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Diss Factsheets
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EC number: 918-105-3 | CAS number: -
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-{6-[3,5-bis(6-isocyanatohexyl)-2,4,6-trioxo-1,3,5-triazinan-1-yl]hexyl}-3,3-bis[3-(trimethoxysilyl)propyl]urea
- EC Number:
- 918-105-3
- IUPAC Name:
- 1-{6-[3,5-bis(6-isocyanatohexyl)-2,4,6-trioxo-1,3,5-triazinan-1-yl]hexyl}-3,3-bis[3-(trimethoxysilyl)propyl]urea
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 17/0241-1, Batch 294-296
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Test animals / tissue source
- Species:
- human
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST SYSTEM
- Source: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
- Tissue model: OCL-200
- Tissue Lot Number: 27004 and 27009
- Incubation conditions: 37°C +/- 1°C, 5% +/- 1% CO2, 90% +/- 5% relative humidity
- Detection agent: MTT
- Ectracting agent: Isopropanol
- Wash buffer: PBS
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Details on study design:
- - Negative control: Deionized water, sterile
- Positive control: Neat methyl acetate
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: tissue viability (% of NC)
- Run / experiment:
- Mean 1st Run
- Value:
- 130.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: tissue viability (% of NC)
- Run / experiment:
- Mean of 2nd Run
- Value:
- 95
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
Any other information on results incl. tables
1st Run: Individual and mean OD570 values, individual and mean viability values and inter-tissue variability
Test substance | Tissue 1 | Tissue 2 | Mean | Inter-tissue variability (%) | |
NC | Mean OD570 | 0.814 | 0.788 | 0.801 | |
NC | Viability (% of NC) | 101.6 | 98.4 | 100.0 | 3.2 |
Test item | Mean OD570 | 0.842 | 1.249 | 1.045 | |
Test item | Viability (% of NC) | 105.1 | 155.9 | 130.5 | 50.8 |
PC | Mean OD570 | 0.255 | 0.215 | 0.235 | |
PC | Viability (% of NC) | 31.8 | 26.8 | 29.3 | 5.1 |
2nd Run: Individual and mean OD570 values, individual and mean viability values and inter-tissue variability
Test substance | Tissue 1 | Tissue 2 | Mean | Inter-tissue variability (%) | |
NC | Mean OD570 | 1.594 | 1.727 | 1.660 | |
NC | Viability (% of NC) | 96.0 | 104.0 |
100.0 |
8.0 |
Test item |
Mean OD570 |
1.540 |
1.616 |
1.578 |
|
Test item |
Viability (% of NC) |
92.7 |
97.3 |
95.0 |
4.6 |
PC |
Mean OD570 |
0.445 |
0.325 |
0.385 |
|
PC |
Viability (% of NC) |
26.8 |
19.6 |
23.2 |
7.2 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results observed for the EpiOcular Test alone and by applying the evaluation criteria it was concluded that the test item does not show an eye irritation potential in the in vitro eye irritation test strategy under the test conditions chosen.
- Executive summary:
The objective was to assess the eye irritating potential of the test item. By using the methods currently available a single in vitro assay is not sufficient to cover the full range of eye irritating potential. Therefore, two in vitro assays were part of this in vitro eye irritation test strategy: The Bovine Corneal Opacity and Permeability Test (BCOP Test) and EpiOcular Eye Irritation Test. However, in the current case the results derived with EpiOcular Eye Irritation Test alone were sufficient for a final assessment. Therefore, further testing in BCOPwas waived.
EpiOcular Eye Irritation Test
The potential of the test substance to cause ocular irritation was assessed by a single topical application of 50 μL undiluted test substance to a reconstructed three-dimensional, human cornea model (EpiOcular™). Two test runs were performed. Two EpiOcular™ tissues per test run were incubated with the test substance for 30 minutes followed by a 2-hour post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation by using a colorimetric test. The reduction of mitochondrial dehydrogenase activity measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the epidermal tissues treated with the test substance is compared to that of negative control tissues. The ratio
of the values indicates the relative tissue viability. The test substance is not able to directly reduce MTT.
As the acceptance criterion for inter-tissue variability of the test substance was not met (values for single tissues: 105.1% and 155.9%) and the mean OD570 of the NC was exceptionally low (0.801), a 2nd experiment was performed to clarify the result. In the 2nd test run, the mean viability of the tissues treated with the test substance was 95.0%. All acceptance criteria were met. Minimal compound residues remained on the tissues treated with the test substance after the washing procedure of both test runs.
Based on the results observed in the EpiOcular Test alone and by applying the evaluation, it was concluded that the test substance does not show an eye irritation potential in the in vitro eye irritation test strategy under the test conditions chosen.
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