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Diss Factsheets
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EC number: 280-084-5 | CAS number: 82985-35-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.