Zirconium oxide, hafnium and ytterbium doped

Genetic toxicity: in vitro

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

Test material information

Constituent 1

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 results

Test results 1

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

Test results 2

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

Test results 3

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

Test results 4

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

Test results 5

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.