In Vitro Toxicology by Shayne C. Gad

By Shayne C. Gad

This quantity demonstrates that there now exists a wide diversity of in vitro versions to be used in both deciding upon or realizing so much varieties of toxicity. the provision of in vitro types spans either the total diversity of endpoints (irritation, sensitisation, lethality, mutagenicity, and developmental toxicity) and the whole spectrum of goal organ structures (skin, eye, center, liver, kidney, frightened approach, etc.). Chapters are dedicated to every one of those speciality parts from a viewpoint of featuring the valuable types and their makes use of and barriers. Chapters that assessment the foundations serious about the overall choice and use of versions, and that deal with the problems of protection issues and regulatory attractiveness of those equipment also are incorporated.

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A similar conclusion was reached in a study sponsored by COLIPA [50], in which 10 alternative methods were applied to a set of 55 cosmetic ingredients and formulations. Again, none of the assays could predict eye irritation reliably enough to be considered a valid replacement for the Draize test. The question is what are the barriers to validation and acceptance in a broad setting? A good general overview of the challenges surrounding replacement of animals in toxicity testing has been published [98], and specific issues impeding “global” validation have also been described [99].

Muir [29,30] reported the development of an opacity assay, using isolated bovine cornea, in which decreases in light transmission through the cornea were monitored as the endpoint. His work with surfactants and some industrial chemicals indicated a good correlation between the in vivo and in vitro data. Igarashi et al. [31] developed a variation on this method, in which isolated porcine corneas (with endothelial cells removed) are exposed to test compounds. Changes in voltage across the corneal epithelium are used as a measure of opacification.

3 SENSITIVITY, SPECIFICITY, AND PREDICTIVE VALUE Two of the key issues that must be confronted when considering any new test system are predictive value and sensitivity. These issues (along with the general scientific requirement of reproducibility) are points that must be evaluated for an in vitro system. 4. Possible test outcomes able to identify situations (in statistical terms, “population elements”) that are different in some specified manner. Sensitivity determines how much “power” a test has: How much different does an endpoint need to be before it is identified as different (or an effect is detected)?

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