Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
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: 3-Aminopropyl(triethoxy)silane
- Name of the substance on which testing is proposed to be carried out : 3-Aminopropyl(triethoxy)silane

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 available
- Available non-GLP studies: None available
- Historical human data : No data
- (Q)SAR: No data
- In vitro methods: No validated alternative in vitro test methods are available for reproduction toxicity.
- 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 available for reproductive toxicity.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: An oral Extended-One-Generation Reproductive Toxicity study (OECD 443) in rats will be conducted with the registered substance after approval by ECHA.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)
Justification for study design:
SPECIFICATION OF STUDY DESIGN FOR EXTENDED ONE-GENERATION REPRODUCTION TOXICITY STUDY WITH JUSTIFICATIONS
- Premating exposure duration for parental (P0) animals : 2 weeks
- Basis for dose level selection : A dose range finding study will be performed prior to initiating this study.
- Inclusion/exclusion of extension of Cohort 1B : Cohort 1B extension will not be included as there are no triggers in existing studies.
- Termination time for F2 : not applicable
- Inclusion/exclusion of developmental neurotoxicity Cohorts 2A and 2B : Cohort 2A and 2B will not be included as there are no triggers for developmental neurotoxicity in existing studies on the registered substance.
- Inclusion/exclusion of developmental immunotoxicity Cohort 3 : Cohort 3 will not be included as there are no triggers for developmental immunotoxicity in existing studies on the registered substance.
- Route of administration: Oral
- Other considerations, e.g. on choice of species, strain, vehicle and number of animals: The study will be conducted in male and female rats.

Test material

Constituent 1
Chemical structure
Reference substance name:
3-aminopropyltriethoxysilane
EC Number:
213-048-4
EC Name:
3-aminopropyltriethoxysilane
Cas Number:
919-30-2
Molecular formula:
C9H23NO3Si
IUPAC Name:
silane

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Results: P0 (first parental generation)

Target system / organ toxicity (P0)

Critical effects observed:
not specified

Results: F1 generation

Target system / organ toxicity (F1)

Critical effects observed:
not specified

Applicant's summary and conclusion