Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
experimental study planned
Study period:
final study report should be available 12 months after the final decision has been received
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: Cesium tetrafluoroaluminate

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies: no GLP studies on cesium tetrafluoroaluminate available addressing this endpoint
- Available non-GLP studies: no non-GLP studies on cesium tetrafluoroaluminate available addressing this endpoint
- Historical human data: no historical human data on cesium tetrafluoroaluminate available addressing this endpoint
- (Q)SAR: QSAR is not possible for inorganic substances and also not for the endpoint chromosome and genome mutation
- In vitro methods: in vitro methods were performed, indicating a concern with the need to perform follow-up studies in vivo (cf. regulation 1907/2008, Annex VIII, Section 8.4, Column 2)
- Weight of evidence: no data available to perform a weight of evidence assessment
- Grouping and read-across: grouping and read-across is not possible

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:
- in vitro methods were performed, indicating a concern with the need to perform follow-up studies in vivo (cf. regulation 1907/2008, Annex VIII, Section 8.4, Column 2)

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Test material

Constituent 1
Reference substance name:
Cesium fluoroaluminate
EC Number:
604-086-6
Cas Number:
138577-01-2
IUPAC Name:
Cesium fluoroaluminate
Test material form:
solid: particulate/powder

Results and discussion

Applicant's summary and conclusion