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Diss Factsheets
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EC number: 251-995-5 | CAS number: 34396-03-7
- 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
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish early-life stage 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. The lead registrant considers 18 months as appropriate for test performance of an OECD 210 and dossier update with results.
- 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 : Testing will be done focussing on (2,4,4-trimethylpentyl)silanetriol, which is the silanol hydrolysis product of the registered compound trimethoxy(2,4,4-trimethylpentyl)silane (CAS No. 34396-03-7). For this purpose, trimethoxy(2,4,4-trimethylpentyl)silane (CAS No. 34396-03-7) will be pre-hydrolysed for test substance application. Because the hydrolysis half-life of the registered substance is < 12 h (DT50 = 5.7 h at pH 7 and 20-25 °C, QSAR), the appropriate assessment entity for the evaluation of environmental hazards and risks is the silanol hydrolysis product of the registered compound (REACH guidance R.16 (ECHA, 2016)). Methanol is known for its absence of environmental effects up to the concentrations that are relevant to the present aquatic studies (OECD SIDS, 2004) and therefore can be disregarded in the environmental hazard and risk assessment.
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 studies on the long-term toxicity on fish are available for the registered compound, its hydrolysis product, or structurally similar substances
- Available non-GLP studies: No studies on the long-term toxicity on fish are available for the registered compound, its silanol hydrolysis product or structurally similar substances
- Historical human/control data
- (Q)SAR : No data is available
- In vitro methods : No data is available
- Weight of evidence : No data is available
- Grouping and read-across : No studies on the long-term toxicity on fish are available for the registered compound, its silanol hydrolysis product, or structurally similar substances
- Substance-tailored exposure driven testing [if applicable]: Not applicable
- Approaches in addition to above [if applicable]: Not applicable
- Other reasons [if applicable]: See below
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:
- The registered compound is produced in a tonnage of 100 - 1000 tonnes annually and thus long-term toxicity testing of fish is a data requirement according to Annex IX of the REACH regulation 1907/2006. Because no studies on the long-term toxicity towards fish are available for the registered compound, its silanol hydrolysis product, or structurally similar substances and the registered substance has a wide dispersive use, it is considered inappropriate to apply other non-testing strategies in order to fulfil the data requirement for this endpoint. Therefore, testing of chronic toxicity towards fish according to OECD guideline 210 is proposed for the silanol hydrolysis product of the registered compound.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
Reference
Description of key information
A long-term toxicity study on fish according to OECD guideline 210 is beeing proposed, targeting the silanol hydrolysis product as the relevant entity for testing.
Key value for chemical safety assessment
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.