MatTek's EpiDerm In Vitro Tissues Headed for Validation in Europe

Acceptance Will Reduce Animal Use in Cosmetics and Chemicals Testing

13-Oct-2008 - USA

MatTek Corp. announced that results of a recently completed US and European multi-laboratory "catch-up" validation study on MatTek's EpiDerm in vitro human skin tissue equivalent. The test results demonstrated the required sensitivity and specificity for EpiDerm to be accepted as a validated alternative to animal testing for determining human skin irritation by the European ECVAM Scientific Advisory Committee (ESAC).

Horst Spielmann, former Director, ZEBET (BfR), commenting on the skin irritation catch-up validation studies in AltTox.org, noted that the "take home message" from these new studies is that EpiDerm was not only successfully validated using just one endpoint (cytotoxicity -- MTT viability), but also that the EpiDerm classification test results met the criteria set by the validated skin irritation test method.

The results obtained for EpiDerm in the catch-up validation studies have been submitted to ECVAM for approval by the ECVAM Scientific Advisory Committee (ESAC) at its next meeting on Nov. 3-4, 2008.

Spielmann went on the say that it would be helpful in promoting the new in vitro skin irritation test in Europe if these catch-up validation results are taken into account at the OECD Expert Meeting being held in Berlin, Germany on October 20-21, 2008 to review the new Draft OECD Test Guideline on "In Vitro Skin Irritation: Human Skin Model." Inclusion of EpiDerm in this OECD Test Guideline will lead to EpiDerm acceptance in the very near future to meet the skin irritation testing requirements of the 6th amendment of the EU Cosmetics Directive and of the new EU Chemicals Directive (REACH).

John Sheasgreen, MatTek's President, added, "It is very gratifying to see MatTek's almost 15 years of in vitro human tissue equivalent development and production culminating in the full validation of these tissues as alternatives to animal testing."

https://www.bionity.com/en/news/88068/mattek-s-epiderm-in-vitro-tissues-headed-for-validation-in-europe.html