The roles played by the European Centre for the Validation of Alternative Methods (ECVAM) and its advisory committee, the ECVAM Scientific Advisory Committee (ESAC), in the evolution of alternative methods are described. Particular emphasis is given to the process by which ECVAM and the ESAC assess the scientific validities of alternative methods, and, in appropriate cases, initiate the progression of scientifically validated methods toward regulatory acceptance.
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BallsM., & FentemJ.H. (1997). Progress toward the validation of alternative tests. ATLA25, 33–43.
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16.
SpielmannH., BallsM., DupuisJ., PapeW.J.W., PechovitchG., de SilvaO., HolzhütterH.G., ClothierR., DesolleP., GerberickF., LiebschM., LovellW.W., MaurerT., PfannenbeckerU., PolthastJ.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.
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SpielmannH., BallsM., DupuisJ., PapeW.J.W., de SilvaO., HolzhütterH.G., GerberickF., LiebschM., LovellW. W., & PfannenbeckerU. (1998). A study on UV filter chemicals from Annex VII of European Union Directive 76/768/EEC, in the in vitro 3T3 NRU phototoxicity test. ATLA26, 679–708.
18.
BarrattM.D., BrantomP.G., FentemJ.H., GernerI., WalkerA.P., & WorthA.P. (1998). The ECVAM international validation study on in vitro tests for skin corrosivity. 1. Selection and distribution of the test chemicals. Toxicology in Vitro12, 471–482.
19.
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.
20.
LiebschM., TraueD., SpielmannH., UphillP., WilkinsS., WiemannC., KaufmannT., RemmeleM., & HolzhütterH-G. (2000). The ECVAM prevalidation study on the use of EpiDerm for skin corrosivity testing. ATLA28, 371–401.
21.
BallsM. (1997). Defined structural and performance criteria would facilitate the validation and acceptance of alternative test procedures. ATLA25, 483–484.
22.
ECVAM (1998). Statement on the scientific validity of the EPISKINTM test (an in vitro test for skin corrosivity). ATLA26, 277–280.
23.
DeboyserP. (1998). Scientific validity of the 3T3 NRU PT test: note to ECVAM. ATLA26, 386.
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SCCNFP (1998). Opinion on In Vitro Methods to Assess Phototoxicity in the Safety Evaluation of Cosmetic Ingredients or Mixtures of Ingredients Adopted by the Plenary Session of the SCCNFP of 25 November 1998 (SCCNFP/0069/98 Final).3 pp. Brussels, Belgium: DG SANCO/C/2.
28.
ECVAM (1998). Statement on the scientific validity of the 3T3 NRU PT test (an in vitro test for phototoxic potential). ATLA26, 7–8.
29.
ECVAM (1998). Statement on the application of the 3T3 NRU PT test to UV filter chemicals. ATLA26, 385–386.
30.
ECVAM (1998). Statement on the scientific validity of the rat skin transcutaneous electrical resistance (TER) test (an in vitro test for skin corrosivity). ATLA26, 275–277.
31.
ECVAM (2001). Statement on the application of the EPIDERM® human skin model for skin corrosivity testing. ATLA28, 365–367.
32.
ECVAM (2001). Statement on the application of the CORROSITEX® assay for skin corrosivity testing. ATLA29, 96–97.
33.
NIH (1999). Corrositex: an In Vitro Test Method for Assessing Dermal Corrosivity Potential of Chemicals. NIH Publication No. 99–4495.233 pp. Research Triangle Park, NC, USA: National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM).
34.
ECVAM (2000). Statement on the validity of the local lymph node assay for skin sensitisation testing. ATLA28, 366–367.
35.
NIH (1999). The Murine Local Lymph Node Assay. the Results of an Independent Peer Review Evaluation Coordinated by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Toxicology Program Center for the Evaluation of Alternative Toxicological Methods (NICEATM). NIH Publication no. 99–4494.211 pp. Research Triangle Park, NC, USA: NIH.
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38.
ECVAM (1998). Statement on the scientific acceptability and practical availability of in vitro methods for the production of monoclonal antibodies. ATLA26, 383–385.
39.
MarxU., EmbletonM.J., FischerR., GruberF.P., HanssonU., HeuerJ., de LeeuwW., LogtenbergT., MerzW., PortetelleD., RometteJ-L., & StraughanD. (1997). Monoclonal antibody production. The report and recommendations of ECVAM workshop 23. ATLA25, 121–137.
40.
ECVAM (2001). Statement on the application of the ELISA procedure for the batch potency testing of tetanus vaccines for human use. ATLA29, 93–94.
41.
ECVAM (2001). Statement on the application of the ToBI test for the batch potency testing of tetanus vaccines for human use. ATLA29, 94–96.
42.
HendriksenC.F.M., WoltjesJ., AkkermansA.M., van der GunJ.W., MarsmanF.R., VerschureM.H., & VeldmanK. (1994). Interlaboratory validation of in vitro serological assay systems to assess the potency of tetanus toxoid in vaccines for veterinary use. Biologicals22, 257–268.
43.
ECVAM (2001). Statement on funding for the development of alternative methods in the Sixth Framework Programme. ATLA29, 391.
44.
ECVAM (2001). Statement on proposals for a seventh amendment to Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. ATLA29, 523.
45.
HalderM. (2001). Three Rs potential in the development and quality control of immunobiologicals. Position Paper of the Advisory Group on Alternatives to Animal Testing in Immunobiologicals (AGAATI) for Fonds für Versuchstierfreie Forschung (FFVFF). ALTEX18, (Suppl. 1), in press.
