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Eye irritation: in vivo rabbit eye test template for pre-existing data

The Draize rabbit eye test is an acute toxicity test for assessing the effects of chemicals, substances and mixtures in terms of their potential to cause eye irritancy or damage to the eye.

The method was originally designed to assess the effects on eye health of cosmetics. It has since been used to test many other substances and chemicals.

The test is controversial from an animal welfare perspective. Concerns about scientific validity have also been raised, with the subjective scoring of effects and differences between rabbit and human eyes being particular points of criticism.

The use of the test has declined over the years for these reasons and others. Nevertheless, the Draize test has been used extensively, not least because the method was adopted for regulatory testing purposes.

As a result there are considerable amounts of data available that have been derived using the test. To this end we developed a template with built-in algorithms for calculating eye irritation classifications from Draize in vivo eye irritation data.

The classifications from the template are based on European Union Dangerous Substances Directive (EU DSD), the European Union Regulation on Classification, Labelling and Packaging (EU CLP), the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS) and of the United States Environmental Protection Agency (US EPA).

EURL ECVAM strongly recommends the use of this template to generate eye irritation classifications from existing reference Draize in vivo data for chemicals that will be used in the development, optimisation and validation of alternative test methods or strategies for eye irritation.

The template and an explanatory document are available below.

How can I find out more?

[collapsed]You can access the template and explanatory note below:

  • 2. FEBRUÁRA 2022
    EURL ECVAM template for in vivo eye irritation classification (*.xls)
    (40.59 KB - XLSX)
  • 2. FEBRUÁRA 2022
    Explanatory document on the use of the EURL ECVAM template
    (362.18 KB - PDF)