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Acute toxicity - Workshop reports and publications

Workshop reports


  • Atterwill et al., 1994. In Vitro Neurotoxicity Testing. ECVAM Workshop Report 3ATLA 22, 350-362.  pdf icon
  • Hawksworth et al., 1995. Nephrotoxicity Testing In Vitro. ECVAM Workshop Report 10ATLA 23, 713-727 pdf icon 
  • Seibert H, Balls M, Fentem JH, Bianchi V, Clothier RH, Dierickx PJ et al. 1996. Acute toxicity testing in vitro and the classification and labelling of chemicals. The report and recommendations of ECVAM Workshop 16. Alt. Lab. Anim. 24:499-510  pdf icon 
  • Le Ferrec, E. et al., 2001. In Vitro Models of the Intestinal Barrier. ECVAM Workshop Report 46ATLA 29, 649-668   pdf icon
  • Prieto et al., 2004. Blood-Brain Barrier In Vitro models and their Application in Toxicology. ECVAM Workshop Report 49ATLA 32, 37-50.  pdf icon 
  • Gennari A, van den Berghe C, Casati S, Castell J, Clemedson C, Coecke S. et al. 2004. Strategies to replace in vivo avute systemic toxicity testing. The report and recommendations of ECVAM Workshop 50. Alt. Lab. Anim. 32:437-459.  pdf icon
  • Coecke et al., 2006. Metabolism: A Bottleneck in In Vitro Toxicological Test Development. ECVAM Workshop 54ATLA 34, 49-84.  pdf icon 
  • Bouvier d'Yvoire et al., 2007. Physiologically-based Kinetic Modelling (PBK Modelling): Meeting the 3Rs Agenda. ECVAM Workshop Report 63.. ATLA 35, 661-671.  pdf icon
  • Kinsner et al., 2009. Overcoming Barriers to Validation of Non-animal Partial Replacement Methods/Integrated Testing Strategies. EPAA-ECVAM Workshop Report. ATLA 37, 1-8  pdf icon
  • Acute Toxicity Testing Across Sectors. EPAA Workshop report 2010. Available at: EPAA Workshop: Acute Toxicity Testing Across Sectors pdf icon


Other relevant publications

  • Spielmann, H., Genschow, E., Liebsch, M., Halle, W., 1999. Determination of the starting dose for acute oral toxicity (LD50) testing in the up and down procedure (UDP) from cytotoxicity data. Alt. Lab. Anim. 27, 957-66.
  • National Institutes of Health (NIH), 2001. Report Of The International Workshop On In Vitro Methods For Assessing Acute Systemic Toxicity. NIH Publication No. 01-4499. Research Triangle Park, NC:National Institute for Environmental Health Sciences. Available from: National Toxicology Program
  • Halle, W., 2003. The Registry of Cytotoxicity: Toxicity Tesing in Cell Cultures to predict Acute Toxicity (LD50) and to reduce Tesing in Animals. Alt. Lab. Anim. 31, 89-198.
  • Botham P.A., 2004. Acute systemic toxicity--prospects for tiered testing strategies. Toxicol In Vitro. 18(2), 227-30.
  • National Institutes of Health (NIH), 2006. Background Review Document (BRD): Validation of Neutral Red Uptake Test Methods NIH /In Vitro Cytotoxicity Test Methods for Estimating Acute Oral Systemic Toxicity. Publication No. 07-4518, November 2006. Available from: National Toxicology Program 
  • Robinson, S., Delongeas, J.L., Donald, E., Dreher, D., Festag, M., Kervyn, S., Lampo, A., Nahas, K., Nogues, V., Ockert, D., Quinn, K., Old, S., Pickersgill, N., Somers, K., Stark, C., Stei, P., Waterson, L., Chapman, K., 2008. A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development. Regul. Toxicol. Pharmacol. 50, 345-352.
  • Clothier, R., Dierickx, P., Lakhanisky, T., Fabre, M., Betanzos, M., Curren, R., Sjöström, M., Raabe, H., Bourne, N., Hernandez, V., Mainez, J., Owen, M., Watts, S., Anthonissen, R., 2008. A database of IC50 values and principal component analysis of results from six basal cytotoxicity assays, for use in the modelling of the in vivo and in vitro data of the EU ACuteTox project. Alt. Lab. Anim. 36, 503–519.
  • Bulgheroni et al., 2009. Estimation of acute oral toxicity using the No Observed Adverse Effect Level (NOAEL) from the 28 day repeated dose toxicity studies in rats. Regul. Toxicol. Pharmacol. 53(1), 16-9
  • ICH, 2009. Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals M3(R2)
  • Kinsner-Ovaskainen, A., Rzepka, R., Rudowski, R., Coecke, S., Cole, T., Prieto, P. 2009. Acutoxbase, an innovative database for in vitro acute toxicity studies. Toxicology in Vitro 23, 476–485
  • National Institutes of Health (NIH), 2009. The report on the ICCVAM-NICEATM/ECVAM/JaCVAM Scientific Workshop on Acute Chemical Safety Testing: Advancing In Vitro Approaches and Humane Endpoints for Systemic Toxicity Evaluations. Available from National Toxicology Program.
  • Creton et al., 2010. Cross-sector review of drivers and available 3Rs approaches for acute systemic toxicity testing. Toxicol Sci. 116(2), 382-96.
  • Forti E, Bulgheroni A, Cetin Y, Hartung T, Jennings P, Pfaller W, Prieto P. 2010. Characterisation of cadmium chloride induced molecular and functional alterations in airway epithelial cells. Cell Physiol Biochem. 25(1): 159-68.
  • Hoffmann S., Kinsner-Ovaskainen A., Prieto P., Mangelsdorf I., Bieler C., Cole T. 2010. Acute oral toxicity: Variability, reliability, relevance and interspecies comparison of rodent LD50 data from literature surveyed for the ACuteTox project. Regulatory Toxicology and Pharmacology. 58(3), 395-407.
  • SCCS, 2010The SCCS's notes of guidance for the testing of cosmetic ingredients and their safety evaluation 7th revision pdf icon.
  • Seidle T, Robinson S, Holmes T, Creton S, Prieto P, Scheel J, Chlebus M. 2010. Cross-sector review of drivers and available 3Rs approaches for acute systemic toxicity testing. Toxicological Sciences 116(2):382-396.
  • Schrage, A., Hempel, K., Schulz, M., Kolle, S.N., van Ravenzwaay, B., Landsiedel, R., 2011. Refinement and Reduction of Acute Oral Toxicity Testing: A Critical Review of the Use of Cytotoxicity Data. Alt. Lab. Anim. 39, 273–295.
  • Seidle T, Prieto P, Bulgheroni A. 2011. Examining the regulatory value of multi-route mammalian acute systemic toxicity studies. ALTEX. 28(2): 95-102.
  • Clothier, R., et al. Comparative analysis of eight cytotoxicity assays evaluated within the ACuteTox Project. Toxicol. In Vitro (2012), Science Direct
  • Kinsner-Ovaskainen et al., 2012. Selection of test methods to be included in a testing strategy to predict acute oral toxicity: An approach based on statistical analysis of data collected in phase 1 of the ACuteTox project. Toxicol In Vitro 
  • Kopp-Schneider, A., et al. Design of a testing strategy using non-animal based test methods: Lessons learnt from the ACuteTox project. Toxicol. in Vitro (2012), Science Direct
  • Prieto, P., et al. The value of selected in vitro and in silico methods to predict acute oral toxicity in a regulatory context: Results from the European Project ACuteTox. Toxicol. in Vitro (2012), Science Direct
  • Stanzel et al., 2013. Data management in large-scale collaborative toxicity studies: How to file experimental data for automated statistical analysis.
  • Zurich, M.-G., et al. Evaluation of aggregating brain cell cultures for the detection of acute organ-specific toxicity. Toxicol. in Vitro (2012), Science Direct