A Synthetic Tissue-based In vitro Ocular Irritation Assay

Jul 1, 2012 | Contact Author | By: Stewart J. Lebrun, Lebrun Labs, CA USA
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Title: A Synthetic Tissue-based In vitro Ocular Irritation Assay
ocular irritationx irritation testingx in vitrox opacityx EPAx GHSx
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Keywords: ocular irritation | irritation testing | in vitro | opacity | EPA | GHS

Abstract: The testing of personal care products for ocular irritancy ensures their safety, proper labeling and consumer satisfaction. In relation, there is a current demand for animal-alternative tests. Thus, described here is a method using synthetic tissue to test for mild, moderate and severe ocular irritation, including data validating this method as an effective means to screen products.

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SJ Lebrun, A synthetic tissue-based on vitro ocular irritation assay, Cosm & Toil 127(7) 498-502 (Jul 2012)

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Traditionally, ocular irritation testing has been conducted using rabbits. One purpose of this test is to evaluate any opacity caused by the test substance in the cornea of the eye and to measure it. Any disruption to the pigmented iris surrounding the pupil, which is deeper within the eye than the cornea, is also measured, and the conjunctiva or tissue surrounding the eye is evaluated for redness, chemosis and discharge. Different designations are used to classify the various physiological responses—i.e., Draize, European Union (EU), Globally Harmonized System (GHS), US Environmental Protection Agency (EPA), Hazardous Materials Identification System (HMIS), Federal Hazardous Substances Act (FHSA), etc.; using the same animal data but with different weights given to the various responses measured, as well as different overall approaches to statistical analysis.

Ocular irritation is distinguished from ocular corrosion based on reversibility. If, after 14 days, there is still an irritant response, the substance is classified as corrosive, but if the effect has reversed, the substance is classified as an irritant. The irritancy classification systems described above typically include substances that are corrosive within their most severe class—i.e., GHS and EPA “Cat I” or EPA “R41.” Ocular irritation is generally considered a less severe class, i.e., GHS “Cat 2A” and “Cat 2B”; EPA “Cat II” and “Cat III”; and EU “R36.” Nonirritant classes are listed as GHS “NC”, EPA “Cat IV” and EU “NC”.

The testing of personal care products for ocular irritancy ensures their safety, proper labeling and consumer satisfaction. In relation, there is a current demand for animal-alternative tests. Thus, described here is a method using synthetic tissue to test for mild, moderate and severe ocular irritation, including data validating this method as an effective means to screen products.

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This content is adapted from an article in GCI Magazine. The original version can be found here.

 

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Table 1. Assay concordance with NICEATM EPA Consensus 1

Table 1. Assay concordance with NICEATM EPA Consensus 1

New biochemical assay concordance with NICEATM EPA Consensus 1; nonirritants versus other chemicals

Table 2. Concordance with NICEATM GHS Consensus 1, 3

Table 2. Concordance with NICEATM GHS Consensus 1, 3

New assay concordance with NICEATM GHS Consensus 1, 3; nonirritants versus other chemicals

Figure 1. Images of corneal opacity

Figure 1. Images of corneal opacity

Figure 1. Images of corneal opacity with a) the test system, in comparison with b) human corneal opacity; left = nonirritant; right = irritant

Footnotes [Lebrun 127(7)]

a Optisafe is a trademarked test method developed by Lebrun Labs, LLC, Anaheim, CA, USA.

b Eyetex is a trademarked test method developed by National Testing Corp., Palm Springs, CA, USA.

c The test chemicals used were purchases from Sigma Chemical, St. Lewis, MI, USA.

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