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Diss Factsheets
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EC number: 235-747-3 | CAS number: 12650-88-3
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
NA
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
See the considerations below.
Short description of key information:
Lysozyme is expected to be non-toxic for reproduction.
Effects on developmental toxicity
Description of key information
Lysozyme is expected to be non-toxic for reproduction.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Both proteolytic and non-proteolytic enzymes have been investigated for their teratogenic and reproductive toxicity potential. Several of these studies have been published in peer reviewed articles [1 -4].
Furthermore, enzymes have been used for decades to treat pancreatic insufficiency in both children and adults without any evidence of reproductive toxicity [5]. Toxicokinetic data together with the enzymatic structure and the weight of evidence from animal studies and human exposure provide no evidence for reproductive toxicity of enzymes. Investigations of enzymes in vitro screening systems for endocrine disrupters cannot be expected to provide any new knowledge due to the nature of enzymes, especially since the majority of screening studies deals with receptor mediated mechanism. It is most unlikely that new animal studies will provide any new knowledge, because the results and conclusions of numerous animal studies, investigating effects on fertility and teratogenicity and the repeated dose oral toxicity studies in vivo have not identified any adverse effects related to reproduction. Thus, reproductive toxicity studies are considered scientifically and ethically unjustified.
In the Luce and Pellegrini handbook [6] is reported that administration of Lysozyme during the organogenesis period in mice and rabbits does not have a teratogenic action: the foetus were normal in weight, number and implantation sites and the same applied to resorptions or skeletal structure.
Taking into account the preliminary considerations and the literature data available, Lysozyme is not expected to be toxic for reproduction and developmental.
Reference
[1] Greenough RJ, Everett DJ (1991) Safety evaluation of alkaline cellulase. Food and Chemical Toxicology 29: 781-785.
[2] Deboer, A.S., Marshall, R., Broadmeadow, A., and Hazelden, K. (1993) Toxicological Evaluation of Acetolactate Decarboxylase. Journal of Food Protection 56, 510-517
[3] 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
[4] 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
[5] Barak, A., Dulitzki,M., Efrati, O., Augarten, A., Szeinberg, A., Reichert, N., Modan, D., Weiss, B., Miller, M., Katzanelson, D., and Yahav, Y. (2005) Pregnancies and outcome in women with cystic fibrosis. Israel Medical Association journal: IMAJ 7, 95-98
[6] Enzymes REACH Consortium. ERC Data waiving argumentation for technical enzymes. 2010
Toxicity to reproduction: other studies
Additional information
NA
Justification for classification or non-classification
According to CLP regulation (EC1272/2008) Lysozyme is not classified for toxicity for reproduction.
Additional information
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.