Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned (based on read-across)
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: 3-(triethoxysilyl)propanethiol (CAS 14814-09-6)
- Name of the substance for which the testing proposal will be used: 3-trimethoxysilylpropane-1-thiol (CAS 4420-74-0)

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: none for the developmental toxicity endpoint
- Available non-GLP studies: none for the developmental toxicity endpoint
- Historical human data: no data
- (Q)SAR: QSAR is not considered to be appropriate method
- In vitro methods: no validated alternative in vitro methods are available
- Weight of evidence: insufficient data
- Grouping and read-across: The test proposal forms part of a planned read-across approach where 90-day Oral Toxicity Study in Rodents (OECD 408) for 3-(triethoxysilyl)propanethiol (CAS 14814-09-6) will be read-across to 3-trimethoxysilylpropane-1-thiol (CAS 4420-74-0).

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 developmental toxicity

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- a Prenatal developmental toxicity study (OECD 414) is required for the analogous substance, 3-(triethoxysilyl)propanethiol (CAS 14814-09-6), to fulfill REACH Annex IX requirements. The study will be conducted when a final decision has been received and will be read-across to the registered substance 3-trimethoxysilylpropane-1-thiol (CAS 4420-74-0).

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 animals

Species:
rat

Administration / exposure

Route of administration:
oral: feed

Results and discussion

Applicant's summary and conclusion