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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- An old complete developmental toxicity study was performed and mentioned in monograph. No details about the test procedures and substance composition are available. The study was performed on the base form; further details about the read across approach in the endpoint summay.
Data source
Reference
- Reference Type:
- other: monograph
- Title:
- Fleming lysozyme. Biological Significance and therapeutic applications.
- Author:
- Barbara L., Pellegrini R.
- Year:
- 1 976
- Bibliographic source:
- Ed. Minerva Medica. 1976.
Materials and methods
- Principles of method if other than guideline:
- Ten gravid rabbits were administered with 200 mg/kg p.o. during the organogenetic period, i.e. from gestation days VI to XVIII. A second group of ten rabbits, used as control, was treated with physiological saline. At the end of treatment all animals were sacrificed and cesarcean 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.
- GLP compliance:
- no
- Remarks:
- pre GLP
Test material
- Reference substance name:
- Lysozyme
- EC Number:
- 232-620-4
- EC Name:
- Lysozyme
- IUPAC Name:
- Lysozyme
Constituent 1
Test animals
- Species:
- rabbit
- Details on test animals or test system and environmental conditions:
- Gravid rabbits
Administration / exposure
- Route of administration:
- oral: unspecified
- Duration of treatment / exposure:
- The test substance was administered during the organogenetic period, i.e. from gestation days VI to XVIII.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
200 mg/kg p.o.
Basis:
- No. of animals per sex per dose:
- 10 rabbits x group
- Control animals:
- yes
- Details on study design:
- Control group was dosed with physiological saline.
Examinations
- Maternal examinations:
- At the end of treatment all animals were sacrificed and cesarcan section was performed with a determination of the number of foetus, weight, macroscopic appearance and implantation sites.
- Fetal examinations:
- The foetus were sacrificed and stained with alizarin, after which they were examined for anomalies in the thoracic and abdominal lumen and the skeleton.
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- dose level:
- Effect level:
- 200 other: mg/kg p.o.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
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 skeletral structure.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The test item did not show tetatogenic effects and/or developmental toxicity.
- Executive summary:
Ten gravid rabbits were administered with 200 mg/kg p.o. during the organogenetic period, i.e. from gestation days VI to XVIII. 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 skeletral structure.
Conclusion
The test item did not show tetatogenic effects and/or developmental toxicity.
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