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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- 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: The stability under storage conditions over the study period was guaranteed.
- Stability under test conditions: room temperature
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Source strain:
- not specified
- Details on animal used as source of test system:
- - Tissue model: EPI-200
- Tissue Lot Number: 25844
- Origin: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia - Justification for test system used:
- The test system is part of an integrated approach on testing and assessment (IATA) for skin corrosion and irritation and is one of the accepted guideline studies.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm model
- Tissue batch number(s): 25844
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation (if applicable): 37°C
NUMBER OF REPLICATE TISSUES: 3
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant if the viability is less than 45% compared to negative control.
- The test substance is considered to be non-irritant if the viability is higher than 55% compared to control.
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 45%, or if the viability after 3 minutes exposure is greater than or equal to 45 % and the viability after 1 hour exposure is less than 10%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than 55% and the viability after 1 hour exposure is greater than 20%.
- The borderline evaluation was determined statistically using historic data and hence considers the variance of the test method.This evaluation is an amendment to the evaluation provided in OECD Guideline 431. - Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µl undiluted liquid test substance
NEGATIVE CONTROL
- PBS, sterile
POSITIVE CONTROL
- 5% (w/v) sodium dodecyl sulfate (SDS) in water - Duration of treatment / exposure:
- 1h
- Duration of post-treatment incubation (if applicable):
- 32 - 36 h
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 1
- Value:
- 76.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 2
- Value:
- 79
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 3
- Value:
- 66
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Individual and mean OD570 values, individual and mean viability values and standard deviations
Test substance | Tissue 1 | Tissue 2 | Tissue 3 | Mean | SD | |
NC | Mean OD570 | 1.370 | 1.417 | 1.298 | 1.362 | |
NC | Viability (% of NC) | 100.6 | 104.1 | 95.3 | 100.0 | 4.4 |
Test substance | Mean OD570 | 1.037 | 1.076 | 0.899 | 1.004 | |
Test substance | Viability (% of NC) | 76.1 | 79.0 | 66.0 | 73.7 | 6.8 |
PC | Mean OD570 | 0.046 | 0.054 | 0.049 | 0.050 | |
PC | Viability (% of NC) | 3.4 | 3.9 | 3.6 | 3.7 | 0.3 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results observed and by applying the evaluation criteria, it was concluded that the test item does not show a skin irritation potential in the EpiDerm™ in vitro skin irritation and corrosion test strategy under the test conditions chosen.
- Executive summary:
The objective was to assess the skin irritation and corrosion potential of the test item. Using the methods currently available, a single in vitro assay is not sufficient to cover the full range of skin irritating/corrosion potential. Therefore, two in vitro assays were part of this in vitro skin irritation and corrosion test strategy: The Skin Corrosion Test (SCT) and Skin Irritation Test (SIT).
However, in the current case the results derived with SIT alone were sufficient for a final assessment. Therefore, further testing in SCT was waived.
The potential of the test substance to cause dermal irritation was assessed by a single topical application of 30 μL of the undiluted test substance to a reconstructed three-dimensional human epidermis model (EpiDerm™). The irritation test was performed with three EpiDerm™ tissues, which were incubated with the test substance for 1 hour followed by a 42-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 quotient of the values indicates the relative tissue viability.
The test substance is not able to reduce MTT directly. The mean viability of the tissues treated with the test substance determined after an exposure period of 1 hour with an about 42-hour post-incubation was 73.7%. Slight compound residues remained on the tissues treated with the test substance after the washing procedure.
Based on the results observed and by applying the evaluation criteria, it was concluded that the test item does not show a skin irritation potential in the EpiDerm™ in vitro skin irritation and corrosion test strategy under the test conditions chosen.
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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