Testing Information

Testing Status of Agents at NTP

Di(2-ethylhexyl) phthalate

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http://ntp.niehs.nih.gov/go/TS-10188-J

CASRN: 117-81-7

Related: CAS 103-23-1

Formula: C24-H38-O4

Synonyms/Common Names:

  • 1,2-Benzenedicarboxylic acid, bis(2-ethylhexyl)ester (9CI)
  • 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).

Nomination Background

Planned Carcinogenicity/Toxicity

  • Perinatal Bioassay (Dosed-Feed) Selected (C10188)  
    • Rats: Harlan Sprague-Dawley
  • 2 years (Dosed-Feed) Selected (C10188B)  
    • Rats: Harlan Sprague-Dawley

Short-Term Toxicity

  • 14-Day (IV Injection and Oral)  (C20526) On Test 
    • Monkey: Rhesus; Monkey: Rhesus; Monkey: Rhesus; 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 
    • NTIS No. PB82-184011  (Peer Review 10/15/1980)
      Citation: Carcinogenesis Bioassay of Di(2-ethylhexyl)phthalate (CAS No. 117-81-7) in F344 Rats and B6C3F1 Mice (Feed Studies)
    • Rats: F344/N; Mice: B6C3F1
  • 13-Week (Dosed-Feed)  (C52733A) Completed 
    • NTIS No. PB82-184011  (Peer Review 10/15/1980)
      Citation: Carcinogenesis Bioassay of Di(2-ethylhexyl)phthalate (CAS No. 117-81-7) in F344 Rats and B6C3F1 Mice (Feed Studies)
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R: 0,1600,25000, M: 0,800,12500 PPM/10 PER GROUP

Long-Term Carcinogenicity

  • 2-Year (Dosed-Feed)  (C52733A) Report Complete 
    • TR-217 (NTIS No. PB82-184011)  (Peer Review 10/15/1980)
      Carcinogenesis Bioassay of Di(2-ethylhexyl)phthalate (CAS No. 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 
    • M Rats: F344/N
  • Mechanisms (Gavage)  (S0678) Completed 
    • Citation: ALBRO, ET. AL., PHARMACOKINTICS, INTERACTIONS WITH MACROMOLECULES & SPECIES DIFFERENCES IN METABOLISM OF DEHP, ENVIR HLTH PERSPEC 45:19-25, 1982
    • Rats: F344/N; Rats: Sprague Dawley
    • Dose: 1.8, 18.0, 180.0 mg/kg
  • Toxicokinetic Study Selected (K10188)  
    • Rats: Sprague Dawley
  • Toxicokinetic Study (Gavage; Intravenous) Selected (S0974)  
    • M 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
    • Chromosome Aberation  Negative (Nonstandard Protocol) 
  • In Vitro Cytogenetics (CA/SCE)  (008270) Completed 
    • Chromosome Aberation Not Tested 
    • Sister Chromatid Exchange Positive 
  • In Vitro Cytogenetics (CA/SCE)  (426348) Completed 
    • Chromosome Aberation Not Tested 
    • Sister Chromatid Exchange Weakly Positive 
  • In Vitro Cytogenetics (CA/SCE)  (515010) Completed 
    • Chromosome Aberation Not Tested 
    • Sister Chromatid Exchange Positive 
  • 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
    • Chromosome Aberation Not Tested 
    • Sister Chromatid Exchange Inconclusive 
  • In Vitro Cytogenetics (CA/SCE)  (594940) Completed 
    • Chromosome Aberation Weakly Positive 
    • Sister Chromatid Exchange Negative 
  • In Vitro Cytogenetics (CA/SCE)  (759843) Completed 
    • Chromosome Aberation Negative 
    • Sister Chromatid Exchange 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
    • Chromosome Aberation Not Tested 
    • Sister Chromatid Exchange Inconclusive 
  • 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
    • Chromosome Aberation Negative 
    • Sister Chromatid Exchange Positive 
  • 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
    • Chromosome Aberation Not Tested 
    • Sister Chromatid Exchange Inconclusive 
  • 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 
  • 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
    •  Negative 
  • Micronucleus  (A04384) Completed 
    • Mice: Tg.AC (FVB/N) Homozygous
    • Male Inconclusive 
    • Female Positive 
  • Micronucleus  (A15851) Completed 
    • Mice: Tg.AC (FVB/N) Homozygous
    • Male Negative 
    • Female Negative 
  • Micronucleus  (A15927) Completed 
    • Mice: B6C3F1
    • Female Inconclusive 
  • 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 D MINIMUM Continuous Breeding (Dosed-Feed)  (RACB82119) Completed 
    • NTIS No. PB84-181734
      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%
  • GD 0-20 Continuous Breeding (Dosed-Feed)  (RACB84118) Completed 
    • NTIS No. PB87-119046
      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
  • 3 GENERATIONS Continuous Breeding (Dosed-Feed)  (RACB98004) Completed 
    • NTIS No. PB2004-104000
      Citation: Diethylhexylphthalate Multigenerational Reproductive Assessment by Continuous Breeding When Administered to Sprague Dawley Rats in the Diet
    • M/F Rats: Sprague Dawley
    • Dose: CONTROL (4), 10, 30, 100, 300, 1000, OR 10,000 PPM
  • GD 0-17 Continuous Breeding (Dosed-Feed)  (T0086E) Completed 
    • NTIS No. PB88-204300
      Citation: Reproduction and Fertility Evaluation of Diethylhexyl Phthalate in CD-1 Mice Exposed During Gestation
    • F Mice: Swiss
    • Dose: 0%, 0.010%, 0.025%, 0.050%
  • GD 7-14 Short-Term in vivo Repro. Tox. (Gavage)  (T0086F) Completed 
    • NTIS No. PB85-220143
      Citation: Screening of Priority Chemicals for Potential Reproductive Hazard
    • F Mice: Swiss
    • Dose: 9860 MG(10ML UNDILUTED)/KG BODY WT
  • GD 0-20 Conventional Teratology (Dosed-Feed)  (TER84063) Completed 
    • NTIS No. PB85-105658
      Citation: Teratologic Evaluation of Diethylhexyl Phthalate (CAS No. 117-81-7) in Fischer 344 Rats
    • F Rats: F344/N
    • Rats Maternal Positive 
    • Rats Fetal Positive 
    • Dose: 0.5, 1.0, 1.5, 2.0 %
  • GD 0-17 Conventional Teratology (Dosed-Feed)  (TER84064) Completed 
    • NTIS No. PB85-105674
      Citation: Teratologic Evaluation of Diethylhexyl Phthalate (CAS No. 117-81-7) in CD-1 Mice
    • F Mice: Swiss
    • Mice Maternal Positive 
    • Mice Fetal Positive 
    • Dose: 0.025, 0.05, 0.10, 0.15 %

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