Betekenis van:
epidermis

Voorbeeldzinnen

1. Histological examination of the reconstructed skin/epidermis should be performed by appropriately qualified personnel demonstrating human skin/epidermis-like structure (including multilayered stratum corneum).
2. The test substance is applied topically to a three-dimensional reconstructed human epidermis model, comprised of normal, human-derived epidermal keratinocytes, which have been cultured to form a multilayered, highly differentiated model of the human epidermis.
3. A reconstructed human epidermis model can be constructed, prepared or obtained commercially (e.g. EpiSkin™, EpiDerm™ and SkinEthic RHE™).
4. The reconstructed human epidermis model systems may be used to test solids, liquids, semi-solids and waxes.
5. A limitation of the reconstructed human epidermis tests falling under this Test Method is that they only classify substances as skin irritants according to UN GHS category 2.
6. Depending on the reconstructed human epidermis model used, the exposure period may vary between 15 to 60 minutes, and the incubation temperature between 20 and 37 °C.
7. The following is a description of the components and procedures of a reconstructed human epidermis model test for skin irritation assessment.
8. This may occur when a specific test substance is not completely removed from the skin by rinsing or when it penetrates the epidermis.
9. This Test Method also includes a set of performance standards for the assessment of similar and modified reconstructed human epidermis based test methods (7).
10. Skin Corrosion means the production of irreversible damage to the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test substance for up to 4 hours.
11. Prevalidation, optimisation and validation studies have been completed for two in vitro test methods (8, 9, 10, 11, 12, 13, 14, 15, 16, 17), commercially available as EpiSkin™ and EpiDerm™, using reconstructed human epidermis models.
12. Two other in vitro reconstructed human epidermis test methods, have been validated in accordance with the requirements under this Test Method, and show similar results as the validated reference method 1 (18).
13. Before a proposed in vitro reconstructed human epidermis model test for skin irritation can be used for regulatory purposes, its reliability, relevance (accuracy), and limitations for its proposed use should be determined to ensure that it is comparable to that of the validated reference method 1, in accordance with the performance standards set out in this Test Method (Appendix).
14. It consists of organised basal, spinous and granular layers, and a multilayered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The principle of the reconstructed human epidermis model test is based on the premise that irritant substances are able to penetrate the stratum corneum by diffusion and are cytotoxic to the cells in the underlying layers.