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EC number: 942-993-1 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Irritation / corrosion
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- 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.
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 75%) 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 75%) 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:
- methyl (9E,12E,15Z)-octadeca-9,12,15-trienoate; methyl (9E,12Z,15E)-octadeca-9,12,15-trienoate; methyl (9Z)-octadec-9-enoate; methyl (9Z,12E,15E)-octadeca-9,12,15-trienoate; methyl (9Z,12Z)-octadeca-9,12-dienoate
- Molecular formula:
- not applicable (reaction mass of constitutional isomers)
- IUPAC Name:
- methyl (9E,12E,15Z)-octadeca-9,12,15-trienoate; methyl (9E,12Z,15E)-octadeca-9,12,15-trienoate; methyl (9Z)-octadec-9-enoate; methyl (9Z,12E,15E)-octadeca-9,12,15-trienoate; methyl (9Z,12Z)-octadeca-9,12-dienoate
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- - Physical state: Liquid.
- Storage condition of test material: In refrigerator (2-8°C protected from light, container flushed with nitrogen
- Other: Colourless to pale yellow
Constituent 1
Test animals
- Species:
- other: EpiDerm Skin Model (EPI-200, Lot no.: 22226 kit N).
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- EpiDerm Skin Model (EPI-200, Lot no.: 22226 kit N).. 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.
All incubations, with the exception of the test substance incubation of 3 minutes at room temperature, were carried out in a controlled environment, in which optimal conditions were a humid atmosphere of 80 - 100% (actual range 75 - 87%), containing 5.0 ± 0.5% CO2 in air in the dark at 37.0 ± 1.0°C (actual range 36.4 - 36.7°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.
- Observation period:
- Observations are made 3-minutes and 1-hour post-test item application
- Number of animals:
- The test was performed on a total of 4 tissues per test substance together with a negative control and positive control.
- 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. After the exposure period, the tissues were washed with phosphate buffered saline to remove residual test substance.
SCORING SYSTEM: Skin corrosion is expressed as the remaining cell viability after exposure to the test substance.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Tissue viability
- Basis:
- mean
- Time point:
- other: 3 minute exposure to test material
- Score:
- 91
- Max. score:
- 100
- Reversibility:
- no data
- Remarks on result:
- other: Score in terms of percentage of control
- Irritation parameter:
- other: Tissue viability
- Basis:
- mean
- Time point:
- other: 1 hour exposure to test material
- Score:
- 94
- Max. score:
- 100
- Reversibility:
- no data
- Remarks on result:
- other: Scored in terms as percentage of control
- Irritant / corrosive response data:
- 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 91% and 94% respectively.
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 14% and 7% 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 |
2.160 |
2.109 |
2.134 |
±0.036 |
100 |
2.033 |
2.098 |
2.065 |
±0.046 |
100 |
Test Material |
2.009 |
1.873 |
1.941 |
±0.096 |
91 |
1.940 |
1.957 |
1.949 |
±0.012 |
94 |
Positive control |
0.290 |
0.290 |
0.290 |
±0.000 |
14 |
0.129 |
0.166 |
0.148 |
±0.026 |
7 |
Values are corrected for background absorption (0.042). Isopropanol was used to measure the background absorption.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information 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. 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 14% after 3 minutes exposure. The absolute mean OD570 (optical density at 570 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 22% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 13%, 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 substance compared to the negative control tissues was 91% 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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