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 Butyl benzyl phthalate CAS Number: 85-68-7 Assessor A: N Struggles, AECOM Assessor B: Atkins Final review: Panel/SF Date 01/06/2009 Date 17/06/2009 Date 26/08/2009 Apply TDIoral to exposure routes Apply IDoral to exposure routes Apply TDIinh to exposure routes Apply IDinh to exposure routes Oral Inhalation Dermal Yes Yes Yes No No No No No No No No No Combine Oral and Inhalation TDIs Yes Justification Insufficient data to assess non threshold effects - so HCV based on threshold effects Insufficient data to assess non threshold effects - so HCV based on threshold effects. Route to route extrapolation from oral HCV TDI oral Recommended TDIoral Units 500 ug.kg-1.d-1 Justification EFSA and Dutch RIVM most recent studies and report same value. Organisation Web Link Last Updated Date Web Checked Health criteria type Value Initial Units CLEA units ug.kg- Confidence rating Basis Value Units UF UF description Study type 1.d-1 European Food Safety Authority (EFSA) http://www.efsa.europa.eu/en.html No data 01/06/2009 TDI 0.5 mg/kg bw/day 500 n/a NOAEL 50 mg/kg bw/day 100 10 each for inter and intraspecies differences (EFSA) Rat, oral IPCS concise International Chemical Assessment Documents (CICADs) http://inchem.org/pages/cicads.html 01/01/1999 01/06/2009 TDI oral 1.3 mg.kgbw-1.d-1 1300 Medium Benchmark Dose 132 mg.kgbw-1.d-1 100 Inter and Intra species variation Subchronic Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels. http://www.rivm.nl/en/ 01/03/2001 01/06/2009 TDI oral 500 ug.kgbw-1.d-1 500 Medium NOAEL 151 mg.kg-1.d-1 300 Inter and Intra species variation Subchronic Health Canada Toxicological Values http://www.hc-sc.gc.ca/index_e.html 25/03/2009 Benchmark Dose 1.3 mg/kg bw/day 1300 Moderate to high lower 95th confidence interval of Benchmark Dose 132 mg/kg bw/day 100 Inter and intraspecies variations (10 each) (Health Canada) Subchronic USEPA Integrated Risk Information System (IRIS) http://epa.gov/iris/ 01/02/1993 01/06/2009 RfD 0.2 mg.kg-1.d-1 200 Medium NOAEL 159 mg.kg-1.d-1 1000 10 for intraspecies sensitivity, 10 for interspecies variability and 10 for extrapolating from subchronic to chronic NOAEL. Repeat dose study US EPA Provisional Peer Reviewed Toxicity Values (PPRTV) http://rais.ornl.gov/tox/unauthorized.shtml 01/10/2002 n/a Provisional Oral Slope Factor 0.0019 mg/kg-day n/a n/a n/a n/a n/a n/a n/a Rat, oral TDI inhal Recommended TDIinhal Units Justification Insufficient data with sufficient detail on derivation to derive a TDIinhal. Use route-to-route extrapolation from oral. Organisation Web Link Last Updated Date Web Checked Health criteria type Value Initial Units CLEA units ug.kg- Confidence rating Basis Value Units UF UF description Study type 1.d-1 IPCS concise International Chemical Assessment Documents (CICADs) http://inchem.org/pages/cicads.html 1999 25/03/2009 none 51 mg/m3 Rat, inhalation Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels http://www.rivm.nl/en/ 01/03/2001 01/06/2009 Due to low volatility of BBP inhalation exposure is considered not relevant Page 1 of 4 EIC proforma butyl benzyl phthalate.xls 26/08/2009
www.esdat.net Esdat Environmental Database Management Software +61 2 8875 7948 Butyl benzyl phthalate TDI oral Organisation Description Target organ/Critical Effect Reference Web link European Food Safety Authority (EFSA) IPCS concise International Chemical Assessment Documents (CICADs) multigenerational reproductive and developmental study Hammond et al. 1987 3 month dietary study of male Wistar rats reduced anogenital distance (AGD) in F1 (1st generation) and F2 at birth (2nd generation) rats. The EFSA Journal (2005) 241. Butylbenzylphthalate in food contact materials Pancreatic lesions Concise International Chemical Assessment Document 17 1999 BUTYL BENZYL PHTHALATE http://www.efsa.europa.eu/cs/BlobServer/Scientific_Opinion/afc_op_ej24 1_bbp_en2.pdfssbinary=true http://inchem.org/documents/cicads/cicads/cicad17.htm#SectionNumber: 6.2 Dutch National Institute for Public Health and the Environment (RIVM) Maximum Permissible Risk (MPR) levels. 3 month study with rats effects on kidney weight Kidney; Testicular atrophy and urinary pH were noticed, NOAEL of 151 mg.kg- 1.d-1. NTP 1997 study marginal effects noticed on haemoglobin concentrations at 550 mg.kg-1.d-1 after 26 weeks. At higher dose levels testicular atrophy was found. NOAEL of 2800 ppm in the diet, which is 161 mg.kg-1.d-1. Baars et al. 2001 'Re-evaluation of human-toxicological maximum permissible risk levels' RIVM report 711701 025. http://www.rivm.nl/bibliotheek/rapporten/711701025.pdf Health Canada Toxicological Values Rat, oral study A 5% increase in the incidence of pancreatic lesions in male Wistar rats. Hammond, B.G., G.J. Levinskas, E.C. Robinson and F.R. Johannsen. 1987. A review of the subchronic toxicity of butyl benzyl phthalate. Toxicol. Ind. Health 3(2): 79-98. Cited in Health Canada, 2000. Canadian Environmental Protection Act. Priority substances list assessment report: Butylbenzylphthalate http://www.hc-sc.gc.ca/ewh-semt/alt_formats/hecs- sesc/pdf/pubs/contaminants/psl2- lsp2/butylbenzylphthalate/butylbenzylphthalate-eng.pdf USEPA Integrated Risk Information System (IRIS) NTP (1985) conducted a toxicity study in F344 rats in which 15 males/group were administered concentrations of either 0, 0.03, 0.09, 0.28, 0.83, or 2.5% BBP in the diet for 26 weeks Reduction in relative brain and liver weights USEPA IRIS http://www.epa.gov/ncea/iris/subst/0425.htm US EPA Provisional Peer Reviewed Toxicity Values (PPRTV) NTP (1997) study based on the increase in Pancreatic acinar cell adenoma and acinar Provisional Peer Reviewed Toxicity values for Butylbenzyl Phthalate (CASRN n/a pancreatic cancer in male F334 rats through a 2 year cell adenoma or carcinoma 85-68-7) Derivation of a Carcinogenicity Assessment. feeding study. Slope factor derived within the PPRTV using the proposed guidelines (U.S. EPA, 1996a, 1999). TDI inhal Organisation Description Response 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 Subchronic inhalation study in rats - endpoints examined were limited to organ weights and histopathology. Adverse effects on body weight gain and serum glucose. World Health Organization International Programme on Chemical Safety, 1999. Concise International Chemical Assessment Document 17: BUTYL BENZYL PHTHALATE Baars et al. 2001 'Re-evaluation of human-toxicological maximum permissible risk levels' RIVM report 711701 025. http://inchem.org/documents/cicads/cicads/cicad17.htm Page 2 of 4 EIC proforma butyl benzyl phthalate.xls 26/08/2009
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