Registration Dossier

Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Type of information:
experimental study planned
Study period:
After approval by 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: Reaction Mass of trimethoxy(aminoalkyl)silanes and modified alkylether oligomers
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: There are no available in vivo genetic toxicity studies. There are three GLP in vitro genetic toxicity studies available.
- Available non-GLP studies: There are no non-GLP studies available.
- Historical human data: No data available.
- (Q)SAR: No data available
- In vitro methods: Applicable in vitro methods to assess genotoxic potential have already been used.
- Weight of evidence: Insufficient data.
- Grouping and read-across: Read-across has already been considered and there are no approrpriate structural analogues available.
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 applicable for in vivo genetic toxicity endpoint.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: The registered substance Reaction Mass of trimethoxy(aminoalkyl)silanes and modified alkylether oligomers will be tested in in vivo comet assay according to OECD 489 Test Guideline and in compliance with GLP after approval by ECHA.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Applicant's summary and conclusion