Assessment of genotoxicity of herbal medicinal products: A co-ordinated approach

Phytomedicine

Volumn 19, Issue 5, 2012, Pages 472-476

  Kelber, Olaf ^a   Steinhoff, Barbara ^a   Kraft, Karin ^a  

^a Kooperation Phytopharmaka GbR   (Germany)

Author keywords

Ames test; Bracketing and matrixing; EMA; Genotoxicity; Herbal Medicinal Products; HMP; HMPC; Marketing authorisation

Indexed keywords

HERBACEOUS AGENT; SOLVENT;

AMES TEST; ARTICLE; DRUG APPROVAL; DRUG INDUSTRY; DRUG MARKETING; DRUG SAFETY; DRUG SCREENING; EUROPE; GENOTOXICITY; GOOD MANUFACTURING PRACTICE; HERBAL MEDICINE; HYPERICUM PERFORATUM; MEDICAL LITERATURE; PRIORITY JOURNAL; RISK ASSESSMENT; TOXICITY TESTING;

CONSUMER PRODUCT SAFETY; DRUG APPROVAL; EUROPEAN UNION; GOVERNMENT REGULATION; HUMANS; LEGISLATION, DRUG; MARKETING; MEDICINE, TRADITIONAL; MUTAGENICITY TESTS; PHARMACOPOEIAS AS TOPIC; PHYTOTHERAPY; PLANT PREPARATIONS; QUALITY CONTROL; REGISTRIES;

EID: 84858081146     PISSN: 09447113     EISSN: 1618095X     Source Type: Journal    
DOI: 10.1016/j.phymed.2011.11.008     Document Type: Article

References (30)

1. V. Bartsch Das Taxol-Buch 2004 Thieme Stuttgart
2. CPMP Note for Guidance on Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals (CPMP/ICH/174/95).
3. CPMP Note for Guidance on Genotoxicity: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals (CPMP/ICH/141/95).
4. A. Crozier, T. Yokota, I.B. Jaganath, S.C. Marks, M. Saltmarsh, and M.N. Clifford Secondary metabolites in fruits, vegetables, beverages and other plant-based dietary components A. Crozier, M.N. Clifford, H. Ashihara, Plant Secondary Metabolites. Occurrence, Structure and Role in the Human Diet 2006 Blackwell Publishing Oxford, UK
5. J.L. Donovan, C. Manach, R.M. Faulks, and P.A. Kroon Absorption and metabolism of dietary plant secondary metabolites A. Crozier, M.N. Clifford, H. Ashihara, Plant Secondary Metabolites. Occurrence, Structure and Role in the Human Diet 2006 Blackwell Publishing Oxford, UK
6. European Pharmacopoeia. Council of Europe.
7. F. Gaedcke, O. Kelber, K. Kraft, B. Steinhoff, and H. Winterhoff Assessment of genotoxicity of herbal medicinal preparations according to the guideline EMEA/HMPC/107079/2007 - a model project of Kooperation Phytopharmaka, Bonn, Germany Conference Abstract Volume, ESCOP Symposium Cologne 18 June 2009 2009
8. F. Gaedcke, O. Kelber, K. Kraft, B. Steinhoff, and H. Winterhoff Assessment of genotoxicity of herbal medicinal preparations according to the guideline EMEA/HMPC/107079/2007: a model project of Kooperation Phytopharmaka, Bonn, Germany Planta Med. 75 2009 994
9. Guideline on Non-Clinical Documentation for Herbal Medicinal Products in Applications for Marketing Authorisation (Bibliographical and Mixed Applications) and in Applications for Simplified Registration. EMEA/HMPC/32116/2005.
10. Guideline on Selection of Test Materials for Genotoxicity Testing for Traditional Herbal Medicinal Products/Herbal Medicinal Products. EMEA/HMPC/67644/2009.
11. Guideline on the Assessment of Genotoxicity of Herbal Substances/Preparations. EMEA/HMPC/107079/2007.
12. M. Harwood, B. Danielewska-Nikiel, J.F. Borzelleca, G.W. Flamm, G.M. Williams, and T.C. Lines A critical review of the data related to the safety of quercetin and lack of evidence of in vivi toxicity, including lack of genotoxic/carcinogenic properties Food Chem. Toxicol. 45 2007 2179 2205 (Pubitemid 47451573)
13. I. Hasslauer, A. Oehme, S. Locher, A. Valotis, G. van't Slot, H.U. Humpf, and P. Schreier Flavan-3-ol C-glycosides - preparation and model experiments mimicking their human intestinal transit Mol. Nutr. Food Res. 54 2010 1546 1555
14. R. Hegnauer, and M. Hegnauer Chemotaxonomie der Pflanzen XI b-2, Teil 3 Leguminosen 2001 345
15. ICH Consensus Guideline S2(R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use. Step 4 version of November 2011.
16. S.M. Jeurissen, A. Punt, T. Delatour, and I.M. Rietjens Basil extract inhibits the sulfotransfemase mediated formation of DNA adducts of the procarcinogen 1′-hydroxyestragole in rat and human S9 homogenates and in HepG2 human hepatoma cells Food Chem. Toxicol. 46 2008 2296 2302
17. K. Keppler, and H.U. Humpf Metabolism of anthocyanins and their phenolic degradation products by the intestinal microflora Bioorg. Med. Chem. 13 2005 5195 5205 (Pubitemid 41039980)
18. T. Matsushima Mutagenicity of the naturally occurring carcinogen cycasin and synthetic methylazoxymethanol conjugates in Salmonella typhimurium Cancer Res. 39 1979 3780 3782 (Pubitemid 10220193)
19. E.C. Miller, A.B. Swanson, D.H. Philips, T.L. Fletcher, A. Liem, and J.A. Miller Structure & activity studies of the carcinogenicities in the mouse and rat of some naturally occurring and synthetic alkenylbenzene derivatives related to safrole and estragole Cancer Res. 43 1983 1124 1134 (Pubitemid 13160033)
20. OECD 471 - OECD Guideline for Testing of Chemicals 1997 OECD
21. S.N. Okpanyi Genotoxizität eines standardisierten Hypericum-Extraktes Arzneim. Forsch./Drug Res. 40 1990 851 855
22. B. Podginsky Johanniskraut (Hypericum perforatum L.). Genotoxizität bedingt durch den Quercetingehalt DAZ 128 1988 1364 1366
23. I.M. Rietjens, M.G. Boersma, H. van der Woude, S.M. Jeurissen, M.E. Schutte, and G.M. Alink Flavonoids and alkylbenzenes: mechanisms of mutagenic action and carcinogenic risk Mutat. Res. 574 2005 124
24. H. Schütt, and V. Schulz Hagers Enzyklopädie der Arzneistoffe und Drogen J. Reichling, W. Blaschek, U. Hilgenfeldt, U. Holzgrabe, P. Ruth, V. Schulz, HagerROM 2010 2010 Springer Verlag Berlin, Germany
25. R.L. Smith, T.B. Adams, J. Doull, V.J. Feron, J.I. Goodman, L.J. Marnett, P.S. Portoghese, W.J. Waddell, B.M. Wagner, A.E. Rogers, J. Caldwell, and I.G. Sipes Safety assessment of allylalkoxybenzene derivatives used as flavouring substances - methyl eugenol and estragole Food Chem. Toxicol. 40 2002 851 870 (Pubitemid 34626695)
26. M. Veit, and A. Klüting Die Prüfung pflanzlicher Zubereitungen auf Genotoxizität - ein Diskussionsbeitrag Z. Phytother. 31 2010 230 235
27. Vissienon, C., Nieber, K., Kelber, O., Butterweck, V. Route of administration determines anxiolytic activity of the flavonols kaempferol, quercetin, and myricetin - are they prodrugs? J. Nutr. Biochem., doi:10.1016/j.jnutbio.2011.03.017, in press.
28. M. Wani, H. Taylor, M. Wall, P. Coggon, and A. McPhail Plant antitumor agents. VI. The isolation and structure of taxol, a novel antileukemic and antitumor agent from Taxus brevifolia J. Am. Chem. Soc. 93 1971 2325 2327
29. J. Wiesner, and W. Knöss Die Prüfung pflanzlicher Zubereitungen auf Genotoxizität. Anforderungen, pragmatische Ansätze, Diskussionen Z. Phytother. 31 2010 127 133
30. P.G. Wislocki, E.C. Miller, J.A. Miller, E.C. McCoy, and H.S. Rosenkranz Carcinogenic and mutagenic activities of safrole, 1′-hydroxysafrole, and some known or possible metabolites Cancer Res. 37 1977 1883 1891 (Pubitemid 8095207)