Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: oral
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: 3-chloropropyl(dimethoxy)methylsilane (CAS 18171-19-2)

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 GLP 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: No data available.
- Weight of evidence: Insufficient data.
- Grouping and read-across: Insufficient data.

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 repeated dose toxicity.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: A Repeated Dose 90-Day Oral Toxicity Study in Rodents (OECD 408) with the registered substance 3-chloropropyl(dimethoxy)methylsilane (CAS 18171-19-2) is proposed in response to draft decision TPE1_DEC_REG_01-2119956366-28-0001_TPE-D-2114330923-52-01 in which read-across was rejected.

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

Results and discussion

Applicant's summary and conclusion