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EC number: 232-800-2 | CAS number: 9025-57-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Xylanase should not be classified as carcinogenic. (For further justification see discussion above).
Additional information
Enzymatic drugs have been used since the 19th century without providing any evidence of a genotoxic or carcinogenic effect (ref. 2-10; 41-44).
Review of the extensive literature concerned with the safety of enzymes from microbial sources strongly supports the general assumption that enzymes from non-toxigenic, non-pathogenic organisms are safe. Numerous tests for in vitro genotoxicity have failed to reveal the presence of a single mutagen or clastogen. These aspects were reviewed by Pariza and Johnson (ref. 1), who presented a compelling argument for the position that tests for genotoxic potential of enzyme preparations produced by well-characterized non-toxigenic microorganisms are unnecessary for safety evaluation.
In conclusion, the large amount of data on genotoxicity available together with structural knowledge, toxicokinetic and human data provide no evidence for genotoxic or carcinogenic potential of enzymes.
The low exposure to enzymes, the low bioavailability in case of exposure, the lack of genotoxic potential and the consequent absence of any evidence of carcinogenic properties from both human and animal data does not justify any requirement for conducting carcinogenicity studies.
References
1) Pariza, M.W. and Johnson, E.A. (2001) Evaluating the safety of microbial enzyme preparations used in food processing: Update for a new century. Regulatory Toxicology and Pharmacology 33, 173-186
2) Barra,E., Stolarczyk,A., Socha,J., Oralewska,B., Kowalska,M., Skoczen,M., and Wawer,Z. (1998) Efficacy of enzyme supplementation in children with cystic fibrosis. Pediatria Polska 73, 177-182
3) Borowitz,D., Goss,C.H., Stevens,C., Hayes,D., Newman,L., O'Rourke,A., Konstan,M.W., Wagener,J., Moss,R., Hendeles,L., Orenstein,D., Ahrens,R., Oermann,C.M., Aitken,M.L., Mahl,T.C., Young,K.R., Dunitz,J., and Murray,F.T. (2006) Safety and preliminary clinical activity of a novel pancreatic enzyme preparation in pancreatic insufficient cystic fibrosis patients. Pancreas 32, 258-263
4) Borowitz,D., Goss,C.H., Limauro,S., Konstan,M.W., Blake,K., Casey,S., Quittner,A.L., and Murray,F.T. (2006) Study of a novel pancreatic enzyme replacement therapy in pancreatic insufficient subjects with cystic fibrosis. Journal of Pediatrics 149, 658-662
5) Keller,J. and Layer,P. (2006) Are monolithic enteric-coated enzyme preparations effective in pancreatic exocrine insufficiency? A multicentre, double blind, placebo controlled cross-over trial. Gastroenterology 130, A517
6) Konstan,M.W., Stern,R.C., Trout,J.R., Sherman,J.M., Eigen,H., Wagener,J.S., Duggan,C., Wohl,M.E.B., and Colin,P. (2004) Ultrase MT12 and ultrase MT20 in the treatment of exocrine pancreatic insufficiency in cystic fibrosis: Safety and efficacy. Alimentary Pharmacology and Therapeutics 20, 1365-1371
7) Konstan,M.W., Liou,T.G., Strausbaugh,S., Ahrens,R.C., Kanga,J.F., Graff,G.R., Moffett,K.S., Millard,S., Nasr,S.Z., Vezina,M., Spenard,J., and Grondin,J. (2008) Efficacy and safety of Ultrase (R) MT20 in treating pancreatic insufficiency in cystic fibrosis. Gastroenterology 134, A228-A229
8) Laake,K. (1980) ENZYMIC DRUGS. Side Effects of Drugs Annual 222-225
9) Patchell,C.J., Desai,M., Weller,P.H., Macdonald,A., Smyth,R.L., Bush,A., Gilbody,J.S., and Duff,S.A. (2002) Creon 10,000 Minimicrospheres vs. Creon 8,000 microspheres--an open randomised crossover preference study. Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society 1, 287-291
10) Saeed,Z., Wojewodka,G., Marion,D., Guilbault,C., and Radzioch,D. (2007) Novel pharmaceutical approaches for treating patients with cystic fibrosis. Current Pharmaceutical Design 13, 3252-3263
11) Ahmad,S.K., Brinch,D.S., Friis,E.P., and Pedersen,P.B. (2004) Toxicological studies on Lactose Oxidase from Microdochium nivale expressed in Fusarium venenatum. Regulatory toxicology and pharmacology: RTP 39, 256-270
12) Andersen,J.R., Diderichsen,B.K., Hjortkjaer,R.K., De Boer,A.S., Bootman,J., West,H., and Ashby,R. (1987) DETERMINING THE SAFETY OF MALTOGENIC AMYLASE PRODUCED BY RECOMBINANT DNA TECHNOLOGY. Journal of Food Protection 50, 521-526
13) Ashby,R., Hjortkjaer,R.K., Stavnsbjerg,M., Gurtler,H., Pedersen,P.B., Bootman,J., Hodson-Walker,G., Tesh,J.M., Willoughby,C.R., and Et,A. (1987) SAFETY EVALUATION OF STREPTOMYCES-MURINUS GLUCOSE ISOMERASE. Toxicology Letters (Shannon) 36, 23-36
14) Bar,A., Krul,C.A.M., Jonker,D., and de,V.N. (2004) Safety evaluation of an alpha-cyclodextrin glycosyltranferase preparation. Regulatory Toxicology and Pharmacology 39, S47-S56
15) Brinch,D.S. and Pedersen,P.B. (2002) Toxicological studies on Laccase from Myceliophthora thermophila expressed in Aspergillus oryzae. Regulatory toxicology and pharmacology: RTP 35, 296-307
16) Brinch,D.S. and Pedersen,P.B. (2002) Toxicological studies on Polyporus pinsitus laccase expressed by Aspergillus oryzae intended for use in food. Food additives and contaminants 19, 323-334
17) Broadmeadow,A., Clare,C., and De Boer,A.S. (1994) An overview of the safety evaluation of the Rhizomucor miehei lipase enzyme. Food additives and contaminants 11, 105-119
18) Bui,Q., Geronian,K., Gudi,R., Wagner,V., Kim,D., and Cerven,D. (2004) Safety evaluation of marmanase enzyme, produced by Bacillus lentus, intended for use in animal feed. International Journal of Toxicology 23, 398
19) Baer,A., Til,H.P., and Timonen,M. (1995) Subchronic oral toxicity study with regular and enzymatically depolymerized sodium carboxymethylcellulose in rats. Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association 33, 909-917
20) Ciofalo,V., Barton,N., Kretz,K., Baird,J., Cook,M., and Shanahan,D. (2003) Safety evaluation of a phytase, expressed in Schizosaccharomyces pombe, intended for use in animal feed. Regulatory Toxicology and Pharmacology 37, 286-292
21) Coenen,T.M., Schoenmakers,A.C., and Verhagen,H. (1995) Safety evaluation of beta-glucanase derived from Trichoderma reesei: summary of toxicological data. Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association 33, 859-866
22) Coenen,T.M., Aughton,P., and Verhagen,H. (1997) Safety evaluation of lipase derived from Rhizopus oryzae: summary of toxicological data. Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association 35, 315-322
23) Coenen,T.M. and Aughton,P. (1998) Safety evaluation of amino peptidase enzyme preparation derived from Aspergillus niger. Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association 36, 781-789
24) Coenen,T.M., Bertens,A.M., de Hoog,S.C., and Verspeek-Rip,C.M. (2000) Safety evaluation of a lactase enzyme preparation derived from Kluyveromyces lactis. Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association 38, 671-677
25) Cook,M.W. and Thygesen,H.V. (2003) Safety evaluation of a hexose oxidase expressed in Hansenula polymorpha. Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association 41, 523-529
26) Deboer,A.S., Marshall,R., Broadmeadow,A., and Hazelden,K. (1993) Toxicological Evaluation of Acetolactate Decarboxylase. Journal of Food Protection 56, 510-517
27) Elvig,S.G. and Pedersen,P.B. (2003) Safety evaluation of a glucanase preparation intended for use in food including a subchronic study in rats and mutagenicity studies. Regulatory Toxicology and Pharmacology 37, 11-19
28) Greenough,R.J., Everett,D.J., and Stavnsbjerg,M. (1991) Safety evaluation of alkaline cellulase. Food Chem.Toxicol 29, 781-785
29) Greenough,R.J., Perry,C.J., and Stavnsbjerg,M. (1996) Safety evaluation of a lipase expressed in Aspergillus oryzae. Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association 34, 161-166
30) Harbak,L. and Thygesen,H.V. (2002) Safety evaluation of a xylanase expressed in Bacillus subtilis. Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association 40, 1-8
31) Hjortkjaer,R.K., Bille-Hansen,V., Hazelden,K.P., McConville,M., McGregor,D.B., Cuthbert,J.A., Greenough,R.J., Chapman,E., Gardner,J.R., and Ashby,R. (1986) Safety evaluation of Celluclast, an acid cellulase derived from Trichoderma reesei. Food Chem.Toxicol 24, 55-63
32) Hjortkjaer,R.K., Stavnsbjerg,M., Pedersen,P.B., Heath,J., Wilson,J.A., Marshall,R.R., and Clements,J. (1993) Safety evaluation of esperase. Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association 31, 999-1011
33) Kondo,M., Ogawa,T., Matsubara,Y., Mizutani,A., Murata,S., and Kitagawa,M. (1994) Safety evaluation of lipase G from Penicillium camembertii. Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association 32, 685-696
34) Landry,T.D., Chew,L., Davis,J.W., Frawley,N., Foley,H.H., Stelman,S.J., Thomas,J., Wolt,J., and Hanselman,D.S. (2003) Safety evaluation of an alpha-amylase enzyme preparation derived from the archaeal order Thermococcales as expressed in Pseudomonas fluorescens biovar I. Regulatory toxicology and pharmacology : RTP 37, 149-168
35) Lane,R.W., Yamakoshi,J., Kikuchi,M., Mizusawa,K., Henderson,L., and Smith,M. (1997) Safety evaluation of tannase enzyme preparation derived from Aspergillus oryzae. Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association 35, 207-212
36) Modderman,J.P. and Foley,H.H. (1995) Safety evaluation of pullulanase enzyme preparation derived from Bacillus licheniformis containing the pullulanase gene from Bacillus deramificans. Regulatory Toxicology and Pharmacology 21, 375-381
37) Ohshita,K., Nakajima,Y., Yamakoshi,J., Kataoka,S., Kikuchi,M., and Pariza,M.W. (2000) Safety evaluation of yeast glutaminase. Food and Chemical Toxicology 38, 661-670
38) Stavnsbjerg,M., Hjortkjaer,R.K., Billehansen,V., Jensen,B.F., Greenough,R.J., McConville,M., Holmstroem,M., and Hazelden,K.P. (1986) Toxicological Safety Evaluation of A Bacillus-Acidopullulyticus Pullulanase. Journal of Food Protection 49, 146-153
39) Pedersen,P.B. and Broadmeadow,A. (2000) Toxicological studies on Thermomyces lanuginosus xylanase expressed by Fusarium venenatum, intended for use in food. Food additives and contaminants 17, 739-747
40) Porter,M.C., Hartnagel,R.E., Jr., Kowalski,R.L., Clemens,G.R., Jasty,V., Bare,J.J., and Boguslawski,G. (1984) SAFETY EVALUATION OF GLUCOSE ISOMERASE DERIVED FROM FLAVOBACTERIUM-ARBORESCENS AND USED IN PRODUCTION OF HIGH FRUCTOSE CORN SYRUP. Journal of Food Protection 47, 359-371
41) Jensen,B.F. and Eigtved,P. (1990) Safety Aspects of Microbial Enzyme Technology, Exemplified by the Safety Assessment of An Immobilized Lipase Preparation, Lipozyme. Food Biotechnology 4, 699-725
42) Klinge,L., Straub,V., Neudorf,U., and Volt,T. (2005) Enzyme replacement therapy in classical infantile Pompe disease: Results of a ten-month follow-up study. Neuropediatrics 36, 6-11
43) Klinge,L., Straub,V., Neudorf,U., Schaper,J., Bosbach,T., Görlinger,K., Wallot,M., Richards,S., and Voit,T. (2005) Safety and efficacy of recombinant acid alpha-glucosidase (rhGAA) in patients with classical infantile Pompe disease: results of a phase II clinical trial. Neuromuscular disorders: NMD 15, 24-31
44) Scheindlin, S. (2007) Clinical enzymology: enzymes as medicine. Mol. Interv. 7, 4-8
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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