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Testing Status of Bisphenol A 10034-Y

 

CASRN: 80-05-7

Formula: C15-H16-O2

Synonyms/Common Names

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

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 days (Gavage)  (C10034D)  On Test 
    • Rats: Hsd:Sprague Dawley SD
    • Dose: 0, 0.1, 1, 10, 30, 100 mg/kg.
  • 14-Day (Dosed-Feed)  (C50635)  Completed 
    • Rats: F344/N; Mice: B6C3F1
  • 90 days (Gavage)  (C10034C)  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
    • 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.
  • 1 day (Gavage)  (C10034E)  On Test 
    • Series Dose Escalation Cardiovascular Functional Assessment Study
    • Rats: Hsd:Sprague Dawley SD
    • Dose: Dose escalation, Single dose + recovery per dose level 0, 0.1, 1, 10, 30, 100 mg/kg.
  • 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)  Completed 
    • Citation: Camacho L, Lewis SM, Vanlandingham MM, Olson GR, Davis KJ, Patton RE, Twaddle NC, Doerge DR, Churchwell MI, Bryant MS, McLellen FM, Woodling KA, Felton RP, Maisha MP, Juliar BE, Gamboa da Costa G, Delclos KB. A two-year toxicology study of bisphenol A (BPA) in Sprague-Dawley rats: CLARITY-BPA core study results. Food Chem Toxicol. 2019 Oct;132:110728. doi: 10.1016/j.fct.2019.110728. Epub 2019 Jul 28.
    • Citation: National Toxicology Program. 2018. NTP Research Report on the CLARITY-BPA Core Study: A Perinatal and Chronic Extended-Dose-Range Study of Bisphenol A in Rats. NTP RR 9. Research Triangle Park, NC. National Toxicology Program (9): 1-221. https://doi.org/10.22427/NTP-RR-9
    • 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)  Completed 
    • 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 Distribution Metabolism Excretion (Gavage; Intravenous)  (K10034)  Completed 
    • Citation: Doerge DR, Twaddle NC, Vanlandingham M, Brown RP, Fisher JW. Distribution of bisphenol A into tissues of adult, neonatal, and fetal Sprague-Dawley rats. Toxicol Appl Pharmacol. 2011 Sep 15;255(3):261-70. doi: 10.1016/j.taap.2011.07.009. Epub 2011 Jul 22.Pubmed Abstract
    • Citation: Doerge DR, Twaddle NC, Vanlandingham M, Fisher JW. Pharmacokinetics of bisphenol A in neonatal and adult CD-1 mice: inter-species comparisons with Sprague-Dawley rats and rhesus monkeys. Toxicol Lett. 2011 Dec 15;207(3):298-305. doi: 10.1016/j.toxlet.2011.09.020. Epub 2011 Sep 29.Pubmed Abstract
    • Citation: Doerge DR, Twaddle NC, Vanlandingham M, Fisher JW. Pharmacokinetics of bisphenol A in neonatal and adult Sprague-Dawley rats. Toxicol Appl Pharmacol. 2010 Sep 1;247(2):158-65. doi: 10.1016/j.taap.2010.06.008. Epub 2010 Jun 26.Pubmed Abstract
    • Citation: Doerge DR, Twaddle NC, Vanlandingham M, Fisher JW. Pharmacokinetics of bisphenol A in serum and adipose tissue following intravenous administration to adult female CD-1 mice. Toxicol Lett. 2012 Jun 1;211(2):114-9. doi: 10.1016/j.toxlet.2012.03.008. Epub 2012 Mar 20.Pubmed Abstract
    • Citation: Doerge DR, Twaddle NC, Woodling KA, Fisher JW. Pharmacokinetics of bisphenol A in neonatal and adult rhesus monkeys. Toxicol Appl Pharmacol. 2010 Oct 1;248(1):1-11. doi: 10.1016/j.taap.2010.07.009. Epub 2010 Jul 23.Pubmed Abstract
    • Citation: Doerge DR, Vanlandingham M, Twaddle NC, Delclos KB. Lactational transfer of bisphenol A in Sprague-Dawley rats. Toxicol Lett. 2010 Dec 15;199(3):372-6. doi: 10.1016/j.toxlet.2010.09.022. Epub 2010 Oct 7.Pubmed Abstract
    • Female Rats: Sprague Dawley (NCTR)
    • Dose: 100 ug/kg.
  • 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)  Completed 
    • Rats: Harlan Sprague-Dawley
  • 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 
  • 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 
  • Micronucleus  (A24930)  Completed 
    • Rats: Fischer 344
    • Male 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 
  • 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) 

Organ Systems Toxicity

  • 120 day minimum Continuous Breeding (Legacy) (Subcutaneous Injection)  (RACB82081)  Completed 
    • 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 
    • 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 
    • 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 
    • 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.