The ECVAM International Validation Study on In Vitro Tests for Skin Corrosivity. 2. Results and Evaluation by the Management Team

As a follow-up to a prevalidation study on IN VITRO tests for replacing the IN VIVO rabbit test for skin corrosivity, an international validation study was conducted during 1996 and 1997 under the auspices of ECVAM. The tests evaluated were the rat skin transcutaneous electrical resistance (TER) assay, CORROSITEX TM, the Skin 2TM ZK1350 corrosivity test and EPISKIN TM. Each test was conducted in three independent laboratories. Sixty coded chemicals were tested. Two of the four test evaluated, the TER assay and EPISKIN, met the criteria agreed by the Management Team concerning acceptable underprediction and overprediction rates for them to be considered scientifically validated for use as replacements for the animal test for distinguishing between corrosive and non-corrosive chemicals for all of the chemical types studied. EPSKIN was the only test able to distinguish between known R35 (UN packing group I) and R34 (UN packing groups II & III) chemicals, for all of the chemical types included, on an acceptable number of occasions. The corrosive potentials of about 40% of the test chemicals could not be assessed with CORROSITEX; however, it may be valid for testing specific classes of chemicals. The Skin 2 assay did not meet the criteria for it to be considered scientifically validated.

FENTEM Julia Helen;  ARCHER Graeme;  BALLS Michael;  BOTHAM Philip A.;  CURREN Rodger D.;  EARL Lesley;  ESDAILE David J.;  HOLZHUTTER Hermann;  LIEBSCH Manfred; 

1998-09-16

PERGAMON-ELSEVIER SCIENCE LTD

JRC16648

0887-2333,   

https://publications.jrc.ec.europa.eu/repository/handle/JRC16648,