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EC number: 263-034-7 | CAS number: 61789-12-6
- 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:
- 19. Feb. 2018 to 22. Feb. 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- OECD Guidelines for the Testing of Chemicals Part 431, adopted 29. Jul. 2016 “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))
- Version / remarks:
- Commission Regulation (EU) No.440/2008, EU-Method B.40 BIS. “IN VITRO SKIN CORROSION: HUMAN SKIN MODEL TEST“ dated 30. May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Glycerides, tall-oil mono-
- EC Number:
- 263-034-7
- EC Name:
- Glycerides, tall-oil mono-
- Cas Number:
- 61789-12-6
- Molecular formula:
- C19H38O4 to C21H42O4 * (mono-glycerides) # C37H66O5 to C39H76O4 * (di-glycerides) # C55H96O6 to C57H108O4 * (tri-glycerides) # * in H2 increments (i,e, decreasing # of double bonds)
- IUPAC Name:
- Glycerides, tall-oil mono-
- Test material form:
- liquid
- Details on test material:
- Name: LUMULSE GMT-K
Batch no.: 385932
Appearance: opaque amber liquid
Purity: 100%
Homogeneity: homogeneous
Expiry date: 26. Oct. 2019
Storage: Room Temperature: (20 ± 5°C)
Constituent 1
- Specific details on test material used for the study:
- No further details specified in the study report.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Not specified
- Source strain:
- not specified
- Details on animal used as source of test system:
- Specification
The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
The EpiDermTM tissue consists of 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. The EpiDermTM tissues are cultured on specially prepared cell cultures inserts.
Origin
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
Designation of the kit: EPI-200-SCT
Day of delivery: 20. Feb. 2018
Batch: 25882 - Justification for test system used:
- The principle of the human skin model assay is based on the hypothesis that corrosive chemicals are able to penetrate the stratum corneum by diffusion or erosion and are cytotoxic to the underlying cell layers.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Pre-Tests
Nylon mesh compatibility
First, the test item was tested for possible reaction with the nylon mesh which is used to ensure sufficient contact with the tissue surface. 50 μL of the liquid test item were brought onto a nylon mesh on a microscope slide. No reaction with the mesh was visible after 1 hour incubation at room temperature.
Assessment of Coloured or Staining Test Items
It was tested whether the test item develops a colour without MTT addition. 50 μL of the test item were given in a test tube with 0.3 mL demineralised water and incubated at 37 ± 1°C and 5.0 ± 0.5% CO2 for 1 hour.
The resulting solution was colourless, therefore no binding capacity had to be tested.
Assessment of Direct Reduction of MTT by the Test Item
The test item was also tested for the ability of direct MTT reduction. To test for this ability, 50 μL of the test item were added to 1 mL of MTT solution and the mixture was incubated in the dark at 37 ± 1°C and 5.0 ± 0.5% CO2 for 1 hour. Untreated MTT solution was used as control.
The MTT solution did not change its colour within 1 hour. Therefore, direct MTT reduction had not taken place and no data correction was necessary.
Preparations
On the day of the start of the experiment, the MTT concentrate was thawed. The concentrate was diluted with the assay medium directly before use.
The tissue plate was brought out of the fridge 1 hour before the treatment.
The assay medium was warmed in the water bath to 37 ± 1°C.
Description of the Method
Four 6-well-plates were prepared with 0.9 mL assay medium in each well. The inserts containing the tissues were transferred to the wells using sterile forceps and the 6-well-plates were set into the incubator at 37 ± 1°C and 5.0 ± 0.5% CO2 for 1 hour (pre-incubation).
For each experiment (“3 minutes” and “1 hour”), one 24-well-plate was prepared as holding plate. 12 wells of each plate were filled with 300 μL assay medium, the other 12 with 300 μL MTT solution. One additional plate was left empty. The plates were stored in the incubator at 37 ± 1°C and 5.0 ± 0.5% CO2.
For each experiment (“3 minutes” and “1 hour”), two 6-well-plates for the assay were used.
After pre-incubation, the assay medium was replaced by fresh assay medium and the test was started, using two wells as negative control with 50 μL demineralised water, two wells as positive controls with 50 μL potassium hydroxide solution and two other wells for testing the test item.
The liquid test item was applied without preparation (50 μL).
At the start of each experiment (application of negative controls), a stop watch was started.
After the respective incubation time (“3 minutes” and “1 hour”) at 37 ± 1°C and 5.0 ±0.5% CO2, the inserts were removed from the plates using sterile forceps. The inserts were thoroughly rinsed with DPBS, blotted with sterile cellulose tissue and set into the respective holding plate, using the wells containing assay medium. After transfer of all inserts, they were immediately moved to the wells containing MTT medium, blotting the bottom with cellulose tissue again before setting the insert into the MTT well. The tissues were incubated with MTT solution for 3 hours at 37 ± 1°C and 5.0 ± 0.5% CO2.
After this time, the MTT solution was aspirated and replaced by DPBS. This was then aspirated, too, and replaced several times. At last, each insert was thoroughly dried and set into the empty, pre-warmed 24-well-plate. Into each well, 2 mL isopropanol were pipetted, taking care to reach the upper rim of the insert. The plate was then shaken for 2 hours at room temperature.
Afterwards, the inserts were pierced with an injection needle, taking care that all colour was extracted. The inserts were then discarded and the content of each well was thoroughly mixed in order to achieve homogenisation.
From each well, three replicates with 200 μL solution (each) were pipetted into a 96-wellplate which was read in a plate spectrophotometer at 570 nm. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The liquid test item was applied without preparation (50 μL).
- Duration of treatment / exposure:
- 3 minutes and 1 hour
- Duration of post-treatment incubation (if applicable):
- The tissues were incubated with MTT solution for 3 hours
- Number of replicates:
- For each experiment, two 6-well-plates for the assay were used.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 99.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour
- Value:
- 87.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Assessment and Validity
Corrosivity of the Test Item
The mean tissue viability obtained after 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 99.6% and 87.8% respectively. Because the mean relative tissue viability for the test item was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment, the test item LUMULSE GMT-K is considered to be not corrosive.
Validity
The criterion for optical density of the negative control (≥ 0.8 and ≤ 2.8) was fulfilled: optical density was 1.8 (3 minutes) resp. 1.9 (1 hour).
The positive control showed clear corrosive effects. The criterion for the viability of the 1 hour experiment, expressed as % of the negative control (< 15%), was fulfilled, too. The mean value of relative tissue viability was 6.6%
Values for negative control and for positive control were within the range of historical data of the test facility.
Therefore the experiment is considered valid.
Any other information on results incl. tables
Measured Values
As blank, the optical density of isopropanol was measured in 12 wells of the 96-well-plate.
The measured values and their mean are given in the following table:
Absorbance values blank isopropanol (OD 570 nm)
Replicate |
1 |
2 |
3 |
4 |
5 |
6 |
Mean 0.038 |
Absorbance |
0.040 |
0.038 |
0.040 |
0.040 |
0.037 |
0.038 |
|
Replicate |
7 |
8 |
9 |
10 |
11 |
12 |
|
Absorbance |
0.039 |
0.038 |
0.037 |
0.038 |
0.038 |
0.037 |
The absorbance values of negative control, test item and positive control are given in the following table:
Absorbance Values (OD 570 nm)
Incubation |
Negative Control |
Test item |
Positive Control |
|||
Tissue 1 |
Tissue 2 |
Tissue 1 |
Tissue 2 |
Tissue 1 |
Tissue 2 |
|
3 min |
1.800 |
1.787 |
1.758 |
1.802 |
0.486 |
0.475 |
1.780 |
1.800 |
1.756 |
1.814 |
0.492 |
0.473 |
|
1.785 |
1.769 |
1.760 |
1.790 |
0.487 |
0.473 |
|
1 h |
1.884 |
1.961 |
1.635 |
1.698 |
0.161 |
0.156 |
1.860 |
1.916 |
1.631 |
1.743 |
0.160 |
0.165 |
|
1.864 |
1.927 |
1.641 |
1.700 |
0.161 |
0.166 |
From the measured absorbances, the mean absorbance of isopropanol was subtracted. The corrected mean and relative standard deviation (RSD) of the two tissues were also calculated.
Mean Absorbance Values of the 3 Minutes Experiment
Designation |
Negative Control |
Test Item |
Positive Control |
Mean – blank (tissue 1) |
1.750 |
1.720 |
0.450 |
Mean – blank (tissue 2) |
1.747 |
1.764 |
0.435 |
Mean of the two tissues |
1.749 |
1.742 |
0.443 |
RSD |
0.1% |
1.8% |
2.3% |
Mean Absorbance Values of the 1 h Experiment
Designation |
Negative Control |
Test Item |
Positive Control |
Mean – blank (tissue 1) |
1.831 |
1.597 |
0.122 |
Mean – blank (tissue 2) |
1.896 |
1.675 |
0.124 |
Mean of the two tissues |
1.864 |
1.636 |
0.123 |
RSD |
2.5% |
3.4% |
1.0% |
Comparison of Tissue Viability
For the test item and the positive control, the following percentage values of mean tissue viability were calculated in comparison to the mean of the negative controls:
% Tissue Viability
Test Item |
Positive Control |
Incubation |
99.6% |
25.3% |
3 min |
87.8% |
6.6% |
1 h |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LUMULSE GMT-K is considered non-corrosive to skin.
The mean tissue viability obtained after 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 99.6% and 87.8% respectively. Because the mean relative tissue viability for the test item was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment, the test item LUMULSE GMT-K is considered to be not corrosive.
The values of the negative control met the required acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for both treatment intervals, thus showing the quality of the tissues.
The positive control has met the validity criterion too, thus ensuring the validity of the test system.
For these reasons, the result of the test is considered valid. - Executive summary:
Title of Study: Determination of Skin Corrosion Potential of LUMULSE GMT-K in the Reconstructed Human Epidermis (RHE) Test Method following OECD Guideline 431 and EU Method B.40-BIS
Findings and Results:
One valid experiment was performed.
Two tissues of the human skin model EpiDermTM were treated with the test item LUMULSE GMT-K for 3 minutes and 1 hour, respectively. The test item was applied to each tissue and spread to match the tissue size.
Demineralised water was used as negative control, 8 M KOH was used as positive control.
After treatment, the respective substance was rinsed from the tissues. Then, cell viability of the tissues was evaluated by addition of MTT, which can be reduced to a blue formazan.
Formazan production was evaluated by measuring the optical density (OD) of the resulting solution.
After treatment with the negative control, the absorbance values were within the requiredacceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for both treatment intervals thus showing the quality of the tissues. The OD was 1.8 (3 minutes experiment) and 1.9 (1 hour experiment).
The positive control showed clear corrosive effects for both treatment intervals. The mean relative tissue viability value was reduced to 6.6% for the 1 hour treatment.
The mean tissue viability obtained after 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 99.6% and 87.8% respectively. Because the mean relative tissue viability for the test item was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment, the test item LUMULSE GMT-K is considered to be not corrosive.
Therefore, LUMULSE GMT-K is considered non-corrosive to skin in the Reconstructed Human Epidermis (RHE) Test Method.
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