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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-12-11 to 2018-02-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
Adopted 21st July, 1997
Deviations:
yes
Remarks:
Concerning preparation of the test Item
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Zirconium oxide, hafnium and ytterbium doped
EC Number:
945-888-9
Molecular formula:
Yb0.109Hf0.013Zr0.879O1.949
IUPAC Name:
Zirconium oxide, hafnium and ytterbium doped
Test material form:
solid
Details on test material:
- Nam in test report: Ytterbium stabilized Zirconium and Hafnium Oxide
- EC No.: 945-888-9
- Batch No.: 7170502
- Physical state: solid
- Colour: white
- Purity: > 95%
- Expiry date: 26 October 2022
- Storage conditions: room temperature, in a tightly closed container in a dry place
Specific details on test material used for the study:
Name in test report: Ytterbium stabilized Zirconium and Hafnium Oxide
EC No.: 945-888-9
Batch No.: 7170502
Physical State: solid
Colour: white
Purity: > 95%
Expiry Date: 26 October 2022
Storage Conditions: room temperature, in a tightly closed container in a dry place

Method

Target gene:
Histidine locus
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
S9

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
not applicable
Genotoxicity:
not determined
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not examined
Untreated negative controls validity:
not examined
Positive controls validity:
not examined
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
not applicable
Genotoxicity:
not determined
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not examined
Untreated negative controls validity:
not examined
Positive controls validity:
not examined
Species / strain:
S. typhimurium TA 98
Metabolic activation:
not applicable
Genotoxicity:
not determined
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not examined
Untreated negative controls validity:
not examined
Positive controls validity:
not examined
Species / strain:
S. typhimurium TA 100
Metabolic activation:
not applicable
Genotoxicity:
not determined
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not examined
Untreated negative controls validity:
not examined
Positive controls validity:
not examined
Species / strain:
S. typhimurium TA 102
Metabolic activation:
not applicable
Genotoxicity:
not determined
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
not examined
Untreated negative controls validity:
not examined
Positive controls validity:
not examined
Additional information on results:
The test item was checked for solubility in Aqua dest., DMSO, ethanol and acetone. Due to the properties of the test item, the material precipitated immediately with all solvents tested. Thus, no suspension, suitable for the dilution series could be obtained. Therefore, due to the insolubility of the test item, it was not possible to perform any further steps with the test item in this study.
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Conclusions:
Zirconium oxide, hafnium and ytterbium doped was not soluble in any of the solvents used. Therefore, it was not possible to perform an Ames test.
Executive summary:

In this study, the test item zirconium oxide, hafnium and ytterbium doped could not be prepared in an appropriate solvent and diluted prior to treatment. Due to the properties of the material, the target substance was not soluble in any of the solvents used (Aqua dest., DMSO, ethanol and acetone). No stable suspension which is suitable for the preparation of the dilution series could be obtained. Therefore, it was not possible to perform any further steps in this study. Since the test item could not be prepared in an appropriate solvent and diluted prior to treatment, it was not possible to perform an Ames test with zirconium oxide, hafnium and ytterbium doped. In line with Annex XI, section 2 of Regulation (EC) 1907/2006 (REACH Regulation), the performance of the study is therefore technically not feasible.