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EC number: 243-797-2 | CAS number: 20407-84-5
- 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 irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP. All relevant validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- yes
- Remarks:
- Minor deviation in environmental conditions (humidity minimum 50%) which does not affect the reliability of the study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- yes
- Remarks:
- Minor deviation in environmental conditions (humidity minimum 50%) which does not affect the reliability of the study
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected: March 2013; signature: May 2013
Test material
- Reference substance name:
- (E)-dodec-2-en-1-al
- EC Number:
- 243-797-2
- EC Name:
- (E)-dodec-2-en-1-al
- Cas Number:
- 20407-84-5
- Molecular formula:
- C12H22O
- IUPAC Name:
- dodec-2-enal
- Details on test material:
- - Physical state: Liquid.
- Storage condition of test material: At room temperature protected from light.
- Other: Colourless
Constituent 1
Test animals
- Species:
- other: EpiDerm Skin Model (EPI-200, Lot no.: 21267 kit Q).
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- EpiDerm Skin Model). The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, 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. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts.
Freeze-killed tissues. Living epidermis was transferred to a freezer (≤-15°C), thawed, and then again transferred to (≤-15°C). The freeze-killed epidermis was stored at ≤ -15°C until use. Freeze-killed tissues were thawed by placing them for 1 hour at room temperature in a 6 well plate on 0.9 ml DMEM medium. Further use of killed tissues was similar to living tissues.
All incubations were carried out in a controlled environment, in which optimal conditions were a humid atmosphere of 80 - 100% (actual range 50 - 87%), containing 5.0 ± 0.5% CO2 in air in the dark at 37.0 ± 1.0°C (actual range 36.5 - 37.4°C). Temperature and humidity were continuously monitored throughout the experiment. The CO2 percentage was monitored once on each working day. Temporary deviations from the temperature, humidity and CO2 percentage may occur due to opening and closing of the incubator door. Based on laboratory historical data these deviations are considered not to affect the study integrity.
Test system
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 μl
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- Two tissues were used for a 3-minute exposure to the test substance and two for a 1-hour exposure.
In addition two freeze-killed tissues treated with test substance and two freeze-killed non treated tissues were used for the cytotoxicity evaluation with MTT. - Number of animals:
- The test was performed on a total of 4 tissues per test substance together with a negative control and positive control. Two tissues were used for a 3-minute exposure to the test substance and two for a 1-hour exposure. In addition two freeze-killed tissues treated with test substance and two
freeze-killed non treated tissues were used for the cytotoxicity evaluation with MTT. - Details on study design:
- TEST SITE
- Area of exposure: 50 μl of the undiluted test substance was added on top of the skin tissues.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: Two tissues were washed after 3 minutes and two tissues were washed after 1 hour.
SCORING SYSTEM: Skin corrosion is expressed as the remaining cell viability after exposure to the test substance.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 minutes exposure
- Run / experiment:
- mean
- Value:
- 87
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- Score in terms of percentage of control
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 1 hour
- Run / experiment:
- mean
- Value:
- 94
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Scored in terms as percentage of control
- Other effects / acceptance of results:
- Table 1 shows the mean tissue viability obtained after 3-minute and 1-hour treatments with test substance compared to the negative control tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with the test substance compared to the negative control tissues was 87% and 94% respectively. The values are corrected for non-specific MTT reaction.
The relative mean tissue viability of the positive control was after the 3-minute and 1-hour treatments compared to the negative control tissues was 8% and 10% respectively.
Any other information on results incl. tables
Table 1. Mean absorption and tissue viability in the in vitro skin corrosion test with the test substance
|
3-minute application (OD540) |
1-hour application (OD540) |
||||||||
OD540measurement |
A |
B |
Mean |
SD |
Mean tissue viability (% of control) |
A |
B |
Mean |
SD |
Mean tissue viability (% of control) |
Negative control |
1.651 |
1.640 |
1.645 |
±0.008 |
100 |
1.669 |
1.603 |
1.636 |
±0.047 |
100 |
Test Substance (1) |
1.500 |
1.362 |
1.431 |
±0.098 |
87 |
1.549 |
1.517 |
1.533 |
±0.022 |
94 |
Positive control |
0.129 |
0.127 |
0.128 |
±0.001 |
8 |
0.184 |
0.153 |
0.169 |
±0.022 |
10 |
(1) The values are corrected for the non-specific MTT reaction
SD = Standard Deviation
Duplicate Exposures are indicated by A and B
Values are corrected for background absorption (0.043). Isopropanol was used to measure the background absorption.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test substance is not considered to be corrosive in the in vitro skin corrosion test using EpiDerm Skin Model.
- Executive summary:
The study was performed to OECD TG 431 and EU Method B.40 BIS to assess the skin corrosion potential of the test substance in accordance with GLP using a human three dimensional epidermal model (EpiDerm (EPI-200). The test was performed on a total of 4 tissues per test substance together with a negative control and positive control. Two tissues were used for a 3-minute exposure to the test substance and two for a 1-hour exposure. The test substance did interact with 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT). Therefore in addition to the normal 1-hour procedure, two freeze-killed tissues treated with test substance and two freeze-killed non treated tissues were used for the cytotoxicity evaluation with MTT. The non-specific reduction of MTT by the test substance was 10% of the negative control tissues. The net OD of the treated freeze-killed tissues was subtracted from the ODs of the test substance treated viable tissues. Fifty μl of the undiluted test substance was added (with a pipette) into the 6-well plates on top of the skin tissues. The remaining tissues were treated with 50 μl Milli-Q water (negative control) and with 50 μl 8N KOH (positive control), respectively. The positive control had a mean relative tissue viability of 8% after 3 minutes exposure. The absolute mean OD540 (optical density at 540 nm) of the negative control tissues was within the laboratory historical control data range. The maximum inter-tissue variability in viability between two tissues treated identically was less than 17% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 10%, indicating that the test system functioned properly. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the test material compared to the negative control tissues was 87% and 94%, respectively. Because the mean relative tissue viability for the test substance was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment the test substance is considered to be not corrosive. Under the conditions of this study the test material is not corrosive in the in vitro skin corrosion test.
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