Bis(trimethoxysilylpropyl)amine

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study planned

Study period:

The test will be conducted after a decision on the requirement to carry out the proposed test has been taken according to the procedure laid down in Regulation (EC) 1907/2006 and a deadline to submit the information required has been set by the Agency.

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: Bis(trimethoxysilypropyl)amine, CAS 82985-35-1

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-compliant studies available on developmental toxicity with the registered substance.
- Available non-GLP studies: There are no non-GLP-compliant studies available on developmental toxicity with the registered substance.
- Historical human data: Not available.
- QSAR: Q(SAR) methods are not applicable to assess the full scope of developmental toxicity.
- In vitro methods: No validated or regulatory accepted alternative methods are available for replacing animal testing with respect to developmental toxicity.
- Weight of evidence: There is no information (QSAR, in vitro data, developmental toxicity or fertility data) available which is suitable to assess developmental toxicity in a weight of evidence approach.
- Grouping and read-across: One OECD 414 study in rodents is available for the structurally similar substance, 3-aminopropyltriethoxysilane (CAS 919-30-2), which is a primary amine and not a secondary amine such as bis(trimethoxysilypropyl)amine. Very limited prenatal developmental toxicity data are available on secondary amines and there are no data on a close structural analogue of bis(trimethoxysilypropyl)amine.

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 is no data available on developmental toxicity with bis(trimethoxysilypropyl)amine, CAS 82985-35-1. Validated or regulatory accepted alternative methods are not available for replacing animal testing with respect to developmental toxicity. One OECD 414 study in rodents is available for the structurally similar substance, 3-aminopropyltriethoxysilane (CAS 919-30-2), which is a primary amine and not a secondary amine such as bis(trimethoxysilypropyl)amine. Very limited prenatal developmental toxicity data are available on secondary amines and there are no data on a close structural analogue of bis(trimethoxysilypropyl)amine. In conclusion, taking into account all available data, a GLP-compliant developmental toxicity study in the rat via the oral route following OECD 414 is proposed according to Annex IX, Column I, 8.7.2.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: a developmental toxicity study in rats via the oral route following OECD guideline 414 will be conducted with bis(trimethoxysilypropyl)amine

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Deviations:

no

Principles of method if other than guideline:

There are no data available on the developmental toxicity/teratogenicity of bis(trimethoxysilypropyl)amine.
In order to fulfil the standard information requirements, a GLP-compliant pre-natal developmental toxicity study in rats via the oral route following OECD guideline 414 is proposed according to Annex IX, Column 1, Section 8.7.2.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(trimethoxysilylpropyl)amine

EC Number:

280-084-5

EC Name:

Bis(trimethoxysilylpropyl)amine

Cas Number:

82985-35-1

Molecular formula:

C12H31NO6Si2

IUPAC Name:

3,3,11,11-tetramethoxy-2,12-dioxa-7-aza-3,11-disilatridecane

Test animals

Species:

rat

Administration / exposure

Route of administration:

oral: gavage

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified