OECD validation study to assess intra- and inter-laboratory reproducibility of the zebrafish embryo toxicity test for acute aquatic toxicity testing

Regulatory Toxicology and Pharmacology

Volumn 69, Issue 3, 2014, Pages 496-511

  Busquet, François ^a,o   Strecker, Ruben ^b,p   Rawlings, Jane M ^c   Belanger, Scott E ^c   Braunbeck, Thomas ^b   Carr, Gregory J ^c   Cenijn, Peter ^d   Fochtman, Przemyslaw ^e   Gourmelon, Anne ^f   Hübler, Nicole ^g   Kleensang, André ^a,q   Knöbel, Melanie ^h,r   Kussatz, Carola ⁱ   Legler, Juliette ^d   Lillicrap, Adam ^j   Martínez Jerónimo, Fernando ^k   Polleichtner, Christian ⁱ   Rzodeczko, Helena ^e   Salinas, Edward ^l   Schneider, Katharina E ^b,l   Scholz, Stefan ^h   van den Brandhof, Evert Jan ^m   van der Ven, Leo T M ^m   Walter Rohde, Susanne ⁱ   Weigt, Stefan ^g   Witters, Hilda ⁿ   Halder, Marlies ^a   more..

^a JOINT RESEARCH CENTRE   (Italy)

^b UNIVERSITY OF HEIDELBERG   (Germany)

^c PROCTER AND GAMBLE COMPANY   (United States)

^d VU UNIVERSITY AMSTERDAM   (Netherlands)

^e INSTITUTE OF INDUSTRIAL ORGANIC CHEMISTRY   (Poland)

^f OECD   (France)

^g MERCK KGAA   (Germany)

^h HELMHOLTZ CENTRE FOR ENVIRONMENTAL RESEARCH UFZ   (Germany)

ⁱ UMWELTBUNDESAMT   (Germany)

^j NORWEGIAN INSTITUTE FOR WATER RESEARCH   (Norway)

^k INSTITUTO POLITÉCNICO NACIONAL   (Mexico)

^l BASF SE   (Germany)

^m NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

ⁿ FLEMISH INSTITUTE FOR TECHNOLOGICAL RESEARCH VITO   (Belgium)

^o UNIVERSITY OF KONSTANZ   (Germany)

^p SCC GmbH Am Grenzgraben 11   (Germany)

^q Johns Hopkins University   (United States)

^r SWISS FEDERAL INSTITUTE OF AQUATIC SCIENCE AND TECHNOLOGY   (Switzerland)

more..

Author keywords

Alternative method; Aquatic acute toxicity; Reproducibility; Validation; Zebrafish embryo

Indexed keywords

TOXIC SUBSTANCE; VOLATILE AGENT; WATER POLLUTANT;

ACUTE TOXICITY; AQUATIC ENVIRONMENT; ARTICLE; BLOOD CLOTTING; CHEMICAL ANALYSIS; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; ECOTOXICITY; EMBRYO; EMBRYOTOXICITY; ENVIRONMENTAL EXPOSURE; FERTILIZATION; HEART BEAT; LABORATORY TEST; LC 50; LETHALITY; NONHUMAN; PRACTICE GUIDELINE; PREDICTION; PRIORITY JOURNAL; REPRODUCIBILITY; RETROSPECTIVE STUDY; SOLUBILITY; TOXICITY TESTING; VALIDATION STUDY; YOLK SAC; ZEBRA FISH; ANIMAL; LABORATORY; LD 50; ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT; PROCEDURES; WATER POLLUTANT;

DANIO RERIO;

ANIMALS; LABORATORIES; LETHAL DOSE 50; ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT; REPRODUCIBILITY OF RESULTS; TOXICITY TESTS, ACUTE; WATER POLLUTANTS, CHEMICAL; ZEBRAFISH;

EID: 84904057656     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2014.05.018     Document Type: Article

References (40)

1. Anon., 2005. Announcement of the Amendment of the Wastewater Charges Act on 18th January 2005 [Bekanntmachung der Neufassung des Abwasserabgabengesetzes vom 18. Januar 2005]. German Federal Law Gazette (Bundesgesetzblatt). 2005 - Part I, No 5, published in Bonn on January 25, 2005 [Jahrgang 2005 Teil I Nr. 5, ausgegeben zu Bonn am 25.01.2005].
2. Ashley, S., Mallett, M., 1990. EEC Ring Test of a Method for Determining the Effects of Chemicals on the Growth Rate of Fish. Final Report to the Commission of the European Communities. CEC 2600-M. Water Research Centre, Buckinghamshire, UK.
3. Balls, M., Blaauboer, B.J., Fentem, J.H., et al., 1995. Practical aspects of the validation of toxicity test procedures - the report and recommendations of ECVAM, workshop 5. ATLA, 23, 129-147.
4. Belanger S.E., Rawlings J.M., Carr G.J. Use of fish embryo toxicity tests for the prediction of acute toxicity to chemicals. Environ. Toxicol. Chem. 2013, 32:1768-1783.
5. Braunbeck T., Böttcher M., Hollert H., et al. Towards an alternative for the acute fish LC50 test in chemical assessment: the fish embryo toxicity test goes multi-species - an update. ALTEX 2005, 22:87-102.
6. Braunbeck, T., Lammer, E., 2006. Background document on fish embryo toxicity assays - UBA Contract Number 203 85 422. Available at: http://www.oecd.org/chemicalsafety/testing/36817242.pdf.
7. DIN, 2003. DIN 38415-6: Deutsche Einheitsverfahren zur Wasser-, Abwasser- und Schlammuntersuchung - Suborganismische Testverfahren (Gruppe T) - Teil 6: Giftigkeit gegenüber Fischen; Bestimmung der nicht akut giftigen Wirkung von Abwasser auf die Entwicklung von Fischeiern über Verdünnungsstufen (T 6).
8. Douglas M.T., Chanter D.O., Pell I.B., et al. A proposal for the reduction of animal numbers required for the acute fish toxicity test (LC50 determination). Aquat. Toxicol. 1986, 8:243-249.
9. EC, 2006. Regulation (EC) No 1907/2006 of the European Parliament and the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Off. J. Eur. Union L396, 1-849.
10. ECHA, 2012. REACH Guidance on information requirements and chemical safety assessment - Chapter R.7b. Endpoint specific guidance. Available at: https://echa.europa.eu/documents/10162/13632/information_requirements_r7b_en.pdf.
11. EU, 2010. Directive 2010/63/EU of the European Parliament and Council of 22 September 2010 on the protection of animals used for scientific purposes. Off. J. Eur. Union L 276, 33-79.
12. Grothe D.R., Kimerle R.A. Inter- and intralaboratory variability in Daphnia magna effluent toxicity test results. Environ. Toxicol. Chem. 1985, 4:189-192.
13. Hanstveit, A.O., The results of an international ring test of the marine algal growth inhibition test according to ISO/DP 10253. TNO, Report 91/236, 1991.
14. Henn K., Braunbeck T. Dechorionation as a tool to improve the fish embryo toxicity test (FET) with the zebrafish (Danio rerio). Comp. Biochem. Physiol. 2011, 153C:91-98.
15. ISO, 2007. International Standard Water quality - determination of the acute toxicity of waste water to zebrafish eggs (Danio rerio). ISO 15088:2007(E) International Organization for Standardization.
16. Jensen A.L. Standard error of LC50 and sample size in fish bioassays. Water Res. 1972, 6:85-89.
17. Knöbel M., Busser F.J.M., Rico-Rico A., et al. Predicting adult fish acute lethality with the zebrafish embryo: relevance of test duration, endpoints, compound properties, and exposure concentration analysis. Environ. Sci. Technol. 2012, 46:9690-9700.
18. Klüver N., Ortmann J., Paschke H., et al. Transient overexpression of adh8a increases allyl alcohol toxicity in zebrafish embryos. PLoS ONE 2014, 9(3):e90619. 10.1371/journal.pone.0090619.
19. Laale H.W. The biology and use of zebrafish, Brachydanio rerio, in fisheries research. A literature review. J. Fish Biol. 1977, 10:121-173.
20. Lammer E., Carr G.J., Wendler K., et al. Is the fish embryo toxicity test (FET) with the zebrafish (Danio rerio) a potential alternative for the fish acute toxicity test?. Comp. Biochem. Physiol. 2009, 149:196-209.
21. Meeker W.Q., Escobar L.A. Teaching about approximate confidence regions based on maximum likelihood estimation. Am. Stat. 1995, 49:48-53.
22. Nagel R. DarT: the embryo test with the zebrafish (Danio rerio) - a general model in ecotoxicology and toxicology. ALTEX 2002, 19:38-48.
23. OECD, 1992. Guideline for Testing of Chemicals, 203. Fish, Acute Toxicity Test. OECD, Paris, France. Available at: http://www.oecd.org.
24. OECD, 2000. Guideline for Testing of Chemicals, 215. Fish, Juvenile Growth Test. OECD, Paris, France. Available at: http://www.oecd.org.
25. OECD, 2005. Guidance document on the validation and international acceptance of new or updated test methods for hazard assessment. Series on Testing and Assessment No. 34. OECD, Paris, France. Available at: http://www.oecd.org.
26. OECD, 2006a. Current Approaches in the Statistical Analysis of Ecotoxicity Data: A Guidance to application. Series on Testing and Assessment No. 54. OECD, Paris, France. Available at: http://www.oecd.org.
27. OECD, 2006b. Draft proposal for a new guideline. Fish Embryo Toxicity (FET) Test. OECD, Paris, France. Available at: http://www.oecd.org/chemicalsafety/testing/36817070.pdf.
28. OECD, 2010. Short Guidance on the Threshold Approach for Acute Fish Toxicity Testing. Series on Testing and Assessment No. 126. OECD, Paris, France. Available at: http://www.oecd.org.
29. OECD, 2011. Validation report (Phase 1) for the zebrafish embryo toxicity test. Series on Testing and Assessment No. 157. OECD, Paris, France. Available at: (Part 1); and (Part 2). http://search.oecd.org/officialdocuments/displaydocumentpdf/?cote=ENV/JM/MONO(2011)40%26doclanguage=en.
30. OECD, 2012. Validation report (Phase 2) for the zebrafish embryo toxicity test. Series on Testing and Assessment No. 179. OECD, Paris, France. Available at: (Summary); (Annexes). http://search.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2012)25/ANN%26doclanguage=en.
31. OECD, 2013. Guideline for Testing of Chemicals, 236. Fish Embryo Acute Toxicity (FET) Test. OECD, Paris, France. Available at: http://www.oecd.org.
32. R Development Core Team R: A language and environment for statistical computing 2011, R Foundation for Statistical Computing, Vienna, Austria.
33. Raimondo, S., Vivian, D., Barron, M., 2010. Web-based Interspecies Correlation Estimation (Web-ICE) for Acute Toxicity: User Manual Version 3.1. United States Environmental Protection Agency, Gulf Breeze, FL, USA.
34. Scholz S., Sela E., Blaha L., et al. A European perspective on alternatives to animal testing for environmental hazard identification and risk assessment. Regul. Toxicol. Pharmacol. 2013, 67:506-530.
35. Schulte C., Nagel R. Testing acute toxicity in the embryo of zebrafish, Brachydanio rerio, as alternative to the acute fish test: preliminary results. ATLA 1994, 22:12-19.
36. US EPA, 2001. Final Report: Interlaboratory Variability Study of EPA Short-term Chronic and Acute Whole Effluent Toxicity Test Methods, vol. 1. EPA 821-B-01-004. Office of Water, U.S. Environmental Protection Agency, Washington, D.C.
37. US EPA, 2002. Methods for measuring the acute toxicity of effluents and receiving waters to freshwater and marine organisms. Available at: http://water.epa.gov/scitech/methods/cwa/wet/disk2_index.cfm.
38. Weigt S., Hübler N., Strecker N., et al. Zebrafish (Danio rerio) embryos as a model for testing proteratogens. Toxicology 2011, 281:25-36.
39. Weigt S., Hübler N., Strecker R., et al. Developmental effects of coumarin and the anticoagulant coumarin derivative warfarin on zebrafish (Danio rerio) embryos. Reprod. Toxicol. 2012, 33:133-141.
40. Westerfield M. The zebrafish book: a guide for the laboratory use of zebrafish Danio (Brachydanio) rerio 2000, University of Oregon Press, Institute of Neuroscience, Eugene, USA.