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Number of animals for sequential testing

J A Springer1, W A Chambers, S Green

  • 1US Food and Drug Administration, Washington, DC 20204.

Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association
|February 1, 1993
PubMed
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Reducing animal use in eye irritation tests is possible. A three-animal or two-stage approach maintains high accuracy, unlike current EPA methods which are less reliable.

Area of Science:

  • Toxicology
  • Regulatory Science
  • Animal Welfare

Background:

  • Current regulatory eye irritation tests often use six animals.
  • Previous investigations explored reducing animal sample sizes in these tests.

Purpose of the Study:

  • To evaluate the accuracy of existing animal eye irritation test classification systems.
  • To determine if reducing the number of animals tested can maintain high accuracy.

Main Methods:

  • Analysis of eye irritation test data from pesticides, consumer products, cosmetics, and cleaning products.
  • Comparison of classification systems used by US regulatory agencies (CPSC, FDA, OSHA, EPA).
  • Evaluation of reduced animal sample sizes (three, two, and one animal) and a two-stage testing approach.

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Main Results:

  • The US EPA's system (1 of 6 animals positive) has low accuracy (50-80%) and high false positives.
  • US CPSC, FDA, and OSHA's system (4 of 6 animals positive) achieves >99% accuracy with minimal errors.
  • Reducing sample size to three animals or using a two-stage test preserves good accuracy.

Conclusions:

  • The US EPA's current eye irritation testing decision rule is suboptimal.
  • A one-stage test with three animals or a two-stage test offers a viable alternative for reducing animal use while maintaining accuracy.