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Testing Status of Perfluorooctanoic acid (PFOA) M910070

 

CASRN: 335-67-1

Formula: C8-H-F15-O2

Synonyms/Common Names

  • C8 Carboxylic acid
  • Pentadecafluorooctanoic acid (9CI)
  • PFOA

Short-Term Toxicity

  • 4 days (Gavage)  (C91070)  Completed 
    • Liver Targeted Testing study of Toxcast Chemicals
    • Rats: Harlan Sprague-Dawley
    • Dose: Male mice: 0, 15, 180 mg/kg/day.
  • 28 days (Gavage)  (C91070B)  Completed 
    • TOX-97 
      Toxicity Studies of Perfluoroalkyl Carboxylates (Perfluorohexanoic Acid, Perfluorooctanoic Acid, Perfluorononanoic Acid, and Perfluorodecanoic Acid) Administered by Gavage to Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Revised)
    • Rats: Harlan Sprague-Dawley
    • Dose: Males: 0, 0.625, 1.25, 2.5, 5, or 10 mg/kg; Females: 0, 6.25, 12.5, 25, 50, or 100 mg/kg.
  • 5 days (Gavage)  (C91070C)  Completed 
    • 5-Day Transcriptomic Dose-Response Studies
    • Citation: Gwinn WM, Auerbach SS, Parham F, Stout MD, Waidyanatha S, Mutlu E, Collins B, Paules RS, Merrick BA, Ferguson S, Ramaiahgari S, Bucher JR, Sparrow B, Toy H, Gorospe J, Machesky N, Shah RR, Balik-Meisner MR, Mav D, Phadke DP, Roberts G, DeVito MJ. Evaluation of 5-day In Vivo Rat Liver and Kidney With High-throughput Transcriptomics for Estimating Benchmark Doses of Apical Outcomes. Toxicol Sci. 2020 Aug 1;176(2):343-354. doi: https://doi.org/10.1093/toxsci/kfaa081.Pubmed Abstract
    • Rats: Harlan Sprague-Dawley
    • Dose: Male rats: 0, 0.156, 0.3125, 0.625, 1.25, 2.5, 5, 10, or 20 mg/kg; N=4.
  • 5 days (Gavage)  (C91070C)  Data in Review 
    • Citation: Gwinn WM, Auerbach SS, Parham F, Stout MD, Waidyanatha S, Mutlu E, Collins B, Paules RS, Merrick BA, Ferguson S, Ramaiahgari S, Bucher JR, Sparrow B, Toy H, Gorospe J, Machesky N, Shah RR, Balik-Meisner MR, Mav D, Phadke DP, Roberts G, DeVito MJ. Evaluation of 5-day In Vivo Rat Liver and Kidney With High-throughput Transcriptomics for Estimating Benchmark Doses of Apical Outcomes. Toxicol Sci. 2020 Aug 1;176(2):343-354. doi: https://doi.org/10.1093/toxsci/kfaa081.Pubmed Abstract
    • Rats: Harlan Sprague-Dawley
    • Dose: Male rats: 0, 0.156, 0.3125, 0.625, 1.25, 2.5, 5, 10, or 20 mg/kg; N=4.

Long-Term Carcinogenicity

  • 2 years (Dosed-Feed)  (C20614)  Completed 
    • TR-598   (Peer Review Approval 12/12/2019A )
      Toxicology and Carcinogenesis Studies of Perfluorooctanoic Acid (CASRN 335-67-1) Administered in Feed to Sprague Dawley (Hsd:Sprague Dawley SD) Rats
    • Rats: Harlan Sprague-Dawley
    • Carcinogenesis Results
      • Male Rats Inadequate Study DUE TO UNANTICIPATED TOXICITY IN MALE RATS OBSERVED AT THE 16-WEEK INTERIM TIME POINT, MALES WERE REMOVED FROM THE FIRST STUDY AT WEEK 21. A SECOND STUDY OF MALES ONLY WAS STARTED THAT USED LOWER POSTWEANING FEED CONCENTRATIONS.
      • Female Rats Some Evidence 
    • DUE TO UNANTICIPATED TOXICITY IN MALE RATS OBSERVED AT THE 16-WEEK INTERIM TIME POINT, MALES WERE REMOVED FROM THE FIRST STUDY AT WEEK 21. A SECOND STUDY OF MALES ONLY WAS STARTED THAT USED LOWER POSTWEANING FEED CONCENTRATIONS.
    • Dose: MR: 0/0, 0/150, 0/300, 150/150, or 300/300; FR: 0/0, 0/300, 0/1000, 150/300, or 300/1000 ppm; 60/sex.
  • 2 years (Dosed-Feed)  (C20614B)  Completed 
    • TR-598   (Peer Review Approval 12/12/2019A )
      Toxicology and Carcinogenesis Studies of Perfluorooctanoic Acid (CASRN 335-67-1) Administered in Feed to Sprague Dawley (Hsd:Sprague Dawley SD) Rats
    • Rats: Harlan Sprague-Dawley
    • Carcinogenesis Results
      • Male Rats Clear Evidence 
    • Dose: MR: 0/0, 0/20, 0/40, 0/80, 300/0, 300/20, 300/40, or 300/80 ppm; 60/sex.

Modified One-Generation

  • Dose Range Finding (Gavage)  (MOG91070)  Completed 
    • Dose Range Finding
    • Rats: Harlan Sprague-Dawley; Mice: CD-1 Reg.[Crl:CD1(ICR)]
    • Dose: R: 0, 6.25, 12.5, 25, or 50 mg/kg.

Special Studies

  • Cell Proliferation (Gavage)  (S0174)  Completed 
    • Citation: Thottassery J, Winberg L, Youssef J, Cunningham M, Badr M. Regulation of perfluorooctanoic acid-induced peroxisomal enzyme activities and hepatocellular growth by adrenal hormones. Hepatology. 1992 Feb;15(2):316-22.Pubmed Abstract
    • Male Rats: Sprague Dawley
    • Dose: 150 MG/KG.
  • Toxicokinetic Study (Gavage; Intravenous)  (K10075)  Completed 
    • Citation: Dzierlenga AL, Robinson VG, Waidyanatha S, DeVito MJ, Eifrid MA, Gibbs ST, Granville CA, Blystone CR. Toxicokinetics of perfluorohexanoic acid (PFHxA), perfluorooctanoic acid (PFOA) and perfluorodecanoic acid (PFDA) in male and female Hsd:Sprague dawley SD rats following intravenous or gavage administration. Xenobiotica. 2020 Jun;50(6):722-732. doi: https://doi.org/10.1080/00498254.2019.1683776. Epub 2019 Nov 7.Pubmed Abstract
    • Male and Female Rats: Hsd:Sprague Dawley SD

Genetic Toxicology

  • 4 days Comet Assay (Gavage)  (G91070B)  Completed 
    • Rats: Sprague Dawley
  • Micronucleus  (G91070)  Completed 
    • Rats: Harlan Sprague-Dawley
    • Male Positive 
    • Female Negative 
  • Salmonella  (A98283)  Completed 
    •  Equivocal 

Toxicogenomics

  • 4 days Microarray Analysis (Gavage)  (T91070)  Completed 
    • Liver Targeted Testing study of Toxcast Chemicals
    • Rats: Harlan Sprague-Dawley
    • Dose: 180 mg/kg; 6 rats.
  • 5 days Transcriptome Sequencing (Gavage)  (T91070B)  Completed 
    • 5-Day Transcriptomic Dose-Response Studies
    • Citation: Gwinn WM, Auerbach SS, Parham F, Stout MD, Waidyanatha S, Mutlu E, Collins B, Paules RS, Merrick BA, Ferguson S, Ramaiahgari S, Bucher JR, Sparrow B, Toy H, Gorospe J, Machesky N, Shah RR, Balik-Meisner MR, Mav D, Phadke DP, Roberts G, DeVito MJ. Evaluation of 5-day In Vivo Rat Liver and Kidney With High-throughput Transcriptomics for Estimating Benchmark Doses of Apical Outcomes. Toxicol Sci. 2020 Aug 1;176(2):343-354. doi: https://doi.org/10.1093/toxsci/kfaa081.Pubmed Abstract
    • Rats: Harlan Sprague-Dawley
  • 5 days Transcriptome Sequencing (Gavage)  (T91070B)  Data in Review 
    • Citation: Gwinn WM, Auerbach SS, Parham F, Stout MD, Waidyanatha S, Mutlu E, Collins B, Paules RS, Merrick BA, Ferguson S, Ramaiahgari S, Bucher JR, Sparrow B, Toy H, Gorospe J, Machesky N, Shah RR, Balik-Meisner MR, Mav D, Phadke DP, Roberts G, DeVito MJ. Evaluation of 5-day In Vivo Rat Liver and Kidney With High-throughput Transcriptomics for Estimating Benchmark Doses of Apical Outcomes. Toxicol Sci. 2020 Aug 1;176(2):343-354. doi: https://doi.org/10.1093/toxsci/kfaa081.Pubmed Abstract
    • Rats: Harlan Sprague-Dawley