Skin Irritation Test (SIT) in a Reconstructed Human Epidermis (RhE) Model Skin Irritation in the regulatory hazard classification and labeling context is defined as the production of reversible damage to skin following a defined chemical exposure. The Skin Irritation Test (SIT) is an in vitro, non-animal test designed to identify those chemicals and mixtures capable...
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Skin Corrosion in the regulatory hazard classification and labeling context is defined as the production of irreversible damage to skin, generally evident as necrosis through the epidermis and into the dermis, following a defined chemical exposure. The In Vitro Skin Corrosion Test is an in vitro, non-animal test designed to identify those chemicals and mixtures...
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The Corrositex® assay is a standardized and quantitative in vitro test developed as a replacement for the dermal corrosivity rabbit test. The Corrositex kit, manufactured by In Vitro International (IVI), uses a proprietary biobarrier membrane to model the skin for evaluating the potential dermal corrosivity of a test material. A test material is evaluated based on its penetration through...
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Product development/product stewardship scientists and formulators typically find it desirable to compare or rank order the skin irritation potential of candidate formulations, or to monitor the impact of changes in formulations or ingredients on skin tolerance. Foremost, industry researchers need timely, accurate, cost-effective test results to help them get safer products to the marketplace. The...
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Under ISO 10993-23, skin irritation testing can now be performed using in vitro testing methods based on Reconstructed human Epidermis (RhE) models for medical device biocompatibility evaluation. Test materials are extracted into physiological saline and sesame oil (extraction performed under ISO 10993-12). Using the MTT reagent, tissue viability is assessed at the completion of the...
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The efficacy of ingredients or final formulations in modulating human skin pigmentation can be assessed in vitro by analysis of melanin production in reconstructed tissue models of various phototypes. In addition, this testing platform is suitable for investigation of the dermal irritation potential of test materials after repeated exposures using a tissue viability endpoint. The...
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Many manufacturers of personal care and cosmetic products expect (along with their customers) that their products will not irritate the skin. Unfortunately, many ingredients (e.g. surfactants, preservatives, emulsifiers and many other organic substances) have an inherent irritating property. Although other in vitro assays can predict irritancy vs. non-irritancy for purposes of regulatory compliance, many of...
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