Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 701-410-9 | CAS number: -
- 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

Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- 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:
- Name of the substance on which testing is proposed to be carried out: Trimethoxy(methyl)silane and its reaction products with 3-aminopropyl(triethoxy)silane and [3-(2,3-epoxypropoxy)propyl]trimethoxysilane; EC No. 701-410-9
- Name of the substance for which the testing proposal will be used [if different from tested substance]: Not applicable
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies:
The following GLP-compliant in vitro studies have been considered prior to making the test proposal:
Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without activation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA102 (OECD Test Guideline 471) (BSL BIOSERVICE, 2012).
In vitro cytogenicity in mammalian cells: positive with and without metabolic activation in Chinese hamster V79 cells (OECD Test Guideline 473) (BSL BIOSERVICE, 2013)
- Available non-GLP studies:
No non-GLP studies are available.
- Historical human data:
No historical human data are available.
- (Q)SAR:
QSAR is not considered to be appropriate because there is no existing QSAR method which can confirm in vivo cytogenicity, which is the remaining uncertainty of the data set.
- In vitro methods:
The following in vitro methods have been considered prior to making test proposal:
OECD 471 – negative data available for registered substance
OECD 473 – positive data available for registered substance
The available in vitro methods have therefore been considered as a part of the tiered approach.
- Weight of evidence:
There are no available data for a weight of evidence approach.
- Grouping and read-across
There are no suitable analogue substance that can be used for read-across to address the positive finding in the in vitro cytogenicity test.
- Substance-tailored exposure driven testing [if applicable]: Not applicable
- Approaches in addition to above [if applicable] : Not applicable
- Other reasons [if applicable]: Not applicable
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:
Annex VIII cites that appropriate in vivo mutagenicity studies shall be considered in the case of a positive result in any of the genotoxicity studies in Annex VII or VIII. Since a positive result for cytogenicity in mammalian cells (OECD 473) is reported, it needs to be established whether the effect is evident in vivo. Therefore, there are no specific adaptation possibilities.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
An in vivo mammalian erythrocyte micronucleus test by the oral route is proposed to be conducted after approval by ECHA, according to OECD Test Guideline 474 and in compliance with GLP.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Type of assay:
- micronucleus assay
Test material
- Test material form:
- liquid
Constituent 1
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.

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