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Mutagenicity and Carcinogenicity01:25

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Mutagenicity and carcinogenicity refer to the ability of drugs to cause genetic defects and induce cancer, respectively. The International Agency for Research on Cancer (IARC) classifies agents into four groups based on their carcinogenic potential. Group 1 agents are known human carcinogens; group 2A agents are probably carcinogenic to humans; group 3 agents lack data to support their role in carcinogenesis; and group 4 includes agents for which data support that they are not likely to be...
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Commentary: Understanding IARC's PFOA and PFOS carcinogenicity assessments.

Nicholas L Drury1, Robyn L Prueitt2, Barbara D Beck1

  • 1One Beacon St., 17th Floor, Boston, MA, 02108, USA.

Regulatory Toxicology and Pharmacology : RTP
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PubMed
Summary

The International Agency for Research on Cancer (IARC) may have overstated evidence classifying perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as carcinogenic. A review suggests epidemiological and animal study data were weak and inconsistent for these persistent organic pollutants.

Keywords:
CancerCarcinogenic mechanismEpidemiologyExperimental animalHazard classificationPerfluorooctanesulfonic acid (PFOS)Perfluorooctanoic acid (PFOA)

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Area of Science:

  • Environmental Health
  • Toxicology
  • Carcinogenesis

Background:

  • The International Agency for Research on Cancer (IARC) recently classified perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as carcinogenic to humans (Group 1) and possibly carcinogenic to humans (Group 2B), respectively.
  • These classifications are based on extensive reviews of epidemiological, experimental animal, and mechanistic evidence.

Purpose of the Study:

  • To critically evaluate the IARC's carcinogenicity classifications for PFOA and PFOS.
  • To assess the strength and consistency of the evidence used in the IARC's re-evaluation process.

Main Methods:

  • Review and analysis of epidemiological studies investigating human exposure to PFOA and PFOS.
  • Evaluation of experimental animal studies reporting tumor incidence following PFOA and PFOS exposure.
  • Assessment of the IARC's application of the Key Characteristics of Carcinogens (KCCs) framework.

Main Results:

  • Epidemiological studies show weak and inconsistent associations between PFOA/PFOS exposure and cancer.
  • Tumor incidences in animal studies were often driven by benign adenomas, questioning the significance of the findings.
  • The IARC's use of the KCCs approach may not adequately consider the quality, external validity, and human relevance of mechanistic data.

Conclusions:

  • The IARC Working Group may have overstated the evidence for the carcinogenicity of PFOA and PFOS.
  • A more rigorous evaluation of mechanistic evidence, focusing on plausibility and human relevance, is recommended over a checklist approach.
  • Further research and critical assessment are needed to accurately determine the carcinogenic potential of PFOA and PFOS.