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EC number: 922-520-5 | CAS number: -
- 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:
- 14 May 2018 - 18 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 29 July 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 31 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- dd. 22 January 2018
Test material
- Reference substance name:
- C12-16 alkyl, glycerol ether
- EC Number:
- 922-520-5
- Molecular formula:
- N.A UVCB
- IUPAC Name:
- C12-16 alkyl, glycerol ether
- Test material form:
- liquid
- Details on test material:
- Identification: C12 – 16 alkyletherdiol
Appearance: Opaque white to light yellow liquid (determined by Charles River Den Bosch)
CAS: Not available
Lot/Batch: D7801-171116001
Date of Production: 17.11.2017
Best before Date: Within 2 years
UVCB 100%
1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- skin obtained from plastic surgery from multiple donors
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm Skin Model
- Tissue batch number(s): 28356
- Surface: 0.6 cm^2
- Pretreatment: The skin tissues were kept on agarose and storen in the refrigerator the day they were received. The next day, at least 1 hour before the assay was started the tissues were transferred to 6-well plates containing 0.9 ml DMEM per well. The level of the DMEM was just beneath the tissue. The plates were incubated for approximately 2.5 hours at 37.0 ± 1.0ºC.
INTERFERENCE WITH THE MTT ENDPOINT:
- Test for color interference by the test item: 50 μL test item was added to 0.3 mL Milli-Q water and the mixture was incubated for approx. 1 hour at 37.0 ± 1.0°C in the dark. At the end of the exposure time the mixture was shaken and it was checked if a blue/purple color change was observed. A negative control (Milli-Q water) was tested concurrently.
- Test for reduction of MTT by the test item: 25 mg test item was added to 1mL MTT solution (1mg/mL) in phosphate buffered saline. The mixture was incubated for approx. 1 hour at 37.0 ± 1.0°C. At the end of the exposure time it was checked if a blue/purple color change was observed or a blue/purple precipitate was observed. A negative control (Milli-Q water) was tested concurrently.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation: 36.3-37.2°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: after exposure and after incubation tissues were washed with phosphate buffered saline (once)
- Observable damage in the tissue due to washing: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- Amount of MTT-medium: 300 μL
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 2 per exposure duration + 2 for the negative control and the positive control each
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: one experiment per exposure period (two in total) with 3 independent OD570 measurements per replicate.
ACCEPTABILITY CRITERIA
- The absolute mean OD570 of the two tissues of the negative control should reasonably be within the acceptance limits of OECD431 (≥0.8 and ≤2.8).
- The mean relative tissue viability following 1-hour exposure to the positive control should be <15 %.
- In the range 20 - 100% viability, the Coefficient of Variation (CV) between tissue replicates should be ≤ 30%.
DECISION CRITERIA (see table 1 in 'any other information on materials and methods')
A test item is considered corrosive in the in vitro skin corrosion test if:
- The relative mean tissue viability obtained after 3-minute treatment compared to the negative control tissues is decreased below 50%.
- In addition, a test item considered non-corrosive (viability ≥ 50%) after the 3-minute treatment is considered corrosive if the relative tissue viability after 1-hour treatment with the test item is decreased below 15%.
A test item is considered non-corrosive in the in vitro skin corrosion test if:
- The relative mean tissue viability obtained after the 3-minute treatment compared to the negative control tissues is not decreased below 50%.
- In addition, the relative tissue viability after the 1-hour treatment is not decreased below 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 50 μL
- The test item was applied directly on top of the skin tissues
NEGATIVE CONTROL
- Amount applied: 50 μL
POSITIVE CONTROL
- Amount applied: 50 μL (8N KOH) - Duration of treatment / exposure:
- 3 minute and 1 hour
- Duration of post-treatment incubation (if applicable):
- 3 hours in MTT medium
- Number of replicates:
- 2 tissues per test item per exposure time (4 tissues in total)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- Mean of 2 replicates
- Run / experiment:
- 3-minute exposure
- Value:
- 102
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- % tissue viability: 9.1
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- Mean of 2 replicates
- Run / experiment:
- 1-hour exposure period
- Value:
- 93
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- % tissue viability: 7.6
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: the results of the positive control data were within the historical data range and thereby showing the test system functioned properly.
ACCEPTANCE OF RESULTS (see table 2 in 'any other information on results' for historical data):
- Acceptance criteria met for negative control: yes, the absolute mean OD570 of the two tissues of the negative control was within the laboratory historical control data range (i.e., 1.760 for the 3-minute exposure period and 1.724 for the 1-hour exposure period).
- Acceptance criteria met for positive control: yes, the mean relative tissue viability following 1-hour exposure to the positive control was <15 % (i.e., 7.6%).
- Acceptance criteria met for variability between replicate measurements: yes, the Coefficient of Variation (CV) between tissue replicates was ≤ 30% (i.e., ≤ 20%)
For individual OD measurements, see table 3 in 'any other information on results'.
Any other information on results incl. tables
Table 2 Historical Control Data
Negative control |
Positive control |
|||
3-minute treatment (OD570) |
1-hour treatment (OD570) |
3-minute treatment (OD570) |
1-hour treatment (OD570) |
|
Range |
1.258 – 2.615 |
1.371 – 2.371 |
0.0172 – 0.56 |
0.046 – 0.339 |
Mean |
1.80 |
1.82 |
0.19 |
0.14 |
SD |
0.26 |
0.22 |
0.09 |
0.05 |
n |
111 |
110 |
106 |
103 |
SD = Standard deviation
n = Number of observations
The above mentioned historical control data range of the controls were obtained by collecting all data over the period of November 2014 to November 2017.
Table 3 Individual OD Measurements at 570 nm
|
3-minute application (OD570) A B |
1-hour application (OD570) A B |
||
Negative control OD570measurement 1 OD570measurement 2 OD570measurement 3 |
|
|
||
1.5954 |
1.9388 |
1.7355 |
1.8148 |
|
1.6171 |
2.0210 |
1.7377 |
1.7981 |
|
1.6223 |
2.0184 |
1.7124 |
1.7972 |
|
Test item OD570measurement 1 OD570measurement 2 OD570measurement 3 |
|
|
||
1.7692 |
1.8490 |
1.5085 |
1.8025 |
|
1.7916 |
1.8660 |
1.4839 |
1.7657 |
|
1.7885 |
1.9120 |
1.4760 |
1.8072 |
|
Positive control OD570measurement 1 OD570measurement 2 OD570measurement 3 |
|
|
||
0.2117 |
0.1925 |
0.1765 |
0.1725 |
|
0.2120 |
0.1924 |
0.1768 |
0.1708 |
|
0.2136 |
0.1940 |
0.1722 |
0.1680 |
OD = Optical density
Duplicate exposures are indicated by A and B.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- From this single study, no conclusion can be drawn for classification of the test item.
- Conclusions:
- In the in vitro skin corrosion test, C12-16 alkyletherdiol was found to be not corrosive to the skin (mean tissue viability of 102% and 93% after a 3-minute and a 1-hour exposure period, respectively).
- Executive summary:
The objective of this study was to evaluate C12 -16 alkyletherdiol for its ability to induce skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)). The possible corrosive potential of C12 -16 alkyletherdiol was tested through topical application for 3 minutes and 1 hour.
The study procedures described in this report were based on the most recent OECD and EC guidelines.
Batch D7801-171116001 of the test item was an opaque white to light yellow liquid. The test item was applied undiluted (50 µL) directly on top of the skin tissue.
The positive control had a mean relative tissue viability of 7.6% after the 1-hour exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit ≤2.8) and the laboratory historical control data range. In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was ≤ 20%, indicating that the test system functioned properly.
Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 102% and 93%, respectively. Because the mean relative tissue viability for the test item was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment the test item is considered to be not corrosive.
In conclusion, C12 -16 alkyletherdiol is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
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