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EC number: 231-034-6 | CAS number: 7417-99-4
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 December 2017 - 16 December 2017
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N'-(methylenedi-p-phenylene)bis(aziridine-1-carboxamide)
- EC Number:
- 231-034-6
- EC Name:
- N,N'-(methylenedi-p-phenylene)bis(aziridine-1-carboxamide)
- Cas Number:
- 7417-99-4
- Molecular formula:
- C19H20N4O2
- IUPAC Name:
- N-[4-({4-[(aziridine-1-carbonyl)amino]phenyl}methyl)phenyl]aziridine-1-carboxamide
- Test material form:
- solid
1
In vitro test system
- Test system:
- human skin model
- Remarks:
- SkinEthic RHE® model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: foreskin (number of donors not specified)
- Source strain:
- not specified
- Justification for test system used:
- This study makes use of reconstructed human epidermis (RhE) (obtained from human derived non-transformed epidermal keratinocytes) which closely mimics the histological, morphological, biochemical and physiological properties of the upper parts of the human skin, i.e., the epidermis. Use of reconstructed human epidermis (RhE) is also recommended by OECD and other regulatory authorities. SkinEthicTM RHE model has been validated and is part of OECD validated reference methods (VRMs) and is also a recommended model for conducting in vitro skin irritation studies.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: SkinEthic RHE® model
- Tissue batch number(s): 17-RHE-127
- Production date:
- Shipping date:
- Delivery date:
- Date of initiation of testing: 12/12/2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): 37ºC
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 25 x 1 mL of DPBS
- Observable damage in the tissue due to washing: no
- Modifications to validated SOP: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 300 µL of a MTT solution at 1.0 mg/mL
- Incubation time: 3 hours at 37°C, 5% CO2
- Spectrophotometer: Synergy™ microplate reader (BioTek)
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: 1.1 (CV = 4.5%) specification OD > 0.7. Historical negative control mean OD range = 1.964-2.776.
- Barrier function: 4.5 h (Specification 4h < ET50< 10h)
- Morphology: 6 Cell layers, absence of significant histological abnormalities, well differentiated epidermis, specification > 4
- Contamination: no
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE: no interference.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the tissue viability after 42 minutes exposure is less than or equal to 50%.
- The test substance is considered to be non-irritant to skin if the tissue viability after 42 minutes exposure is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16 mg (32mg/cm2)
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 16 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 16 µL
- Concentration (if solution): 5% SDS - Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours ± 60 minutes
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 93.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- (DPBS)
- Positive controls validity:
- valid
- Remarks:
- 1.2% viability (5% SDS)
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes. A full demonstration of proficiency was performed for the EpiSkin-SM model, plus a reduced validation with the SkinEthic RHE model. Adequate results were obtained for the evaluated chemicals.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, SD of the negative control group was 0.03% (acceptablility criteria, SD ≤ 18%) and OD mean is 2.002 (acceptability criteria, 0.8≤OD≤3).
- Acceptance criteria met for positive control: yes, SD of the positive control group was 0.06% (acceptablility criteria, SD ≤ 18%)
- Acceptance criteria met for variability between replicate measurements: yes. SD of test item was 1.21% (acceptablility criteria, SD ≤ 18%).
Any other information on results incl. tables
Table 1: Data Summary of Percent Viability
Treatment |
Tissue Replicate |
O.D. at 570 nm |
Blank Corrected O.D. |
Mean of Corrected O.D. |
Mean O.D. of Three Tissues |
% Viability/ Tissue |
Mean % Viability |
S.D. of % Viability |
C.V. of % Viability |
Corrosivity Class |
Negative Control (Dulbecco’s Phosphate Buffered Saline (DPBS)) |
1 |
2.067 |
2.026 |
2.004 |
2.002 |
100 |
100 |
0.03 |
1.50 |
NA |
2.017 |
1.976 |
|||||||||
2.051 |
2.010 |
|||||||||
2 |
2.021 |
1.980 |
1.988 |
|||||||
2.033 |
1.992 |
|||||||||
2.034 |
1.993 |
|||||||||
3 |
2.019 |
1.978 |
2.014 |
|||||||
2.105 |
2.064 |
|||||||||
2.042 |
2.001 |
|||||||||
N,N’-(Methylenedi-P-Phenylene)Bis(Aziridine-1-Carboxamide) (Poly-U-01) |
1 |
1.947 |
1.906 |
1.889 |
1.864 |
94.4 |
93.1 |
1.21 |
1.30 |
No Category |
1.910 |
1.869 |
|||||||||
1.932 |
1.891 |
|||||||||
2 |
1.847 |
1.806 |
1.842 |
92.0 |
||||||
1.896 |
1.855 |
|||||||||
1.905 |
1.864 |
|||||||||
3 |
1.900 |
1.859 |
1.861 |
93.0 |
||||||
1.895 |
1.854 |
|||||||||
1.910 |
1.869 |
|||||||||
Positive control (Sodium dodecyl sulphate (5% aq.)) |
1 |
0.068 |
0.027 |
0.026 |
0.025 |
1.3 |
1.2 |
0.06 |
5.00 |
Category 2 |
0.067 |
0.026 |
|||||||||
0.066 |
0.025 |
|||||||||
2 |
0.067 |
0.026 |
0.025 |
1.2 |
||||||
0.065 |
0.024 |
|||||||||
0.066 |
0.025 |
|||||||||
3 |
0.066 |
0.025 |
0.025 |
1.2 |
||||||
0.065 |
0.024 |
|||||||||
0.066 |
0.025 |
Key: O.D. = Optical density, S.D. = Standard deviation, C.V. = Coefficient of variation, NA = Not applicable
Note: For Negative control SD and CV of % viability was calculated using OD at 570 nm and for test item and positive control SD and CV of % viability was calculated using % viability/tissue.
Applicant's summary and conclusion
- Interpretation of results:
- other: No category (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The test substance was found to not be a skin irritant in a reconstructed human epidermis test.
- Executive summary:
An in vitro skin irritation test of the test item was performed in a reconstructed human SkinEthic RHE® model, according to OECD TG 439 (GLP study). Three epidermis units were treated with 16 mg test item for 42 minutes at room temperature. Exposure of the test item was terminated by rinsing with 25 x 1 mL of DPBS. The epidermis units were then incubated at 37°C for 42 hours in an incubator with 5% CO2. The viability of each disk was assessed by incubating the tissues with MTT, extracting the precipitated formazan crystals using isopropanol and incubating the tissues for overnight in a refrigerator protected from light, and finally measuring the concentration of formazan by determining the OD at 570 nm. Under the test conditions, the mean percent viability of the treated tissues was 93.1%, versus 1.2% of the positive control (5% Sodium Dodecyl Sulfate). Therefore, the test item must be considered as not classified for skin irritation.
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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