Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
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 : tri{[(2S)-1-ethoxy-1-oxopropan-2-yl]oxy}(vinyl)silane.

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies : Not available.
- Available non-GLP studies : Not available.
- Historical human data : Not available.
- (Q)SAR : Not available.
- In vitro methods : Not available.
- Weight of evidence : No data available.
- Grouping and read-across : No data on analogues.

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 item is not considered to be genotoxic carcinogen nor germ cell mutagen. Moreover, it can't be proven that there is no systemic absorption and there is significant human exposure.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Stabilisation: in water undergoes hydrolysis

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion