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EC number: 205-398-1 | CAS number: 140-10-3
- 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:
- The study was conducted between 23 May 2018 and 25 May 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: 18/07/2017 - 20/07/2017 Date of Issue: 28/11/2017
Test material
- Reference substance name:
- trans-cinnamic acid
- EC Number:
- 205-398-1
- EC Name:
- trans-cinnamic acid
- Cas Number:
- 140-10-3
- Molecular formula:
- C9H8O2
- IUPAC Name:
- 3-phenylacrylic acid
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 20171106
- Expiration date of the lot/batch: 10 April 2020
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark, over silica gel
In vitro test system
- Test system:
- human skin model
- Source species:
- other: reconstructed human epidermis
- Cell type:
- other: normal, human-derived epidermal keratinocytes (NHEK)
- Cell source:
- other: reconstructed human epidermis
- Source strain:
- other: reconstructed human epidermis
- Details on animal used as source of test system:
- Not applicable
- Justification for test system used:
- This 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:
- EpiDerm™ Reconstructed Human Epidermis Model Kit
Supplier : MatTek
Date received : 22 May 2018
EpiDermTM Tissues (0.63cm2) lot number : 28615
Assay Medium lot number : 051718TMA
Upon receipt of the EpidermTM tissues, the sealed 24-well plate was stored in a refrigerator until use.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C
- Temperature of post-treatment incubation (if applicable): room temperature
REMOVAL OF TEST MATERIAL AND CONTROLS
2 mL of MTT extractant (isopropanol) was used
to completely immerse each insert and the plate was covered with plate sealer to prevent
Isopropanol evaporation.
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Inspected by visual observation
Absorbency at 570 nm (OD570) of each well was measured using the Labtech LT-4500 microplate reader and LT-com analysis software
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION:
24-well plates; one run
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after the 3 and 60-Minute exposure periods, compared to the mean of the negative control tissues (n=2) treated with sterile distilled water. The relative mean viabilities were calculated in the following way:
Relative mean viability (%) = (mean OD570 of test item/mean OD570 of negative control) x 100
Classification of corrosivity potential is based on the relative viabilities for both exposure times according Table 1 below. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- 25 mg of test item
- Duration of treatment / exposure:
- 60 minutes/3 minutes
- Duration of post-treatment incubation (if applicable):
- Overnight
- Number of replicates:
- 24-well plates
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean 3 minute exposure period
- Value:
- 96.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean 60 minute
- Value:
- 94
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
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.
Assessment of Colour Interference with the MTT endpoint
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.
Test Item, Positive Control Item and Negative Control Item
Mean OD570 values and viabilities for the negative control, positive control and test item are given in the below table:
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 Viability (%) |
Negative Control |
3 Minutes |
2.145 |
2.217 |
0.101 |
4.6 |
100* |
2.288 |
||||||
60 Minutes |
1.871 |
1.922 |
0.071 |
3.7 |
||
1.972 |
||||||
Positive Control |
3 Minutes |
0.055 |
0.051 |
0.006 |
n/a |
2.3 |
0.047 |
||||||
60 Minutes |
0.030 |
0.040 |
0.014 |
n/a |
2.1 |
|
0.050 |
||||||
Test Item |
3 Minutes |
2.115 |
2.132 |
0.023 |
1.1 |
96.1 |
2.148 |
||||||
60 Minutes |
1.766 |
1.806 |
0.057 |
3.1 |
94.1 |
|
1.846 |
The relative mean viabilities for each treatment group were as follows:
Exposure Period |
Percentage Viability |
||
Negative Control |
Positive Control |
Test Item |
|
3 minutes |
100* |
2.3 |
96.1 |
60 minutes |
100* |
2.1 |
94.0 |
*The mean viability of the negative control tissues is set at 100%
Quality Criteria
The mean OD570 for the negative control treated tissues was 2.217 for the 3-Minute exposure period and 1.922 for the 60-Minute exposure period. The negative control acceptance criteria were therefore satisfied.
The relative mean tissue viability for the positive control treated tissues was 2.1% relative to the negative control following the 60-Minute exposure period. The positive control acceptance criterion was therefore satisfied.
In the range 20 to 100% viability the Coefficient of Variation between the two tissue replicates of each treatment group did not exceed 30%. The acceptance criterion was therefore satisfied
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was considered to be non-corrosive to the skin.
- Executive summary:
Introduction
The purpose of this test is to evaluate the corrosivity potential of the test item using the EpiDerm™ Human Skin Model after treatment periods of 3 and 60 minutes.
Corrosion is directly related to cytotoxicity in the EpiDerm™ tissue. Cytotoxicity is determined by the reduction of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to formazan by viable cells in the test item treated tissues relative to the
corresponding negative control. The results are used to make a prediction of the corrosivity potential of the test item.
Methods
Duplicate tissues were treated with the test item for exposure periods of 3 and 60 minutes. Negative and positive control groups were treated for each exposure period. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for
MTT-loading. After MTT-loading each tissue was placed in 2 mL of Isopropanol for MTT extraction.
At the end of the formazan extraction period each well was mixed thoroughly and triplicate 200 µL samples were transferred to the appropriate wells of a pre-labeled 96-well plate. The optical density (OD) was measured at 570 nm (OD570).
Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).
Results
The relative mean viabilities for each treatment group were as follows:
Exposure Period
Percentage Viability
Negative Control
Positive Control
Test Item
3 minutes
100*
2.3
96.1
60 minutes
100*
2.1
94.0
* The mean viability of the negative control tissues is set at 100%
Quality Criteria
The quality criteria required for acceptance of the results in the test were satisfied
Conclusion
The test item was considered to be non-corrosive to the skin
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