SkinEthic Labotories

SkinEthic Reconstructed Human Epidermis RHE validated in Europe

19.12.2008

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SkinEthic announces the validation of its Reconstructed Human Epidermis as a full replacement of the Draize test for skin irritation after the ECVAM Scientific Advisory Committee (ESAC) statement on November 5th, submitted to the ECVAM under a catch up validation process.

  

At its 29th meeting, the ECVAM Scientific Advisory Committee (ESAC) unanimously endorsed a Statement on the scientific validity of two in vitro tests for skin irritation testing: these "two test methods are both based on reconstructed human epidermis and measure or predict the same biological or toxic effect as the fully validated and accepted reference method (*) ….
1. EpiDerm SIT – update validation study: modification of the validated EpiDerm Test (MTT endpoint)
2. SkinEthic RHE assay –external catch up validation study (MTT endpoint)".
 
This statement reinforces the SkinEthic leadership in tissue engineering with two validated methods: EpiSkin in 2007 and RHE in 2008.
 
The SkinEthic RHE validated protocol, 42 min exposure, 42 hours incubation time, based on a simple cytotoxic end-point (MTT), showed a good specificity (80%) and sensitivity (90%) with an overall accuracy of 85% during the validation process by three lead and participating laboratories. This ready-to-use model, also validated for skin corrosion, is exclusively commercialized by SkinEthic Laboratories, an ISO 9001 certified company.
 
Both validated models RHE and  Episkin , and the others patented models (HCE,…) proposed worldwide by SkinEthic will reduce the animal use in cosmetics and chemicals testing. Right now, thousands of cosmetic finished products and hundred of raw materials have been tested on Episkin and RHE. But they are all available to Industries, Contract Research Organizations and Academic Research Institutions that promote in vitro toxicology testing.
 
 
(*) The fully validated Reference Method is EpiSkin provided by SkinEthic
 
 
About us: SkinEthic, founded in 1992, is the world leader in 3D human reconstructed tissues development and production. SkinEthic leadership is based on a cumulated experience in R&D, mass production under quality management, and customer education and training.
 
With validated methods for skincorrosion and skin irritation, SkinEthic provides solutions compliant with both, the REACh Regulation and the 7th Amendment of the European Cosmetic Directive.
 
SkinEthic models are recognized as reference tools for safety assessment, basic research, product development, drug discovery, claim substantiation by major chemical, pharmaceutical, household, biotech and cosmetic companies.

 

 EpiSkin (reference method)Modified EpiDerm SITSkinEthic RHE
Specificity808080
Sensitivity708090
False positive rate202020
False negative rate302010
Accuracy758085





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