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EC number: 237-511-5 | CAS number: 13822-56-5
- 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
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Endpoint summary
Administrative data
Description of key information
Additional information
Approach to the Terrestrial Chemical Safety Assessment
The hydrolysis half-life of 3-(trimethoxysilyl)propylamine (CAS 13822-56-5, EC 237-511-5) is 2.6 hours at pH 7 and 25°C. The registered substance will hydrolyse in contact with water and atmospheric moisture to form 3-aminopropylsilanetriol and methanol. The chemical safety assessment for the terrestrial compartment is therefore based on the silanol hydrolysis product, 3-aminopropylsilanetriol.
In accordance with Column 2 of REACH Annex IX, there is no need to further investigate the effects of this substance in long-term terrestrial toxicity studies because, as indicated in guidance R.7.11.6 (ECHA 2016), the quantitative chemical safety assessment (conducted according to Annex I of REACH) indicates that the Risk Characterisation Ratio is well below 1, and therefore the risk is already adequately controlled and further testing is not justifiable.
The silanol hydrolysis product, 3-aminopropylsilanetriol, upon which the chemical safety assessment is based, is highly water soluble and has a low log Kowvalue and therefore, exposure of the soil compartment is expected to be low.
The substance is not adsorbing (based on log Koc-0.6), has low bioavailability (based on log Kow<3 (-2.0)) and low toxicity was observed in short- and long-term aquatic tests. Therefore, the occurrence of more severe toxic effects in the terrestrial compartment that were not expressed in the aquatic studies would be considered unlikely.
3-Aminopropylsilanetriol classed as hazard category 3 for the terrestrial environment (Table R.7.11-2 of ECHA guidance R7.c, 2017) based on potential for high persistence (DT50 > 180 days), lack of ready biodegradability and low toxicity to aquatic organisms (EC/LC50 not <1 mg/l). In this situation, a screening approach is applied: a confirmatory long-term terrestrial test is usually appropriate, in addition to the equilibrium partitioning approach with an extra factor of ten, in order to determine whether further full tests are necessary.
The PNECscreen(EQPM) for 3-aminopropylsilanetriol is derived from the short-term key aquatic invertebrates EC50, generating a PNECsoil value of 0.069 mg/kg dwt. For the purpose of the screening assessment comparison only, an extra factor of ten is applied to the predicted environmental concentration (PEC) to derive the screening risk characterisation ratio (RCR) (PECx10/PNECsoil(EQPM)). Based on the exposure assessment for 3-aminopropylsilanetriol, the highest agricultural soil RCR is 0.252, which has a corresponding PEC of 0.017 mg/kg dw. The screening RCR ((PECx10)/PNECsoil(EQPM)) for 3-aminopropylsilanetriol is therefore (0.017 * 10)/0.069 = screening RCR 2.46.
Long-term terrestrial toxicity testing is therefore required in accordance with the recommendations for hazard category 3 substances. If long-term terrestrial tests were to be conducted, an assessment factor of 10 would be applied to derive PNECsoil from three long-term tests. Long-term tests with terrestrial plants, invertebrates and soil microorganisms would result in a new value for PNECsoil. This value could only be more conservative than the value of PNECscreen(EQPM) in the situation that standard testing in terrestrial plants or invertebrates exhibited a dose response with a NOEC/EC10 = 6.9 mg/kg dw (and applying an assessment factor of 100). There is no basis to expect such toxicity for 3-aminopropylsilanetriol based on the absence of significant toxicity observed in aquatic tests (all E(L)C50 values >100 mg/l).
In the case of 3-aminopropylsilanetriol, the registrants consider that a long-term terrestrial study is unlikely to affect the outcomes of the chemical safety assessment. As such the registrants propose that further testing is not necessary.
The PNEC calculated by the Equilibrium Partitioning Method has been determined for the purpose of deriving a chemical safety assessment and the risk characterisation ratios are below 1.
It is recognised that the aquatic PNEC used in the EQPM does not take into account any indicator for effects in aquatic microorganisms. However, according to REACH guidance, Chapter R.7c (ECHA, 2017), where inhibition of sewage sludge microbial activity has been observed, a test on soil microbial activity will additionally be necessary for a valid PNEC to be derived. A sewage treatment plant microorganisms toxicity test has been conducted with an analogue substance. Some inhibition of microbial activity was observed at concentrations below 100 mg/l but above 1 mg/l (EC10 13 mg/l). Significant toxicity to soil microorganisms is therefore not expected and it is unlikely that the PNECsoil based on aquatic ecotoxicity test results would not be protective for terrestrial microorganisms, therefore testing with soil microorganisms is not necessary.
Overall it is concluded that the risk characterisation conclusion is sufficiently conservative in respect of any uncertainties and therefore further in is not considered necessary.
Details on how the PNEC and the risk characterisation ratio have been derived can be found in IUCLID Section 6.0 and Chapters 9 and 10 of the Chemical Safety Report, respectively.
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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