Wind of change challenges toxicological regulators

Environmental Health Perspectives

Volumn 120, Issue 11, 2012, Pages 1489-1494

  Tralau, Tewes ^a   Riebeling, Christian ^a   Pirow, Ralph ^a   Oelgeschläger, Michael ^a   Seiler, Andrea ^a   Liebsch, Manfred ^a   Luch, Andreas ^a  

^a FEDERAL INSTITUTE FOR RISK ASSESSMENT   (Germany)

Author keywords

Alternative testing approach; Chemical safety testing; In vitro testing strategy; In vivo testing; Regulatory acceptance; Stem cells; Tox Test Dummy

Indexed keywords

TOXIC SUBSTANCE;

ANIMAL TESTING ALTERNATIVE; ARTICLE; BLOOD BRAIN BARRIER; CHEMICAL INDUSTRY; COST BENEFIT ANALYSIS; DEVELOPMENTAL TOXICITY; EMBRYOTOXICITY; HIGH THROUGHPUT SCREENING; HUMAN; LIVER TOXICITY; METABOLOMICS; NEUROTOXICITY; NONHUMAN; PRIORITY JOURNAL; REPRODUCTIVE TOXICITY; RISK ASSESSMENT; TOXICOKINETICS; TOXICOLOGICAL PARAMETERS; TRANSCRIPTOMICS; WEIGHT GAIN; XENOBIOTIC METABOLISM;

ANIMAL TESTING ALTERNATIVES; ANIMALS; ECOTOXICOLOGY; ENVIRONMENTAL POLLUTANTS; GOVERNMENT REGULATION; HUMANS; TOXICITY TESTS;

ANIMALIA;

EID: 84868535998     PISSN: 00916765     EISSN: 15529924     Source Type: Journal    
DOI: 10.1289/ehp.1104782     Document Type: Article

References (66)

1. Adler S, Basketter D, Creton S, Pelkonen O, van Benthem J, Zuang V, et al. 2011. Alternative (non-animal) methods for cosmetics testing: current status and future prospects-2010. Arch Toxicol 85:367-485.
2. AXLR8 Consortium, ed. 2010. Alternative Testing Strategies: Progress Report 2010. Available: http://axlr8.eu/axlr8-2010-progress-report.pdf [accessed 31 July 2012].
3. Binetti R, Costamagna FM, Marcello I. 2008. Exponential growth of new chemicals and evolution of information relevant to risk control. Ann Ist Super Sanita 44:13-15.
4. Chandler KJ, Barrier M, Jeffay S, Nichols HP, KleinstreuerNC, Singh AV, et al. 2011. Evaluation of 309 environmental chemicals using a mouse embryonic stem cell adherent cell differentiation and cytotoxicity assay. PLoS One 6:e18540; doi:10.1371/journal.pone.0018540 [Online 7 June 2011].
5. Chen YF, Tseng CY, Wang HW, Kuo HC, Yang VW, Lee OK. 2012. Rapid generation of mature hepatocyte-like cells from human induced pluripotent stem cells by an efficient three-step protocol. Hepatology 55:1193-1203.
6. Collins FS, Gray GM, Bucher JR. 2008. Toxicology. Transforming environmental health protection. Science 319:906-907.
7. Dai X, He YD, Dai H, Lum PY, Roberts CJ, Waring JF, et al. 2006. Development of an approach for ab initio estimation of compound-induced liver injury based on global gene transcriptional profiles. Genome Inform 17:77-88.
8. DARPA (Defense Advanced Research Projects Agency). 2011. Defense Sciences Office. Microphysiological Systems. Available: www.darpa.mil/Our_Work/DSO/Programs/Microphysiological_Systems.aspx [accessed 26 July 2012].
9. Dix DJ, Houck KA, Martin MT, Richard AM, Setzer RW, Kavlock RJ. 2007. The ToxCast program for prioritizing toxicity testing of environmental chemicals. Toxicol Sci 95:5-12.
10. Dorne JL. 2010. Metabolism, variability and risk assessment. Toxicology 268:156-164.
11. Esch MB, King TL, Shuler ML. 2011. The role of body-on-a-chip devices in drug and toxicity studies. Ann Rev Biomed Eng 13:55-72.
12. European Commission. 1976. European Parliament and Council Directive 76/768/EEC. Off J Eur Union L262:169-332.
13. European Commission. 2003. Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003. Off J Eur Union L66:26-35.
14. European Commission. 2006. Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006. Off J Eur Union L396:1-849.
15. European Commission. 2008. Regulations: Council Regulation (EC) No. 440/2008 of 30 May 2008. Off J Eur Union L142:1-739.
16. Fielden MR, Adai A, Dunn RT, Olaharski A, Searfoss G, Sina J, et al. 2011. Development and evaluation of a genomic signature for the prediction and mechanistic assessment of nongenotoxic hepatocarcinogens in the rat. Toxicol Sci 124:54-74.
17. Fleischer M. 2007. Testing costs and testing capacity according to the REACH requirements-results of a survey of independent and corporate GLP laboratories in the EU and Switzerland. J Business Chem 4:96-114.
18. Genschow E, Spielmann H, Scholz G, Pohl I, Seiler A, Clemann N, et al. 2004. Validation of the embryonic stem cell test in the international ECVAM validation study on three in vitro embryotoxicity tests. Altern Lab Anim 32:209-244.
19. Gilbert SF. 2003. Developmental Biology. 7th ed. Sunderland, MA:Sinauer Associates Inc.
20. Giri S, Acikgöz A, Pathak P, Gutschker S, Kürsten A, Nieber K, et al. 2011. Three dimensional cultures of rat liver cells using a natural self-assembling nanoscaffold in a clinically relevant bioreactor for bioartificial liver construction. J Cell Physiol 227:313-327.
21. Hartung T. 2009. Toxicology for the twenty-first century. Nature 460:208-212.
22. Hettwer M, Reis-Fernandes MA, Iken M, Ott M, Steinberg P, Nau H. 2010. Metabolic activation capacity by primary hepatocytes expands the applicability of the embryonic stem cell test as alternative to experimental animal testing. Reprod Toxicol 30:113-120.
23. Hewitt M, Ellison CM, Enoch SJ, Madden JC, Cronin MT. 2010. Integrating (Q)SAR models, expert systems and read-across approaches for the prediction of developmental toxicity. Reprod Toxicol 30:147-160.
24. Huh D, Matthews BD, Mammoto A, Montoya-Zavala M, HsinHY, Ingber DE. 2010. Reconstituting organ-level lung functions on a chip. Science 328:1662-1668.
25. Judson RS, Houck KA, Kavlock RJ, Knudsen TB, MartinMT, Mortensen HM, et al. 2010. Invitro screening of environmental chemicals for targeted testing prioritization: the ToxCast project. Environ Health Perspect 118:485-492.
26. Kavlock R, Dix D. 2010. Computational toxicology as implemented by the U.S. EPA: providing high throughput decision support tools for screening and assessing chemical exposure, hazard, and risk. J Toxicol Environ Health B Crit Rev 13:197-217.
27. Kleinstreuer NC, Smith AM, West PR, Conard KR, Fontaine BR, Weir-Hauptman AM, et al. 2011. Identifying developmental toxicity pathways for a subset of ToxCast chemicals using human embryonic stem cells and metabolomics. Toxicol Appl Pharmacol 257:111-121.
28. Krewski D, Acosta D Jr, Andersen M, Anderson H, Bailar JC III, Boekelheide K, et al. 2010. Toxicity testing in the 21st century: a vision and a strategy. J Toxicol Environ Health B Crit Rev 13:51-138.
29. Landsiedel R, Fabian E, Tralau T, Luch A. 2011. Chemical toxicity testing in vitro using P450-expressing cell lines, such as human CYP1B1. Nat Protoc 6:677-688.
30. Laschinski G, Vogel R, Spielmann H. 1991. Cytotoxicity test using blastocyst-derived euploid embryonal stem cells: a new approach to in vitro teratogenesis screening. Reprod Toxicol 5:57-64.
31. Liebsch M, Grune B, Seiler A, Butzke D, Oelgeschläger M, Pirow R, et al. 2011. Alternatives to animal testing: current status and future perspectives. Arch Toxicol 85:841-858.
32. Liu Z, Kelly R, Fang H, Ding D, Tong W. 2011. Comparative analysis of predictive models for nongenotoxic hepatocarcinogenicity using both toxicogenomics and quantitative structure-activity relationships. Chem Res Toxicol 24:1062-1070.
33. Low Y, Uehara T, Minowa Y, Yamada H, Ohno Y, Urushidani T, et al. 2011. Predicting drug-induced hepatotoxicity using QSAR and toxicogenomics approaches. Chem Res Toxicol 24:1251-1262.
34. Makris SL, Raffaele K, Allen S, Bowers WJ, Hass U, Alleva E, et al. 2009. A retrospective performance assessment of the developmental neurotoxicity study in support of OECD Test Guideline 426. Environ Health Perspect 117:17-25.
35. Medine CN, Greenhough S, Hay DC. 2010. Role of stem-cell-derived hepatic endoderm in human drug discovery. Biochem Soc Transactions 38:1033-1036.
36. Meyer M, Schneckener S, Ludewig B, Kuepfer L, Lippert J. 2012. Using expression data for quantification of active processes in physiologically based pharmacokinetic modeling. Drug Metab Dispos 40:892-901.
37. Mielke H, Anger LT, Schug M, Hengstler JG, Stahlmann R, Gundert-Remy U. 2011. A physiologically based toxicokinetic modelling approach to predict relevant concentrations for in vitro testing. Arch Toxicol 85:555-563.
38. Ministry of Economy, Trade and Industry, Ministry of the Environment of the Japanese Government, Ministry of Health, Labor and Welfare. 2007. Japan HPV Challenge Program. Available: http://www.env.go.jp/en/chemi/hpv.html [accessed 26 July 2012].
39. NCATS (National Center for Advancing Translational Science). 2011. Tissue Chip for Drug Screening. Available: http://www.ncats.nih.gov/research/reengineering/tissue-chip/tissue-chip.html [accessed 26 July 2012].
40. NRC (National Research Council). 2007. Toxicity Testing in the 21st Century: A Vision and a Strategy. Washington, DC:National Academies Press.
41. OECD (Organisation for Economic Co-operation and Development). 2001. OECD Guidelines for the Testing of Chemicals, Section 4. Test No. 416: Two-Generation Reproduction Toxicity. Available: http://www.oecd-ilibrary.org/environment/test-no-416-two-generation-reproduction-toxicity_9789264070868-en [accessed 2 February 2012].
42. OECD (Organisation for Economic Co-operation and Development). 2007. OECD Guidelines for the Testing of Chemicals, Section 4. Test No. 426: Developmental Neurotoxicity Study. Available: http://www.oecd-ilibrary.org/environment/test-no-426-developmental-neurotoxicity-study_9789264067394-en [accessed 2 February 2012].
43. OECD (Organisation for Economic Co-operation and Development). 2011. OECD Guidelines for the Testing of Chemicals, Section 4. Text No. 433: Extended One-Generation Reproductive Toxicity Study. Available: http://www.oecd-ilibrary.org/environment/test-no-443-extended-one-generation-reproductive-toxicity-study_9789264122550-en [accessed 2 February 2012].
44. Pampaloni F, Stelzer E. 2010. Three-dimensional cell cultures in toxicology. Biotechnol Genet Eng Rev 26:117-138.
45. Pannetier M, Feil R. 2007. Epigenetic stability of embryonic stem cells and developmental potential. Trends Biotechnol 25:556-562.
46. Peljto M, Wichterle H. 2011. Programming embryonic stem cells to neuronal subtypes. Curr Opin Neurobiol 21:43-51.
47. Prot JM, Bunescu A, Elena-Herrmann B, Aninat C, Snouber LC, Griscom L, et al. 2012. Predictive toxicology using systemic biology and liver microfluidic "on chip" approaches: application to acetaminophen injury. Toxicol Appl Pharmacol 259:270-280.
48. 4). ALTEX 26:187-208.
49. Schardein JL, Keller KA. 1989. Potential human developmental toxicants and the role of animal testing in their identification and characterization. Crit Rev Toxicol 19:251-339.
50. Schenk B, Weimer M, Bremer S, van der Burg B, Cortvrindt R, Freyberger A, et al. 2010. The ReProTect Feasibility Study, a novel comprehensive invitro approach to detect reproductive toxicants. Reprod Toxicol 30:200-218.
51. Seiler A, Spielmann H. 2011. The validated embryonic stem cell test to predict embryotoxicity in vitro. Nat Protoc 6:961-978.
52. Sonntag F, Schilling N, Mader K, Gruchow M, Klotzbach U, LindnerG, et al. 2010. Design and prototyping of a chip-based multi-micro-organoid culture system for substance testing, predictive to human (substance) exposure. JBiotechnol 148:70-75.
53. Subramanian K, Raghavan S, Bhat AR, Das S, Dikshit JB, Kumar R, et al. 2008. A systems biology based integrative framework to enhance the predictivity of invitro methods for drug-induced liver injury. Exp Opin Drug Saf 7:647-662.
54. Sung JH, Shuler ML. 2010. In vitro microscale systems for systematic drug toxicity study. Bioprocess Biosyst Eng 33:5-19.
55. Takayama K, Inamura M, Kawabata K, Katayama K, Higuchi M, Tashiro K, et al. 2012. Efficient generation of functional hepatocytes from human embryonic stem cells and induced pluripotent stem cells by HNF4α transduction. Mol Ther 20:127-137.
56. Tralau T, Luch A. 2012. Drug-mediated toxicity: illuminating the 'bad' in the test tube by means of cellular assays? Trends Pharmacol Sci 33:353-364.
57. U.S. Environmental Protection Agency. 1998. Final Report of the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC). Available: http://www.epa.gov/endo/pubs/edstac/coverv14.pdf [accessed 2 February 2012].
58. Voisin EM, Ruthsatz M, Collins JM, Hoyle PC. 1990. Extrapolation of animal toxicity to humans: interspecies comparisons in drug development. Regul Toxicol Pharmacol 12:107-116.
59. Walton K, Dorne JL, Renwick AG. 2001. Uncertainty factors for chemical risk assessment: interspecies differences in glucuronidation. Food Chem Toxicol 39:1175-1190.
60. Winkler J, Sotiriadou I, Chen S, Hescheler J, Sachinidis A. 2009. The potential of embryonic stem cells combined with-omics technologies as model systems for toxicology. Curr Med Chem 16:4814-4827.
61. Wobus A, Löser P. 2011. Present state and future perspectives of using pluripotent stem cells in toxicology research. Arch Toxicol 85:79-117.
62. Wongkajornsilp A, Sa-Ngiamsuntorn K, Hongeng S. 2012. Development of immortalized hepatocyte-like cells from hMSCs. Methods Mol Biol 826:73-87.
63. Yildirimman R, Brolén G, Vilardell M, Eriksson G, Synnergren J, Gmuender H, et al. 2011. Human embryonic stem cell derived hepatocyte-like cells as a tool for in vitro hazard assessment of chemical carcinogenicity. Toxicol Sci 124:278-290.
64. Zeng X, Rao MS. 2006. The therapeutic potential of embryonic stem cells: a focus on stem cell stability. Curr Opin Mol Ther 8:338-344.
65. Zimmer B, Kuegler PB, Baudis B, Genewsky A, Tanavde V, Koh W, et al. 2011. Coordinated waves of gene expression during neuronal differentiation of embryonic stem cells as basis for novel approaches to developmental neurotoxicity testing. Cell Death Differ 18:383-395.
66. zur Nieden NI, Davis LA, Rancourt DE. 2010. Comparing three novel endpoints for developmental osteotoxicity in the embryonic stem cell test. Toxicol Appl Pharmacol 247:91-97.