This paper outlines the research, prevalidation and validation activities that ECVAM has undertaken in collaboration with its partners in the field of topical toxicity testing and human volunteer studies, from its creation until now (1994–2002).
RogiersV., BallsM., BasketterD., BerardescaE., EdwardsC., ElsnerP., EnnenJ., LévêqueJ.L., LódenM., MassonP., ParraJ., PayeM., PiérardG., RodriguesL., SchaeferH., SalterD., & ZuangV. (1999). The potential use of non-invasive methods in the safety assessment of cosmetic products. The report and recommendations of an ECVAM/EEMCO workshop (ECVAM workshop 36). ATLA27, 515–537.
2.
ZuangV., RonaC., DistanteF., & BerardescaE. (1997). The use of a capacitance device to evaluate the hydration of human skin. Journal of Applied Cosmetology15, 95–102.
3.
ZuangV., & BerardescaE. (1998). Designing and performing clinical studies with bioengineering techniques. In Skin Bioengineering Techniques and Applications in Dermatology and Cosmetology: Current Problems in Dermatology. Vol. 26. (ed. ElsnerP., BarelA.O., BerardescaE., GabardB., & SerupJ.), 209–216. Basle, Switzerland: S. Karger.
4.
ZuangV., ArcherG., RonaC., VigniniM., MoscaM., & BerardescaE. (2000). Predicting visual assessment of allergic patch test reactions by non-invasive measurements. Skin Pharmacology and Applied Skin Physiology13, 39–51.
5.
ZuangV., RonaC., ArcherG., & BerardescaE. (2000). Detection of skin irritation potential of cosmetics by non-invasive measurements. Skin Pharmacology and Applied Skin Physiology13, 358–371.
6.
BothamP.A., ChamberlainM., BarrattM.D., CurrenR.D., EsdaileD.J., GardnerJ.R., GordonV.C., HildebrandB., LewisR.W., LiebschM., LogemannP., OsborneR., PonecM., RégnierJ-F., SteilingW., WalkerA.P., & BallsM. (1995). A prevalidation study on in vitro skin corrosivity testing. The report and recommendations of ECVAM workshop 6. ATLA23, 219–255
7.
FentemJ.H., ArcherG.E.B., BallsM., BothamP.A., CurrenR.D., EarlL.K., EsdaileD.J., HolzhütterH-G., & LiebschM. (1998). The ECVAM international validation study on in vitro tests for skin corrosivity. 2. Results and evaluation by the Management Team. Toxicology in Vitro12, 483–524, 1998.
8.
LiebschM., TraueD., BarrabasC., SpielmannH., UphillP., WilkinsS., McPhersonJ.P., WiemannC., KaufmannT., RemmeleM., & HolzhütterH-G. (2000). The ECVAM prevalidation study on the use of EpiDerm™ for skin corrosivity testing. ATLA28, 371–401.
9.
ECVAM (1998). Statement on the scientific validity of the TER and EPISKIN™ methods. ATLA26, 275–280.
10.
ECVAM (2000). Statement on the application of the EpiDerm™ human skin model for skin corrosivity testing. ATLA28, 365–366.
11.
ECVAM (2001). Statement on the application of the CORROSITEX® assay for skin corrosivity testing. ATLA29, 96–97.
12.
EC (2000). Commission Directive 2000/33/EC of 25 April 2000 adapting to technical progress for the 27th time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal of the European CommunitiesL136, 90–107.
13.
BothamP.A., EarlL.K., FentemJ.H., RoguetR., & van de SandtJ.J.M. (1998). Alternative methods for skin irritation testing: the current status. ECVAM Skin Irritation Task Force Report 1. ATLA26, 195–211.
14.
FentemJ.H., BriggsD., ChesnéC., ElliottG.R., HarbellJ.W., HeylingsJ.R., PortesP., RoguetR., van de SandtJ.J.M., & BothamP.A. (2001). A prevalidation study on in vitro tests for acute skin irritation: results and evaluation by the Management Team. Toxicology in Vitro15, 57–93.
15.
ZuangV., BallsM., BothamP.A., CoquetteA., CorsiniE., CurrenR.D., ElliottG.R., FentemJ.H., HeylingsJ.R., LiebschM., MedinaJ., RoguetR., van de SandtJ.J.M., WiemannC., & WorthA.P. (2002). Follow-up to the ECVAM prevalidation study on in vitro tests for acute skin irritation. ECVAM Skin Irritation Task Force Report 2. ATLA30, 109–129.
16.
De SilvaO., BasketterD.A., BarrattM.D., CorsiniE., CroninM.T.D., DasP.K., DegwertJ., EnkA., GarrigueJ.L., HauserC., KimberI., LepoittevinJ-P., PeguetJ., & PonecM. (1996). Alternative methods for skin sensitisation testing. ECVAM workshop report 19. ATLA24, 683–705.
17.
ECVAM (2000). Statement on the scientific validity of the local lymph node assay. ATLA28, 366–367.
18.
SpielmannH., BallsM., DupuisJ., PapeW.J.W., PechovitchG., DeSilvaO., HölzhutterH.G., ClothierR.H., DesolleP., GerberickF., LiebschM., LovellW.W., MaurerT., PfannenbeckerU., PotthastJ.M., CsatoM., SladowskiD., SteilingW., & BrantomP. (1998). The international EU/COLIPA in vitro phototoxicity validation study: results of Phase II (blind trial); part 1: the 3T3 NRU phototoxicity test. Toxicology in Vitro12, 305–327.
19.
SpielmannH., BallsM., DupuisJ., PapeW.J.W., DeSilvaO., HolzhütterH.G., GerberickF., LiebschM., LovellW.W., & PfannenbeckerU. (1998). A study on the phototoxic potential of UV filter chemicals from Annex VII of European Union Directive 76/768/EEC in the 3T3 NRU in vitro phototoxicity test. ATLA26, 679–705.
20.
ECVAM (1998). Statement on the scientific validity of the 3T3 NRU PT test (an in vitro test for phototoxic potential). ATLA26, 7–8.
21.
ECVAM (1998). Statement on the application of the 3T3 NRU PT test to UV filter chemicals. ATLA26, 385–386.
22.
LiebschM., BarrabasC., TraueD., & SpielmannH. (1997). Entwicklung eines neuen in vitro Tests auf dermale Phototoxizität mit einem Modell menschlicher Epidermis (EpiDerm™). ALTEX4, 165–174.
23.
SpielmannH., MüllerL., AverbeckD., BallsM., Brendler-SchwaabS., CastellJ.V., CurrenR., de SilvaO., GibbsN.K., LiebschM., LovellW.W., MerkH.F., NashJ.F., NeumannN.J., PapeW.J.W., UlrichP., & VohrH.W. (2000). The second ECVAM workshop on phototoxicity testing. The report and recommendations of ECVAM workshop 42. ATLA28, 777–814.
24.
HowesD., GuyR., HadgraftJ., HeylingsJ., HoeckU., KemperF., MaibachH., MartyJ-P., MerkH., ParraJ., RekkasD., RondelliI., SchaeferH., TäuberU., & VerbieseN. (1996). Methods for assessing percutaneous absorption. The report and recommendations of ECVAM workshop 13. ATLA24, 81–106.
25.
BallsM., BothamP.A., BrunerL.H., & SpielmannH. (1995). The EC/HO international validation study on alternatives to the Draize eye irritation test. Toxicology in Vitro9, 871–929.
26.
BrantomP.G., BrunerL.H., ChamberlainM., De SilvaO., DupuisJ., EarlL.K., LovellD.P., PapeW.J.W., & UttleyU. (1997). A summary report of the COLIPA international validation study on alternatives to the Draize rabbit eye irritation test. Toxicology in Vitro11, 141–179.
27.
SpielmannH., KalweitS., LiebschM., Wirns-bergerT., GernerI., Bertram-NeisE., KrauserK., KreilingR., MiltenburgerG., PapeW., & SteilingW. (1993). Validation study of alternatives to the Draize eye irritation test in Germany: cytotoxicity testing and HETCAM test with 136 industrial chemicals. Toxicology in Vitro7, 505–510.
28.
SpielmannH., LiebschM., KalweitS., MoldenhauerF., WirnsbergerT., HolzhütterH-G., SchneiderB., GlaserS., GernerI., PapeW.J.W., KreilingR., KrauserK., MiltenburgerH.G., SteilingW., LuepkeN.P., MüllerN., KreuzerH., MurmannP., SpenglerJ., Bertram-NeisE., SiegemundB., & WiebelF.J. (1996). Results of a validation study in Germany on two in vitro alternatives to the Draize eye irritation test, the HETCAM test and the 3T3 NRU cytotoxicity test. ATLA24, 741–858.
29.
GettingsS.D., TealJ.J., BagleyD.M., DemetruliasJ.L., DiPasqualeL.C., HintzeK.L., RozenM.G., WeiseS.L., ChudrowskiM., MarenusK.D., PapeW.J.W., RoddyM., SchnetzingerR., SilberP.M., GlazaS.M., & KurtzP.J. (1991). The CTFA evaluation of alternatives program: an evaluation of in vitro alternatives to the Draize primary eye irritation test (Phase I) Hydroalcoholic formulations; (Part 2) Data analysis and biological significance. In Vitro Toxicology4, 247–288.
30.
GettingsS.D., DiPasqualeL.C., BagleyD.M., CastertonP.L., ChudkowskiM., CurrenR.D., DemetruliasJ.L., FederP.I., GalliC.L., GayR., GlazaS.M., HintzeK.L., JanusJ., KurtzP.J., LordoR.A., MarenusK.D., MoralJ., MuscatielloM., PapeW.J.W., RenskersK.J., RoddyM.T., & RozenM.G. (1994). The CTFA evaluation of alternatives program: an evaluation of in vitro alternatives to the Draize primary eye irritation test (Phase II) Oil/water emulsions. Food and Chemical Toxicology32, 943–976.
31.
GettingsS.D., LordoR.A., DemetruliasJ., FederP.I., & HintzeK.L. (1996). Comparison of low-volume, Draize and eye irritation test data. I. Hydroalcoholic formulations. Food and Chemical Toxicology8, 737–749.
32.
GettingsS.D., LordoR.A., HintzeK.L., BagleyD.M., CastertonP.L., ChudrowskiM., CurrenR.D., DemetruliasJ.L., DipasqualeL.C., EarlL.K., FederP.I., GalliC.L., GlazaS.M., GordonV.C., JanusJ., KurtzP.J., MarenusK.D., MoralJ., PapeW.J.W., RenskersK.J., RheinsL.A., RoddyM.T., RozenM.G., TedeschiJ.P., & ZyrackiJ. (1996). The CTFA evaluation of alternatives program: an evaluation of in vitro alternatives to the Draize primary eye irritation test (Phase III) Surfactant-based formulations. Food and Chemical Toxicology34, 79–117.
33.
BradlawJ., GuptaK., GreenS., HillR., & WilcoxN. (1997). Practical application of non-whole animal alternatives: summary of IRAG workshop on eye irritation testing. Food and Chemical Toxicology35, 175–178.
34.
OhnoY., KanekoT., KobayashiT., InoueT., KuroiwaY., YoshidaT., MommaJ., HayashiM., AkiyamaJ., AtsumiT., ChibaK., EndoT., FujiiA., KakishimaH., KojimaH., MasamotoK., MasudaM., MatsukawaS., OhkoshiK., OkadaJ., SakamotoK., TakanoK., & TakanakaA. (1994). First-phase validation of the in vitro eye irritation tests for cosmetic ingredients. In Vitro Toxicology7, 89–94.
35.
BallsM., BergN., BrunerL.H., CurrenR.D., de SilvaO., EarlL.K., EsdaileD.J., FentemJ.H., LiebschM., OhnoY., PrinsenM.K., SpielmannH., & WorthA.P. (1999). Eye irritation testing: the way forward. The report and recommendations of ECVAM workshop 34. ATLA27, 53–77.
36.
ZuangV. (2001). The neutral red release assay: a review. ATLA29, 575–599.
