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Diss Factsheets
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EC number: 430-960-1 | 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 November 2017 - 09 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 430-960-1
- EC Name:
- -
- Molecular formula:
- C21H20N4O2
- IUPAC Name:
- Reaction mass of aniline and m-tolylidene diisocyanate
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: epithelial
- Cell source:
- other: human
- Justification for test system used:
- The EpiDerm™ Reconstructed Human Epidermis Model incorporates several features, which make it advantageous in the study of potential dermal corrosivity. The target cells are epithelial, derived from human skin, and formed into a stratified, cornified epithelium. Test items are applied to the culture surface, at the air interface, so that undiluted and/or end use dilutions can be tested directly.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ Reconstructed Human Epidermis Model
- Tissue batch number(s): 25855
- Production date: Not reported
- Shipping date: Not reported
- Delivery date: 07 November 2017
- Date of initiation of testing: 08 November 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C
- Temperature of post-treatment incubation (if applicable): 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Rinsing was achieved by filling and emptying each tissue under a constant soft stream of Dulbecco’s Phosphate Buffered Saline (DPBS) to gently remove any residual test item.
- Observable damage in the tissue due to washing: None reported
- Modifications to validated SOP: None reported
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: Labtech LT-4500 microplate reader
- Wavelength: 570 nm
- Filter: None reported
- Filter bandwidth: Not applicable
- Linear OD range of spectrophotometer: Not reported
NUMBER OF REPLICATE TISSUES: 2 per exposure period
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
25 mg of the test item was added to 1 mL of a freshly prepared 1.0 mg/mL MTT solution. The solution was incubated in the dark at 37 °C, 5% CO2 in air for 60 minutes. Untreated MTT solution was tested concurrently to act as a control. If the MTT solution containing the test item turns blue/purple relative to the control, the test item is presumed to have reduced the MTT. The MTT solution containing the test item did not turn blue/purple. This was taken to indicate the test item did not reduce MTT.
An assessmemt of colour interference with the MTT endpoint was also made. 25 mg of test item was added to 300 μL of sterile water. The solution was incubated in the dark at 37 °C, 5% CO2 in air for 60 minutes. A visual assessment of the color was then made.
The solution containing the test item did not become colored. This was taken to indicate the test item did not have the potential to cause color interference.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- 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(s) applied (volume or weight with unit): 25 mg
VEHICLE
- Not applicable
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): Not applicable
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): 8.0 N - Duration of treatment / exposure:
- 3 or 60 minutes
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- 2 per exposure period
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean; 3 minutes exposure
- Value:
- 93.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean; 60 minute exposure
- Value:
- 86.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: None reported
- Direct-MTT reduction: The MTT solution containing the test item did not turn blue/purple. This was taken to indicate the test item did not reduce MTT.
- Colour interference with MTT: The solution containing the test item did not become colored. This was taken to indicate the test item did not have the potential to cause color interference.
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes
Any other information on results incl. tables
Mean OD570 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Tissue | Exposure Period | Mean OD570 of individual tissues | Mean OD570 of duplicate tissues | Standard Deviation | Coefficient of Variation | Relative Mean Variability |
Negative Control | 3 minutes | 1.686 |
1.694 |
0.011 |
0.6 |
100* |
1.701 |
||||||
60 minutes |
1.803 |
1.831 |
0.040 |
2.2 |
||
1.859 |
||||||
Positive Control |
3 minutes |
0.065 |
0.055 |
0.015 |
n.a. |
3.2 |
0.044 |
||||||
60 minutes |
0.038 |
0.038 |
0.001 |
n.a. |
2.0 |
|
0.037 |
||||||
Test Item |
3 minutes |
1.634 |
1.581 |
0.075 |
4.7 |
93.3 |
1.528 |
||||||
60 minutes | 1.578 |
1.589 |
0.015 |
0.9 |
86.8 |
|
1.599 |
n.a = not applicable
* the mean percentage viability of the negative control tissue is set at 100%
OD = Optical density
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean viability of test item treated tissues after 3 and 60 minute exposure periods was 93.3 and 86.8 %, respectively. The test item was considered to be non-corrosive to skin.
- Executive summary:
The skin corrosivity potential of the test item was assessed in an in vitro study Skin Corrosion: Reconstructed Human EpiDermis (RHE) test according to OECD 431 and EU B.40bis test guidelines alongside sterilised water and 8.0N potassium hydroxide as negative and positive controls, respectively. The mean viability of test item treated tissues after a 3 and 60 minute exposure period was 93.3 and 86.8 %, respectively. The test item was considered to be non-corrosive to skin.
The study is a GLP compliant guideline experimental study with no restrictions and therefore fully adequate for assessment for this endpoint.
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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