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EC number: 245-876-7 | CAS number: 23779-32-0
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation (OECD TG 404): not irritating
Eye irritation (OECD TG 405): not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No information about skin and eye irritation is available for the registered substance, however, reliable data is available for the closely related substance Ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters (CAS 116912-64-2). The read-across is justified as follows:
READ-ACROSS JUSTIFICATION
To reduce animal testing REACH recommends to make use of a read-across approach where appropriate based on the high accordance in properties relevant for the specific endpoint. In the case of irritation/corrosion relevant properties are structural similarity as well as physical-chemical properties in the same range. In the following paragraphs the read-across approach for [3-(triethoxysilyl)propyl]urea (CAS 23779-32-0) is evaluated point by point.
Read-across hypothesis
Health hazards for both, skin irritation/corrosion and eye irritation, are characterised by local effects exhibited by the test material. Thus, similar toxicokinetics are not considered to be of importance for the development of an appropriate read-across strategy. Therefore, the following read-across justification will solely focus on the similarity of the physical-chemical properties and the structural similarity of the submission substance for [3-(triethoxysilyl)propyl]urea (CAS 23779-32-0) and the read-across substance [3-(trimethoxysilyl)propyl]urea (CAS 23843-64-3).
Both the submission substance and the read-across substance are close structural analogues, differing only in the length of the alkoxy moiety bound to the central atom silane (methoxy vs. ethoxy). Both substances hydrolyse rapidly to the common hydrolysis products [3-(trihydroxysilyl)propyl]urea. The hydrolysis half-lives are approximately 2.4 h at 25°C and pH 7 (relevant for skin and eyes) for [3-(trimethoxysilyl)propyl]urea (CAS 23843-64-3) and 16.4 h at pH7 and 20-25°C for [3-(triethoxysilyl)propyl]urea (CAS 23779-32-0) (see Section 4.1.1.1).
None of the substances does meet the skin and eye irritation inclusion rules by BfR (OECD Toolbox 2.3.0.1132).
The non-silanol hydrolysis products, ethanol and methanol, are not expected to contribute to any local adverse effects.
It is therefore considered appropriate to read-across the available skin and eye irritation data from [3-(trimethoxysilyl)propyl]urea (CAS 23843-64-3) to [3-(triethoxysilyl)propyl]urea (CAS 23779-32-0).
Additional information is given in a supporting report (PFA 2013a) attached in Section 13 of the IUCLID 5 dossier.
Skin irritation:
In a key skin irritation study, conducted in compliance with GLP and according to OECD TG 404, the test substance was not found to be corrosive or irritant (WIL Research Laboratories, Inc., 1996b). Treatment of 3 New Zealand White rabbits with 0.5 ml of the neat test substance for 4 h under semi-occlusive conditions provoked slight erythema (grade 1) but no oedema reactions after 1 h in all 3 animals. The effects were fully reversible within 24 h. Therefore mean values for erythema and oedema over 24, 48, and 72 h was 0 for both endpoints. In conclusion, the test material is not irritant / corrosive under the conditions tested.
Eye irritation:
In an eye irritation study according to OECD TG 405 and GLP, only minor, transient eye irritation was observed following instillation of ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters in 3 rabbits (WIL Research Laboratories, Inc., 1996c). The scores (mean over 24, 48, and 72 h) of 0 for cornea and iris and the mean scores of 1.7 for conjunctivae and 0.9 for chemosis indicate that the test material would not be considered irritating to the eyes of rabbits.
Justification for selection of skin irritation / corrosion endpoint:
The key study was selected for assessment.
Justification for selection of eye irritation endpoint:
The key study was selected for assessment.
Justification for classification or non-classification
The available data on skin and eye irritation of the registered substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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.
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