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EC number: - | CAS number: 1309389-73-8
- 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:
- weight of evidence
- Study period:
- 2009-09-08 to 2009-11-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- adopted 2004-04-13
- Deviations:
- yes
- Remarks:
- MTT concentration used was not stated; supporting information for the specific skin model used incl. its validity was not stated
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- adopted 2008
- Deviations:
- yes
- Remarks:
- MTT concentration used was not stated; supporting information for the specific skin model used incl. its validity was not stated
- Principles of method if other than guideline:
- Minor deviations from the guideline OECD 431 (2015) occurred:
- according to the guideline complete information for the specific RhE model used including e.g. viability, barrier function, morphology, and tissue quality control should be stated. This is missing in this study report. - colour interference test was not conducted
- acceptability criteria are different from guideline
- MTT and isopropanol concentrations used were not stated - GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2009-10-22
Test material
- Reference substance name:
- (2E)-3-(2H-1,3-benzodioxol-5-yl)-N,N-diphenylprop-2-enamide
- Cas Number:
- 1309389-73-8
- Molecular formula:
- C22H17NO3
- IUPAC Name:
- (2E)-3-(2H-1,3-benzodioxol-5-yl)-N,N-diphenylprop-2-enamide
Constituent 1
Test animals
- Details on test animals or test system and environmental conditions:
- Not applicable - Since this is an in vitro study there is no information on test animals.
Test system
- Vehicle:
- other: highly de-ionized water
- Controls:
- other: Control (50 µL highly de-ionised water) skin cultures were used.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 μL of the test item
VEHICLE
- Amount(s) applied (volume or weight with unit): 25 µL of the vehicle - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Observation period:
- not applicable
- Number of animals:
- Number of skin tissue replicates per dose and per exposure time:
Test item: duplicates
Negative control: duplicates
Positive control: duplicates - Details on study design:
- THREE DIMENSIONAL HUMAN EPIDERMIS MODEL:
- EpiDerm™ 200 kit were obtained from MatTek Corporation, Ashland MA, USA
- EpiDermTM tissues (surface 0.6 cm²) consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo.
DIRECT MTT REDUCTION:
- approximately 25 μL bulk volume of the test item was added to 0.9 mL of the MTT solution.
- mixture was incubated in the dark at about 37 °C for 55 to 65 minutes.
- negative control (50 μL of vehicle) was tested concurrently.
- if the MTT solution colour or, in case of water-insoluble test items the border to the water-phase, turned blue / purple, the test item was presumed to directly reduce MTT.
- in case that direct MTT reduction occurred, one freeze-killed control tissue per exposure time was treated with, each, the test article and the negative control, in the same way as described below.
CORROSION TEST:
- tissues were kept in the refrigerator.
- at least 1 hour but not more than 1.5 hours before test-item application, tissues were transferred to 6-well plates with assay medium and preconditioned in the incubator at 37 °C.
- preincubation medium was replaced with fresh medium before application.
- two tissues per exposure time (3 minutes at room temperature or 1 hour in the incubator) and test material, negative control (50 μL highly de-ionized water) and positive control (50 μL 8 n potassium hydroxide) were used.
- for the test item, the vehicle was applied first followed by the test material.
- control tissues were concurrently applied.
- tissues were washed with PBS to remove residual test material 3 minutes or 1 hour after start of the application.
- tissues were incubated in MTT solution for 3 hours.
- after incubation, tissues were washed with PBS
- formazan produced by the tissues was extracted with isopropanol over night at room temperature.
- optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically.
- blank values were established of 6 microtiter wells filled with isopropanol for each microtiter plate.
DATA EVALUATION.
- Principle: the OD570 values determined for the various tissues are measures of their viability. The quotient of the OD570 of tissues treated with the test material and the mean OD570 values of the negative control (percent of control) is used for evaluating whether or not a test material is corrosive.
- Calculation of individual and mean optical densities: the individual tissue OD570 is calculated by subtracting the mean blank value of the respective microtiter plate from the respective individual tissue OD570 value. The mean OD570 for a test group of two tissues treated in the same way is calculated.
- Tissue viability: the quantification of tissue viability is presented as the quotient of the mean OD570 divided by the respective OD570 negative control value in percent for each exposure time.
EVALUATION OF RESULTS:
Corrosive potential of the test materials is predicted from the mean relative tissue viabilities obtained after 3 minutes treatment compared to the negative control tissues. A chemical is considered as "corrosive" or "non-corrosive" according to table 1 in the field "Any other information on materials and methods incl. tables" below.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour exposure (mean of 2 tissue replicates)
- Value:
- 104
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure (mean of 2 tissue replicates)
- Value:
- 123
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
HISTORICAL DATA
Table 1: Historical range of negative control (OD570)
Exposure time |
Historical period |
Mean OD |
Standard deviation |
Mean + 2 Standard deviation |
Mean – 2 Standard deviation |
3 minutes |
Mar 2008 – Nov 2009 |
1.891 |
0.257 |
2.40 |
1.38 |
60 minutes |
Mar 2008 – Nov 2009 |
1.897 |
0.230 |
2.36 |
1.44 |
Table 2: Historical range of positive control (OD570)
Exposure time |
Historical period |
Mean OD |
Standard deviation |
Mean + 2 Standard deviation |
Mean – 2 Standard deviation |
3 minutes |
Mar 2008 – Nov 2009 |
0.408 |
0.110 |
0.63 |
0.19 |
60 minutes |
Mar 2008 – Nov 2009 |
0.189 |
0.051 |
0.29 |
0.09 |
Table 3: Viability (%)
Exposure time |
Historical period |
Mean % |
Standard deviation |
Mean + 2 Standard deviation |
Mean – 2 Standard deviation |
3 minutes |
Mar 2008 – Nov 2009 |
21.84 |
5.21 |
32.26 |
11.42 |
60 minutes |
Mar 2008 – Nov 2009 |
9.97 |
2.11 |
14.18 |
5.75 |
RESULTS
Table 4: Result of corrosion test with the test item
Test article |
|
Exposure: 3 minutes |
Exposure: 1 hour |
||||
tissue 1 |
tissue 2 |
mean |
tissue 1 |
tissue 2 |
mean |
||
Negative control |
mean OD570 |
1.2662 |
1.4622 |
1.3642 |
1.6587 |
1.7942 |
1.7264 |
viability [% of negative control] |
92.8 |
107.2 |
100 |
96.1 |
103.9 |
100 |
|
Test item |
mean OD570 |
1.6172 |
1.7452 |
1.6812 |
1.7767 |
1.8022 |
1.7894 |
viability [% of negative control] |
118.5 |
127.9 |
123 |
102.9 |
104.4 |
104 |
|
Positive control |
mean OD570 |
0.3322 |
0.3452 |
0.3387 |
0.2282 |
0.1947 |
0.2114 |
viability [% of negative control] |
24.3 |
25.3 |
25 |
13.2 |
11.3 |
12 |
The test item is not able to reduce MTT directly.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- For classification purposes, results of this in vitro skin corrosion study need to be assessed together with the results from an in vitro skin irritation study.
- Conclusions:
- In an in vitro skin irritation study according to OECD guideline 431, the substance was not corrosive to the skin.
- Executive summary:
In this in vitro study the substance was tested for its skin corrosive potential according to the OECD guideline 431 (2004) by the means of the human skin model test using EpiDerm™. Duplicates of EpiDerm™ tissues were exposed to either the substance (25 µL) with the vehicle (25 µL), the positive control (8 n potassium hydroxide; 50 µL) or the negative control (highly de-ionised water; 50 µL) for each of two different exposure periods: 3 minutes and 1 hour. Afterwards the test and the control items were rinsed off the tissues, and a 3 hour incubation period with MTT solution followed.
After incubation, tissues were washed and the formazan produced by the tissues was extracted with isopropanol overnight. This was followed by the measurement of the optical density (OD570).
After an exposure period of 3 minutes the relative tissue viability increased to 123 % (threshold for corrosivity: 50 %). After an exposure period of 1 hour the relative tissue viability increased to 104 % (threshold for corrosivity: 15 %). Therefore, the substance was not considered to be corrosive. The controls confirmed the validity of the study.
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not corrosive to the skin.
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