Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Type of information:
experimental study planned
Study period:
The test will be conducted after a decision on the requirement to carry out the proposed test has been taken according to the procedure laid down in Regulation (EC) 1907/2006 and a deadline to submit the information required has been set by the Agency.
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 : dimethoxy(dimethyl)silane, CAS 1112-39-6

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies : no GLP in vivo genotoxicity studies are available for dimethoxy(dimethyl)silane
- Available non-GLP studies : no non-GLP in vivo gentoxicity studies are available for dimethoxy(dimethyl)silane
- Historical human data : no historical human data is available
- (Q)SAR : Q)SAR tools sufficiently addressing the endpoint genetic toxicity in vivo are currently not available.
- In vitro methods : Three in vitro studies are available: bacterial mutagenicity, mammalian cytogenicity and mammalian mutagenicity. Bacterial mutagenicity and mammalian cytogenicity showed negative results for the test substance. However, in the in vitro mammalian mutagenicity study according to OECD 490 and GLP positive results were observed with metaoblic activation. Therefore, further evaluation of the mutagenic potential of dimethoxy(dimethyl)silane needs to be performed.
- Weight of evidence: There are no studies available on in vitro mammalian mutagenicity or in vivo mutagenicity with the registered substance which could be used in a weight of evidence approach.
- Grouping and read-across : No suitable read-across options are available on genetic toxicity.

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:
- An in vitro mammalian mutagenicity assay according to OECD 490 indicated a mutagenic potential for the registered substance. In order to clarify this mutagenic potential an in vivo mutagenicity study is necessary according to standard information requirements according to Annex VIII, Column II, 8.4. No appropriate read-across substances are available.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
mammalian comet assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethoxydimethylsilane
EC Number:
214-189-4
EC Name:
Dimethoxydimethylsilane
Cas Number:
1112-39-6
Molecular formula:
C4H12O2Si
IUPAC Name:
dimethoxydimethylsilane
Test material form:
liquid

Test animals

Species:
rat
Sex:
male

Administration / exposure

Route of administration:
oral: gavage

Examinations

Tissues and cell types examined:
glandular stomach, liver, duodenum

Results and discussion

Applicant's summary and conclusion