By JoAnn Cleland
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Extra resources for I Hear, Sing and Read
The results published to date appear encouraging, but, as for SKINTEX™, validation from disinterested sources would improve the credibility of the validation. In the above equivalence data, the percentage of equivalence falls to 79% on the criterion of falling within one classification of the Draize score. The experience across industry has been somewhat variable, and, with the current emphasis on the role of inflammatory mechanisms in irritancy, the mechanistic basis of EYTEX™, founded on opacification, is seen by some as too restricted (54), particularly with respect to the classical view of ocular irritancy potential, in which the significance of a compound's ability to Irritancy Testing 33 penetrate ocular membranes is rated above its ability to react with ocular tissues (36).
Thus, considerable work on validation remains to be done. The isolated rabbit eye test (50), as expected, gives a good correlation with corneal irritation (thickening), but still involves the use of animals for the isolated organ. Precipitation tests Turbidity tests using solutions of biological macromolecules (51) have been used by at least one major cosmetics concern to replace animal testing. The results have correlated well with published irritancy data, but this approach may be incompatible with a significant proportion of chemicals likely to require eye testing (3).
In fact, it is much less variable than an LDSO value. So, in that case, I think that that sort of level of reassurance was important in getting Europe to agree that this method provides as much information as an LDSO test for use in risk assessment apart from dose response. I think the Fixed Dose Procedure provides as much information as is provided by conventional toxicity studies, and it avoids the use of death as an endpoint. In this case, one needed to use a large number of laboratories in order to avoid these criticisms.