Registration Dossier
Registration Dossier
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EC number: 280-084-5 | CAS number: 82985-35-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Waiving - extended one-generation reproductive toxicity study
Link to relevant study records
- 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:
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No reliable information about effects on fertility is available for the registered substance or any structurally related silane containing secondary amine groups. A 90-day repeated dose toxicity study with special emphasis on the male and female reproductive tissues is proposed for the registered substance. When the results become available the further need of an extended one-generation reproductive toxicity study (required in Section 8.6.2 of REACH Annex IX) will be evaluated again.
Effects on developmental toxicity
Description of key information
No adequate information about developmental toxicity is available for bis(trimethoxysilylpropyl)amine (CAS 82985-35-1) or any structurally related silane containing secondary amine groups. Therefore, a testing proposal is included into this dossier.
Link to relevant study records
- 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 - 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
- Species:
- rat
- Route of administration:
- oral: gavage
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available (further information necessary)
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No adequate information about developmental toxicity is available for bis(trimethoxysilylpropyl)amine (CAS 82985-35-1) or any structurally related silane containing secondary amine groups. Therefore, a testing proposal is included into this dossier.
Justification for classification or non-classification
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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