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

Known Uses

Plasticizer added to vacuum pump fluid, PVC polymers, elastomers, rubber & resins, agaricide used in orchards, inert ingredient in pesticide formulations, in dielectric fluids, photographic film, adhesives, cosmetics, detergents (HSDB 1990). The most commonly used plasticizer for polyvinylchloride polymers. Associated with tobacco: reported either as a natural component of tobacco, pyrolysis product (in tobacco smoke), or additive for one or more types of tobacco products.

Chemical Properties

Toxicity Effects (HSDB)

Short-Term Toxicity

  • 4 days (Gavage)  (C10188C)  Completed 
    • Liver Targeted Testing study of Toxcast Chemicals
    • Rats: Harlan Sprague-Dawley
    • Dose: Male rats: 0, 600 mg/kg/day.
  • 5 days (Gavage)  (C10188D)  On Test 
    • 5-Day Transcriptomic Dose-Response Studies
    • Rats: Harlan Sprague-Dawley
    • Dose: Male rats: 0, 8, 16, 31.25, 62.5, 125, 250, 500, or 1000 mg/kg; N=4.
  • 14 days (IV Injection and Oral)  (C20526)  Completed 
    • Monkey: 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
  • 13-Week (Dosed-Feed)  (C52733A)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R: 0, 1600, 25000, M: 0, 800, 12500 PPM/10 PER GROUP.

Long-Term Carcinogenicity

  • 2 years (Dosed-Feed)  (C10188B)  Histopath in progress 
    • Rats: Harlan Sprague-Dawley
    • Dose: R: 0, 300, 1000, 3000, or 10, 000 ppm; 50/sex/group.
  • Perinatal + 2 years (Dosed-Feed)  (C10188)  Histopath in progress 
    • Rats: Harlan Sprague-Dawley
    • Dose: R: 0, 300, 1000, 3000, or 10, 000 ppm; 50/sex/group.
  • 2-Year (Dosed-Feed)  (C52733A)  Report Complete 
    • 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, 12000, 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 Monkey: 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) 
  • 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 
  • 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 
  • (G10188)  On Test 
    • 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 
    • 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 
    • 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: Final Report - Diethylhexyl Phthalate (DEHP) : Reproduction and Fertility Assessment in CD-1 Mice When Administered in the Feed
      • 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 
      • Citation: Final Report - Reproduction and Fertility Evaluation of Diethyhexyl Pthalate
      • 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: Diethylhexylphthalate Multigenerational Reproductive Assessment by Continuous Breeding When Administered to Sprague Dawley Rats in the Diet
      • Male and Female Rats: Sprague Dawley
      • Dose: CONTROL (4), 10, 30, 100, 300, 1000, OR 10, 000 PPM.
    • 1 to 17 GD Continuous Breeding (Legacy) (Dosed-Feed)  (T0086E)  Completed 
      • Citation: Reproduction and Fertility Evaluation of Diethylhexyl Phthalate in CD-1 Mice Exposed During Gestation
      • Female Mice: Swiss
      • Dose: 0%, 0.010%, 0.025%, 0.050%.
    • 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(10ML UNDILUTED)/KG BODY WT.
    • 0 to 20 GD Conventional Teratology (Dosed-Feed)  (TER84063)  Completed 
      • Citation: Teratologic Evaluation of Diethylhexyl Phthalate (CASRN 117-81-7) in Fischer 344 Rats
      • 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 
      • Citation: Teratologic Evaluation of Diethylhexyl Phthalate (CASRN 117-81-7) in CD-1 Mice
      • Female Mice: Swiss
      • Mice Maternal Positive 
      • Mice Fetal Positive 
      • Dose: 0.025, 0.05, 0.10, 0.15 %.
    • Utero-Lactational (Gavage)  (R10188)  Completed 
      • Mice: B6C3F1
    • Utero-Lactational (Gavage)  (R10188)  Completed 
      • Mice: NIH Swiss

    Toxicogenomics

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