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EC number: 263-160-2 | CAS number: 61790-69-0
- 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:
- weight of evidence
- Study period:
- 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 guideline
- 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
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (from the competent authority) Landesamt für Umwelt Rheinland-Pfalz
Test material
- Reference substance name:
- Fatty acids, tall-oil, reaction products with diethylenetriamine
- EC Number:
- 263-160-2
- EC Name:
- Fatty acids, tall-oil, reaction products with diethylenetriamine
- Cas Number:
- 61790-69-0
- Molecular formula:
- not applicable (UVCB substance)
- IUPAC Name:
- Fatty acids, tall-oil, reaction products with diethylenetriamine
- Test material form:
- other: solid, waxy, white to yellowish
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 0017319511
- Expiration date of the batch: 18 Dec 2018
- Purity: > 99 %
- pH value: ca. 6
- Physical state / color: Solid, wxy / white to yellowish
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: To improve application, the solid waxy test substance was heated at about 50 °C for about 15 minutes. Before application, the test substance was cooled down to room temperature.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The Skin Corrosion Test is based on the experience that corrosive and irritant chemicals produce cytotoxicity in human reconstructed epidermis after a short term topical exposure. The test is designed to predict a skin corrosion or irritation potential of a chemical by using the three-dimensional human epidermis model EpiDerm. After application of the test material to the stratum corneum surface of the EpiDerm tissue, the induced cytotoxicity (= loss of viability) is measured by a colorimetric assay. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity. The mitochondrial dehydrogenase reduces the yellow-colored water-soluble 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) to the insoluble blue-colored formazan. After isopropanol extraction of the formazan from the tissues, the optical density of the extract is determined spectrophotometrically. The optical density of the extracts of tissues treated with the test substance is compared to negative control values from tissues and expressed as relative tissue viability.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPI-200
- Tissue batch number(s): 25882
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature or 37 °C
- Temperature of post-treatment incubation (if applicable): room temperature
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: The tissues were washed with PBS to remove residual test material 3 minutes or 1 hour after start of the application treatment. After incubation, the tissues were washed with PBS to stop the MTT incubation.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.9 mL MTT solution
- Incubation time: 3 hours
- Spectrophotometer: Sunrise Absorbance Reader
- Wavelength: 570 nm
- Filter: filter wavelength 570 nm without reference filter
NUMBER OF REPLICATE TISSUES: two tissues per exposure time
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- killed tissues
- Procedure used to prepare the killed tissues (if applicable): freeze-killed
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL - Duration of treatment / exposure:
- 3 min and 1 h
- Number of replicates:
- 2 tissues per exposure time
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure period
- Value:
- 104.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 h exposure period
- Value:
- 59.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Exposure period 3 min: Individual and mean OD570 values, individual and mean viability values, standard deviations and coefficient of variation
Test substance Identification |
|
|
Tissue 1 |
Tissue 2 |
Mean |
SD |
CV [%] |
NC |
Viable tissues |
Mean OD570 |
1.789 |
1.779 |
1.784 |
|
|
Viability [% of NC] |
100.3 |
99.7 |
100.0 |
0.4 |
0.4 |
||
KC tissues |
Mean OD570 |
0.085 |
0.083 |
0.084 |
|
|
|
Viability [% of NC] |
4.8 |
4.7 |
4.7 |
0.1 |
1.7 |
||
Test substance |
Viable tissues |
Mean OD570 |
1.833 |
1.930 |
1.882 |
|
|
Viability [% of NC] |
102.7 |
108.2 |
105.5 |
3.9 |
3.7 |
||
KC tissues |
Mean OD570 KC NC corrected |
0.020 |
0.005 |
0.012 |
|
|
|
Viability [% of NC] |
1.1 |
0.3 |
0.7 |
0.6 |
83.7 |
||
Final relative mean viability of tissues after KC correction [% of NC] |
104.8 |
|
|
||||
PC |
Viable tissues |
Mean OD570 |
0.179 |
0.185 |
0.182 |
|
|
Viability [% of NC] |
10.0 |
10.4 |
10.2 |
0.2 |
2.3 |
Table 2: Exposure period 1 h: Individual and mean OD570 values, individual and mean viability values, standard deviations and coefficient of variation
Test substance Identification |
|
|
Tissue 1 |
Tissue 2 |
Mean |
SD |
CV [%] |
NC |
Viable tissues |
Mean OD570 |
1.479 |
1.668 |
1.574 |
|
|
Viability [% of NC] |
94.0 |
106.0 |
100.0 |
8.5 |
8.5 |
||
KC tissues |
Mean OD570 |
0.092 |
0.069 |
0.080 |
|
|
|
Viability [% of NC] |
5.8 |
4.4 |
5.1 |
1.0 |
20.3 |
||
Test substance |
Viable tissues |
Mean OD570 |
1.160 |
0.856 |
1.008 |
|
|
Viability [% of NC] |
73.7 |
54.4 |
64.1 |
13.7 |
21.3 |
||
KC tissues |
Mean OD570 KC NC corrected |
0.062 |
0.089 |
0.075 |
|
|
|
Viability [% of NC] |
3.9 |
5.6 |
4.8 |
1.2 |
24.9 |
||
Final relative mean viability of tissues after KC correction [% of NC] |
59.3 |
|
|
||||
PC |
Viable tissues |
Mean OD570 |
0.065 |
0.089 |
0.077 |
|
|
Viability [% of NC] |
4.1 |
5.7 |
4.9 |
1.1 |
22.5 |
Applicant's summary and conclusion
- Interpretation of results:
- other: No skin corrosion potential observed.
- Conclusions:
- No prediction can be made for skin corrosion according to GHS criteria based on the results of this in vitro study alone.
- Executive summary:
The potential of the test substance to cause dermal corrosion was assessed by a single topical application of 50 µL undiluted test substance to a reconstructed three-dimensional, human epidermis model (EpiDerm).
The test substance could not be homogeneously distributed on the whole application area. Therefore, a metal pin covered with 50 µL undiluted, at ca. 50 °C heated test substance was applied covering the whole tissue surface. Before application, the test substance was cooled down to room temperature.
Two EpiDerm tissues were incubated with the test substance for 3 minutes and 1 hour each. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure by using a colorimetric test. The reduction of mitochondrial dehydrogenase activity measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the epidermal tissues treated with the test substance is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
The test substance is able to reduce MTT directly. Therefore, an additional MTT reduction control KC (freeze-killed control tissues) was introduced. The final relative mean viability of the tissues treated with the test substance determined after an exposure period of 3 minutes was 104.8 %, and it was 59.3 % after an exposure period of 1 hour.
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