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 Diethyl Phthalate CAS Number: 84-66-22 Assessor A: Mathew Rouge Assessor B: Gareth Wills Final Review: Panel/SF Date: March 09 Halcrow Date: April 09 PB Date: 26/08/2009 Apply TDIoral to exposure routes Apply IDoral to exposure routes Oral Dermal Inhalation Combine Oral and Inhalation TDIs Yes Yes Yes No No No Justification TDIoral applied to oral and dermal routes. Not classifiable as a human carcinogen Apply TDIinh to exposure routes Apply IDinh to exposure routes No No No No No No Yes Not classifiable as a human carcinogen. Insufficient data with sufficient detail on derivation to derive inhalation TDI. Use routeto-route extrapolation from oral route. TDI oral Recommended TDIoral 200 Units ug.kg-1.d-1 Justification Most conservative value chosen (RIVM and EC SCF), based on longest term study (Brown et al 1978). RfD from IRIS has low confidence, although is taken from same study (Brown et al, 1978). Organisation Web Link Last Updated Date Web Checked Health criteria type Value Initial Units CLEA units ug.kg- Confidence Basis Value Units UF UF description 1.d-1 rating IPCS concise International Chemical Assessment Documents (CICADs) http://inchem.org/pages/cicads.html 2003 Mar-09 TDI 5000 ug/kg/bw/day 5000 Not provided NOAEL 1600 mg/kg bw/day 300 3 for incompleteness of database, 10 each for intra and interspecies variation 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 http://www.rivm.nl/en/ 2000 Mar-09 TDI (Provisional). It was adopted from the European Communities temporary limit value of 0.2 mg/kg/ day http://www.atsdr.cdc.gov/ 1995 Mar-09 Database not adequate for determination of a chronic MRL 200 ug/kg/bw/day 200 Not provided NOAEL 100 mg/kg bw/day 500 intra and interspecies extrapolation and a poor database n/a n/a n/a n/a n/a n/a n/a n/a n/a http://www.atsdr.cdc.gov/ 1995 Mar-09 acute oral MRL 7 mg/kg bw/d 7,000 Not provided LOAEL 2000 mg/kg bw/d 300 3 for conversion of minimal LOAEL to NOAEL, 10 for interspecies variability, 10 for protection of sensitive humans http://www.atsdr.cdc.gov/ 1995 Mar-09 intermediate duration oral MRL 6 mg/kg bw/d 6,000 Not provided LOAEL 1753 mg/kg bw/d 300 3 for conversion of minimal LOAEL to NOAEL, 10 for interspecies variability, 10 for inter individual variation USEPA Integrated Risk Information System (IRIS) EC Scientific Committee for Food http://epa.gov/iris/ 1993 Mar-09 RfD 8.00E-01 mg/kg/d 800 Study - Medium, Database - Low, RfD - Low http://archive.food.gov.uk/maff/archive/foo d/infsheet/1996/no82/82phthal.htm NOAEL:1% of diet (750 mg/kg bw/day) 800 mg/kg bw/day 1000 10 extrapolation from subchronic to chronic, 10 for interspecies variation and an additional 10-fold factor to protect sensitive human subpopulation 1996 Mar-09 Oral TDI 0.2 mg/kg bw/d 200 Not Provided Not Provided Not Provided Not Provided Not Provided Not Provided (Page 1 of 4) (EIC proforma diethyl phthalate.xls 26/08/2009)
www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Diethyl Phthalate TDI oral Organisation Study type Description Target organ/Critical Effect Reference Web link IPCS concise International Chemical Assessment Documents (CICADs) Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels Mice, dermal study Rat, Subchronic Oral Feeding Study. Brown et al, 1978 Diethylphthalate at 500, 1600 and 5600 mg/kg bw/day administered percutaneously to pregnant ICR mice from day 0 to day 17 of gestation Groups of CD rats (15/sex) were fed diets containing 0, 0.2, 1.0, or 5.0% DEP for 16 weeks Reproductive toxicity Tanaka C et al, (1987) A teratological evaluation following dermal application of diethylphthalate to pregnant mice liver and testes Brown, D., K.R. Butterworth, I.F. Gaunt, P. Grasso and S.D. Gangolli. 1978. Short-term oral toxicity study of diethyl phthalate in the rat. Food Cosmet. Toxicol. 16: 415-422 http://inchem.org/documents/cicads/cicads/cicad52.htm http://www.rivm.nl/en/ US Agency for Toxic Substances and Disease Registry (ATSDR) Toxicological Profiles and Minimal Risk levels n/a n/a n/a n/a http://www.atsdr.cdc.gov/toxprofiles/tp73.html acute rat study 2 day study, rats received 2,000 mg/kg bw/d DEP for 2 days by gavage Leydig cell ultra structural changes Jones et al 1993 http://www.atsdr.cdc.gov/toxprofiles/tp73.html male rat study peroxisomal proliferation, slightly elevated liver weight, changes in hepatic enzyme activities Moody and Reddy 1978 http://www.atsdr.cdc.gov/toxprofiles/tp73.html USEPA Integrated Risk Information System (IRIS) Rat, Subchronic Oral Feeding Study. Brown et al, 1978 Groups of CD rats (15/sex) were fed diets Decreased growth rate, food consumption Brown, D., K.R. Butterworth, I.F. Gaunt, P. Grasso and S.D. Gangolli. 1978. containing 0, 0.2, 1.0, or 5.0% DEP for 16 weeks and altered organ weights Short-term oral toxicity study of diethyl phthalate in the rat. Food Cosmet. Toxicol. 16: 415-422 http://epa.gov/iris/ EC Scientific Committee for Food Not Provided Not Provided Not Provided Not Provided http://archive.food.gov.uk/maff/archive/food/infsheet/1996/no82/82phth al.htm (Page 2 of 4) (EIC proforma diethyl phthalate.xls 26/08/2009)
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: www.esdat.net Esdat Environmental D
Page 227: www.esdat.net Esdat Environmental D
Page 279 and 280:
Page 281 and 282:
Page 283 and 284:
Page 285 and 286:
Page 287 and 288:
Page 289 and 290:
Page 291 and 292:
Page 293 and 294:
Page 295 and 296:
Page 297 and 298:
Page 299 and 300:
Page 301 and 302:
Page 303 and 304:
Page 305 and 306:
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?