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Testing Status of Di(2-ethylhexyl) Phthalate 10188-J

 

CASRN: 117-81-7

Formula: C24-H38-O4

Synonyms/Common Names

  • 1,2-Benzenedicarboxylic acid, bis(2-ethylhexyl) ester
  • Bis(2-ethylhexyl) phthalate
  • DEHP
  • Diethylhexyl phthalate

Short-Term Toxicity

  • 4 days (Gavage)  (C10188C)  Completed 
    • Liver Targeted Testing study of Toxcast Chemicals
    • Rats: Harlan Sprague-Dawley
    • Dose: MR: 0, 600 mg/kg/day.
  • 5 days (Gavage)  (C10188D)  Data in Review 
    • 5-Day Transcriptomic Dose-Response Studies
    • Rats: Harlan Sprague-Dawley
    • Dose: MR: 0, 8, 16, 31.25, 62.5, 125, 250, 500, or 1000 mg/kg; N=4.
  • 14 days (IV Injection and Oral)  (C20526)  Completed 
    • Monkeys: Rhesus
    • Dose: 5 mg/kg D4-DEHP in 10% intralipid -- IV: 1, 5, or 9 weeks; oral: 10 weeks of age.
  • 14-Day (Dosed-Feed)  (C52733A)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R&M: 0, 6300, 12,500, 25,000, 50,000, 100,000 ppm. 5 per group.
  • 13-Week (Dosed-Feed)  (C52733A)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R: 0, 1600, 25,000 ppm. M: 0, 800, 12500 ppm. 10 per group.

Long-Term Carcinogenicity

  • Perinatal + 2 years (Dosed-Feed)  (C10188)  Completed 
    • TR-601 
      Toxicology and Carcinogenesis Studies of Di(2-ethylhexyl) Phthalate (CASRN 117-81-7) Administered in Feed to Sprague Dawley (Hsd:Sprague Dawley SD) Rats
    • Rats: Harlan Sprague-Dawley
    • Carcinogenesis Results
      • Male Rats Clear Evidence 
      • Female Rats Clear Evidence 
    • Dose: R: 0, 300, 1000, 3000, or 10,000 ppm; 50/sex/group.
  • 2 years (Dosed-Feed)  (C10188B)  Completed 
    • TR-601 
      Toxicology and Carcinogenesis Studies of Di(2-ethylhexyl) Phthalate (CASRN 117-81-7) Administered in Feed to Sprague Dawley (Hsd:Sprague Dawley SD) Rats
    • Rats: Harlan Sprague-Dawley
    • Carcinogenesis Results
      • Male Rats Clear Evidence 
      • Female Rats Clear Evidence 
    • Dose: R: 0, 300, 1000, 3000, or 10,000 ppm; 50/sex/group.
  • 2-Year (Dosed-Feed)  (C52733A)  Completed 
    • TR-217 (NIH Number: 82-1773)  (Peer Review Approval 10/15/1980A )
      Carcinogenesis Bioassay of Di(2-ethylhexyl)phthalate (CASRN 117-81-7) in F344 Rats and B6C3F1 Mice (Feed Studies)
    • Rats: F344/N; Mice: B6C3F1
    • Carcinogenesis Results
      • Male Rats Positive 
      • Female Rats Positive 
      • Male Mice Positive 
      • Female Mice Positive 
    • Dose: R: 0, 6000, 12,000 ppm. M: 0, 3000, 6000 ppm. 50 per group.

Special Studies

  • Absorption Disposition Metabolism Elimination (Topical Application)  (S0054)  Completed 
    • Male Rats: F344/N
  • Mechanisms (Gavage)  (S0678)  Completed 
    • Citation: Albro PW, Corbett JT, Schroeder JL, Jordan S, Matthews HB. Pharmacokinetics, interactions with macromolecules and species differences in metabolism of DEHP. Environ Health Perspect. 1982 Nov;45:19-25.Pubmed Abstract
    • Rats: F344/N; Rats: Sprague Dawley
    • Dose: 1.8, 18.0, 180.0 mg/kg.
  • Toxicokinetic Study (Gavage; Intravenous)  (S0974)  Completed 
    • Male Monkeys: Rhesus
    • Dose: 5 mg/kg bwt D4-DEHP. 5 mg/kg bwt D4-DEHP [2 ml/kg of a 2.5 mg/ml dosing solution].

Genetic Toxicology

  • Chromosome Aberrations  (A15927)  Completed 
    • Mice
    •  Negative (Nonstandard Protocol) 
  • 4 days Comet Assay (Gavage)  (G10188)  Completed 
    • Rats: Sprague Dawley
  • Drosophila  (507426)  Completed 
    • Citation: Zimmering, S., Mason, J.M., and Valencia, R. Chemical mutagenesis testing in Drosophila. VII. Results of 22 coded compounds tested in larval feeding experiments. Environ. Molec. Mutagen. Vol. 14 (1989) 245-252
    • Reciprocal Translocation/Sex-Linked Recessive Lethal Negative 
  • Drosophila  (967176)  Completed 
    • Citation: Yoon, J.S., Mason, J.M., Valencia, R., Woodruff, R.C., and Zimmering, S. Chemical mutagenesis testing in Drosophila: IV. Results of 45 coded compounds tested for the National Toxicology Program. Environ. Mutagen. Vol. 7 (1985) 349-367
    • Reciprocal Translocation/Sex-Linked Recessive Lethal Negative 
  • In Vitro Cytogenetics (CA/SCE)  (008270)  Completed 
    • Sister Chromatid Exchange Positive 
    • Chromosome Aberrations Not Tested 
  • In Vitro Cytogenetics (CA/SCE)  (426348)  Completed 
    • Sister Chromatid Exchange Weakly Positive 
    • Chromosome Aberrations Not Tested 
  • In Vitro Cytogenetics (CA/SCE)  (515010)  Completed 
    • Sister Chromatid Exchange Positive 
    • Chromosome Aberrations Not Tested 
  • In Vitro Cytogenetics (CA/SCE)  (587571)  Completed 
    • Citation: Gulati, D., Witt, K., Anderson, B., Zeiger, E.,and Shelby, M. Chromosome aberration and sister chromatid exchange test in Chinese hamster ovary cells in vitro III: Results with 27 chemicals Environ. Molec. Mutagen. Vol. 13 (1989) 133-193
    • Sister Chromatid Exchange Equivocal 
    • Chromosome Aberrations Not Tested 
  • In Vitro Cytogenetics (CA/SCE)  (594940)  Completed 
    • Sister Chromatid Exchange Negative 
    • Chromosome Aberrations Weakly Positive 
  • In Vitro Cytogenetics (CA/SCE)  (759843)  Completed 
    • Sister Chromatid Exchange Negative 
    • Chromosome Aberrations Negative 
  • In Vitro Cytogenetics (CA/SCE)  (890544)  Completed 
    • Citation: Gulati, D., Witt, K., Anderson, B., Zeiger, E.,and Shelby, M. Chromosome aberration and sister chromatid exchange test in Chinese hamster ovary cells in vitro III: Results with 27 chemicals Environ. Molec. Mutagen. Vol. 13 (1989) 133-193
    • Sister Chromatid Exchange Equivocal 
    • Chromosome Aberrations Not Tested 
  • In Vitro Cytogenetics (CA/SCE)  (923560)  Completed 
    • Citation: Gulati, D., Sabharwal, P., and Shelby, M. Tests for the induction of chromosomal aberrations and sister chromatid exchanges in cultured Chinese hamster ovary (CHO) cells. In Evaluation of Short-Term Tests for Carcinogens, Elsevier/North Holland 413-426
    • Citation: Gulati, D., Witt, K., Anderson, B., Zeiger, E.,and Shelby, M. Chromosome aberration and sister chromatid exchange test in Chinese hamster ovary cells in vitro III: Results with 27 chemicals Environ. Molec. Mutagen. Vol. 13 (1989) 133-193
    • Sister Chromatid Exchange Positive 
    • Chromosome Aberrations Negative 
  • In Vitro Cytogenetics (CA/SCE)  (978423)  Completed 
    • Citation: Gulati, D., Witt, K., Anderson, B., Zeiger, E.,and Shelby, M. Chromosome aberration and sister chromatid exchange test in Chinese hamster ovary cells in vitro III: Results with 27 chemicals Environ. Molec. Mutagen. Vol. 13 (1989) 133-193
    • Sister Chromatid Exchange Equivocal 
    • Chromosome Aberrations Not Tested 
  • Micronucleus  (A04384)  Completed 
    • Mice: Tg.AC (FVB/N) Homozygous
    • Male Equivocal 
    • Female Positive 
  • Micronucleus  (A15851)  Completed 
    • Mice: Tg.AC (FVB/N) Homozygous
    • Male Negative 
    • Female Negative 
  • Micronucleus  (A15927)  Completed 
    • Mice: B6C3F1
    • Female Equivocal 
  • Mouse Lymphoma  (913224)  Completed 
    • Citation: Myhr, B., Bower, L., and Caspary, W. Assays for the induction of gene mutations at the thymine kinase locus in L1578Y mouse lymphoma cells in culture. In Evaluation of Short-Term Tests for Carcinogens, Elsevier/North Holland Vol. (1985) 555-568
    • Mice
    •  Negative 
  • Salmonella  (064176)  Completed 
    • Citation: Zeiger, E., Haworth, S., Mortelmans, K., and Speck, W. Mutagenicity testing of Di(2-ethylhexyl)phthalate and related chemicals in Salmonella Environ. Mutagen. Vol. 7 (1985) 213-232
    •  Negative 
  • Salmonella  (195347)  Completed 
    • Citation: Zeiger, E., Haworth, S., Mortelmans, K., and Speck, W. Mutagenicity testing of Di(2-ethylhexyl)phthalate and related chemicals in Salmonella Environ. Mutagen. Vol. 7 (1985) 213-232
    •  Negative 
  • Salmonella  (483211)  Completed 
    • Citation: Zeiger, E., Haworth, S., Mortelmans, K., and Speck, W. Mutagenicity testing of Di(2-ethylhexyl)phthalate and related chemicals in Salmonella Environ. Mutagen. Vol. 7 (1985) 213-232
    •  Negative 
  • Salmonella  (894518)  Completed 
    • Citation: Zeiger, E., and Haworth, S. Tests with a preincubation modification of the Salmonella/microsome assay. In Evaluation of Short-Term Tests for Carcinogens Elsevier/North Holland 187-199
    •  Negative 
  • Salmonella  (960176)  Completed 
    • Citation: Zeiger, E., Haworth, S., Mortelmans, K., and Speck, W. Mutagenicity testing of Di(2-ethylhexyl)phthalate and related chemicals in Salmonella Environ. Mutagen. Vol. 7 (1985) 213-232
    •  Negative 
  • Salmonella  (965968)  Completed 
    •  Negative 

Organ Systems Toxicity

  • 120 day minimum Continuous Breeding (Legacy) (Dosed-Feed)  (RACB82119)  Completed 
    • Citation: Lamb JC 4th, Chapin RE, Teague J, Lawton AD, Reel JR. Reproductive effects of four phthalic acid esters in the mouse. Toxicol Appl Pharmacol. 1987 Apr;88(2):255-69. doi: https://doi.org/10.1016/0041-008x(87)90011-1.
    • Mice: Swiss CD-1
    • Dose: [Task 1] 0, .01, .025, .05%. [Task 2] 0, .01, .025, .05%. [Task 3] 0, .01, .025, .05%. [Task 4] 0, .05%.
  • 0 to 20 GD Continuous Breeding (Legacy) (Dosed-Feed)  (RACB84118)  Completed 
    • Rats: F344/N
    • Dose: [Task 1] 0, .25, .5, 1.0%. [Task 2] 0, .25, .5, 1.0%. [Task 3] 0, .25, .5, 1.0%. [Task 4] N/A.
  • 3rd generation Continuous Breeding (Legacy) (Dosed-Feed)  (RACB98004)  Completed 
    • Citation: Blystone CR, Kissling GE, Bishop JB, Chapin RE, Wolfe GW, Foster PM. Determination of the di-(2-ethylhexyl) phthalate NOAEL for reproductive development in the rat: importance of the retention of extra animals to adulthood. Toxicol Sci. 2010 Aug;116(2):640-6. doi: https://doi.org/10.1093/toxsci/kfq147. Epub 2010 May 19.
    • Citation: National Toxicology Program (NTP). 2005. Diethylhexylphthalate (CASRN 117-81-7): Multigenerational reproductive assessment by continuous breeding when administered to Sprague-Dawley rats in the diet. Research Triangle Park, NC: National Toxicology Program. RACB Report 98004. https://ntp.niehs.nih.gov/go/racb98004abs
    • Male and Female Rats: Sprague Dawley
    • Dose: [Control] (1.5), 10, 30, 100, 300, 1000, 7500, OR 10,000 ppm.
  • 1 to 17 GD Continuous Breeding (Legacy) (Dosed-Feed)  (T0086E)  Completed 
    • Female Mice: Swiss
    • Dose: 0%, 0.010%, 0.025%, 0.050%.
  • 0 to 20 GD Conventional Teratology (Dosed-Feed)  (TER84063)  Completed 
    • Female Rats: F344/N
    • Rats Maternal Positive 
    • Rats Fetal Positive 
    • Dose: 0.5, 1.0, 1.5, 2.0 %.
  • 1 to 17 GD Conventional Teratology (Dosed-Feed)  (TER84064)  Completed 
    • Female Mice: Swiss
    • Mice Maternal Positive 
    • Mice Fetal Positive 
    • Dose: 0.025, 0.05, 0.10, 0.15 %.
  • 7 to 14 GD Short-Term in vivo Repro. Tox. (Gavage)  (T0086F)  Completed 
    • Citation: Screening of Priority Chemicals for Potential Reproductive Hazard
    • Female Mice: Swiss
    • Dose: 9860 mg (10 ml undiluted)/kg body wt.
  • Utero-Lactational (Gavage)  (R10188)   
    • Mice: B6C3F1
  • Utero-Lactational (Gavage)  (R10188)  Completed 
    • Mice: NIH Swiss

Toxicogenomics

  • 4 days Microarray Analysis (Gavage)  (T10188)  Completed 
    • Liver Targeted Testing study of Toxcast Chemicals
    • Rats: Harlan Sprague-Dawley
    • Dose: not provided; 6 rats.
  • 5 days Transcriptome Sequencing (Gavage)  (T10188B)  Data in Review 
    • 5-Day Transcriptomic Dose-Response Studies
    • Rats: Harlan Sprague-Dawley