Lessons learned from validation of in vitro toxicity test: From failure to acceptance into regulatory practice

Toxicology in Vitro

Volumn 15, Issue 4-5, 2001, Pages 585-590

  Spielmann, H ^a   Liebsch, M ^a  

^a FEDERAL INSTITUTE FOR RISK ASSESSMENT   (Germany)

Author keywords

Embryonic stem cell test; Embryotoxicity; EST; In vitro toxicity; Micromass assay; Phototoxicity; Regulatory acceptance; Skin corrosivity; Validation; Whole embryo culture

Indexed keywords

CELL CULTURE; CONFERENCE PAPER; EMBRYO CELL; EMBRYOTOXICITY; HUMAN; IN VITRO STUDY; INTERNATIONAL COOPERATION; LAW; LIMB BUD; MATHEMATICAL MODEL; NONHUMAN; PHOTOTOXICITY; PRACTICE GUIDELINE; PREDICTION; SENSITIZATION; SKIN TEST; STEM CELL; SWITZERLAND; UNITED STATES; VALIDATION PROCESS;

ANIMAL TESTING ALTERNATIVES; ANIMALS; DRUG AND NARCOTIC CONTROL; EUROPEAN UNION; INTERNATIONAL COOPERATION; MULTICENTER STUDIES; REPRODUCIBILITY OF RESULTS; TOXICITY TESTS; TOXICOLOGY;

EID: 0034824347     PISSN: 08872333     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0887-2333(01)00070-4     Document Type: Conference Paper

References (27)

1. Defined structural and performance criteria would facilitate the validation and acceptance of alternative test procedures
2. Statement on the scientific validity of the 3T3 NRU PT test (an in vitro test for phototoxic potential)
3. Report and recommendations of the CAAT/ERGATT workshop on the validation of toxicity test procedures
4. The EC/HO international validation study on alternatives to the Draize eye irritation test
5. Practical aspects of the validation of toxicity test procedures. The report and recommendations of ECVAM Workshop 5
6. Summary report of the COLIPA international validation study on alternatives to the Draize rabbit eye irritation test
7. The role of prevalidation in the development, validation and acceptance of alternative methods
8. Statement on the scientific validity of the rat skin transcutaneous resistance (TER) test and the EPISKIN™ test (in vitro tests for skin corrosivity)
9. Statement on the application of the EpiDerm™ human skin model for skin corrosivity testing
10. Statement on the validity of the local lymph node assay for skin sensitisation testing
11. Test guideline B-41 "phototoxicity - In vitro 3T3 NRU phototoxicity test" of Annex V of the EU Directive 86/906/EEC for classification and labelling of hazardous chemicals
12. Test guideline B-40 "skin corrosivity - In vitro method" of Annex V of the EU Directive 86/906/EEC for classification and labelling of hazardous chemicals
13. The ECVAM international validation study on in vitro tests for skin corrosivity 2. Results and evaluation by the Management Team
14. Development of prediction models for three in vitro embryotoxicity tests in an ECVAM validation study
15. The ECVAM prevalidation study on the use of EpiDerm for skin corrosivity testing
16. First-phase validation of the in vitro eye irritation test for cosmetic ingredients
17. EC/COLIPA project on in vitro phototoxicity testing: first results obtained with the Balb/c 3T3 cell phototoxicity assay
18. In vitro phototoxicity testing. The report and recommendations of ECVAM Workshop 2
19. Results of a validation study in Germany on two in vitro alternatives to the Draize eye irritation test, the HET-CAM test and the 3T3 NRU cytotoxicity test
20. IRAG Working Group 2: CAM-based assays
21. The international EU/COLIPA in vitro phototoxicity validation study: Results of Phase II (blind trial); Part 1: The 3T3 NRU phototoxicity test
22. W and Pfannenbecker U.A. study on UV filter chemicals from Annex VII of European Union Directive 76/768/EEC, in the in vitro 3T3 NRU phototoxicity test