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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:
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. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name: 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: 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 results
Species / strain:
S. typhimurium, other: TA98, TA100, TA102, TA1535 and TA1537
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:
Ytterbium stabilized Zirconium and Hafnium Oxide 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 Ytterbium stabilized Zirconium and Hafnium oxide (target substance) 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 Ytterbium stabilized Zirconium and Hafnium oxide.