Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 240-465-9 | CAS number: 16415-13-7
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No data in order to evaluate reproductive toxicity of the registered substance are available.
According to Regulation (EC) No 1907/2006, Annex VIII, 8.7.1., column 2, a screening test for toxicity to reproduction has to be performed in one species via the most appropriate route of administration, having regard to the likely route of human exposure. A pre-natal developmental toxicity study via the oral route according to OECD Guideline 414 for the structurally related read-across substance Hexadecyltrimethoxysilane (CAS 16415-12-6) is proposed and the generated data will comply with the criteria for read-across according to Annex XI, article 1.5. The results of the study will be used to determine the following steps in the testing regime.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Reproductive effects observed:
- not specified
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
Effects on developmental toxicity
Description of key information
No data in order to evaluate developmental toxicity are available. A testing proposal for a developmental toxicity study according to OECD TG 414 is submitted for the structural analogue substance hexadecyl(trimethoxy)silane (16415-12-6). As soon these data is available they will be included in the dossier.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned (based on read-across)
- 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
OECD Guideline 414 (Prenatal Developmental Toxicity Study) in rats with a read-across substance. The testing proposal for the read-across substance is already submitted.
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: hexadecyl(trimethoxy)silane / CAS 16415-12-6 / EC 240-464-3
- Name of the substance for which the testing proposal will be used: triethoxyhexadecylsilane / CAS 16415-13-7 / EC 240-465-9
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies: No adequate and reliable GLP studies addressing developmental toxicity or reproductive toxicity in general are available with the test substance itself or similar substances defined according to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No. 1907/2006.
- Available non-GLP studies: No adequate and reliable non-GLP studies addressing developmental toxicity or reproductive toxicity in general are available with the test substance or similar substances.
- Historical human data: not available
- (Q)SAR: Currently available Q(SAR) methods are not applicable to assess the full scope of developmental toxicity
- In vitro methods: No validated in vitro methods to assess developmental toxicity are available so far.
- Weight of evidence: So far there is no information (QSAR, in vitro data, repeated dose or fertility data) available which is suitable to assess developmental toxicity in a weight of evidence approach.
- Grouping and read-across: The proposed test is part of a sequential testing strategy program for alkoxysilanes which is developed in close collaboration with ECHA to minimise the need for additional animal testing.
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:
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.
Column 2 adaption possibilities at the Annex IX level where considered and do not apply: Based on the available data the test substance is not regarded as CMR substance. In particular it is not known to be a genotoxic carcinogen or germ cell mutagen. In addition it is not classified for reproductive toxicity Cat 1 or 2 in accordance with Regulation (EC) No. 1272/2008. In addition, there are no toxicokinetic studies available which could justify the absence of systemic absorption.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION: none - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rat
- Route of administration:
- oral: gavage
- 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
Justification for classification or non-classification
No data available in order to justify 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.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)