The SEURAT-1 approach towards animal free human safety assessment

Altex

Volumn 32, Issue 1, 2015, Pages 9-24

  Gocht, Tilman ^a   Berggren, Elisabet ^b   Ahr, Hans Jürgen ^c   Cotgreave, Ian ^d,e   Cronin, Mark T D ^f   Daston, George ^g   Hardy, Barry ^h   Heinzle, Elmar ⁱ   Hescheler, Jürgen ^j   Knight, Derek J ^k   Mahony, Catherine ^g   Peschanski, Marc ^l   Schwarz, Michael ^a   Thomas, Russell S ^m   Verfaillie, Catherine ⁿ   White, Andrew ^o   Whelan, Maurice ^b  

^a UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

^b JOINT RESEARCH CENTRE   (Italy)

^c BAYER AG   (Germany)

^d Swedish Toxicology Sciences Research Center   (Sweden)

^e KAROLINSKA INSTITUTE   (Sweden)

^f LIVERPOOL JOHN MOORES UNIVERSITY   (United Kingdom)

^g PROCTER AND GAMBLE COMPANY   (United States)

^h Douglas Connect ^*  (Switzerland)

ⁱ SAARLAND UNIVERSITY   (Germany)

^j UNIVERSITY HOSPITAL OF COLOGNE   (Germany)

^k EUROPEAN CHEMICALS AGENCY   (Finland)

^l I Stem   (France)

^m U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

ⁿ UNIVERSITY OF LEUVEN   (Belgium)

^o UNILEVER RESEARCH   (United Kingdom)

more..

Author keywords

Alternatives to animal testing; Integrated testing strategy; Mode of action theory; Proof of concept case studies; Safety assessment

Indexed keywords

AB INITIO CALCULATION; ADVERSE OUTCOME; ARTICLE; CASE STUDY; COMPUTER MODEL; CONCEPTUAL FRAMEWORK; HUMAN; IN VITRO STUDY; LIVER FIBROSIS; NONHUMAN; RISK ASSESSMENT; SCIENTIFIC LITERATURE; TOXICITY TESTING; ANIMAL; ANIMAL TESTING ALTERNATIVE; EUROPE; PROCEDURES;

ANIMAL TESTING ALTERNATIVES; ANIMALS; EUROPE; HUMANS; RISK ASSESSMENT; TOXICITY TESTS;

EID: 84921416823     PISSN: 1868596X     EISSN: 18688551     Source Type: Journal    
DOI: 10.14573/altex.1408041     Document Type: Article

References (59)

1. Adler, S., Basketter, D., Creton, S. et al. (2011). Alternative (non-animal) methods for cosmetics testing: current status and future prospects - 2010. Arch Toxicol 85, 367-485. http://dx.doi.org/10.1007/s00204-011-0693-2
2. Amacher, D. E. (2011). The mechanistic basis for the induction of hepatic steatosis by xenobiotics. Expert Opin Drug Met Toxicol 7, 949-965. http://dx.doi.org/10.1517/17425255.2011.577740
3. Andersen, M. E., Clewell, H. J., Carmichael, P. L. and Boekelheide, K. (2011). Food for thought ... Can case study approaches speed implementation of the NRC report: "Toxicity testing in the 21st century: A vision and a strategy"? ALTEX 28, 175-182. http://dx.doi.org/10.14573/altex.2011.3.175
4. Ankley, G. T., Bennett, R. S., Erickson, R. J. et al. (2010). Adverse outcome pathways: A conceptual framework to support ecotoxicology research and risk assessment. Environ Toxicol Chem 29, 730-741. http://dx.doi.org/10.1002/etc.34
5. Basketter, D. A., Clewell, H., Kimber, I. et al. (2012). A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing. ALTEX 29, 5-91. http://dx.doi.org/10.14573/altex.2012.1.003
6. Blaauboer, B. J., Barratt, M. D. and Houston, J. B. (1999). The integrated use of alternative methods in toxicological risk evaluation: ECVAM Integrated Testing Strategies Task Force Report I. Altern Lab Animals 27, 229-237.
7. Blaauboer, B. J., Boekelheide, K., Clewell, H. J. et al. (2012). The use of biomarkers of toxicity for integrating in vitro hazard estimation into risk assessment for humans. ALTEX 29, 411-425. http://dx.doi.org/10.14573/altex.2012.4.411
8. Blackburn, K., Bjerke, D., Daston, G. et al. (2011). Case studies to test: A framework for using structural, reactivity, metabolic and physicochemical similarity to evaluate the suitability of analogs for SAR-based toxicological assessments. Regul Toxicol Pharm 60, 120-135. http://dx.doi.org/10.1016/j.yrtph.2011.03.002
9. Boekelheide, K. and Andersen, M. (2010). A mechanistic redefinition of adverse effects - a key step in the toxicity testing paradigm shift. ALTEX 27, 243-252. http://www.altex.ch/Current-issue.50.html?iid=121&aid=2 (accessed 30.10.14).
10. Boobis, A. R., Doe, J. E., Heinrich-Hirsch, B. et al. (2008). IPCS framework for analyzing the relevance of a noncancer mode of action for humans. Crit Rev Toxicol 38, 87-96. http://dx.doi.org/10.1080/10408440701749421
11. Brenner, D. A. (2009). Molecular pathogenesis of liver fibrosis. Trans Am Clin Climatol Assoc 120, 361-368. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2744540/ (accessed 30. 10.14).
12. Ducheix, S., Montagner, A., Theodorou, V. et al. (2013). The liver X receptor: A master regulator of the gut-liver axis and a target for non alcoholic fatty liver disease. Biochem Pharmacol 86, 96-105. http://dx.doi.org/10.1016/j.bcp.2013.03.016
13. ECHA - European Chemicals Agency (2013a). Grouping of chemicals and read-across approach. Part 1: Introductory note. ECHA Report, Nr. ECHA-13-R-02-EN. http://echa.europa.eu/documents/10162/13628/read-across-introductory-note-en.pdf (accessed July 2014).
14. ECHA (2013b). Read-across illustrative example. Part 2: Example 1 - Analogue approach: similarity based on breakdown products. ECHA Report, Nr. ECHA-13-R-03-EN. http://echa.europa.eu/documents/10162/13628/read-across-example-1-en.pdf (accessed July 2014).
15. EFSA - European Food Safety Authority (2014). Modern methodologies and tools for human hazard assessment of chemicals. EFSA J 12, 3638.
16. Ellison, C. M., Enoch, S. J. and Cronin, M. T. (2011). A review of the use of in silico methods to predict the chemistry of molecular initiating events related to drug toxicity. Expert Opin Drug Metab Toxicol 7, 1481-1495. http://dx.doi.org/10.1517/17425255.2011.629186
17. EPAA (2008). New Perspectives on Safety. https://circabc.europa.eu/sd/d/82d88bee-c433-4470-bdc0-65e266ca8a8d/newperspectives.pdf (accessed July 2014).
18. Groothuis, F. A., Heringa, M. B., Nicol, B. et al. (2013). Dose metric considerations in in vitro assays to improve quantitative in vitro-in vivo dose extrapolations. Toxicology, in press. http://dx.doi.org/10.1016/j.tox.2013.08.012
19. Gubbels-van Hal, W. M. L. G., Blaauboer, B. J., Barentsen, H. M. et al. (2005). An alternative approach for the safety evaluation of new and existing chemicals, an exercise in integrated testing. Regul Toxicol Pharm 42, 284-295. http://dx.doi.org/10.1016/j.yrtph.2005.05.002
20. Hardy, B., Apic, G., Carthew, B. et al. (2012). Food for thought ... A toxicology ontology roadmap. ALTEX 29, 129-137. http://dx.doi.org/10.14573/altex.2012.2.129
21. Hartung, T. and McBride, M. (2011). Food for thought ... on mapping the human toxome. ALTEX 28, 83-93. http://dx.doi. org/10.14573/altex.2011.2.083
22. Hartung, T., Blaauboer, B. J., Bosgra, S. et al. (2011). An expert consortium review of the EC-commissioned report "Alternative (non-animal) methods for cosmetics testing: current status and future prospects - 2010". ALTEX 28, 183-209. http://dx.doi.org/10.14573/altex.2011.3.183
23. Hartung, T., Luechtefeld, T., Maertens, A. et al. (2013a). Integrated testing strategies for safety assessment. ALTEX 30, 3-18. http://dx.doi.org/10.14573/altex.2013.1.003
24. Hartung, T., Hoffmann, S. and Stephens, M. (2013b). Food for thought ... Mechanistic validation. ALTEX 30, 119-130. http://dx.doi.org/10.14573/altex.2013.2.119
25. Hoehme, S., Brulport, M., Bauer, A. et al. (2010). Prediction and validation of cell alignment along microvessels as order principle to restore tissue architecture in liver regeneration. PNAS 107, 10371-10376. http://dx.doi.org/10.1073/pnas.0909374107
26. Jennings, P. (2013). Stress response pathways, toxicity pathways and adverse outcome pathways. Arch Toxicol 87, 13-14. http://dx.doi.org/10.1007/s00204-012-0974-4
27. Kavlock, R. J., Chandler, K., Houck, K. et al. (2012). Update on EPA's ToxCast program: Providing high throughput decision support tools for chemical risk management. Chem Res Toxicol 25, 1287-1302. http://dx.doi.org/10.1021/tx3000939
28. Kimber, I., Humphris, C., Westmoreland, C. et al. (2011). Computational chemistry, systems biology and toxicology. Harnessing the chemistry of life: revolutionizing toxicology. A commentary. J Appl Toxicol 31, 206-209. http://dx.doi.org/10.1002/jat.1666
29. Kleensang, A., Maertens, A., Rosenberg, M. et al. (2014). t4 workshop report. Pathways of toxicity. ALTEX 31, 53-61. http://dx.doi.org/10.14573/altex.1309261
30. Kohonen, P., Ceder, R., Smit, I. et al. (2014). Cancer biology, toxicology and alternative methods development go hand-inhand. Basic Clin Pharmacol Toxicol 115, 50-58. http://dx.doi.org/10.1111/bcpt.12257
31. Kongsbak, K., Vinggaard, A. M., Hadrup, N. and Audouze, K. (2014). A computational approach to mechanistic and predictive toxicology of pesticides. ALTEX 31, 11-22. http://dx.doi.org/10.14573/altex.1304241
32. Krewski, D., Acosta Jr., D., Andersen, M. et al. (2010). Toxicity testing in the 21st century: A vision and a strategy. J Toxicol Environ Health B Crit Rev 13, 51-138. http://dx.doi.org/10.1080/10937404.2010.483176
33. Krewski, D., Westphal, M., Al-Zoughool, M. et al. (2011). New directions in toxicity testing. Ann Rev Public Health 32, 161- 178. http://dx.doi.org/10.1146/annurev-publhealth-031210-101153
34. Landesmann, B., Goumenou, M., Munn, S. and Whelan, M. (2012). Description of prototype modes-of-action related to repeated dose toxicity. JRC Scientific and Policy Report, Nr. JRC75689, Luxembourg. http://dx.doi.org/10.2788/71112
35. Low, Y., Sedykh, A., Fourches, D. et al. (2013). Integrative chemical-biological read-across approach for chemical hazard classification. Chem Res Toxicol 26, 1199-1208. http://dx.doi.org/10.1021/tx400110f
36. Niklas, J., Diaz Ochoa, J. G., Bucher, J. and Mauch, K. (2013). Quantitative evaluation and prediction of drug effects and toxicological risk using mechanistic multiscale models. Mol Informatics 32, 14-23. http://dx.doi.org/10.1002/minf.201200043
37. NRC - National Research Council (2007a). Toxicity Testing in the 21st Century: A Vision and a Strategy. Washington, DC: The National Academies Press.
38. NRC (2007b). Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment. Washington, DC: The National Academies Press.
39. OECD - Organisation for Economic Co-operation and Development (2013). Guidance Document on Developing and Assessing Adverse Outcome Pathways. OECD Environment, Health and Safety Publications - Series on Testing and Assessment, No.184.
40. OECD (2014a). QSAR Toolbox. http://www.qsartoolbox.org (consulted July 2014).
41. OECD (2014b). Guidance on Grouping of Chemicals. 2nd edition, OECD Environment, Health and Safety Publications - Series on Testing and Assessment, No.194.
42. Padda, M. S., Sanchez, M., Akhtar, A. J. and Boyer, J. L. (2011). Drug-induced cholestasis. Hepatology 53, 1377-1387. http://dx.doi.org/10.1002/hep.24229
43. Patlewicz, G., Ball, N., Booth, E. D. et al. (2013). Use of category approaches, read-across and (Q)SAR: General considerations. Regul Toxicol Pharm 67, 1-12. http://dx.doi.org/10.1016/j.yrtph.2013.06.002
44. Péry, A. R. R., Brochot, C., Zeman, F. A. et al. (2013). Prediction of dose - hepatotoxic response in humans based on toxicokinetic/ toxicodynamic modeling with and without in vivo data: A case study with acetaminophen. Toxicol Lett 220, 26-34. http://dx.doi.org/10.1016/j.toxlet.2013.03.032
45. Pistollato, F., Bremer-Hoffmann, S., Healy, L. et al. (2012). Standardization of pluripotent stem cell culturesfor toxicity testing. Expert Opin Drug MetabToxicol 8, 239-257. http:// dx.doi.org/10.1517/17425255.2012.639763
46. Sturla, S. J., Boobis, A. R., FitzGerald, R. E. et al. (2014). Systems toxicology: From basic research to risk assessment. Chem Res Toxicol 27, 314-329. http://dx.doi.org/10.1021/tx400410s
47. Thomas, R. S., Philbert, M. A., Auerbach, S. S. et al. (2013). Incorporating new technologies into toxicity testing and risk assessment: Moving from 21st century vision to a data-driven framework. Toxicol Sci 136, 4-18. http://dx.doi.org/10.1093/toxsci/kft178
48. Thomson, J. P., Hunter, J. M., Lempiäinen, H. et al. (2013). Dynamic changes in 5-hydroxymethylation signatures underpin early and late events in drug exposed liver. Nucleic Acids Res 41, 5639-5654. http://dx.doi.org/10.1093/nar/gkt232
49. ToxBank (2014). Compound Summary Table. http://wiki.toxbank.net/wiki/CompoundSummaryTable (accessed July 2014).
50. Vinken, M., Pauwels, M., Ates, G. et al. (2012). Screening of repeated dose toxicity data present in SCC(NF)P/SCCS safety evaluations of cosmetic ingredients. Arch Toxicol 86, 405-412. http://dx.doi.org/10.1093/toxsci/kft177
51. Vinken, M. (2013). The adverse outcome pathway concept: A pragmatic tool in toxicology. Toxicol 312, 158-165. http://dx.doi.org/10.1016/j.tox.2013.08.011
52. Vinken, M., Landesmann, B., Goumenou M. et al. (2013). Development of an adverse outcome pathway from drug-mediattus ed bile salt export pump inhibition to cholestatic liver injury. Toxicol Sci 136, 97-106. http://dx.doi.org/10.1093/toxsci/kft177
53. Wetmore, B. A., Wambaugh, J. F., Ferguson, S. S. et al. (2012). Integration of dosimetry, exposure, and high-throughput screening data in chemical toxicity assessment. Toxicol Sci 125, 157-174. http://dx.doi.org/10.1093/toxsci/kfr254
54. Wilmes, A., Limonciel, A., Aschauer, L. et al. (2013). Application of integrated transcriptomic, proteomic and metabolomic profiling for the delineation of mechanisms of drug induced cell stress. J Proteomics 79, 180-194. http://dx.doi.org/10.1016/j.jprot.2012.11.022
55. Wink, S., Hiemstra, S., Huppelschoten, S. et al. (2014). Quantitative high content imaging of cellular adaptive stress response pathways in toxicity for chemical safety assessment. Chem Res Toxicol 27, 338-355. http://dx.doi.org/10.1021/tx4004038
56. Wu, S., Blackburn, K., Amburgey, J. et al. (2010). A framework for using structural, reactivity, metabolic and physicochemical similarity to evaluate the suitability of analogs for SARbased toxicological assessments. Regul Toxicol Pharm 56, 67-81. http://dx.doi.org/10.1016/j.yrtph.2009.09.006
57. Wu, S., Fisher, J., Naciff, J. et al. (2013). Framework for identifying chemicals with structural features associated with the potential to act as developmental or reproductive toxicants. Chem Res Toxicol 26, 1840-1861. http://dx.doi.org/10.1021/tx400226u
58. Yoon, M., Campbell, J. L., Andersen, M. E. and Clewell, H. J. (2012). Quantitative in vitro to in vivo extrapolation of cell-based toxicity assay results. Crit Rev Toxicol 42, 633-652. http://dx.doi.org/10.3109/10408444.2012.692115
59. Zelcer, N. and Tontonoz, P. (2006). Liver X receptors as integrators of metabolic and inflammatory signaling. J Clin Invest 116, 607-614. http://dx.doi.org/10.1172/JCI27883