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EC number: 245-904-8 | CAS number: 23843-64-3
- 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 sensitisation (OECD 406), Buehler test: not sensitising (RA from CAS 116912-64-2)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to the attached justification below and the overall justification for grouping of substances attached in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 0%, challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects observed
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 100%, challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects observed
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0%, challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects observed
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 100%, challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects observed
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- In a Buehler Test conducted to GLP and OECD 406 the source substance was not sensitising to the skin. As explained in the analogue justification, the differences in molecular structure between the target and the source are unlikely to lead to differences in the skin sensitisation potential.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No data on skin sensitisation of 1-[3-(trimethoxysilyl)propyl]urea (CAS 23843-64-3) are available. Therefore, the risk assessment was performed based on the available data from the source substance ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters (CAS 116912-64-2). The source substance is the reaction mass of 1-[3-(trimethoxysilyl)propyl]urea, [3-(dimethoxyethoxysilyl)propyl]urea, [3-(methoxydiethoxysilyl)propyl]urea and 1-[3-(triethoxysilyl)propyl]urea and therefore contains the target substance as one of its components. In accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and in accordance with the Read across assessment framework (RAAF, ECHA 2017) read across from the analogue substance has been applied to support the human health hazard assessment of 1-[3-(trimethoxysilyl)propyl]urea (CAS 23843-64-3). Details on read across justifications can be found in the attached justification in the respective target entry and in the overall justification for grouping of substances attached in IUCLID Section 13.
Skin sensitisation
The skin sensitising properties of CAS 116912-64-2 were tested in a study according to OECD TG 406 under GLP conditions using the test for delayed contact hypersensitivity in guinea pigs (Buehler test, NOTOX, 2000a). The test for delayed contact hypersensitivity was performed on 30 female Himalayan guinea pigs. For the dermal inductions the initial test item concentration was 100% (v/v). A 50% (v/v) preparation of the test substance was selected for the challenge application. Topical application of the appropriate test substance concentration (20 test animals) or vehicle (10 control animals) was performed once a week for 6 hours at the flanks of each animal for three consecutive weeks. Seven days following the last induction treatment all animals were challenged with the test substance at a concentration of 50% (v/v) for 6 hours. Skin reactions of all animals were evaluated 24 and 48 hours after challenge administration. No skin reactions were noted after challenge administration. Periodic reliability checks with the positive control gave the expected results. Thus, ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters (CAS 116912-64-2) was not skin sensitising under the conditions of this Buehler test.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.
Justification for classification or non-classification
The available data on skin sensitisation of the registered substance do not meet the criteria for classification according to Regulation (EC) No 1272/2008 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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