Toxicological studies on Thermomyces lanuginosus xylanase expressed by Fusarium venenatum, intended for use in food

Food Additives and Contaminants

Volumn 17, Issue 9, 2000, Pages 739-747

  Pedersen, P B ^a   Broadmeadow, A ^b  

^a NOVO NORDISK A S   (Denmark)

^b HUNTINGDON LIFE SCIENCES   (United Kingdom)

Author keywords

Fusarium Venenatum; Safety; Toxicology; Xylanase

Indexed keywords

XYLAN ENDO 1,3 BETA XYLOSIDASE;

AMES TEST; ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CHROMOSOME ABERRATION; CONTROLLED STUDY; FEMALE; FERMENTATION; FOOD HANDLING; FOOD INDUSTRY; FUSARIUM; FUSARIUM VENENATUM; HUMAN; HUMAN CELL; LYMPHOCYTE CULTURE; MALE; MOLECULAR STABILITY; MUTAGENICITY; NONHUMAN; PRIORITY JOURNAL; PROTEIN EXPRESSION; RAT; SALMONELLA TYPHIMURIUM; TOXICITY TESTING; TOXICOLOGY;

ANIMALIA; FUSARIUM; FUSARIUM VENENATUM; SALMONELLA TYPHIMURIUM; THERMOMYCES LANUGINOSUS; TYPHIMURIUM;

EID: 0033849391     PISSN: 0265203X     EISSN: 14645122     Source Type: Journal    
DOI: 10.1080/026520300415273     Document Type: Article

References (39)

1. Armitage, P., 1979, Statistical Methods in Medical Research (Oxford, UK: Blackwell Scientific Publications), p. 189.
2. Baguley, J. K., 1999, Xylanase, PPQ 6125: Toxicity study by oral (gavage) administration to CD rats for 13 weeks. Huntingdon Life Sciences. Report No.: NVO166/992031. Huntingdon, Cambridgeshire, UK. Novo Nordisk A/S Study No. 986012.
3. Bartlett, M. S., 1937, Properties of sufficiency and statistical tests. Proceedings of the Royal Society. Series A, 160, 268-282.
4. Bergman, A., and Broadmeadow, A., 1997, An overview of the safety evaluation of the T hermomyces lanuginosu s xylanase enzyme (SP 628) and the Aspergillus aculeatus xylanase enzyme (SP 578). Food Additives and Contaminants, 14, 389-398.
5. Berkowitz, D., and Maryanski, J., 1989, Implications of biotechnology on international food standards and codes of practice. Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission, Eighteenth Session, Geneva, July 3-12.
6. Burman, M., 1999, Xylanase: induction of chromosome aberrations in cultured human peripheral blood lymphocytes. Covance Laboratories, North Yorkshire, UK. Study No. 665/242, Novo Nordisk A/S Study No. 986011.
7. Courtin, C. M., Roelants, A., and Delcour, J. A., 1999, Fractionation-reconstruction experiments provide insight into the role of endoxylanases in bread-making. Journal of Agricultural and Food Chemistry, 47(5), 1870-1877
8. EU Scientific Committee for Food, 1991, Guidelines for the presentation of data on food enzymes. Reports of the Scientific Committee for Food, 27th series (Luxembourg: CEC).
9. European Agency for the Evaluaticn of Medicinal Products, 1996, ICH Topic S 2 A. Genotoxicity: Guidance on Speciec Aspects of Genotoxicity test for Pharmaceuticals. ICH Harmonized Tripartite Guideline. ICH-Technical Coordination-R. Bass, London.
10. FAO/WHO, 1996. Biotechnology and Food Safety, Report of a Joint FAO/WHO Consultation. FAO Food and Nutrition Paper 61 (Rome: WHO).
11. FCC, 1996, Food Chemicals Codex, 4th edition, Committee on Foods Chemicals Codex, Institute of Medicine (USA: Interpharm Press Inc), p. 133.
12. Fisher, R. A., 1973, Statistical Methods for Research Workers, 14th edition (New York, USA: Hafner Publishing Company), p. 98.
13. Green, M. H. L., 1984, Mutagen testing using Trp+ reversion in Escherichia coli. Handbook of Mutagenicity Test Procedures, 2nd edition, edited by B. J. Kilbey et al. (Elsevier), pp. 161-187.
14. IFBC (International Food Biotechnology Council), 1990, safety evaluation of foods and food ingredients derived from microorganisms in biotechnologies and food: assuring the safety of foods produced by genetic modification. Regulatory Toxicology and Pharmacology, 12, 1-S196.
15. ISCN, 1985, An International System for Human Cytogenetic Nomenclature, edited by D. G. Harnden (Switzerland: S. Karger).
16. JECFA (Joint FAO/WHO Expert Committee on Food Additives), 1992, Compendium of Food Additive Specifications, Vol. 1, Annex 1, FAO (Geneva: WHO).
17. Jonas, D. A., Antignac, E., Antoine, J. M., Classen, H. G., Huggett, A., Knudsen, I., Mahler, J., Ockhuizen, T., Smith, M., Teuber, M., Walker, R., and de Vogel, p., 1996, The safety assessment of novel foods, guidelines prepared by ILSI Europe Novel Food Task Force. Food and Chemical Toxicology, 34, 931-940.
18. Krishnarau, L., and Hoseney, R. C., 1994, Enzymes increase loaf volume of bread supplemented with starch tailings and insoluble pentosans. Journal of Food Science, 59(6), 1251-1254.
19. Kruskal, W. H., and Wallis, W. A., 1952, Use of ranks in one-criterion variance analysis. Journal of the American Statistical Association, 47, 583-621.
20. Kruskal, W. H., and Wallis, W. A., 1953, Erratum to above reference. Journal of the American Statistical Association, 48, 907-912.
21. Mahon, G. A.T., Green, M. H. L., Middleton, B., Mitchell, I. deG., Robinson, W. D., and Tweats, D. J., 1989, Analysis of data from microbial colony assays. Statistical Evaluation of Mutagenicity Test Data in the report of the UKEMS Subcommittee on Guidelines for Mutagenicity Testing, Part III, edited by D. J. Kirkland (Cambridge: Cambridge University Press), pp. 26-65.
22. Maron, D. M., and Ames, B. N., 1983, Revised methods for the Salmonella mutagenicity test. Mutation Research, 113, 173-215.
23. Miller, D. J., and Mackenzie, S., Secondary metabolites of Fusarium venenatum strains with deletions in the Tri5 gene encoding trichodiene synthetase. Mycologia (in press).
24. Nirenberg, H.I. 1995, Morphological differentiation of Fusarium sambucinum Fuckel sensu stricto, F. torulosum (Berk.& Curt.) Nirenberg comb.nov. and F.venenatum Nirenberg sp.nov. The European Fusarium sambucinum project. Mycopathologia, 129(3), 131-141.
25. O’Donnell, K., Cigelnik, E., and Casper, H. H., 1998, Molecular phylogenetic, morphological and mycotoxin data support reidentification of the quorn mycoprotein fungus as Fusarium venenatum. Fungal Genetics and Biology, 23, 57-67.
26. OECD, 1997, principles of Good Laboratory Practice (GLP) (as revised in 1997), ENV/MC/CHEM(98)17 (Paris: OECD).
27. OECD, 1997, Genetic toxicology: in vitro mammalian cytogenetic test. OECD Guidelines for testing of chemicals Test Guideline 473. Revised document 1997 (Paris: OECD).
28. OECD, 1998, Repeated dose 90-day oral toxicity study in rodents. OECD Guidelines for testing of chemicals Test Guideline 408, Revised document (Paris: OECD).
29. Olsen, H. S., 1995, Enzymes in Food Processing, Biotechnology, vol. 9, edited by H.-J. Rehm and G. Reed (Weinheim: VCH), pp. 663-736.
30. Organization for Economic Cooperation and Development, 1992, Safety Considerations for Biotechnology (Paris: OECD).
31. Organization for Economic Cooperation and Development, 1993, Safety Evaluation of Foods Derived by Modern Biotechnology (Paris: OECD).
32. Pariza, M. W., and Foster, E. M., 1983, Determining the Safety of Enzymes Used in Food Processing. Journal of Food Protection, 46(5), 453-468.
33. Pedersen, P. B., 1999, Xylanase (Batch Number: PPQ 6125): Test for Mutagenic Activity with Strains of Salmonella typhimurium and Escherichia coli. Novo Nordisk A/S internal report, Study No. 998012.
34. Rouau, X., El-Hayek, M., and Moreau, D., 1994, Effect of an enzyme preparation containing pentosasases on the breadmak-ing quality of flours in relation to changes in pentosan properties. Journal of Cereal Science, 19, 259-272.
35. Royer, J. C., Christianson, L. M., Yoder, W. T., Gambetta, G. A., Klotz, A. V., Morris, C. L., Brody, H., and Otani, S., 1999, Deletion of the trichodiene synthetase gene of Fusarium venenatum; two systems for repeated gene deletions. Fungal Genetics and Biology, 28(1), 68-78.
36. Sprosler, B. G., 1996, Xylanases in baking. Proceedings First European Symposium on Enzymes and Grain Processing, Netherlands Dec. 2-4 1996, edited by S. A. G. F. Angelino, R. J. Hamer, W. Hartingsveldt, F. van Heidekamp and J. P. van der Lugt (Zeist, The Netherlands: TNO Nutrition and Food Research Institute), pp. 177-187.
37. Steel, R. G. D., 1959, A multiple comparison rank sum test: treatments versus control. Biometrics, 15, 560-572.
38. Trinci, A. P. J., 1992, Myco-protein: a twenty-year overnight success story. Mycological Research, 96, 1-13.
39. Yoder, W. T., and Christianson, L. M., 1998, species specific primers resolve members of Fusarium Section Fusarium. Fungal Genetics and Biology, 23, 68-80.