Erratum: Genotoxicity of flubendazole and its metabolites in vitro and the impact of a new formulation on in vivo aneugenicity (Mutagenesis (2016) 31:3 (309-321) DOI: 10.1093/mutage/gev070);Genotoxicity of flubendazole and its metabolites in vitro and the impact of a new formulation on in vivo aneugenicity

Mutagenesis

Volumn 31, Issue 3, 2016, Pages 309-321

  Tweats, David J ^a   Johnson, George E ^a   Scandale, Ivan ^b   Whitwell, James ^c   Evans, Dean B ^b  

^a SWANSEA UNIVERSITY   (United Kingdom)

^b Drugs for Neglected Diseases Initiative   (Switzerland)

^c Bioanalytical Department   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALBENDAZOLE; ALBENDAZOLE SULFOXIDE; FLUBENDAZOLE; MEBENDAZOLE; MITOMYCIN; VINBLASTINE SULFATE; ANEUGEN; ANTINEMATODAL AGENT; DNA; MUTAGENIC AGENT;

AMES TEST; ANIMAL CELL; ANIMAL EXPERIMENT; ARTICLE; BONE MARROW; CHROMOSOME NUMBER; CONTROLLED STUDY; DOSE RESPONSE; DRUG ABSORPTION; DRUG POTENCY; ESCHERICHIA COLI; FEMALE; GENOTOXICITY; HUMAN; HUMAN CELL; IN VITRO STUDY; IN VIVO STUDY; LIVER; LYMPHOCYTE; MALE; MICRONUCLEUS TEST; MUTAGENICITY; NONHUMAN; NORMAL HUMAN; PRIORITY JOURNAL; RAT; RISK ASSESSMENT; SALMONELLA ENTERICA SEROVAR TYPHIMURIUM; ANALOGS AND DERIVATIVES; ANIMAL; CELL CULTURE; CHROMOSOME ABERRATION; DNA DAMAGE; DRUG EFFECTS; HUMAN CHROMOSOME; METABOLIC ACTIVATION; METABOLISM;

ACTIVATION, METABOLIC; ANEUGENS; ANIMALS; ANTINEMATODAL AGENTS; CELLS, CULTURED; CHROMOSOME ABERRATIONS; CHROMOSOMES, HUMAN; DNA; DNA DAMAGE; HUMANS; LYMPHOCYTES; MALE; MEBENDAZOLE; MICRONUCLEUS TESTS; MUTAGENS; RATS;

EID: 84966659014     PISSN: 02678357     EISSN: 14643804     Source Type: Journal    
DOI: 10.1093/mutage/gey006     Document Type: Erratum

References (44)

1. WHO (2015) Fact Sheet No 2012. http://www.who.int/mediacentre/factsheets/fs102/en/(accessed September 22, 2015).
2. Onchocerciasis-River Blindness, Fact Sheet No 95. http://www.who.int/mediacentre/factsheets/fs095/en/
3. WHO (2007) Onchocerciasis meeting of the International Task Force for Disease Education, Weekly Epidemiological Record, 1st June 2007, Nos 22/23, 82, pp. 197-208.
4. Zour H. G. M., Wanji, S., Noma, M., Amazigo, U. V., Diggle, P. J., Tekle, A. H., Remme, J. H. (2011) The geographic distribution of Loa loa in Africa: results of large-scale implementation of the Rapid Assessment Procedure for Loiasis (RAPLOA). PLoS Negl. Trop. Dis., 5, e1210.
5. Simonsen, P. E., Pedersen, E. M., Rwegoshora, R. T., Malecela, M. N., Derua, Y. A., Magesa, S. M. (2010) Lymphatic filariasis control in Tanzania: effect of repeated mass drug administration with ivermectin and albendazole on infection and transmission. PLoS Negl. Trop. Dis., 4, e696.
6. Feldmeier, H., Bienzle, U., Dohring, E., Dietrich, M. (1982) Flubendazole versus mebendazole in intestinal helminthic infections. Acta Trop., 39, 185-189.
7. Mackenzie, C. D., Geary, T. G. (2011) Flubendazole: a candidate macrofilaricide for lymphatic filariasis and onchocerciasis field programs. Expert Rev. Anti. Infect. Ther., 9, 497-501.
8. EMEA (2006) Flubendazole (Extrapolation to Poultry), summary report (4). Committee for Medicinal products for Veterinary Use. EMEA/CVMP/33128/2006-FINAL, http://www.ema.europa.eu/docs/en-GB/document-library/Maximum-Residue-Limits-Report/2009/11/WC500014292.pdf.
9. Spagnuolo, P.A., Hu, J., Hurren, R. et al. (2010) The antihelmintic flubendazole inhibits microtubule function through a mechanism distinct from Vinca alkaloids and displays preclinical activity in leukemia and myeloma. Blood, 115, 4824-4833.
10. Nianjun, H., Cerepnalkoski, L., Nwankwo, J. O., Dews, M., Landolph, J. R. (1994) Induction of chromosomal aberrations, cytotoxicity, and morphological transformation in mammalian cells by the antiparasitic drug flubendazole and the antineoplastic drug harringtonine. Toxicol Sci., 22, 304-313.
11. COM (2010) Guidance Statement: Thresholds for In Vivo Mutagens. Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment. https://www.gov.uk/government/uploads/system/uploads/attachment-data/file/315698/assessment-of-threshold-for-in-vivo-mutagens.pdf
12. COM (2000) Statement on Thresholds for Aneugens. Extrapolation of Data from Somatic Cells to Germ Cells. Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment. Annual Report 2000. Published HMSO, London, pp 88-90.
13. Elhajouji, A., Lukamowicz, M., Cammerer, Z., Kirsch-Volders, M. (2011) Potential thresholds for genotoxic effects by micronucleus scoring. Mutagenesis, 26, 199-204.
14. Elhajouji, A., Tibaldi, F., Kirsch-Volders, M. (1997) Indication for thresholds of chromosome non-disjunction versus chromosome lagging induced by spindle inhibitors in vitro in human lymphocytes. Mutagenesis, 12, 133-140.
15. Elhajouji, A., Van Hummelen, P., Kirsch-Volders, M. (1995) Indications for a threshold of chemically-induced aneuploidy in vitro in human lymphocytes. Environ. Mol. Mutagen., 26, 292-304.
16. Bolt, H. M., Degen, G. H. (2004) Human carcinogenic risk evaluation, part II: contributions of the EUROTOX specialty section for carcinogenesis. Toxicol. Sci., 81, 3-6.
17. Parry, E. M., Parry, J. M., Corso, C. et al. (2002) Detection and characterization of mechanisms of action of aneugenic chemicals. Mutagenesis, 17, 509-521.
18. COM (1994) Thresholds for Aneuploidy Inducing Chemicals, in, The 1993 Annual Report of the Committees on Toxicity, Mutagenicity, Carcinogenicity of Chemicals in Food, Consumer Products and the Environment. Published HMSO, London, pp 36-38.
19. Ermler, S., Scholze, M., Kortenkamp, A. (2013) Seven benzimidazole pesticides combined at sub-threshold levels induce micronuclei in vitro. Mutagenesis, 28, 417-426.
20. COM (2008) Staement: Benzimidazoles: An Approach to Defining a Common Aneugenic Grouping, In: The 2007 Annual Report of the Committees on Toxicity, Mutagenicity, Carcinogenicity of Chemicals in Food, Consumer Products and the Environment. Published by the Food Standards Agency/Department of Health, pp, 146-153
21. Bentley, K. S., Kirkland, D., Murphy, M., Marshall, R. (2000) Evaluation of thresholds for benomyl-and carbendazim-induced aneuploidy in cultured human lymphocytes using fluorescence in situ hybridization. Mutat. Res., 464, 41-51.
22. Gollapudi, B. B., Johnson, G. E., Hernandez, L. G. et al. (2013) Quantitative approaches for assessing dose-response relationships in genetic toxicology studies. Environ. Mol. Mutagen., 54, 8-18.
23. OECD (2010) Test No. 487: In Vitro Mammalian Cell Micronucleus Test, OECD Guidelines for the Testing of Chemicals, Section 4, OECD Publishing, Paris. doi: http://dx.doi.org/10.1787/9789264091016-en
24. Gatehouse, D., Haworth, S., Cebula, T. et al. (1994) Recommendations for the performance of bacterial mutation assays. Mutat. Res., 312, 217-233.
25. Slob, W., Setzer, R. W. (2014) Shape and steepness of toxicological dose-response relationships of continuous endpoints. Crit. Rev. Toxicol., 44, 270-297.
26. Hern?dez, L. G., Slob, W., Van Steeg, H., Van Benthem, J. (2011) Can carcinogenic potency be predicted from in vivo genotoxicity data? A metaanalysis of historical data. Environ. Mol. Mutagen., 52, 518-528.
27. Bemis, J., Wills, J., Bryce, S., Torous, D., Dertinger, D., Slob, W. (2015) Comparison of in vitro and in vivo clastogenic potency based on benchmark dose analysis of flow cytometric micronucleus data in its current form. Mutagenesis, 10.1093/mutage/gev041.
28. Hern?dez, L. G., Van Benthem, J., Johnson, G. E. (2013) A modeof-action approach for the identification of genotoxic carcinogens. PLoS One, 8, e64532.
29. Slob, W. (2002) PROAST: Software for Dose-Response Modeling and Benchmark Dose Analysis. RIVM, http://www.rivm.nl/en/Library/Scientific/Models/PROAST (accessed September 22, 2015).
30. MacGregor, J. T., Fr?schl, R., White, P. A. et al. (2015) IWGT Report on quantitative approaches to genotoxicity risk assessment I. Methods and metrics for defining exposure-response relationships and points of departure (PoDs). Mutat. Res. Gen. Toxicol., 783, 55-65.
31. MacGregor, J. T., Fr?schl, R., White, P. A. et al. (2015) IWGT report on quantitative approaches to genotoxicity risk assessment II. Use of pointof-departure (PoD) metrics in defining acceptable exposure limits and assessing human risk. Mutat. Res. Gen. Toxicol, 783, 66-78.
32. Johnson, G. E., Soeteman-Hernandez, L. G., Gollapudi, B. B. et al. (2014) Derivation of point of departure (PoD) estimates in genetic toxicology studies and their potential applications in risk assessment. Environ. Mol. Mutagen., 55, 609-623.
33. Johnson, G. E., Slob, W., Doak, S. H. et al. (2015) New approaches to adVance the use of genetic toxicology analyses for human health risk assessment. Toxicol. Res., 4, 667-676.
34. Crump, K. S. (1995) Calculation of benchmark doses from continuous data. Risk Anal., 15, 79-89.
35. Hixon, G., Bichteler, A. (2013) drsmooth: Dose-Response Modeling with Smoothing Splines. http://CRAN.R-project.org/package=drsmooth (accessed September 22, 2015).
36. AVancini, D., Menzies, G., Morgan, C., Wills, J., Johnson, G. E., White, P. A., Lewis, P. D. (2016) MutAIT-a online genetic toxicology data portal and analysis tools. Mutagenesis, 31, 323-328.
37. Johnson, G. E., Wills, J., Doak, S. H., Soeteman-Hernandez, L. G., White, P. A. (2015) Empirical analysis of BMD metrics in genetic toxicology part I: in vitro BMD comparisons for potency ranking and to support MOA evaluation. Mutagenesis, in press.
38. Yoshimura, H. (2003) Effect of oral dosing vehicles on the developmental toxicity of flubendazole in rats. Reprod. Toxicol., 17, 377-385.
39. Bolt, H. M., Foth, H., Hengstler, J. G., Degen, G. H. (2004) Carcinogenicity categorization of chemicals-new aspects to be considered in a European perspective. Toxicol. Lett., 151, 29-41.
40. IPCS Inchem (1987) 770 Flubendazole (WHO Food Additive Series 31. http://www.inchem.org/documents/jecfa/jecmono/v31je02.htm (accessed September 22, 2015).
41. IPCS Inchem (1990) Joint FAO/WHO Expert Committee on Food Additives, WHO Food additive Series 25, 666 Albendazole. http://www. inchem.org/documents/jecfa/jecmono/v25je02.htm (accessed September 22, 2015).
42. EMEA Vetrinary Medicines Evaluation Unit (1999) Mebendazole, Summary Report (1), EMEA/MRL/625/99-FINAL. http://www.ema. europa.eu/docs/en-GB/document-library/Maximum-Residue-Limits-Report/2009/11/WC500014872.pdf
43. EMEA/CVMP (2001) Mebendazole Summary Report (2) EMEA/MRL/781/01-FINAL March 2001. http://www.ema.europa.eu/docs/en-GB/document-library/Maximum-Residue-Limits-Report/2009/11/WC500014873.pdf
44. FSCJ (2010) Food Safety Commission of Japan: Risk Assessment Report Mebendazole (veterinary medicines). http://www.fsc.go.jp/english/evaluationreports/vetmedicine/mebendazole-fs156-2010.pdf (accessed September 22, 2015).