Testing Status of Bisphenol A 10034-Y

 

CASRN: 80-05-7

Formula: C15-H16-O2

Synonyms/Common Names

  • BPA
  • 4,4'-(1-Methylethylidene)bisphenol

Known Uses

Intermediate for resins, flame retardants, & rubber chemicals, fungicide (HSDB 1990). An intermediate used in the manufacture of epoxy, polycarbonate, and polyester-styrene resins.

Chemical Properties

Toxicity Effects (HSDB)

Short-Term Toxicity

  • 4 days (Gavage)  (C10034B)  Completed 
    • Liver Targeted Testing study of Toxcast Chemicals
    • Rats: Harlan Sprague-Dawley
    • Dose: Male rats: 0, 450 mg/kg/day.
  • 14-Day (Dosed-Feed)  (C50635)  Completed 
    • Rats: F344/N; Mice: B6C3F1
  • 90 days (Gavage)  (C10034C)  Report Draft 
    • Citation: Churchwell MI, Camacho L, Vanlandingham MM, Twaddle NC, Sepehr E, Delclos KB, Fisher JW, Doerge DR. Comparison of life-stage-dependent internal dosimetry for bisphenol A, ethinyl estradiol, a reference estrogen, and endogenous estradiol to test an estrogenic mode of action in Sprague Dawley rats. Toxicol Sci. 2014 May;139(1):4-20. doi: 10.1093/toxsci/kfu021. Epub 2014 Feb 4.
    • Citation: Delclos KB, Camacho L, Lewis SM, Vanlandingham MM, Latendresse JR, Olson GR, Davis KJ, Patton RE, Gamboa da Costa G, Woodling KA, Bryant MS, Chidambaram M, Trbojevich R, Juliar BE, Felton RP, Thorn BT. Toxicity evaluation of bisphenol A administered by gavage to Sprague Dawley rats from gestation day 6 through postnatal day 90. Toxicol Sci. 2014 May;139(1):174-97. doi: 10.1093/toxsci/kfu022. Epub 2014 Feb 4.
    • Rats: Sprague Dawley (NCTR)
    • Dose: 0, 2.5, 8, 25, 80, 260, 840, 2700, 100,000, or 300,000 micrograms/kg bwt; 18-23 litters/group.
  • 13-Week (Dosed-Feed)  (C50635)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R: 0, 250, 4000, M: 0, 5000, 25000 PPM/10 PER GROUP.

Long-Term Carcinogenicity

  • 2-years (Gavage)  (C10034)  Histopath in progress 
    • Citation: Schug TT, Heindel JJ, Camacho L, Delclos KB, Howard P, Johnson AF, Aungst J, Keefe D, Newbold R, Walker NJ, Thomas Zoeller R, Bucher JR. A new approach to synergize academic and guideline-compliant research: the CLARITY-BPA research program. Reprod Toxicol. 2013 Sep;40:35-40. doi: 10.1016/j.reprotox.2013.05.010. Epub 2013 Jun 5.
    • Rats: Sprague Dawley (NCTR)
    • Dose: 0, 2.5, 25, 250, 2500, or 25000 ug/kg/bw/day.
  • 2-Year (Dosed-Feed)  (C50635)  Report Complete 
    • TR-215 (NIH Number: 82-1771)  (Peer Review Approval 10/15/1980A )
      Carcinogenesis Bioassay of Bisphenol A (CASRN 80-05-7) in F344 Rats and B6C3F1 Mice (Feed Study)
    • Rats: F344/N; Mice: B6C3F1
    • Carcinogenesis Results
      • Male Rats Equivocal 
      • Female Rats Equivocal 
      • Male Mice Equivocal 
      • Female Mice Negative 
    • Dose: R: 0, 1000, 2000, FM: 0, 5000, 10000, MM: 0, 1000, 5000 PPM/50 PER GROUP.

Special Studies

  • Absorption Disposition Metabolism Elimination (in-vitro)  (K10034)  Completed 
    • Citation: Camacho L, Basavarajappa MS, Chang CW, Han T, Kobets T, Koturbash I, Surratt G, Lewis SM, Vanlandingham MM, Fuscoe JC, Gamboa da Costa G, Pogribny IP, Delclos KB. Effects of oral exposure to bisphenol A on gene expression and global genomic DNA methylation in the prostate, female mammary gland, and uterus of NCTR Sprague-Dawley rats. Food Chem Toxicol. 2015 Jul;81:92-103. doi: 10.1016/j.fct.2015.04.009. Epub 2015 Apr 8.Pubmed Abstract
    • Male and Female Rats: Sprague Dawley (NCTR)
    • Dose: 0, 2.5, 8, 25, 80, 260, 840, 2700, 100000 and 300000 µg/kg bw/ day.
  • C. elegans  (W10034)  Completed 
    • C. elegans
    • Dose: Growth: 0, 50, 63, 79, 100, 130, 160, 200, 250, 320, 400, 500 uMFeed: 0, 450, 525, 600, 675, 750, 825, 900, 975, 1050, 1125, 1200uMRepro: 0, 50, 75, 150, 300, 450, 600, 750, 900, 1050, 1200, 1350 uM.

Genetic Toxicology

  • Chromosome Aberrations  (070061)  Completed 
    • Mice
    •  Positive (Nonstandard Protocol) 
  • Comet Assay (Gavage)  (G10034B)  On Test 
    • Rats: Harlan Sprague-Dawley
  • Comet Assay  (G10034)  On Test 
    • In Vitro Cytogenetics (CA/SCE)  (791721)  Completed 
      • Citation: Ivett, J.L., Brown, B.M., Rodgers, C., Anderson, B.E., Resnick, M.A., Zeiger, E. Chromosomal aberration and sister chromatid exchange tests in Chinese hamster ovary cells in vitro IV: Results for 15 chemicals Environ. Molec. Mutagen. Vol. 14 (1989) 165-187
      • Sister Chromatid Exchange Negative 
      • Chromosome Aberrations Negative 
    • Drosophila  (839656)  Completed 
      • Citation: Foureman, P., Mason, J.M., Valencia, R., Zimmering, S. Chemical Mutagenesis Testing in Drosophila. X. Results of 70 coded compounds tested for the National Toxicology Program. Environ. Molec. Mutagen. Vol. 23 (1994) 208-227
      • Reciprocal Translocation/Sex-Linked Recessive Lethal Negative 
    • Mouse Lymphoma  (831513)  Completed 
      • Citation: Myhr, B. and Caspary, W. Chemical mutagenesis at the TK locus in L5178Y mouse lymphoma cells. I. Results for 31 coded compounds in the National Toxicology Program. Environ. Molec. Mutagen. Vol. 18 (1991) 51-83
      • Mice
      •  Negative 
    • Micronucleus  (A24930)  Completed 
      • Rats: Fischer 344
      • Male Negative 
    • Salmonella  (121422)  Completed 
      • Citation: Haworth, S., Lawlor, T., Mortelmans, K., Speck, W., and Zeiger, E. Salmonella mutagenicity test results for 250 chemicals Environ. Mutagen. Vol. 5 (Suppl 1) (1983) 3-142
      •  Negative 
    • Salmonella  (441712)  Completed 
      • Citation: Haworth, S., Lawlor, T., Mortelmans, K., Speck, W., and Zeiger, E. Salmonella mutagenicity test results for 250 chemicals Environ. Mutagen. Vol. 5 (Suppl 1) (1983) 3-142
      •  Negative 
    • Salmonella  (680342)  Completed 
      • Citation: Haworth, S., Lawlor, T., Mortelmans, K., Speck, W., and Zeiger, E. Salmonella mutagenicity test results for 250 chemicals Environ. Mutagen. Vol. 5 (Suppl 1) (1983) 3-142
      •  Negative 
    • Sister Chromatid Exchanges  (070061)  Completed 
      • Mice
      • Sister Chromatid  Negative (Nonstandard Protocol) 

    Bioassay

    • Chronic Special (Gavage)  (C10034)  Histopath in progress 
      • 52-week interim
      • Rats: Sprague Dawley (NCTR)

    Organ Systems Toxicity

    • 120 day minimum Continuous Breeding (Legacy) (Subcutaneous Injection)  (RACB82081)  Completed 
      • Citation: Final Report - Bisphenol A: Reproduction and Fertility Assessment in CD-1 Mice When Administered via Subcutaneous Silastic Implants
      • Male and Female Mice: Swiss
      • Dose: 0, 6.25, 12.5, 25, 50, 100 MG; 0, 25, 50, 100 MG/KG; N/A; N/A.
    • 120 day minimum Continuous Breeding (Legacy) (Dosed-Feed)  (RACB84080)  Completed 
      • Citation: Bisphenol A: Reproduction and Fertility Assessment in CD-1 Mice When Administered In the Feed
      • Male and Female Mice: Swiss
      • Dose: 0, .312, .625, 1.25, 2.5, 5.0%; 0, .25, .5, 1%; 0, 1%; 0, .25, .5, 1.0%; .
    • 6 to 15 GD Conventional Teratology (Gavage)  (TER85051)  Completed 
      • Citation: Final Report - Teratologic Evaluation of Bisphenol A Administered to CD® Rats on Gestational Days 6 through 15
      • Female Rats: Sprague Dawley
      • Rats Maternal Negative 
      • Rats Fetal Negative 
      • Dose: 160, 320, 640, 1280 MG/KG/DY.
    • 6 to 15 GD Conventional Teratology (Gavage)  (TER85052)  Completed 
      • Citation: Final Report - Teratologic Evaluation of Bisphenol A Administered to CD-1 Mice on Gestational Days 6 through 15
      • Female Mice: Swiss
      • Mice Maternal Positive 
      • Mice Fetal Positive 
      • Dose: 500, 750, 1000, 1250 MG/KG/DAY.
    • Utero-Lactational (Gavage)  (R10034)  Completed 

      Toxicogenomics

      • 4 days Microarray Analysis (Gavage)  (T10034)  Completed 
        • Liver Targeted Testing study of Toxcast Chemicals
        • Rats: Harlan Sprague-Dawley
        • Dose: 450 mg/kg; 6 rats.