Progress Report 2011
EXECUTIVE SUMMARY 9
INTRODUCTION 13
PROGRESS REPORTS FROM EU-FUNDED
PROJECTS 21
ACuteTox Optimisation & Pre-Validation of an In Vitro Test
Strategy for Predicting Human Acute Toxicity 22
carcinoGENOMICS Development of a High-Throughput
Genomics-Based Test for Assessing Genotixic & Carcinogenic
Properties of Chemical Compounds In Vitro 47
ChemScreen Chemical Substance In Vitro/In Silico Screening
System to Predict Human & Ecotoxicological Effects 63
COMICS Comet Assay & Cell Array for Fast & Efficient
Genotoxicity Testing 71
ESNATS Embryonic Stem Cell-Based Novel Alternative Testing
Strategies
76
INVITROHEART Reducing Animal Experimentation in Drug
Testing by Human Cardiomyocyte In Vitro Models Derived
from Embryonic Stem Cells 89
LIINTOP Optimisation of Liver & Intestine In Vitro Models for
Pharmacokinetics & Pharmacodynamics Studies 94
NanoTEST Development of Methodology for Alternative
Testing Strategies for the Assessment of the Toxicological
Profile of Nanoparticles Used in Medical Diagnostics 117
OpenTox Promotion, Development, Acceptance &
Implementation of QSARs for Toxicology 130
PREDICT-IV Profiling the Toxicity of New Drugs: A Non-AnimalBased
Approach Integrating Toxicodynamics & Biokinetics 147
Sens-it-iv Novel Testing Strategies for In Vitro Assessment of
Allergens 157
START-UP Scientific & Technological Issues in 3Rs
Alternatives Research in the Process of Drug Development
& Union Politics 179
VITROCELLOMICS Reducing Animal Experimentation in
Preclinical Predictive Drug Testing by Human Hepatic In
Vitro Models Derived from Embryonic Stem Cells 188
AXLR8-2 WORKSHOP REPORT 196
3.1 Overview 197
3.2 Scientific Programme 199
3.3 Workshop Presentations 201
The Human Toxicology Project Accelerating the
Transition to 21st Century Toxicology 203
Human Skin Disease Models 211
The Virtual Liver Spatial-Temporal Modelling of Tissue
Damage & Regeneration 218
The IMI eTOX Project Efforts to Develop In Silico Tools
to Predict In Vivo Toxicity 226
Update on EPA’s ToxCast Programme Providing
High-Throughput Decision Support Tools for
Chemical Risk Management 232
Embryonic Stem Cell Approaches Towards
Biomarkers of Embryotoxicity 244
The Virtual Embryo A Computational Framework
for Developmental Toxicity 253
The GARD Test A Novel Assay for Prediction of
Skin Sensitisers 259
Marker Discovery & Their Functional Role in the
Adverse Outcome Pathway for Skin Sensitisation 267
Skin Sensitisation Modelling the Human Adverse
Response 279
The OECD Adverse Outcome Pathway (AOP) Approach
A Case Study for Skin Sensitisation 288
Alternatives Research in Japan High-Throughput Assay
Systems for Carcinogenicity, Immunotoxicity &
Developmental Toxicity 301
Case Study Approaches for Implementing the 2007
NRC Report 312
Safety Assessment at Unilever Applying 21st
Century Toxicology 323
3.4 Breakout Group Reports 332
3.5 AXLR8 Scientific Panel Recommendations for
Future EU Research & Innovation Funding 351
DIRECTORY OF PROJECTS &
CO-ORDINATORS 358
GLOSSARY OF TERMS 360