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Diss Factsheets
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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
- 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: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 February 2018 to 03 June 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, C18-unsatd., dimers
- Cas Number:
- 61788-89-4
- Molecular formula:
- C36H64O4 (representative)
- IUPAC Name:
- Fatty acids, C18-unsatd., dimers
- Reference substance name:
- Fatty acids, tall-oil
- Cas Number:
- 61790-12-3
- Molecular formula:
- C18H32O2 (representative)
- IUPAC Name:
- Fatty acids, tall-oil
- Reference substance name:
- 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-nortall-oil alkyl derivs.
- Cas Number:
- 61791-39-7
- Molecular formula:
- C22H40N2O (representative)
- IUPAC Name:
- 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-nortall-oil alkyl derivs.
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
- Specific details on test material used for the study:
- -Purity: >95% (nominal); UVCB
-Description: Amber Liquid
- Storage: room temperature, in the dark
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: reconstructed human epidermis tissues
- Cell source:
- other: Not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Triplicate tissues were treated with the test material for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for 42 hours. The test material was found to have the potential to directly reduce MTT and therefore, as a precaution, additional non-viable tissues were incorporated into the testing for correction purposes. The test material was found to cause color interference with the MTT endpoint therefore, additional tissues were incorporated into the testing to correct for this. A third set of controls was included, comprising non-viable tissues, to prevent a double correction from a colored test item that also reduces MTT. At the end of the post exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre labeled micro tubes and stored in a freezer for possible inflammatory mediator IL-1α determination. After MTT-loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT loaded tissues.
At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µL samples were transferred to the appropriate wells of a pre labeled 96 well plate. The optical density was measured at 570 nm (OD570). - Control samples:
- other: Negative Control: Dulbecco’s Phosphate Buffered Saline (DPBS) with Ca++ and Mg++ and Positive Control: Sodium Dodecyl Sulphate (SDS)
- Amount/concentration applied:
- 10 µL (26.3 µL/cm2) of the test item was applied to the epidermis surface.
- Duration of treatment / exposure:
- Triplicate tissues were treated with the test item for an exposure period of 15 minutes
- Duration of post-treatment incubation (if applicable):
- At the end of the exposure period each tissue was rinsed before incubating for 42 hours.
- Number of replicates:
- Three
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- using the EPISKINTM reconstructed human epidermis model after a treatment period of 15 minutes followed by a post exposure incubation period of 42 hours
- Value:
- 133.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Test for Direct MTT Reduction
The MTT solution containing the test item turned purple which indicated that the test material directly reduced MTT. Therefore, an additional procedure using water-killed tissues was performed. However, the results obtained showed that no effects on OD570values that indicated the test material was totally rinsed off with no residual test material remained on or in the tissues. It was therefore considered unnecessary to use the results of the water-killed tissues for quantitative correction of results.
Test Item, Positive Control Item and Negative Control Item
The relative mean viability of the test material treated tissues was 133.9% (>50%) after a 15‑minute exposure period and 42‑hour post‑exposure incubation period.
Assessment of Color Interference with the MTT endpoint
The test item was found to produce a colored solution which might interfere with the MTT endpoint. Therefore, color correction tissues were incorporated into the test to correct for this possibility. These tissues were treated identically to the tissues of the main test with the exception of being placed into assay medium for 3 hours post exposure instead of MTT. Three tissues were dosed with the test material and three remained untreated to act as negative controls.
Quality Criteria
The relative mean viability for tissues treated with 5% (w/v) SDS aqueous solution (positive control) was 2.7% relative to the negative control treated tissues and the standard deviation value of the viability was 0.6% (≤18%). The positive control acceptance criteria were therefore satisfied.
The mean OD570for the negative control (DPBS) treated tissues was 0.736, within the range of 0.6 - 1.5 and the standard deviation value of the viability was 1.2% (≤18%). The negative control acceptance criteria were therefore satisfied.
The standard deviation calculated from individual tissue viabilities of the three identically test item treated tissues was 7.1% (≤18%). The test item acceptance criterion was therefore satisfied.
However, the interference of the remained test item on the viable tissues with the MTT endpoint could not be corrected because the amber colored test material adhered to remained on the viable tissue surfaces, but not on the non-viable tissue surfaces after rinsing and the precise tissue viability could not be obtained.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Although the precise tissue viability could not be obtained, the relative mean viability of the test material treated tissues was 133.9%, well above 50% that would require classification for skin irritation.
- Executive summary:
The test material, Fatty acids, C18-unsatd., dimers, compds, with 4,5-dihydro-2-nortall-oil alkyl-1H-imidazole-1-ethanol and tall-oil fatty acids, was amber color that interfered with the MTT endpoint of this assay. Additionally the test item adhered to and remained on the culture surfaces of the viable tissues, but not on the non-viable tissues after rinsing. Therefore, the interference of the remained amber color test material on the viable tissues with the MTT endpoint could not be corrected with non-viable tissues. Although the precise tissue viability could not be obtained, the relative mean viability of the test material treated tissues was 133.9%, well above 50% that would require classification for skin irritation. In addition, the score of the test material in the BCOP assay was 0.2, well below the score of 3 that would require classification for eye irritation. The undiluted test material had no signs of local skin irritation to mouse ears in the LLNA in mice. The acute oral toxicity study of the test material showed no clinical signs of toxicity, no gross lesions at necropsy, and acceptable weight gain by all animals dosed by gavage at 2000 mg/kg. Therefore, the existing data provide sufficient weight of evidence to justify not classifying the test item for dermal irritation in accordance to Regulation (EC) No. 1272/2008 Classification, Labelling and Packaging of Substances and Mixtures (EU CLP) and United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS).
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