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Related Experiment Videos

Alternative models for carcinogenicity testing.

S M Cohen1, D Robinson, J MacDonald

  • 1Department of Pathology and Microbiology and the Eppley Institute for Cancer Research, University of Nebraska Medical Center, 983135 Nebraska Medical Center, Omaha, Nebraska 68198-3135, USA.

Toxicological Sciences : an Official Journal of the Society of Toxicology
|October 19, 2001
PubMed
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This study evaluated six alternative assays for chemical safety evaluation. Some models show promise for hazard identification when used with other data in risk assessment.

Area of Science:

  • Toxicology
  • Risk Assessment
  • Genotoxicity

Background:

  • The International Conference on Harmonisation (ICH) Expert Working Group on Safety proposed using alternative assay data in safety evaluations.
  • Several alternative models were discussed for potential use in place of traditional bioassays.

Purpose of the Study:

  • To collaboratively evaluate six alternative in vitro and in vivo models for chemical safety assessment.
  • To determine the utility of these models in hazard identification and risk assessment.

Main Methods:

  • Six alternative models were selected for evaluation: p53(+/-) heterozygous knockout mouse, rasH2 transgenic mouse, TgAC transgenic mouse (dermal and oral), homozygous XPA knockout mouse, XPA/p53 knockout mouse, neonatal mouse models, and the Syrian Hamster Embryo (SHE) transformation assay.
  • Twenty-one diverse chemicals (genotoxic, nongenotoxic, carcinogenic, noncarcinogenic) were tested across the evaluated models.

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  • Standardized protocols, pathology reviews, and statistical evaluations were established for the study.

    • Main Results:

    • The study comprehensively evaluated multiple alternative models for chemical safety testing.
    • Results indicate that certain models may be valuable for hazard identification.
    • The performance of each model varied depending on the chemical's properties and the assay used.

    Conclusions:

    • Some evaluated alternative models show potential utility in hazard identification.
    • These models are most effective when integrated with other data sources within a weight-of-evidence approach.
    • Further refinement and validation may enhance the role of these alternative assays in integrated risk assessment strategies.