Ytterbium (III) oxide

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Type of information:

experimental study planned

Study period:

Awaiting feedback from ECHA

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : ytterbium trioxide

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies : Three GLP-compliant, in vitro genetic toxicity studies are available. A key in vitro mutagenicity study in bacteria was performed according to OECD guideline 471. Ytterbium trioxide did not show mutagenic activity in the applied bacterium tester strains in the absence or presence of metabolic activation under the conditions of the test system. A key in vitro mammalian chromosome aberration test was performed according to OECD guideline 473. The test substance was considered as clastogenic in the test system (Chinese hamster V79 cells). A key in vitro gene mutation study in mammalian cells (HPRT assay) was performed according to OECD guideline 476. In this study, no mutagenic effect of ytterbium trioxide was observed either in the presence or absence of metabolic activation system under the conditions of this HPRT assay in CHO K1 Chinese hamster ovary cells.
- Available non-GLP studies: No studies available
- Historical human data: No data available
- (Q)SAR: No data available
- In vitro methods: No other adequate in vitro method, other than the ones already conducted is available.
- Weight of evidence: No data is available which would allow a weight of evidence approach.
- Grouping and read-across: No chemical grouping or read-across approach was identified.
- Substance-tailored exposure driven testing [if applicable]: Not applicable
- Approaches in addition to above [if applicable]: Not applicable
- Other reasons [if applicable]: Not applicable

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- The test proposal is fully compliant with ECHA guidance document R.7a (Dec 2016). It is not possible to waive the study based on Column 2 adaptations of the REACH regulation.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- No additional information

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Test material

Test material information

Constituent 1

Reference substance name:

Ytterbium (III) oxide

EC Number:

215-234-0

EC Name:

Ytterbium (III) oxide

Cas Number:

1314-37-0

Molecular formula:

O3Yb2

IUPAC Name:

ytterbium(III) oxide

Test material form:

solid: particulate/powder

Details on test material:

Batch to be tested not yet known.