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EC number: - | 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
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- 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
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- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
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- Endpoint summary
- Stability
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- Environmental data
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- 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
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Sediment toxicity
- Terrestrial toxicity
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- 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:
- 28th June 2012 to 8th November 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
Test material
- Reference substance name:
- High molecular weight adducts of Fatty acids, C18-unsatd dimers and trimers with amines, polyethylenepoly-, triethylenetetramine fraction
- IUPAC Name:
- High molecular weight adducts of Fatty acids, C18-unsatd dimers and trimers with amines, polyethylenepoly-, triethylenetetramine fraction
- Reference substance name:
- Low Molecular weight adducts of Fatty acids, C16-18 sat. C18 unsat., linear, dimers, with Amines, polyethylenepoly-, triethylenetetramine fraction
- IUPAC Name:
- Low Molecular weight adducts of Fatty acids, C16-18 sat. C18 unsat., linear, dimers, with Amines, polyethylenepoly-, triethylenetetramine fraction
- Reference substance name:
- Amines, polyethylenepoly-, triethylenetetramine fraction
- EC Number:
- 292-588-2
- EC Name:
- Amines, polyethylenepoly-, triethylenetetramine fraction
- Cas Number:
- 90640-67-8
- Molecular formula:
- C6H18N4, C8H20N4, C8H20N4, C6H18N4
- IUPAC Name:
- Amines, polyethylenepoly-, triethylenetetramine fraction
- Details on test material:
- - Name of test material (as cited in study report):OLEIC DimerFA TETA PAA
- Physical state:Yellow-red, transparent, viscous liquid
- Analytical purity: 8% free amine
- Storage condition of test material:Room temperature (15°C to 30°C)
-Sponsor batch: BB100860V1
Constituent 1
Constituent 2
Constituent 3
In vitro test system
- Test system:
- other: Three-dimensional human skin model
- Source species:
- human
- Cell type:
- other: Human keratinocytes
- Cell source:
- other: skin model EpiDermTM
- Source strain:
- not specified
- Details on animal used as source of test system:
- Not applicable
- Justification for test system used:
- The tissue has been shown to demonstrate reproducibility over time, and it has been shown to be capable of predicting the corrosive potential of the reference chemicals when using the testing protocol selected.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEST SYSTEM
Specification
Three-dimensional human skin model, comprising a reconstructed epidermis with a functional stratum corneum supplied by MatTek Corporation, Ashland, Massachusetts, USA.
Identification
The test system was appropriately labelled with the study number, date of treatment, duration of treatment and negative/positive/test article.
General model conditions
Human keratinocytes are used to construct the epithelium. Multiple layers of viable epithelial cells are present under a functional stratum corneum. The stratum corneum is multi-layered with the necessary lipid profile to produce a functional barrier. The containment properties of the model prevent the passage of material around the stratum corneum to the viable model tissue. The skin model was supplied free of contamination with bacteria, mycoplasma and fungi. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- In order to assess the potential non-specific reduction of the test article, 40 mg of test article was added to 0.3 mL of 1.0 mg/mL MTT. In the Epiderm test, an average of approximately 44 mg of test article was applied to each tissue. Further tissues were concurrently treated with 40 μL distilled water (negative control) and with 40 μL 8N potassium hydroxide (positive control).
- Duration of treatment / exposure:
- 3 minutes and 1 hour.
- Duration of post-treatment incubation (if applicable):
- Not applicable
- Number of replicates:
- duplicate
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean, after three minute exposure to the test article
- Value:
- 72
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Not corrosive
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean, after one hour exposure to the test article
- Value:
- 52
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Not corrosive
Any other information on results incl. tables
Three minute exposure period
Test substance |
OD570 |
Mean |
Tissue Mean |
Adjusted tissue mean value |
% variability |
% survival |
||
Negative |
1.810 |
1.860 |
2.034 |
1.901 |
1.970 |
N/A |
6.8 |
100 |
Negative |
2.030 |
2.029 |
2.057 |
2.039 |
||||
Test article |
1.734 |
1.732 |
1.709 |
1.725 |
1.599 |
1.415 |
-17.1 |
72 |
Test article |
1.445 |
1.446 |
1.530 |
1.474 |
||||
Test article# |
0.165 |
0.177 |
0.179 |
0.173 |
0.184 |
|
-12.7 |
|
Test article# |
0.196 |
0.195 |
0.195 |
0.195 |
||||
Positive |
0.380 |
0.440 |
0.434 |
0.418 |
0.479 |
N/A |
-29.071 |
24 |
Positive |
0.542 |
0.531 |
0.545 |
0.539 |
# Freeze-killed tissues
One hour exposure period
Test substance |
OD570 |
Mean |
Tissue Mean |
Adjusted tissue mean value |
% variability |
% survival |
||
Negative |
1.814 |
1.863 |
1.755 |
1.811 |
1.796 |
N/A |
-1.6 |
100 |
Negative |
1.700 |
1.832 |
1.814 |
1.782 |
||||
Test article |
1.147 |
1.237 |
1.215 |
1.200 |
1.238 |
0.926 |
6.0 |
52 |
Test article |
1.262 |
1.339 |
1.2226 |
1.276 |
||||
Test article# |
0.262 |
0.274 |
0.273 |
0.270 |
0.312 |
|
-30.9 |
|
Test article# |
0.351 |
0.354 |
0.355 |
0.354 |
||||
Positive |
0.238 |
0.224 |
0.236 |
0.233 |
0.222 |
N/A |
9.271 |
12 |
Positive |
0.212 |
0.221 |
0.201 |
0.211 |
# Freeze-killed tissues
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 article, OLEIC_DimerFA_TETA_TEPA_PAA, was not considered to be corrosive to skin in the in vitro skin model EpiDerm.
- Executive summary:
The skin corrosion potential of OLEIC_DimerFA_TETA_PAA was evaluated in a GLP study using the in vitro skin model EpiDermTM. The study was conducted in accordance with guidelines OECD Test Guideline 431 and EU Method B.40.
Duplicate EpiDermTM inserts were treated with OLEIC_DimerFA_TETA_PAA, distilled water (negative control) and 8N potassium hydroxide (positive control) for 3 minutes and 1 hour. At the end of the treatment period, the tissues were washed with phosphate buffered saline (PBS) and cell viability was assessed using the MTT assay. The skin corrosivity potential was classified according to the remaining cell viability obtained after test material treatment with either of the two treatment times.
Skin viability after a three minute or one hour exposure to the test article was 72% and 52%, respectively. Skin viability after a three minute or one hour exposure to the positive control article was 24% and 12%, respectively, demonstrating appropriate performance of the assay.
Under the conditions of this study, the test article, OLEIC_DimerFA_TETA_TEPA_PAA, was not considered to be corrosive to skin in the in vitro skin model EpiDermTM.
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