Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 500-382-3 | CAS number: 157707-73-8
- 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 irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted in accordance with GLP and appropriate testing guidelines.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other 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:
- Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C18-unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine
- EC Number:
- 500-382-3
- EC Name:
- Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C18-unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine
- Cas Number:
- 157707-73-8
- IUPAC Name:
- Reaction product of fatty acids, C18-unsatd., dimers, and trimers, with Amines, polyethylenepoly-, triethylenetetramine fraction and amines, polyethylenepoly-, tetraethylenepentamine fraction
- Reference substance name:
- MonoFA_DimerFA_TETA_TEPA_PAA
- IUPAC Name:
- MonoFA_DimerFA_TETA_TEPA_PAA
- Reference substance name:
- Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C-18 unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine
- IUPAC Name:
- Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C-18 unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): MonoFA_DimerFA_TETA_TEPA_PAA- Physical state: Yellow liquid with a brown hue. - Analytical purity: 100%- Lot/batch No.: BB001148V1- Expiration date of the lot/batch: 30th June 2013- Storage condition of test material: When not in use the test article was stored in a sealed container, at room temperature in the dark.
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- other: Not applicable - in vitro study
- Strain:
- other: Not applicable - in vitro study
- Details on test animals or test system and environmental conditions:
- Not applicable - in vitro study.
Test system
- Type of coverage:
- other: Not applicable
- Preparation of test site:
- other: Not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIALIn the preliminary MTT test, 40 μL of test article was added to 0.3 mL of 1.0 mg/mL MTT.In the Epiderm test, an average of approximately 50 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:
- Not applicable.
- Observation period:
- Not applicable.
- Number of animals:
- Not applicable.
- Details on study design:
- In order to assess the potential non-specific reduction of the test article, 40 μL of test article was added to 0.3 mL of 1.0 mg/mL MTT and the colour change was assessed after three hours.An increase in optical density was noted over the control (untreated MTT solution) therefore additional controls were included to enable assessment of the potential impact of the non-specific reduction of MTT by residual test article following the wash-off procedure.To evaluate whether residual test article was binding to the tissue, a functional check (using freeze-killed control tissue) was performed. Freeze-killed tissues were prepared by placing untreated EpiDerm constructs in the -20°C freezer overnight. The freeze-killed tissues were allowed to thaw once at room temperature and placed back in the freezer overnight.On the day of receipt EpiDermTM tissues were placed in a refrigerator. Ninety minutes before starting the assay, the tissues were transferred to 6-well plates containing the assay medium. The test was performed on a total of four tissues per test article, negative and positive control, out of which two were used for a 3 minute application and two tissues were used for a 1 hour application. Sufficient test article was applied to cover the apical surface. The cryovials containing the test article were weighed both prior to and post treatment and an average of approximately 50 mg of test article was applied to each tissue (an average of 34 mg was applied to the freeze-killed tissues).Further tissues were concurrently treated with 40 μL distilled water (negative control) and with 40 μL 8N potassium hydroxide (positive control). After the 3-minute or 1-hour contact periods, the tissues were washed with phosphate buffered saline (PBS) to remove residual material. The rinsed tissues were kept in 24-well plates (holding plates) until all tissues were dosed and rinsed.Once all tissues had been rinsed, they were transferred to wells containing 300 μL of 1 mg/mL MTT-medium and were incubated for 3 hours (37°C, 5% CO2). After incubation, the tissues were washed with PBS and any resultant colour was extracted with 2 mL isopropanol overnight. The optical density of each resultant extract was determined spectrophotometrically at 570 nm and cell viability was calculated for each tissue as a percentage of the mean of the negative control tissue. Skin corrosivity potential of the test article was classified according to the remaining cell viability obtained after test article treatment with either of the two treatment times. Also, to evaluate whether residual test article was binding to the tissue, a functional check (using freeze-killed control tissue) was performed. Freeze-killed tissues were prepared by placing untreated EpiDerm constructs in the -20°C freezer overnight. The killed tissues were allowed to thaw once at room temperature and were placed back at -20°C overnight. Once killed, the tissues were stored in the freezer until required.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Skin viability
- Basis:
- mean
- Time point:
- other: 3 minute exposure
- Remarks on result:
- other: 57% skin viability
- Irritation parameter:
- other: Skin viability
- Basis:
- mean
- Time point:
- other: 1 hour exposure
- Remarks on result:
- other: 56% skin viability
- Irritant / corrosive response data:
- Skin viability after a three minute exposure was 57%.Skin viability after a one hour exposure was 56%.Skin viability in the positive control after a three minute exposure was 23%.Skin viability in the positive control after a one hour exposure was 16%.
- Other effects:
- No other effects reported.
Any other information on results incl. tables
Three minute exposure period
Test substance | OD570 | Mean | Tissue Mean | Adjusted mean value | % variability | % survival | ||
Negative | 1.862 | 1.902 | 1.921 | 1.895 | 1.771 | N/A/ | -15.1 | 100 |
Negative | 1.603 | 1.622 | 1.714 | 1.646 | ||||
Test article | 1.437 | 1.457 | 1.430 | 1.441 | 1.398 | 1.006 | -6.4 | 57 |
Test article | 1.343 | 1.340 | 1.381 | 1.355 | ||||
Test article# | 0.453 | 0.477 | 0.490 | 0.474 | 0.392 |
| 34.4 | |
Test article# | 0.313 | 0.307 | 0.312 | 0.311 | ||||
Positive | 0.406 | 0.436 | 0.439 | 0.427 | 0.413 | N/A/ | 6.4 | 23 |
Positive | 0.394 | 0.399 | 0.406 | 0.399 |
# Freeze-killed tissues
One hour exposure period
Test substance | OD570 | Mean | Tissue Mean | Adjusted mean value | % variability | % survival | ||
Negative | 1.584 | 1.587 | 1.676 | 1.616 | 1.640 | M/A | 2.9 | 100 |
Negative | 1.688 | 1.650 | 1.654 | 1.664 | ||||
Test article | 1.311 | 1.306 | 1.274 | 1.297 | 0.328 | 0.926 | 4.5 | 56 |
Test article | 1.368 | 1.348 | 0.359 | 1.359 | ||||
Test article# | 0.370 | 0.393 | 0.400 | 0.388 | 0.402 |
| -7.1 | |
Test article# | 0.410 | 0.421 | 0.415 | 0.415 | ||||
Positive | 0.251 | 0.270 | 0.261 | 0.261 | 0.268 | N/A/ | -5.7 | 16 |
Positive | 0.281 | 0.273 | 0.272 | 0.275 |
# Freeze-killed tissues
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test article, MonoFA_DimerFA_TETA_TEPA_PAA, was not corrosive to skin in the in vitro skin model EpiDerm.
- Executive summary:
The potential of MonoFA_DimerFA_TETA_TEPA_PAA to cause skin corrosion was evaluated using the in vitro skin model, EpiDermTM, in accordance with GLP and OECD Test Guideline 431 and EU Method B.40.
Duplicate EpiDermTM inserts were treated with the test article, 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 assessed 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 57% and 56%, respectively. Skin viability after a three minute or one hour exposure to the positive control article was 23% and 16%, respectively, demonstrating appropriate performance of the assay.
Based on these results and under the conditions of this test, the test article, MonoFA_DimerFA_TETA_TEPA_PAA, was not corrosive to skin in the in vitro skin model EpiDermTM.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.