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Considerations on photochemical genotoxicity. II: report of the 2009 International Workshop on Genotoxicity Testing Working Group.
Mutat Res. 2011 Aug 16; 723(2):91-100.MR

Abstract

A workshop to reappraise the previous IWGT recommendations for photogenotoxicity testing [E. Gocke, L. Muller, P.J. Guzzie, S. Brendler-Schwaab, S. Bulera, C.F. Chignell, L.M. Henderson, A. Jacobs, H. Murli, R.D. Snyder, N. Tanaka, Considerations on photochemical genotoxicity: report of the International Workshop on Genotoxicity Test Procedures working group, Environ. Mol. Mutagen., 35 (2000) 173-184] was recently held as part of the 5th International Workshop on Genotoxicity Testing (IWGT) meeting in Basel, Switzerland (August 17-19, 2009). An Expert Panel was convened from regulatory, academic and industrial scientists (with several members serving on the original panel) and chaired by Dr Peter Kasper (BfArM, Germany). The aim of the workshop was to review progress made in photo(geno)toxicity testing over the past decade; a period which saw the introduction of several regulatory photosafety guidances in particular in Europe and the USA. Based on current regulatory guidelines a substantial proportion of compounds trigger the requirements for photosafety testing. Moreover, there has been growing concern within industry about the performance of the in vitro photosafety tests in the "real world" of compound development. Therefore, the expert group reviewed the status of the current regulatory guidance's and the impact these have had on compound development in the context of the various triggers for photosafety testing. In addition, the performance of photogenotoxicity assays (old and new) was discussed, particularly in view of reports of pseudophotoclastogencity. The Expert Panel finished with an assessment of the positioning of photogenotoxicity testing within a photosafety testing strategy. The most significant conclusion made by the Expert Panel was that photogenotoxicity testing should no longer be recommended as part of the standard photosafety testing strategy. In addition, progress was made on the refinement of triggers for photosafety testing. For example, there was support for harmonisation of methods to determine the Molar Extinction Coefficient (MEC) and a consensus agreement that there should be no requirement for testing of compounds with a MEC<1000Lmol(-1)cm(-1).

Links

Publisher Full Text

Authors+Show Affiliations

Lynch AM
GlaxoSmithKline, Ware, United Kingdom. anthony.m.lynch@gsk.com
Guzzie PJ
No affiliation info available
Bauer D
No affiliation info available
Gocke E
No affiliation info available
Itoh S
No affiliation info available
Jacobs A
No affiliation info available
Krul CA
No affiliation info available
Schepky A
No affiliation info available
Tanaka N
No affiliation info available
Kasper P
No affiliation info available

MeSH

AnimalsComet AssayDrug and Narcotic ControlEyeGuidelines as TopicMicronucleus TestsModels, AnimalMutagenicity TestsPhotochemical ProcessesRatsRisk AssessmentSkinToxicity Tests

Pub Type(s)

Journal Article

Language

eng

PubMed ID

21296679

Citation

Lynch, Anthony M., et al. "Considerations On Photochemical Genotoxicity. II: Report of the 2009 International Workshop On Genotoxicity Testing Working Group." Mutation Research, vol. 723, no. 2, 2011, pp. 91-100.
Lynch AM, Guzzie PJ, Bauer D, et al. Considerations on photochemical genotoxicity. II: report of the 2009 International Workshop on Genotoxicity Testing Working Group. Mutat Res. 2011;723(2):91-100.
Lynch, A. M., Guzzie, P. J., Bauer, D., Gocke, E., Itoh, S., Jacobs, A., Krul, C. A., Schepky, A., Tanaka, N., & Kasper, P. (2011). Considerations on photochemical genotoxicity. II: report of the 2009 International Workshop on Genotoxicity Testing Working Group. Mutation Research, 723(2), 91-100. https://doi.org/10.1016/j.mrgentox.2010.10.010
Lynch AM, et al. Considerations On Photochemical Genotoxicity. II: Report of the 2009 International Workshop On Genotoxicity Testing Working Group. Mutat Res. 2011 Aug 16;723(2):91-100. PubMed PMID: 21296679.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Considerations on photochemical genotoxicity. II: report of the 2009 International Workshop on Genotoxicity Testing Working Group. AU - Lynch,Anthony M, AU - Guzzie,Peggy J, AU - Bauer,Daniel, AU - Gocke,Elmar, AU - Itoh,Satoru, AU - Jacobs,Abby, AU - Krul,Cyrille A M, AU - Schepky,Andreas, AU - Tanaka,Noriho, AU - Kasper,Peter, Y1 - 2011/02/03/ PY - 2010/10/06/received PY - 2010/10/07/accepted PY - 2011/2/8/entrez PY - 2011/2/8/pubmed PY - 2011/9/16/medline SP - 91 EP - 100 JF - Mutation research JO - Mutat Res VL - 723 IS - 2 N2 - A workshop to reappraise the previous IWGT recommendations for photogenotoxicity testing [E. Gocke, L. Muller, P.J. Guzzie, S. Brendler-Schwaab, S. Bulera, C.F. Chignell, L.M. Henderson, A. Jacobs, H. Murli, R.D. Snyder, N. Tanaka, Considerations on photochemical genotoxicity: report of the International Workshop on Genotoxicity Test Procedures working group, Environ. Mol. Mutagen., 35 (2000) 173-184] was recently held as part of the 5th International Workshop on Genotoxicity Testing (IWGT) meeting in Basel, Switzerland (August 17-19, 2009). An Expert Panel was convened from regulatory, academic and industrial scientists (with several members serving on the original panel) and chaired by Dr Peter Kasper (BfArM, Germany). The aim of the workshop was to review progress made in photo(geno)toxicity testing over the past decade; a period which saw the introduction of several regulatory photosafety guidances in particular in Europe and the USA. Based on current regulatory guidelines a substantial proportion of compounds trigger the requirements for photosafety testing. Moreover, there has been growing concern within industry about the performance of the in vitro photosafety tests in the "real world" of compound development. Therefore, the expert group reviewed the status of the current regulatory guidance's and the impact these have had on compound development in the context of the various triggers for photosafety testing. In addition, the performance of photogenotoxicity assays (old and new) was discussed, particularly in view of reports of pseudophotoclastogencity. The Expert Panel finished with an assessment of the positioning of photogenotoxicity testing within a photosafety testing strategy. The most significant conclusion made by the Expert Panel was that photogenotoxicity testing should no longer be recommended as part of the standard photosafety testing strategy. In addition, progress was made on the refinement of triggers for photosafety testing. For example, there was support for harmonisation of methods to determine the Molar Extinction Coefficient (MEC) and a consensus agreement that there should be no requirement for testing of compounds with a MEC<1000Lmol(-1)cm(-1). SN - 0027-5107 UR - https://www.unboundmedicine.com/medline/citation/21296679/Considerations_on_photochemical_genotoxicity__II:_report_of_the_2009_International_Workshop_on_Genotoxicity_Testing_Working_Group_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1383-5718(11)00040-4 DB - PRIME DP - Unbound Medicine ER -