Skip to Main Navigation
Skip to Page Content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Testing Status of Dibutyl Phthalate 10987-X

 

CASRN: 84-74-2

Formula: C16-H22-O4

Synonyms/Common Names

  • 1,2-Benzenedicarboxylic acid, dibutyl ester
  • DBP
  • Di-n-butyl phthalate

Short-Term Toxicity

  • perinatal (Dosed-Feed)  (C62022)  Completed 
    • TOX-30 (NIH Number: 95-3353)
      Toxicity Studies of Dibutyl Phthalate Administered in Feed to F344/N Rats and B6C3F1 Mice
    • Rats: F344/N; Mice: B6C3F1
  • post-wean (Dosed-Feed)  (C62022)  Completed 
    • TOX-30 (NIH Number: 95-3353)  (Tox Peer Review 08/00/1994A )
      Toxicity Studies of Dibutyl Phthalate Administered in Feed to F344/N Rats and B6C3F1 Mice
    • Rats: F344/N
    • Dose: IN UTERO WITH F344 RATS; SEE C62022B.
  • 13 weeks (Dosed-Feed)  (C62022B)  Completed 
    • TOX-30 (NIH Number: 95-3353)  (Tox Peer Review 08/00/1994A )
      Toxicity Studies of Dibutyl Phthalate Administered in Feed to F344/N Rats and B6C3F1 Mice
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R: 0, 2500, 5000, 10000, 20000, OR 40000 PPM R: 0, 1250, 2500, 5000, 10000, 20000 PPM (10/S/S).

Long-Term Carcinogenicity

  • 2 years (Dosed-Feed)  (C10987)  Completed 
    • TR-600 
      Toxicology and Carcinogenesis Studies of Di-n-butyl Phthalate (CASRN 84-74-2) Administered in Feed to Sprague Dawley(Hsd:Sprague Dawley SD) Rats and B6C3F1/N Mice
    • Rats: Harlan Sprague-Dawley; Mice: B6C3F1
    • Carcinogenesis Results
      • Male Rats Equivocal Evidence 
      • Female Rats No Evidence 
      • Male Mice No Evidence 
      • Female Mice No Evidence 
    • Dose: R: 0, 300, 1000, 3000, or 10,000 ppm; M: 0, 1000, 3000, or 10,000 ppm; 50/sex/species/group.

Special Studies

  • Absorption Distribution Metabolism Excretion (Topical Application)  (S0045)  Completed 
    • Rats
  • Toxicokinetic Study (Gavage; Intravenous; Gavage; Intravenous; Gavage; Intravenous)  (S0545)  Completed 
    • Male Rats: Sprague Dawley; Male Mice: B6C3F1; Male Hamsters: Syrian Golden
    • Dose: PRELM MOUSE IV:40, 32 MG/KG; PO:166, 2320, 133 MG/KG. PRELM RAT IV:10, 8 MG/KG; PO:42.9, 857.1, 34 MG/KG. PRELIM HAMSTER IV:20 MG/KG; PO:66.67, 1333 MG/KG. FEED STUDIES ALL SPECIES: 1000 & 20000 PPM. SA MOUSE IV: 30 MG/KG; PO:83, 166, 332 MG/KG. SA RAT IV:20 MG/KG PO:20, 60, 200 MG/KG. SA HAMSTER IV:20 MG/KG; PO:67, 135, 270 MG/KG..
  • Toxicokinetic Study (Dosed-Feed)  (S0580)  Completed 
    • Male Rats: Sprague Dawley; Male Mice: B6C3F1; Male Hamsters: Syrian Golden
    • Dose: 100, 2500, 5000, 10,000 or 20,000 ppm, 14d. 1000, 2500, 5000, 10,000, 20,000 ppm, 90d [R,M].

Genetic Toxicology

  • Micronucleus  (A17278)  Completed 
    • Mice: B6C3F1
    • Male Negative 
    • Female Negative 
  • Mouse Lymphoma  (800748)  Completed 
    • Mice
    •  Positive 
  • Salmonella  (077089)  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 

Organ Systems Toxicity

  • Continuous Breeding (Legacy) (Gavage)  (RACB20107A)  Completed 
    • Male and Female Rats: SD & Wistar
    • Dose: 600 MG/KG/DAY.
  • continuous exposure, 120 day minimum Continuous Breeding (Legacy) (Dosed-Feed)  (RACB83084)  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.
    • Citation: National Toxicology Program (NTP). 1984. Di(n-butyl) phthalate (CASRN 84-74-2): Reproduction and fertility assessment in CD-1 mice when administered in the feed. Research Triangle Park, NC: National Toxicology Program. RACB Report 83084. https://ntp.niehs.nih.gov/go/racb83084abs
    • Male and Female Mice: Swiss
    • Dose: N/A; 0, .03, .3, or 1.0%; N/A; N/A.
  • greater than 120 days Continuous Breeding (Legacy) (Dosed-Feed)  (RACB89012)  Completed 
    • Citation: National Toxicology Program (NTP). 1991. Reproductive toxicity of di-n-butyl phthalate (CASRN 84-74-2) in Sprague-Dawley rats. Research Triangle Park, NC: National Toxicology Program. RACB Report 89012. https://ntp.niehs.nih.gov/go/racb89012abs
    • Citation: Wine RN, Li LH, Barnes LH, Gulati DK, Chapin RE. Reproductive toxicity of di-n-butylphthalate in a continuous breeding protocol in Sprague-Dawley rats. Environ Health Perspect. 1997 Jan;105(1):102-7. doi: https://doi.org/10.1289/ehp.97105102.
    • Male and Female Rats: Sprague Dawley
    • Dose: 0.1, 0.5, 1.0, 1.5, 2.0%; 0, .1, .5, 1.0%; 0, 1%; 0, .1, .5, 1.0%.
  • Continuous Breeding (Legacy) (Dosed-Feed)  (RACB97003)  Completed 
    • Male and Female Rats: Sprague Dawley
    • Dose: 0, 4, 10, 30, 100, 1000, OR 10,000 ppm.
  • 7 to 14 GD Short-Term in vivo Repro. Tox. (Gavage)  (T0035A)  Completed 
    • Citation: Screening of Priority Chemicals for Potential Reproductive Hazard
    • Female Mice: Swiss
    • Dose: 2500 mg/kg body wt.
  • Utero-Lactational (Gavage)  (R10987B)  Completed 
    • Rats: F344/N