximum permissible levels By Baars et al RIVM 711701025/2001 superseded by RIVM Report 609021064/2008 Exposure to chemicals via house dust A. G. Oomen P. J.C.M. Janssen A. Dusseldorp C. W. Noorlander http://www.inchem.org/documents/ehc/ehc/ehc131.htm http://www.rivm.nl/bibliotheek/rapporten/609021064.pdf & http://www.rivm.nl/bibliotheek/rapporten/711701025.pdf (Baars et al) Health Canada Toxicological Values US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk levels Bis(2-ethylhexyl) Phthalate - PLS1 TOXICOLOGICAL PROFILE FOR DI-n-OCTYLPHTHALATE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Agency for Toxic Substances and Disease Registry September 1997 http://www.hc-sc.gc.ca/ewh-semt/pubs/contaminants/psl1- lsp1/bis_2_ethylhexyl/bis_2_ethylhexyl_3-eng.php http://www.atsdr.cdc.gov/toxprofiles/tp9.pdf (& http://www.atsdr.cdc.gov/mrls/index.html for MRLs) ID oral Organisation Food Standards Agency (FSA) Description Response Reference Web link http://www.food.gov.uk/foodlabelling/packagingbranch/phthalates/ & http://www.eatwell.gov.uk/healthissues/factsbehindissues/phthalates/lang=en & http://cot.food.gov.uk/pdfs/TOX-2004-14.pdf SCF ( Committee on the Carcinogenicity of Chemicals in Food, Consumer Products and the Environment (COC) Chemicals for which a tumorigenic effect was first observed between 53 and 80 week in rats and/or mice. CC/01/25 COMMITTEE ON CARCINOGENICITY OF CHEMICALS IN FOOD CONSUMER PRODUCTS AND THE ENVIRONMENT THE MINIMUM DURATION OF CARCINOGENICITY STUDIES IN RATS, November 2001 http://www.iacoc.org.uk/papers/documents/mindurcarcstudy.PDF Page 4 of 6 EIC proforma di-n-octylphthalate 09/09/2009
Page 1 and 2:
www.esdat.net Esdat Environmental D
Page 3 and 4:
Page 5 and 6:
Page 7 and 8:
Page 9 and 10:
Page 11 and 12:
Page 13 and 14:
Page 15 and 16:
Page 17 and 18:
Page 19 and 20:
Page 21 and 22:
Page 23 and 24:
Page 25 and 26:
Page 27 and 28:
Page 29 and 30:
Page 31 and 32:
Page 33 and 34:
Page 35 and 36:
Page 37 and 38:
Page 39 and 40:
Page 41 and 42:
Page 43 and 44:
Page 45 and 46:
Page 47 and 48:
Page 49 and 50:
Page 51 and 52:
Page 53 and 54:
Page 55 and 56:
Page 57 and 58:
Page 59 and 60:
Page 61 and 62:
Page 63 and 64:
Page 65 and 66:
Page 67 and 68:
Page 69 and 70:
Page 71 and 72:
Page 73 and 74:
Page 75 and 76:
Page 77 and 78:
Page 79 and 80:
Page 81 and 82:
Page 83 and 84:
Page 85 and 86:
Page 87 and 88:
Page 89 and 90:
Page 91 and 92:
Page 93 and 94:
Page 95 and 96:
Page 97 and 98:
Page 99 and 100:
Page 101 and 102:
Page 103 and 104:
1,3,5-Trimethylbenzene CAS 108-67-8
Page 105 and 106:
Page 107 and 108:
Page 109 and 110:
Page 111 and 112:
Page 113 and 114:
Page 115 and 116:
Page 117 and 118:
Page 119 and 120:
Page 121 and 122:
Page 123 and 124:
Page 125 and 126:
Page 127 and 128:
Page 129 and 130:
Page 131 and 132:
Page 133 and 134:
Page 135 and 136:
Page 137 and 138:
Page 139 and 140:
Page 141 and 142:
Page 143 and 144:
Page 145 and 146:
Page 147 and 148:
Page 149 and 150:
Page 151 and 152:
Page 153 and 154:
Page 155 and 156:
Page 157 and 158:
Page 159 and 160:
Page 161 and 162:
Page 163 and 164:
Page 165 and 166:
Page 167 and 168:
Page 169 and 170:
Page 171 and 172:
Page 173 and 174:
Page 175 and 176:
Page 177 and 178:
Page 179 and 180:
Page 181 and 182:
Page 183 and 184:
Page 185 and 186:
Page 187 and 188:
Page 189 and 190:
Page 191 and 192:
Page 193 and 194:
Page 195 and 196:
Page 197 and 198:
Page 199 and 200:
Page 201 and 202:
Page 203 and 204:
Page 205 and 206: www.esdat.net Esdat Environmental D
Page 255: www.esdat.net Esdat Environmental D
Page 307 and 308:
Page 309 and 310:
Page 311 and 312:
Page 313 and 314:
Page 315 and 316:
Page 317 and 318:
Page 319 and 320:
Page 321:
show all

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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?