What is the Irritection Assay System?
The Irritection Assay System is a standardized, quantitative invitro
test method that can be employed to detect, rank, and predict the
ocular and/or dermal irritation potential of cosmetics, consumer
products, pharmaceuticals, and chemical raw materials. This advanced
technology enhances and replaces the Company's earlier Eytex and Skintex products.
Why Use the Irritection Assay System?
- The Irritection Assay System provides a reliable
alternative to the traditional animal tests of ocular and/or dermal
irritancy, and is considerably less expensive than in vivo tests.
- Irritection data may be obtained in as little as 5 hours, versus the standard 2-3 weeks required for in vivo studies. Rapid results provide quicker feedback on formulation changes and significantly decrease product development times.
- The Irritection assays are quantitative and highly reproducible,
thus allowing comparative ranking of samples and formulations with
- Prior studies have demonstrated that the Irritection assay results
are highly correlated with those obtained in standard Draize tests.
Ocular Irritection Assays
The corneal irritancy of test materials is known to be related to
their propensity to promote denaturation and disruption of corneal
proteins. The Ocular Irritection Assay System is an in vitro test method that mimics these biochemical phenomena. This test consists of two essential components:
- A membrane disc that permits controlled delivery of the test material to a reagent solution and;
- A proprietary reagent solution that is composed of proteins,
glycoproteins, lipids and low molecular weight components that
self-associate to form a complex macromolecular matrix.
Controlled mixing of the test material and the reagent solution
during the assay incubation period promotes protein denaturation and
disaggregation of the macromolecular matrix.
The changes in
protein structure that are induced by the test material may be readily
quantitated by measuring the resulting changes in turbidity (OD405) of the reagent solution.
of these optical density measurements to those produced by standard
chemical irritants permits calculation of an "irritancy score" that has
been shown to be directly related to the potential corneal irritancy of
the test material.
Dermal Irritection Assays
Chemicals that cause
dermal irritation are known to induce alterations in the structure of
keratin, collagen and other dermal proteins. The Dermal Irritection Assay System is an in vitro test that mimics these biochemical phenomena.
This test also consists of two components:
- A membrane substrate that has been modified by covalently
crosslinking a mixture of keratin, collagen and an indicator dye to it
- A reagent solution consisting of a highly organized globulin/protein macromolecular matrix.
of an irritant chemical to the membrane disc disrupts the ordered
structure of keratin and collagen and results in release of the bound
indicator dye. Additionally, dermal irritants induce changes in
conformation in the globular proteins found in the reagent solution.
extent of dye release and protein denaturation may be quantitated by
measuring the changes in optical density of the reagent solution at 450
Comparison of these optical density
measurements to those produced by standard chemical irritants permits
calculation of an "irritancy score" that has been shown to be directly
related to the potential dermal irritancy of the test material.
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