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EC number: 420-150-4 | CAS number: 80498-15-3 SP 807
- 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
Carcinogenicity
Administrative data
Description of key information
The large amount of available data on genotoxicity of laccase and a wide variety of other enzyme proteins together with structural knowledge, toxicokinetic and human data provide no evidence for genotoxic or carcinogenic potential of laccase.
The low exposure to enzymes and 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 do not justify any requirement for conducting carcinogenicity studies.
Key value for chemical safety assessment
Justification for classification or non-classification
Laccase should not be classified as carcinogenic (For further justification see discussion above).
Additional information
Enzyme proteins are not regarded as either genotoxic and/or carcinogenic substances. Genotoxicity testing is in general performed to confirm that the production strain does not produce any genotoxic or carcinogenic metabolites. Basically all enzyme substances have therefore been tested in the Ames test and in the chromosome aberration test in vitro and a few enzyme substances have also been tested in the mouse lymphoma test (ref. 11-40). In none of these test systems did enzyme proteins show evidence of genotoxicity.
Enzymes have been used for decades to treat pancreatic insufficiency and similar diseases in both children and adults 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 and 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 and 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 do not justify any requirement for conducting carcinogenicity studies.
References
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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.
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