(3-chloropropyl)triethoxysilane

Repeated dose toxicity: oral

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)triethoxysilane (CAS 5089-70-3)

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 with the registered substance. Repeated dose inhalation toxicity studies on (3-chloropropyl)trimethoxysilane (CAS 2530-87-2): a 90-day repeated dose study (OECD Test Guideline 413) and a 28-day combined repeated dose / reproductive and developmental toxicity screening study (OECD Test Guideline 422) are available with the source substance (3-chloropropyl)trimethoxysilane (CAS 2530-87-2)
- Available non-GLP studies: A 21-day dermal repeated dose study with the registered substance is available, which was not conducted according to current OECD test guideline or in compliance with GLP
- Historical human data: No data available.
- (Q)SAR: No data available.
- In vitro methods: No validated alternative in vitro test methods are available
- Weight of evidence: Insufficient data available.
- Grouping and read-across: Insufficient data available. A close structural analogue has been identified and data are available for this substance, (3-chloropropyl)trimethoxysilane (CAS 2530-87-2), and these studies are used for interim hazard assessment. The registration and read-across substances have different rates of hydrolysis at pH7 which is a concern for inhalation exposure, therefore the data are not considered adequate to generate the necessary information. There is also a difference between the two substances for vapour pressure.

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 of Annexes VI to X of the REACH Regulation 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 will be performed with the registered substance, (3-chloropropyl)triethoxysilane (CAS 5089-70-3), according to OECD Test Guideline 408 and in compliance with GLP, after approval by ECHA. The oral route has been selected based on physicochemical properties and significant inhalation exposure is not expected.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)

Test material

Test material information

Constituent 1

Reference substance name:

(3-chloropropyl)triethoxysilane

EC Number:

225-805-6

EC Name:

(3-chloropropyl)triethoxysilane

Cas Number:

5089-70-3

Molecular formula:

C9H21ClO3Si

IUPAC Name:

(3-chloropropyl)triethoxysilane

Test animals

Species:

rat