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Skin Sensitization

929

Experiments in the EpiDerm 3D Skin In Vitro Model and Minipigs In Vivo Indicate Comparatively Lower In Vivo Skin Sensitivity of Topically Applied Aneugenic Compounds

Risk management of in vitro aneugens for topically applied compounds is not clearly defined because there is no validated methodology to accurately measure compound concentration in proliferating stratum basale keratinocytes of the skin. Here, we experimentally tested several known aneugens in the EpiDerm reconstructed human skin in vitro micronucleus assay and compared the results to […]
882

In vitro RHE skin sensitization assays: Applicability to challenging substances

In the last 20 years, alternative approaches to the identification of skin sensitization hazards have been at the forefront of the 3Rs and have helped refine the validation and acceptance processes. However, experience with the local lymph node assay showed that, post-validation, challenges still occurred, particularly when a wider diversity of chemical substances was addressed, […]
809

Application of Mattek In Vitro Reconstructed Human Skin Models for Safety, Efficacy Screening, and Basic Preclinical Research

During the past three decades, great progress has been achieved in the development of in vitro reconstructed human epidermal (RhE) tissue models. This technology is now available via various manufacturers of commercially available tissue models, and has provided opportunities for researchers worldwide to reduce or even completely avoid in vivo experimentation for screening and prediction of cutaneous […]
796

Evaluation of an In Vitro Human Dermal Sensitization Test for Use with Medical Device Extracts

In accordance with ISO 10993-10, the guinea pig maximization test, Buehler test, or murine local lymph node assay are used to assess the dermal sensitization potential of medical devices. The goal of our study was to determine if the in vitro SenCeeTox assay could be an acceptable alternative. The SenCeeTox assay has previously been shown to accurately […]