Reference Libraries

December 11, 2015

IN VITRO HUMAN SKIN IRRITATION TEST FOR EVALUATION OF MEDICAL DEVICE EXTRACTS.

Purpose: The aim of this study was to determine if the EpiDerm™ reconstructed human skin model (MatTek Corp.) could be an acceptable alternative to the ISO 10993-required rabbit skin irritation test for assessing medical device biocompatibility. Eleven medical device polymers were... Read More

December 11, 2015

CLASSIFICATION AND LABELING OF INDUSTRIAL PRODUCTS WITH EXTREME PH BY MAKING USE OF IN VITRO METHODS FOR THE ASSESSMENT OF SKIN AND EYE IRRITATION AND CORROSION IN A WEIGHT OF EVIDENCE APPROACH.

Classification and labeling of products with extreme pH values (62 or P11.5) is addressed in chemicals legislation. Following determination of pH and alkaline/acid reserve, additional in vitro tests are needed, especially to substantiate results less than corrosive. However, only limited... Read More

December 11, 2015

A REPRODUCIBLE SKIN MODEL FOR DERMAL SAFETY AND EFFICACY TESTING.

The utility of any toxicological test system or method critically depends on the short and long term reproducibility of the method. Over the past 6 years, histological observations and quantitative quality control test methods utilizing the MTT assay have established... Read More

December 11, 2015

EVALUATION OF AN IN VITRO HUMAN SKIN IRRITATION TEST FOR USE WITH MEDICAL DEVICE EXTRACTS

In accordance with ISO 10993, the rabbit skin irritation test is used to assess medical device biocompatibility, however, this method is time-consuming and expensive. Our study’s goal was to determine if the EpiDerm™ reconstructed human skin model (MatTek Corp.) could... Read More

December 11, 2015

IN VITRO SKIN IRRITATION TEST: INCREASING THE SENSITIVITY OF THE EPIDERM SKIN IRRITATION PROTOCOL EVALUATED IN THE ECVAM SKIN IRRITATION VALIDATION STUDY.

This study by scientists at MatTek Corp. demonstrated that a modification of the common Skin Irritation protocol that extended the exposure time from 15 minutes to 60 minutes for MatTek’s EpiDerm in vitro human skin tissue model produced a significant... Read More