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EC number: 947-918-6 | 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 - 23 Feb 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted in 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU B.40 bis (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- Council Regulation 440/2008 of 30 May 2008
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP-Landesleitstelle Bayern, Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany
Test material
- Reference substance name:
- Reaction product of C16-18 (even numbered) alcohols with reaction products of 1,3,5-Triazine, 2,4,6,-triamine, polymer with formaldehyde, methylated
- EC Number:
- 947-918-6
- Molecular formula:
- not applicable, UVCB substance.
- IUPAC Name:
- Reaction product of C16-18 (even numbered) alcohols with reaction products of 1,3,5-Triazine, 2,4,6,-triamine, polymer with formaldehyde, methylated
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDerm™; reconstructed three-dimensional human epidermis (EPI-200), MaTek Corporation, Bratislava, Slovakia
- Justification for test system used:
- The EpiDerm™ Skin Model is a well-established validated organotypic, three-dimensional model of the human epidermis.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEST METHOD:
A reconstructed three-dimensional skin model is used based on normal human-derived epidermal keratinocytes which have been cultured to form a multilayered epidermis including basal, spinous and granular layers, and a multi-layered stratum corneum. Irritant materials are identified by their ability to penetrate the stratum corneum and to damage the underlaying cell layers. Irritant properties are determined through a decrease in cell viability as determined by a MTT reduction assay.
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™(EPI-200) (MatTek Corporation, Bratislava, Slovakia)
- Tissue batch number: 25882
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature (3 min-exposure); 37 ± 1.5 °C (60 min-exposure)
- Temperature of post-treatment incubation: 37 ± 1 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: after exposure the tissues were removed from the 6-well plate with forceps; using a wash bottle the tissues were gently rinsed about 20 times with PBS (phosphate buffered saline) to remove any residual test item; excess PBS was removed by gently shaking the insert and blotting bottom with blotting paper
- Observable damage in the tissue due to washing: not specified
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: plate spectrophotometer (not further specified)
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The quality of the EpiDerm tissue was assessed by undertaking an MTT cell viability test. The determined OD (540 - 570 nm) was 1.52 ± 0.086 (acceptance criteria: 1.0 - 3.0).
- Barrier function: The barrier function was assessed by determination of the exposure time required to reduce tissue viability by 50% (ET-50) upon application of 100 μL of 1% Triton X-100. The ET-50 value was 7.27 h (acceptance criteria: 4.77 - 8.72 h).
- Contamination: The cells used to produce the EpiDermTM tissue were screened for the presence of viruses, bacteria, yeast and other fungi
NUMBER OF REPLICATE TISSUES: 2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
The test item did not show reduction of MTT, therefore no tests with control tissues were performed.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: single experiment
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 25 mg; applied directly to the EpiDerm™ tissue using an application spoon avoiding compression of the test item; to ensure good contact with the skin the test item was moistened with 25 µL H2O; the test item was spread to match the size of the tissue.
VEHICLE
- not applicable
NEGATIVE CONTROL
- Amount applied: 50 µL
POSITIVE CONTROL
- Amount applied: 50 µL - Duration of treatment / exposure:
- 3 min and 60 min
- Duration of post-treatment incubation (if applicable):
- 3 h
- Number of replicates:
- duplicates for each treatment and control group
Test animals
- Species:
- other: in vitro system
Test system
- Type of coverage:
- other: in vitro system
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- test item
- Run / experiment:
- 3 min
- Value:
- 105
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- test item
- Run / experiment:
- 60 min
- Value:
- 99.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- positive control
- Run / experiment:
- 3 min
- Value:
- 11.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- positive control
- Run / experiment:
- 60 min
- Value:
- 5.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: The mixture of test item and MTT medium showed no reduction of MTT compared with the solvent.
- Colour interference with MTT: The mixture of test item and distilled water and isopropanol showed no colouring compared with the solvent.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: the mean OD570 nm of the two negative control tissues of the 3 min and 60 min treatment period is between 0.8 and 2.8 (1.769 and 1.900, respectively)
- Acceptance criteria met for positive control: the mean relative tissue viability of the two positive control tissues of the 60 min treatment period is < 15% (5.1%)
- Acceptance criteria met for variability between replicate measurements: the coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is ≤ 30% (1.6 - 9.1%)
Any other information on results incl. tables
Table 1. Results of 3 min-experiment
Name |
Negative Control |
Test Item |
Positive Control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD570 |
1.730 |
1.801 |
1.766 |
1.947 |
0.193 |
0.300 |
1.702 |
1.800 |
1.748 |
1.949 |
0.203 |
0.278 |
|
1.784 |
1.800 |
1.769 |
1.958 |
0.227 |
0.287 |
|
OD570 - Blank Corrected |
1.685 |
1.759 |
1.721 |
1.902 |
0.148 |
0.255 |
1.657 |
1.755 |
1.703 |
1.904 |
0.158 |
0.233 |
|
1.739 |
1.755 |
1.724 |
1.913 |
0.182 |
0.242 |
|
Mean OD570 of 3 Aliquots (Blank Corrected) |
1.694 |
1.755 |
1.716 |
1.906 |
0.163 |
0.243 |
SD OD570 of 3 Aliquots |
0.042 |
0.001 |
0.011 |
0.006 |
0.017 |
0.011 |
Total Mean OD570 of 2 Replicate Tissues (Blank Corrected) |
1.724* |
1.811 |
0.203 |
|||
SD OD570 of 2 Replicate Tissues |
0.043 |
0.135 |
0.057 |
|||
Mean Relative Tissue Viability [%] |
100.0 |
105.5 |
11.8 |
|||
Coefficient Of Variation [%]*** |
2.5 |
7.4 |
28.0 |
* corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability.
*** coefficient of variation (CV) (in the range of 20–100% viability) between two tissues treated identically is ≤ 30%.
Table 2: Results of 60 min-experiment
Name |
Negative Control |
Test Item |
Positive Control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD570 |
1.763 |
2.027 |
1.899 |
1.879 |
0.096 |
0.176 |
1.786 |
2.030 |
1.922 |
1.872 |
0.099 |
0.182 |
|
1.793 |
2.003 |
1.915 |
1.863 |
0.102 |
0.181 |
|
OD570 - Blank Corrected |
1.736 |
1.975 |
1.854 |
1.834 |
0.051 |
0.131 |
1.741 |
1.985 |
1.877 |
1.827 |
0.054 |
0.137 |
|
1.748 |
1.958 |
1.870 |
1.818 |
0.057 |
0.136 |
|
Mean OD570 of 3 Aliquots (Blank Corrected) |
1.736 |
1.975 |
1.867 |
1.826 |
0.054 |
0.135 |
SD OD570 of 3 Aliquots |
0.016 |
0.015 |
0.012 |
0.008 |
0.003 |
0.003 |
Total Mean OD570 of 2 Replicate Tissues (Blank Corrected) |
1.856* |
1.847 |
0.0594 |
|||
Mean Relative Tissue Viability [%] |
100.0 |
99.5 |
5.1** |
|||
Coefficient Of Variation [%]*** |
9.1 |
1.6 |
60.3 |
* corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability.
** mean relative tissue viability of the 60 min positive control <15%.
*** coefficient of variation (CV) (in the range of 20–100% viability) between two tissues treated identically is ≤ 30%.
Table 3. Historical control data
|
Mean |
SD |
n |
OD570 of Negative Control (3 min Experiment) |
1.895 |
0.313 |
10 |
OD570 of Negative Control (60 min Experiment) |
1.867 |
0.261 |
11 |
Relative Tissue Viability [%] of Positive Control (60 min experiment) |
6.1 |
1.99 |
11 |
CV [%] (in the range of 20 – 100% viability) |
7.8 |
7.5 |
31 |
Historical control data were generated from 2015 - 2016.
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Conclusions:
- Under the conditions of the reconstructed human epidermis test the test substance does not possess corrosive properties. There is regulatory acceptance in the EU that a substance can be considered corrosive (Skin Corrosive Cat. 1, 1A, 1B/C) based on a positive result in the Reconstructed human epidermis test method (in vitro skin corrosion). A negative in vitro corrosivity response is not conclusive with respect to non-classification or classification as a skin irritant and therefore requires further evaluation and/or data generation.
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