Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
experimental study planned
Study period:
Planned: after approval by ECHA
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
[Please provide information for all of the points below. The information should be specific to the endpoint for which testing is proposed. Note that for testing proposals addressing testing on vertebrate animals under the REACH Regulation this document will be published on the ECHA website along with the third party consultation on the testing proposal(s).]

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane (CAS 2554-06-5)
- Name of the substance for which the testing proposal will be used [if different from tested substance]: 2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane (CAS 2554-06-5)

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: An In Vitro Bacterial Mutagenicity Study (OECD 471) and an In Vitro Chromosome Aberration Study in Mammalian Cells (OECD 473).
- Available non-GLP studies: There are no non-GLP studies available
- Historical human data: no data
- (Q)SAR: no data
- In vitro methods: An In Vitro Bacterial Mutagenicity Study (OECD 471) and an In Vitro Chromosome Aberration Study in Mammalian Cells (OECD 473).
- Weight of evidence: Insufficient data
- Grouping and read-across: Insufficient data


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:
- There are no Column 2 adaptations for Genetic toxicity in vivo.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: An In Vivo Mammalian Erythrocyte Micronucleus Test (OECD 474) will be conducted with the registered substance after approval by ECHA.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Applicant's summary and conclusion