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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
Description of key information
Lysozyme is expected to have no adverse local/systemic effects for repeated exposure.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
SUB-ACUTE TOXICITY
No data on oral/inhalation/dermal routes are available.
In the Luce and Pellegrini handbook [1] was reported that published data referred to a period of 21 [2] days and 10 days [3], respectively, are available.
Lysozyme showed little toxicity even after medium-term administration in high doses, such as in rats treated for 10 days with 1 g/kg i.p.. The guinea pigs and rabbits tolerated intramuscular doses of 100 mg/kg for 10 days without symptoms or local tissue.
CHRONIC TOXICITY
In a study dogs [1] were treated for 5 days/week, for 12 months with 100 and 500 mg/kg p.o and with 25 and 50 mg/kg i.v. As for the local tolerance, no signs of intolerance or tissue reactions were observed. The haematological and blood chemistry data (RBC, WBC, Hb, platelets, differential WBC, haematocrit, clotting time, total serum proteins, bilirubinemia, cholosterolemia, alkaline phosphatase, transaminases) did not deviate from normal in the treated and untreated animals and the same applies to the parameters of liver and kidney function. Furthermore in the post mortem examination, the weight of the individual organs confirmed the optimum tolerance of lysozyme and analogous conclusions could be deduced from the histological reports.
In the handbook of Luce and Pellegrini [1] were also reported results indicating no toxicity on rats administrated p.o. and that the data available egg white lysozyme is devoid of toxic effects even after rather prolonged administration (referred to chronic toxicity in rats and dogs).
No data of sub-acute, nor chronic toxicity on inhalation and dermal route are available. Nevertheless the nature of the substance and the data available on oral route lead to the conclusion that Lysozyme can be expected to have no adverse local/systemic effects for repeated exposure.
Reference
[1] Luce Barbara, Pellegrini Rinaldo, “Fleming lysozyme. Biological Significance and therapeutic applications”. Ed. Minerva Medica. 1976
[2] Sangiorgi G. “Sulla tossicità del losozima da albume d’uovo, iniettato per diverse vie.” Boll. Soc. Ital. Biol. Sperim. 28, 1017, 1952
[3] Gialdroni Grassi G. “Ricerche farmacologiche sul lisozima”. Terap. Antib, Chemioter. 6, 89, 1956.
Justification for classification or non-classification
According to CLP regulation (EC1272/2008) Lysozyme is not classified for repeated dose toxicity.
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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