International round-robin study on the Ames fluctuation test

被引:74
作者
Reifferscheid, G. [1 ]
Maes, H. M. [2 ]
Allner, B. [3 ]
Badurova, J. [4 ]
Belkin, S. [5 ]
Bluhm, K. [6 ]
Brauer, F. [7 ]
Bressling, J. [8 ]
Domeneghetti, S. [9 ]
Elad, T. [5 ]
Flueckiger-Isler, S. [10 ]
Grummt, H. J. [11 ]
Guertler, R. [12 ]
Hecht, A. [5 ]
Heringa, M. B. [13 ]
Hollert, H. [6 ]
Huber, S. [14 ]
Kramer, M. [15 ]
Magdeburg, A. [16 ]
Ratte, H. T. [2 ]
Sauerborn-Klobucar, R. [17 ]
Sokolowski, A. [18 ]
Soldan, P. [4 ]
Smital, T. [17 ]
Stalter, D. [16 ]
Venier, P. [9 ]
Ziemann, Chr. [19 ]
Zipperle, J. [20 ]
Buchinger, S. [1 ]
机构
[1] Fed Inst Hydrol BfG, Dept Biochem Ecotoxicol, D-56068 Koblenz, Germany
[2] Rhein Westfal TH Aachen, Inst Environm Res Bio5, Chair Environm Biol & Chemodynam, D-52056 Aachen, Germany
[3] GOBIO GmbH, Inst Gewasserokol & Angew Biol, D-65326 Aarbergen, Germany
[4] Vyzkumny Ustav Vodohospodarsky TG Masaryka, Vvi, Ostrava 70200, Czech Republic
[5] Hebrew Univ Jerusalem, Inst Life Sci, IL-91904 Jerusalem, Israel
[6] Rhein Westfal TH Aachen, Inst Environm Res, Dept Ecosyst Anal, D-52074 Aachen, Germany
[7] Fed Environm Agcy, FG Uberwachungsverfahren III 2 5, D-12307 Berlin, Germany
[8] Rhein Westfal TH Aachen, Inst Hyg & Environm Med, D-52074 Aachen, Germany
[9] Univ Padua, Dept Biol, I-35121 Padua, Italy
[10] Xenometrix AG, CH-4123 Allschwil, Switzerland
[11] Fed Environm Agcy, Bad Elster Branch, D-08645 Bad Elster, Germany
[12] BfR Fed Inst Risk Assessment, Dept Food Safety, D-14195 Berlin, Germany
[13] KWR Watercycle Res Inst, NL-3430 BB Nieuwegein, Netherlands
[14] Bavarian Environm Agcy, D-80539 Munich, Germany
[15] RheinEnergie AG, D-50823 Cologne, Germany
[16] Goethe Univ Frankfurt, Div Biol Sci, Dept Aquat Ecotoxicol, D-60054 Frankfurt, Germany
[17] Rudjer Boskovic Inst, Div Marine & Environm Res, Zagreb 10000, Croatia
[18] Harlan Cytotest Cell Res GmbH, D-64380 Rossdorf, Germany
[19] Fraunhofer Inst Toxicol & Expt Med ITEM, D-30625 Hannover, Germany
[20] State Inst Environm Measurements & Nat Conservat, D-76185 Karlsruhe, Germany
关键词
mutagenicity; genotoxicity; ISO; standardisation; round-robin study; Ames fluctuation test; SALMONELLA MUTAGENICITY ASSAY; VITRO MICRONUCLEUS TEST; ZERO DOSE CONTROL; STATISTICAL PROCEDURES; SURFACE WATERS; GENOTOXICITY; STRAINS; CARCINOGENICITY; SEDIMENTS; HAZARDS;
D O I
10.1002/em.21677
中图分类号
X [环境科学、安全科学];
学科分类号
08 ; 0830 ;
摘要
An international round-robin study on the Ames fluctuation test [ISO 11350, 2012], a microplate version of the classic plate-incorporation method for the detection of mutagenicity in water, wastewater and chemicals was performed by 18 laboratories from seven countries. Such a round-robin study is a precondition for both the finalization of the ISO standardization process and a possible regulatory implementation in water legislation. The laboratories tested four water samples (spiked/nonspiked) and two chemical mixtures with and without supplementation of a S9-mix. Validity criteria (acceptable spontaneous and positive control-induced mutation counts) were fulfilled by 92-100%, depending on the test conditions. A two-step method for statistical evaluation of the test results is proposed and assessed in terms of specificity and sensitivity. The data were first subjected to powerful analysis of variance (ANOVA) after an arcsine-square-root transformation to detect significant differences between the test samples and the negative control (NC). A threshold (TH) value based on a pooled NC was then calculated to exclude false positive test results. Statistically, positive effects observed by the William's test were considered negative, if the mean of all replicates of a sample did not exceed the calculated TH. By making use of this approach, the overall test sensitivity was 100%, and the test specificity ranged from 80 to 100%. Environ. Mol. Mutagen. 2012. (c) 2012 Wiley Periodicals, Inc.
引用
收藏
页码:185 / 197
页数:13
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