Food for thought: Integrated testing strategies for safety assessments

Altex

Volumn 30, Issue 1, 2013, Pages 3-18

  Hartung, Thomas ^a,b   Luechtefeld, Tom ^a   Maertens, Alexandra ^a   Kleensang, Andre ^a  

^a JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^b UNIVERSITY OF KONSTANZ   (Germany)

Author keywords

Integrated testing strategies; Predictivity; Prioritization; Quality assurance; Tox 21c

Indexed keywords

ANALYTIC METHOD; ARTICLE; CYTOTOXICITY; DECISION MAKING; DRUG INDUSTRY; EMBRYONIC STEM CELL; ENVIRONMENTAL FACTOR; EYE IRRITATION; GENOTOXICITY; HUMAN; INTEGRATED TESTING STRATEGY; NONHUMAN; QUALITY CONTROL; QUANTITATIVE STRUCTURE ACTIVITY RELATION; RISK ASSESSMENT; SKIN IRRITATION; SKIN SENSITIZATION; TOXICITY TESTING; TOXICOLOGY; ANIMAL; ANIMAL TESTING ALTERNATIVE; METHODOLOGY; REPRODUCIBILITY; STANDARD;

ANIMAL TESTING ALTERNATIVES; ANIMALS; HUMANS; REPRODUCIBILITY OF RESULTS; TOXICITY TESTS;

MLCS; MLOWN;

EID: 84876323285     PISSN: 1868596X     EISSN: 18688551     Source Type: Journal    
DOI: 10.14573/altex.2013.1.003     Document Type: Article

References (94)

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.
2. Ahlers, J., Stock, F., and Werschkun, B. (2008). Integrated testing and intelligent assessment-new challenges under REACH. Env Sci Pollut Res Int 15, 565-572.
3. Aldenberg, T. and Jaworska, J. S. (2010). Multiple test in silico weight-of-evidence for toxicological endpoints. Issues Toxicol 7, 558-583.
4. Anon. (2005). REACH and the need for Intelligent Testing Strategies [EUR 21554 EN]. Institute for Health and Consumer Protection, EC Joint Research Centre, Ispra, Italy. http://reach-support.com/download/Intelligent%20Testing. pdf
5. Anon. (2011). Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy. http://srdta.cochrane.org/handbook-dta-reviews
6. Balls, M., Amcoff, P., Bremer, S., et al. (2006). The principles of weight of evidence validation of test methods and testing strategies. The report and recommendations of ECVAM workshop 58. Altern Lab Animal 34, 603-620. (Pubitemid 46238600)
7. Basketter, D. A., Clewell, H., Kimber, I., et al. (2012). A roadmap for the development of alternative (non-Animal) methods for systemic toxicity testing -t4 report. ALTEX 29, 3-91.
8. Benfenati, E., Gini, G., Hoffmann, S., and Luttik, R. (2010). Comparing in vivo, in vitro and in silico methods and intetest grated strategies for chemical assessment: problems and prospects. Altern Lab Animal 38, 153-166.
9. Berg, N., De Wever, B., Fuchs, H. W., et al. (2011). Toxicology in the 21st century -working our way towards a visionary reality. Toxicol In Vitro 25, 874-881.
10. Blaauboer, B. J. (2010). Biokinetic modeling and in vitro-in vivo extrapolations. J Toxicol Environ Health B Crit Rev 13, 242-252.
11. Blaauboer, B. and Barratt, M. (1999). The integrated use of alternative methods in toxicological risk evaluation. Altern Lab Animal 27, 229-237.
12. Blaauboer, B. J., Boekelheide, K., Clewell, H. J., et al. (2012). The use of biomarkers of toxicity for integrating in vitro hazard estimates into risk assessment for humans. ALTEX 29, 411-425.
13. Bouhifd, M., Hartung, T., Hogberg, H. T., et al. (in press). Review: Toxicometabolomics. J Appl Toxicol.
14. Breiman, L. (2001). Random Forests. Statistics Department, University of California. Machine Learning. http://oz.berkeley.edu/users/breiman/ randomforest2001.pdf
15. Combes, R. D. and Balls, M. (2011). Integrated testing strategies for toxicity employing new and existing technologies. Altern Lab Animal 39, 213-225.
16. Dale, H. H. (1929). Croonian lectures on some chemical factors in the control of the circulation. Lancet 213, 1285-1290.
17. De Wever, B., Fuchs, H. W., Gaca, M., et al. (2012). Implementation challenges for designing integrated in vitro testing strategies (ITS) aiming at reducing and replacing animal experimentation. Toxicol 26, 526-534.
18. De Wolf, W., Comber, M., and Douben, P. (2007). Animal use replacement, reduction, and refinement: Development of an integrated testing strategy for bioconcentration of chemicals in fish. Integr Environ Assess Manag 3, 3-17.
19. Deeks, J. J. (2001). Systematic reviews in health care: Systematic reviews of evaluations of diagnostic and screening tests. Brit Med J 323, 157-162. (Pubitemid 32678396)
20. Devillé, W. L., Buntinx, F., Bouter, L. M., et al. (2002). Conducting systematic reviews of diagnostic studies: didactic guidelines. BMC Med Res Methodol 2, 9.
21. Dejongh, J., Forsby, A., Houston, J. B., et al. (1999). An Integrated Approach to the Prediction of Systemic Toxicity using Computer-based Biokinetic Models and Biological In vitro Test Methods: Overview of a Prevalidation Study Based on the ECITTS Project. Toxicol In Vitro 13, 549-554. (Pubitemid 29354176)
22. Fernández, A., Lombardo, A., Rallo, R., et al. (2012). Quantitative consensus of bioaccumulation models for integrated testing strategies. Environ Intern 45, 51-58.
23. Forsby, A. and Blaauboer, B. (2007). Integration of in vitro neurotoxicity data with biokinetic modelling for the estimation of in vivo neurotoxicity. Hum Exp Toxicol 26, 333-338. (Pubitemid 46733356)
24. Gabbert, S. and van Ierland, E. C. (2010). Cost-effectiveness analysis of chemical testing for decision-support: How to include animal welfare? Hum Ecol Risk Assess 16, 603-620.
25. Gabbert, S. and Benighaus, C. (2012). Quo vadis integrated testing strategies? Experiences and observations from the work floor. J Risk Res 15, 583-599.
26. Griffin, J. L. J. (2006). The Cinderella story of metabolic profiling: does metabolomics get to go to the functional genomics ball? Philosophical Transactions of the Royal Society B: Biological Sciences 361, 147-161.
27. Gubbels-van Hal, W. M., 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 Pharmacol 42, 284-295. (Pubitemid 41021978)
28. Hao, T., Ma, H.-W., Zhao, X.-M., and Goryanin, I. (2012). The reconstruction and analysis of tissue specific human metabolic networks. Molec BioSyst 8, 663-670.
29. Hareng, L., Pellizzer, C., Bremer, S., et al. (2005). The Integrated Project ReProTect: A novel approach in reproductive toxicity hazard assessment. Reprod Toxicol 20, 441-452. (Pubitemid 40943563)
30. Hartung, T., Bremer, S., Casati, S., et al. (2004). A modular approach to the ECVAM principles on test validity. Altern Lab Anim 32, 467-472. (Pubitemid 40128842)
31. Hartung, T. (2007). Food for thought ... on validation. ALTEX 24, 67-73.
32. Hartung, T. (2008). Food for thought ... on alternative methods for cosmetics safety testing. ALTEX 25, 147-162.
33. Hartung, T. (2009a). A toxicology for the 21st century -mapping the road ahead. Toxicol Sci 109, 18-23.
34. Hartung, T. (2009b). Food for thought ... on evidence-based toxicology. ALTEX 26, 75-82.
35. Hartung, T. (2009c). Toxicology for the twenty-first century. Nature 460, 208-212.
36. Hartung, T. and Hoffmann, S. (2009). Food for thought ... on in silico methods in toxicology. ALTEX 26, 155-166.
37. Hartung, T. (2010a). Comparative analysis of the revised Directive 2010/63/EU for the protection of laboratory animals with its predecessor 86/609/EEC -A t4 report. ALTEX 27, 285-303.
38. Hartung, T. (2010b). Evidence-based toxicology -The toolbox of validation for the 21st century? ALTEX 27, 253-263.
39. Hartung, T. (2010c). Food for thought ... on alternative methods for chemical safety testing. ALTEX 27, 3-14.
40. Hartung, T. (2010d). Lessons learned from alternative methods and their validation for a new toxicology in the 21st century. J Toxicol Environ Health B Crit Rev 13, 277-290.
41. Hartung, T. and McBride, M. (2011). Food for thought ... on mapping the human toxome. ALTEX 28, 83-93.
42. Hartung, T. and Zurlo, J. (2012). Alternative approaches for medical countermeasures to biological and chemical terrorism and warfare. ALTEX 29, 251-260.
43. Hartung, T., van Vliet, E., Jaworska, J., et al. (2012). Food for thought ... systems toxicology. ALTEX 29, 119-128.
44. Hattis, D. (2009). High-throughput testing -The NRC vision, the challenge of modeling dynamic changes in biological systems, and the reality of low-throughput environmental health decision making. Risk Anal 29, 483-484.
45. Hengstler, J. G., Foth, H., Kahl, R., et al. (2006). The REACH concept and its impact on toxicological sciences. Toxicol 220, 232-239. (Pubitemid 43279497)
46. Hill, A. B. (1965). The environment and disease: association or causation? Proc R Soc Med 58, 295-300.
47. Hoffmann, S. and Hartung, T. (2005). Diagnosis: toxic! -trying to apply approaches of clinical diagnostics and prevalence in toxicology considerations. Toxicol Sci 85, 422-428. (Pubitemid 40614273)
48. Hoffmann, S., Cole, T., and Hartung, T. (2005). Skin irritation: prevalence, variability, and regulatory classification of existing in vivo data from industrial chemicals. Regulat Toxicol Pharmacol 41, 159-166. (Pubitemid 40312815)
49. Hoffmann, S. and Hartung, T. (2006). Toward an evidencebased toxicology. Hum Exp Toxicol 25, 497-513.
50. Hoffmann, S., Saliner, A. G., Patlewicz, G., et al. (2008a). A feasibility study developing an integrated testing strategy assessing skin irritation potential of chemicals. Toxicol Lett 180, 9-20.
51. Hoffmann, S., Edler, L., Gardner, I., et al. (2008b). Points of reference in the validation process: the report and recommendations of ECVAM Workshop 66. Altern Lab Anim 36, 343-352.
52. Jaworska, J. and Hoffmann, S. (2010). Integrated Testing Strategy (ITS) -Opportunities to better use existing data and guide future testing in toxicology. ALTEX 27, 231-242.
53. Jaworska, J., Gabbert, S., and Aldenberg, T. (2010). Towards optimization of chemical testing under REACH: A Bayesian network approach to Integrated Testing Strategies. Regul Toxicol Pharmacol 57, 157-167.
54. Jaworska, J., Harol, A., Kern, P. S., et al. (2011). Integrating nonanimal test information into an adaptive testing strategy -skin sensitization proof of concept case. ALTEX 28, 211-225.
55. Kinsner-Ovaskainen, A., Akkan, Z., Casati, S., et al. (2009). Overcoming barriers to validation of non-Animal partial replacement methods/Integrated Testing Strategies: the report of an EPAA-ECVAM workshop. Altern Lab Anim 37, 437-444.
56. Kinsner-Ovaskainen, A., Maxwell, G., Kreysa, J., et al. (2012). Report of the EPAA-ECVAM workshop on the validation of Integrated Testing Strategies (ITS). Altern Lab Anim 40, 175-181.
57. Kirkland, D., Aardema, M., Henderson, L., et al. (2005). Evaluation of the ability of a battery of three in vitro genotoxicity tests to discriminate rodent carcinogens and non-carcinogens. Mutat Res 584, 1-256. (Pubitemid 40922793)
58. Leeflang, M., Deeks, J. J., and Gatsonis, C. (2008). Systematic reviews of diagnostic test accuracy. Annals Internal Med 49, 889-897.
59. Leist, M., Lidbury, B. A., Yang, C., et al. (2012). Novel technologies and an overall strategy to allow hazard assessment and risk prediction of chemicals, cosmetics, and drugs with animal-free methods. ALTEX 29, 373-388.
60. Ma, H., Sorokin, A., Mazein, A., et al. (2007). The Edinburgh human metabolic network reconstruction and its functional analysis. Mol Syst Biol 3, 135.
61. Marshall, M. (2012). How to prove cause leads to effect. New Scientist of 29 Sep 2012, 8-9.
62. Marx-Stoelting, P., Adriaens, E., Ahr, H.-J., et al. (2009). A review of the implementation of the embryonic stem cell test (EST). The report and recommendations of an ECVAM/Re-ProTect Workshop. Altern Lab Anim 37, 313-328.
63. McNamee, P., Hibatallah, J., Costabel-Farkas, M., et al. (2009). A tiered approach to the use of alternatives to animal testing for the safety assessment of cosmetics: Eye irritation. Regulat Toxicol Pharmacol 54, 197-209.
64. Mehling, A., Eriksson, T., Eltze, T., et al. (2012). Non-Animal test methods for predicting skin sensitization potentials. Arch Toxicol. 86, 1273-1295.
65. Nordberg, A., Ruden, C., and Hansson, E. (2008). Towards more efficient testing strategies -Analyzing the efficiency of toxicity data requirements in relation to the criteria for classification and labelling. Regulat Toxicol Pharmacol 50, 412-419.
66. OECD (2002a). TG 404 ''Acute dermal irritation/corrosion'', adopted April 24th 2002, including a Supplement to TG 404 entitled. A sequential testing strategy for dermal irritation and, corrosion. (pp. 11-14). http://www.oecd- ilibrary.org/environment/test-no-404-Acute-dermal-irritationcorrosion- 9789264070622-en
67. OECD (2002b). TG 405 ''Acute eye irritation/corrosion'', adopted April 24th 2002, including a Supplement to TG 405 entitled. A sequential testing strategy for eye irritation and, corrosion. (pp. 9-13). http://www.oecd- ilibrary.org/environment/test-no-405-Acute-eye-irritation-corrosion- 9789264185333-en
68. OECD (2005). Series on Testing and Assessment No. 34. Guidance document on the validation and international acceptance of new or updated test methods for hazard assessment. http://search. oecd.org/officialdocuments/ displaydocumentpdf/?cote=env/jm/mono(2005)14&doclanguage=en
69. OECD (2008). Series on Testing and Assessment No. 88. Workshop on integrated approaches to testing and assessment. http://www.oecd.org/ chemicalsafety/testingofchemicals/40705314.pdf
70. Romero, P., Wagg, J., Green, M. L., et al. (2005). Computational prediction of human metabolic pathways from the complete human genome. Genome Biol 6, R2. doi: 10.1186/gb-2004-6-1-r2
71. Robertson, D.G., Watkins, P. B., and Reily, M. D. (2011). Metabolomics in toxicology: preclinical and clinical applications. Toxicol Sci 120, Suppl 1, S146-170.
72. Rockel, C. and Hartung, T. (2012). Systematic review of membrane components of Gram-positive bacteria responsible as pyrogens for inducing human monocyte/macrophage cytokine release. Front Pharmacol 3, 56.
73. Romero, P., Wagg, J., Green, M. L., et al. (2005). Computational prediction of human metabolic pathways from the complete human genome. Genome Biol 6, R2.
74. Rolfsson, O., Palsson, B. O., and Thiele, I. (2011). The human metabolic reconstruction Recon 1 directs hypotheses of novel human metabolic functions. BMC Syst Biol 5, 155.
75. Rusyn, I., Sedykh, A., Low, Y., et al. (2012). Predictive modeling of chemical hazard by integrating numerical descriptors of chemical structures and short-term toxicity assay data. Toxicol Sci 127, 1-9.
76. Schenk, B., Weimer, M., Bremer, S., et al. (2010). The RePro-Tect feasibility study, a novel comprehensive in vitro approach to detect reproductive toxicants. Reprod Toxicol 30, 200-218.
77. Scott, L., Eskes, C., Hoffmann, S., et al. (2009). A proposed eye irritation testing strategy to reduce and replace in vivo studies using Bottom-Up and Top-Down approaches. Toxicol In Vitro 24, 1-9.
78. Schaafsma, G., Kroese, E. D., Tielemans, E. L., et al. (2009). REACH, non-testing approaches and the urgent need for a change in mind set. Regul Toxicol Pharmacol 53, 70-80.
79. Schneider, K., Schwarz, M., Burkholder, I., et al. (2009). "ToxRtool", a new tool to assess the reliability of toxicological data. Toxicol Lett 189, 138-144.
80. Schünemann, H. J., Oxman, A. D., Brozek, J., et al. (2008). Rating Quality of Evidence and Strength of Recommendations: GRADE: Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. Brit Med J 336, 1106-1110. (Pubitemid 351731739)
81. Seidle, T. and Stephens, M. L. (2009). Bringing toxicology into the 21st century: A global call to action. Toxicol In Vitro 23, 1576-1579.
82. Seiler, A. E. M., and Spielmann, H. (2011). The validated embryonic stem cell test to predict embryotoxicity in vitro. Nature Protoc 6, 961-978.
83. Spielmann, H., Seiler, A., Bremer, S., et al. (2006). The practical application of three validated in vitro embryotoxicity tests. The report and recommendations of an ECVAM/ZEBET workshop (ECVAM workshop 57). Altern Lab Anim 34, 527-538.
84. Sugihara, G., May, R., Ye, H. et al. (2012). Detecting causality in complex ecosystems. Science 338, 496-500.
85. Sugimoto, M., Kawakami, M., Robert, M., et al. (2012). Bioinformatics tools for mass spectroscopy-based metabolomic data processing and analysis. Curr Bioinform 7, 96-108.
86. Thompson, K. M. and Graham, J. D. (1996). Going beyond the single number: Using probabilistic risk assessment to improve risk management. Hum Ecolog Risk Assessm 2, 1008-1034. (Pubitemid 126713671)
87. van der Voet, H. and Slob, W. (2007). Integration of probabilistic exposure assessment and probabilistic hazard characterization. Risk Anal 27, 351-371. (Pubitemid 46776188)
88. Van Leeuwen, C. J., Patlewicz, G. Y., and Worth, A. P. (2007). Intelligent Testing Strategies. In C. J. Van Leeuwen and T. G. Vermeire (eds.), Risk Assessment of Chemicals. An Intro duction. 2nd edition (467-509). Dordrecht The Netherlands: Springer
89. van Vliet, E. (2011). Current standing and future prospects for the technologies proposed to transform toxicity testing in the 21st century. ALTEX 28, 17-44.
90. Vecchio, T. J. (1966). Predictive value of a single diagnostic test in unselected populations. New Engl J Med 274, 1171-1173.
91. Vonk, J. A., Benigni, R., Hewitt, M., et al. (2009). The use of mechanisms and modes of toxic action in integrated testing strategies: the report and recommendations of a workshop held as part of the European Union OSIRIS Integrated Project. Altern Lab Anim 37, 557-571.
92. Willett, C. E., Bishop, P. L., and Sullivan, K. M. (2011). Application of an integrated testing strategy to the U.S. EPA endocrine disruptor screening program. Toxicol Sci 123, 15-25.
93. Worth, A. P., Bassan, A., de Bruijn, J., et al. (2007). The role of the European Chemicals Bureau in promoting the regulatory use of (Q)SAR methods. SAR QSAR Environ Res 18, 111-125.
94. Zuang, V., Eskes, C., and Griesinger, C. (2008). ECVAM key area topical toxicity: Update on activities. AATEX 14, Spec Issue, 523-528. http://altweb.jhsph.edu/wc6/paper523.pdf