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Related Experiment Videos

Animal carcinogenicity studies: 1. Poor human predictivity.

Andrew Knight1, Jarrod Bailey, Jonathan Balcombe

  • 1Animal Consultants International, London SE11 4NR, UK. info@animalconsultants.org

Alternatives to Laboratory Animals : ATLA
|March 9, 2006
PubMed
Summary

The U.S. Environmental Protection Agency (EPA) over-relies on animal data for carcinogenicity assessments, leading to inflated human risk predictions compared to international standards. This highlights the poor predictivity of animal data for human health risks.

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Area of Science:

  • Toxicology
  • Risk Assessment
  • Environmental Health

Background:

  • Societal reliance on animal carcinogenicity data for regulating human exposure to chemicals.
  • The U.S. Environmental Protection Agency (EPA) Integrated Risk Information System (IRIS) database lists key environmental contaminants.
  • A significant number of chemicals lack human exposure data but have undergone carcinogenicity assessment.

Purpose of the Study:

  • To compare the human carcinogenicity classifications of the EPA with those of the International Agency for Research on Cancer (IARC).
  • To evaluate the EPA's reliance on animal carcinogenicity data in the absence of human data.
  • To assess the predictivity of animal data for human carcinogenicity.

Main Methods:

  • Analysis of 160 chemicals in the EPA's IRIS database lacking human exposure data but possessing animal data.

Related Experiment Videos

  • Comparison of EPA carcinogenicity assessments with IARC classifications for 128 chemicals.
  • Statistical analysis (p-values) to determine compatibility of EPA and IARC classifications.

    • Main Results:

    • The EPA deemed animal data inadequate for classification in 58.1% of assessed chemicals lacking human data.
    • EPA and IARC classifications were compatible only for 17 chemicals with limited human data.
    • For chemicals reliant on animal data, the EPA assigned higher risk classifications than IARC (p < 0.0001).

    Conclusions:

    • The EPA demonstrates over-reliance on animal carcinogenicity data when human data is limited.
    • This over-reliance leads to an over-prediction of carcinogenic risk to humans.
    • The predictive accuracy of animal data for human carcinogenicity is questionable, as indicated by discrepancies with IARC assessments.