Adaptation of the validated SkinEthic Reconstructed Human Epidermis (RHE) skin corrosion test method to 0.5 cm2 tissue sample.

At its 25th meeting the ECVAM Scientific Advisory Committee (ESAC) unanimously endorsed that the SkinEthic Reconstructed Human Epidermis (RHE) model could be used for distinguishing between corrosive and non-corrosive chemicals within the context of the Organisation Economic for Co-operation and Development (OECD) test guideline, TG 431 (ESAC 16-17 November 2006). Both test method development and multi-center study were performed using 0.63 cm(2) RHE tissue samples.

A catch-up validation study on reconstructed human epidermis (SkinEthic RHE) for full replacement of the Draize skin irritation test.

Efforts to fully replace the in vivo Draize skin irritation test, according to the Directive 67/548/ECC or OECD TG 404, were reinforced with the seventh Amendment of the Cosmetic Directive and the REACh regulation. In 2007, the EpiSkin test method was scientifically validated and recognized as the stand alone method to discriminate skin irritants (R38) from non-irritants (no label) according to the definition of the EU risk phrases. An ECVAM performance standards (PS) document was defined to evaluate the accuracy and reliability of other analogous test methods (ECVAM SIVS, May 2007).

Assessment of the optimized SkinEthic Reconstructed Human Epidermis (RHE) 42 bis skin irritation protocol over 39 test substances.

The development of in vitro protocols able to discriminate skin irritants from non-irritants integrates the toxicologists' needs for reliable and robust in vitro tools for screening test substances. Based on EpiSkin test method, validated by ESAC (ECVAM Scientific Advisory Committee) in April 2007 as the Draize skin irritation replacement reference test method, we present and discuss here the results obtained by adapting protocols to the SkinEthic Reconstructed Human Epidermis (RHE) model. The main adaptations of the validated reference protocol consists in a modulated exposure time (15, 42 or 60min) followed by a rinsing step and a 42h post-incubation period before quantitative measurement of cell viability by MTT reduction.

Transcriptional profiling defines the effects of nickel in human epidermal keratinocytes.

Nickel is a ubiquitous and virtually unavoidable environmental pollutant and occupational hazard, but its molecular and cellular effects are not well understood. Human epidermal keratinocytes are the sentinel and the primary target for nickel. We treated with nickel salts skin equivalents containing differentiating epidermal keratinocytes grown on air-liquid interface in standard cell culture conditions.

LAV694, a new antiproliferative agent showing improved skin tolerability vs. clinical standards for the treatment of actinic keratosis.

The skin tolerability of the tubulin polymerisation inhibitor LAV694 was compared to that of 5% 5-fluorouracil (5-FU) and 0.5% podophyllotoxin in vitro using a human reconstructed epidermis (HRE), and in vivo using minipigs. Topical treatment of HRE for 1 or 3 days with a 0.