Ocular Irritection® OECD 496 - Eye Irritation Test

The first and only 100% animal free eye irritation test adopted by the OECD

Ocular Irritection® OECD 496, the in vitro macromolecular test for the identification and classification of chemicals that inducesevere eye damage (UN GHS Category 1) and chemicals that do not require classification (UN GHS No Category).

  • Globally accepted and recognized
  • 100% animal free
  • It can be carried out in 3 hours
  • Results in 24 hours
  • Easy to use

First and only OECD Test Guideline 100% animal free

TG OECD 492 uses a RhCE tissue model based on a human cell culture.

TG OECD 491 uses a rabbit corneal cell line.

TG OECD 437 and 438 make use of fabrics from abattoirs.

TG OECD 460 makes use of kidney cells.

Only Ocular Irritection® OECD 496 makes use of a fully acellular macromolecular Assay System.

Recommended by the OECD as a first test for both Bottom-Up and Top-Down strategy

Ocular Irritection® is recommended as an initial step in a Top-Down testing strategy, as described in the guidance document OECD 263, to positively identify chemicals that induce severe eye damage, i.e., chemicals to be classified as UN GHS Category 1 without further testing.

Ocular Irritection® is also recommended to identify chemicals that do not require classification for ocular irritation or serious ocular damage as defined by the UN GHS (UN GHS No Category), and can therefore be used as an initial step within a Bottom-Up testing strategy approach.

The test

Ocular Irritection® is a standardized, quantitative in vitro test that predicts the ocular irritation potential of surfactant and non-surfactant chemical, petrochemical, consumer, and cosmeticproducts, mixtures, or formulations.

Part 1

Part 2

How does it work?

The test is based on the understanding that the ability of a chemical to irritate the cornea is related to its propensity to promote denaturation and destruction of corneal proteins. Ocular Irritection® mimics these biochemical phenomena using a protein reagent.

When the assay is performed, the changes in protein structure induced by the test sample are then quantified by measuring the resulting changes in turbidity (optical density) of the solution reagent at a wavelength of 405 nm using a spectrometer.

The results of past comparative studies were used to develop what is called an “Irritection Draize Equivalent” (IDE) score, which is a value derived from in vitro studies that is equivalent to the expected irritation potential in vivo (Draize rabbit eye test).

Il test per l'irritazione oculare Ocular Irritection è il primo test 100% animal free OECD adopted

Ocular Irritection® is part of the Irritection® Assay System with Irritection® Dermal.

Ocular Irritection® is OECD TG 496, the first and only OECD in vitro test that is totally animal free.

According to the 11th revision of the SCCS concerning the “Notes of Guidance for the Testing of Cosmetic Ingredients and the Evaluation of their Safety“, at paragraph 34.6, Ocular Irritection® is the first and only OECD adopted test that is completely animal free.

Do you perform ophthalmological testing? Do a preliminary screening with Ocular Irritection®.

The second general principle of the World Medical Association’s Declaration of Helsinki, updated 2013, on “Ethical Principles for Biomedical Research Involving Human Beings,” capstone reads:

It is the physician’s duty to promote and safeguard the health, well-being, and rights of patients, including those involved in biomedical research. Physician science and co-science must be placed in service of this mission.

The next point further states:

Medical advances are based on research, which ultimately must be based on clinical trials conducted in humans.”

Don’t use your informed volunteer as a “guinea pig”, do a pre-screening ophthalmology test with Ocular Irritection®.

Irritection® Dermal

Dermal Irritection® is the technology that has accompanied Ocular Irritection® for over 30 years and provides GHS-accepted results through the weight of evidence.

Although they are two different methods, both make use of the Irritection® Assay System and employ matrices specifically designed to mimic the biochemical phenomenon of alteration of the proteins of the dermis or cornea when brought into contact with the substance under examination.