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Diss Factsheets
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EC number: 235-911-4 | CAS number: 13040-19-2
- 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
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Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1977
Materials and methods
- Principles of method if other than guideline:
- Animals were exposed to test material by inhalation and sacrificed after treatment. Chromosome preparations were made from the bone marrow cells and stained. Cells were analysed for chromosome aberrations.
- GLP compliance:
- not specified
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Zinc oxide
- EC Number:
- 215-222-5
- EC Name:
- Zinc oxide
- Cas Number:
- 1314-13-2
- IUPAC Name:
- oxozinc
- Details on test material:
- - Name of test material (as cited in study report): Zinc oxide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Not reported
Administration / exposure
- Route of administration:
- inhalation
- Vehicle:
- Not applicable
- Details on exposure:
- The exposure chambers were equipped with dosing devices, to ensure a constant concentration throughout the exposure period, with a fluctuation not exceeding +/- 10 % of the set values of 0.1 and 0.5 mg/m3.
- Duration of treatment / exposure:
- 5 months
- Frequency of treatment:
- Animals were exposed to the test material aerosol continuously
- Post exposure period:
- Not reported
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.5 and 0.1 mg/m3
Basis:
nominal conc.
- No. of animals per sex per dose:
- Not reported
- Control animals:
- yes
- Positive control(s):
- Not reported
Examinations
- Tissues and cell types examined:
- Bone marrow cells examined for all types of chromosome and chromatid-type aberrations and hyperdiploid cells.
- Details of tissue and slide preparation:
- Specimens were prepared according to Tjio and Whang (1962) method.
- Evaluation criteria:
- Not reported
- Statistics:
- Frequencies of chromosome damages, the Student criterion and the confidence intervals were calculated using the Fisher transformation. The level of significance was 0.05.
Results and discussion
Test results
- Sex:
- female
- Genotoxicity:
- positive
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Additional information on results:
- RESULTS OF DEFINITIVE STUDY
- Statistical evaluation: Both the total number of cells with chromosomal damage and frequency of hyperdiploid cells were increased significantly (p < 0.05) at 0.1 and 0.5 mg/m3.
Any other information on results incl. tables
Frequency of cells with chromosome damages (%) in the bone marrow:
Type of chromosome damages |
Control |
ZnO (mg/m3) |
|
0.1 |
0.5 |
||
Structural aberrations | 0 | 1.0 | 0.5 |
Hyperdiploid cells | 1.0 | 3.5* | 6.0* |
Total cells damaged | 1.0 | 4.5* | 6.5* |
Metaphases studied | 200 | 200 | 200 |
*significant at p<0.05
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: weakly positive
The test material caused a statistically significant increase in the frequency of damaged cells, primarily hyperdiploid under the conditions of this test. - Executive summary:
A study was conducted to determine the potential genotoxicity of the test material using chromosomal aberration assay.
Non-inbred female white rats were exposed to the test material aerosols at a concentration of 0.5 and 0.1 mg/m3 continuously for 5 months. The samples for chromosomal analysis were prepared according to Tjio and Whang (1962) method.
Statistically significant increase in the frequency of damaged cells, primarily hyperdiploid cells were observed at both tested concentration.
The test material caused a statistically significant increase in the frequency damaged cells, primarily hyperdiploid under the conditions of this test.
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.
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