Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: oral
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 repeated dose toxicity endpoint
- Available non-GLP studies: 19-day dermal repeated dose study available, which was not conducted according to current OECD test guideline or in compliance with GLP.
- Historical human data: no data
- (Q)SAR: no data
- 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 applicable column 2 adaptations for repeated dose toxicity.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- a Repeated Dose 90-day Oral Toxicity Study in rodents (OECD 408) will be conducted with the structural analogous substance 3-(triethoxysilyl)propanethiol (CAS 14814-09-6).

See endpoint summary for read-across justification

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Applicant's summary and conclusion