Bis(trimethoxysilylpropyl)amine

Toxicity to reproduction

Administrative data

Endpoint:

extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

sub-chronic toxicity: oral

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 subchronic repeated dose toxicity with the registered substance.
- Available non-GLP studies: There are no non-GLP-compliant studies available on subchronic repeated dose toxicity with the registered substance.
- Historical human data: Not available.
- QSAR: (Q)SAR methods are not applicable to assess the full scope of subchronic repeated dose toxicity.
- In vitro methods: No validated or regulatory accepted alternative methods are available for replacing animal testing with respect to subchronic repeated dose toxicity.
- Weight of evidence: There is no information (QSAR, in vitro data, developmental toxicity or fertility data) available which is suitable to assess subchronic repeated dose toxicity in a weight of evidence approach.
- Grouping and read-across: One OECD 408 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 long-term systemic 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 subchronic repeated dose 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 subchronic repeated dose toxicity. One OECD 408 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 long-term systemic 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 repeated toxicity study in the rat via the oral route following OECD 408 is proposed according to Annex IX, Column I, 8.6.2.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: a subchronic toxicity study (90-day) in rats via the oral route following OECD guideline 408 will be conducted with bis(trimethoxysilypropyl)amine

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

(Additional reproductive endpoints will be covered. These could include but are not limited to "Examination of reproductive organs, sperm parameters, and oestrus cycle".)

Principles of method if other than guideline:

There are no data available on the repeated dose toxicity of bis(trimethoxysilypropyl)amine.
In order to fulfil the standard information requirements, a GLP-compliant subchronic toxicity study (90-day) in rats via the oral route following OECD guideline 408 is proposed according to Annex IX, Column 1, Section 8.6.2.

GLP compliance:

yes

Species:

rat

Route of administration:

oral: gavage