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EC number: 232-954-0 | CAS number: 9066-59-5
- 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
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
The study does not need to be conducted if pre-natal developmental toxicity information are available.
Justification for selection of Effect on fertility via oral route:
The study does not need to be conducted if pre-natal developmental toxicity information is available.
Effects on developmental toxicity
Description of key information
Lysozyme did not show teratogenic effects and/or developmental toxicity in both mice and rabbits.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- subacute
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
The lysozyme enzyme has been widely studied and a specific monograph is available. An old complete developmental toxicity study was performed and mentioned in monograph; no details about the test procedures and substance composition are available, nevertheless the outcomes reached can be considered as reliable and representative.
In general lysozyme can be regarded as the precursor of lysozyme hydrochloride; the transformation into the salt form does not significantly impact the reproductive toxicity potential and it is expected that lysozyme and lysozyme hydrochloride share the same potential breakdown products via physical and biological process. Furthermore, it has to be taken into account that the lysozyme as such can be considered as a conservative representative, based on the greater bioavailability potential. After oral intake the extent of absorption via the gastrointestinal tract is determined by the lipophilicity of the substance that can be considered to be comparable for lysozyme and lysozyme hydrochloride. The oral mucosa has a thin epithelium and rich vascularity, which favour absorption; however, contact is usually too brief for substantial absorption. The following step regards the stomach, in which the strong acid pH conditions carry, in both cases, to the same unfolded enzyme structure, with the same salification grade.
Twenty gravid mice and ten gravid rabbits were administered with 200 mg/kg p.o. during the organogenetic period, i.e. from gestation days VI to XV and VI to XVIII, respectively. A second group of ten rabbits was treated with physiological saline, as control.
At the end of treatment all animals were sacrificed and carcass section was performed with a determination of the number of foetus, weight, macroscopic appearance and implantation sites. Subsequently, the foetus were sacrificed and stained with alizarin, after which they were examined for anomalies in the thoracic and abdominal lumen and the skeleton. This revealed that the test substance does not have teratogenic action, the foetus were normal in weight, number and implantation sites, and the same applied to resorption or skeletal structure.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), 3.7 Reproductive toxicity section, reproductive toxicity includes adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring.
Lysozyme did not show teratogenic effects and/or developmental toxicity in both mice and rabbits, thus the information available bring to a conclusion not sufficient for a classification, according to the CLP Regulation (EC 1272/2008).
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.
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