European Commission
Joint Research Centre
Institute for Health & Consumer Protection
ECVAM Unit21020 Ispra (VA)
Italy

ECVAM

European Centre for the Validation of Alternative Methods

STATEMENT ON THE APPLICATION OF THE CORROSITEX ASSAY
FOR SKIN CORROSIVITY TESTING

At its 15th meeting, held on 5-6 December 2000 at the European Centre for the Validation of
Alternative Methods (ECVAM), Ispra, Italy, the ECVAM Scientific Advisory Committee (ESAC) 1
unanimously endorsed the following statement:
Following a review of scientific reports and publications on the CORROSITEX assay2-7, it
is concluded that the CORROSITEX assay is a scientifically validated test, but only for
those acids, bases and their derivatives which meet the technical requirements of the assay.

Michael Balls
Head of Unit
ECVAM
Institute for Health & Consumer Protection
Joint Research Centre
European Commission
Ispra

Eva Hellsten
Head of Unit E.2
Environment Directorate General
European Commission
Brussels

6 December 2000

1. The ESAC was established by the European Commission, and is composed of representativesof the EU Member States, industry, academia and animal welfare, together withrepresentatives of the relevant Commission services. The following members of the ESAC
were present at the meeting on 5-6 December 2000:
Dr B Blaauboer (ERGATT)
Professor J Castell (Spain)
Dr D Clark (UK)Dr B Garthoff (EFPIA)
Professor A Guillouzo (France)
Professor C Hendriksen (The Netherlands)
Professor G Koptopoulos (Greece)
Professor V Rogiers (Belgium)
Dr B Rusche (EUROGROUP for Animal Welfare)
Dr O de Silva (COLIPA)
Professor H Spielmann (Germany)
Professor O Svendsen (Denmark)Professor H Tritthart (Austria)
Dr M Viluksela (Finland)
Professor E Walum (Sweden)
Dr F Zucco (EUROGROUP for Animal Welfare)Mr M Balls (ECVAM - Chairman)
Ms B Lucaroni (DG RTD)
Mr L Nørgaard (DG ENTR)
Mr J Riego Sintes (ECB)Mr E Sabbioni (ECVAM)
Mr F Mc Sweeney (IHCP)Mr G Willmott (DG ENV)
Mr A Worth (ECVAM)

2. NIH (1999). Corrositex: an in vitro test method for assessing dermal corrosivity potential ofchemicals. NIH Publication No. 99-4495. National Toxicology Program (NTP) Interagency
Center for the Evaluation of Alternative Toxicological Methods (NICEATM), NC, USA.
3. Botham, P.A., Chamberlain, M., Barratt, M.D., Curren, R.D., Esdaile, D.J., Gardner, J.R.,
Gordon, V.C., Hildebrand, B., Lewis, R.W., Liebsch, M., Logemann, P., Osborne, R., Ponec,M., Régnier, J-F., Steiling, W., Walker, A.P. & Balls, M. (1995). A prevalidation study on invitro skin corrosivity testing. The report and recommendations of ECVAM Workshop 6. ATLA23, 219-255.
4. Fentem, J.H., Archer, G.E.B., Balls, M., Botham, P.A., Curren, R.D., Earl, L.K., Esdaile, D.J.,
Holzhütter, H.G. & Liebsch, M. (1998). The ECVAM international validation study on in vitro
tests for skin corrosivity. 2. Results and evaluation by the management team. Toxicology inVitro 12, 483-524.
5. Gordon, V.C., Harvell, J.D. & Maibach, H.I. (1994). Dermal corrosion, the CORROSITEXTM
system: a DOT accepted method to predict corrosivity potential of test materials. In In Vitro
Skin Toxicology - Irritation, Phototoxicity, Sensitization. Alternative Methods inToxicology, Volume 10 (ed. A. Rougier, A.M. Goldberg & H.I. Maibach). pp. 37-45. MaryAnn Liebert, New York.
6. Scala, R., Stokes, W., Hill, R., Goldsworthy, T., Tice, R. & Haneke, K. The results of an
independent peer review panel evaluation of the validation status of CORROSITEX. Abstractsof the 3rd World Congress on Alternatives and Animal use in the Life Sciences. ATLA 27,p.334.

7. Comments on the NIH report2 from the Agency for Toxic Substances and Disease Registry(ATSDR), the Environmental Protection Agency (EPA), and the National Institute for
Occupational Safety and Health (NIOSH).