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EC number: 500-058-1 | CAS number: 27252-75-1 1 - 2.5 moles ethoxylated
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 03 - 20 Dec 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 442E (in vitro Skin Sensitisation: human Cell Line Activation Test)
- Version / remarks:
- adopted 20 Jul 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Medicines and Healthcare Products Regulatory Agency, Department of Health, London, United Kingdom
- Type of study:
- activation of dendritic cells
Test material
- Reference substance name:
- Octan-1-ol, ethoxylated
- EC Number:
- 500-058-1
- EC Name:
- Octan-1-ol, ethoxylated
- Cas Number:
- 27252-75-1
- Molecular formula:
- C10H22O2
- IUPAC Name:
- Octan-1-ol, ethoxylated
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
In vitro test system
- Details on the study design:
- TEST METHOD:
The in vitro human Cell Line Activation Test (h-CLAT) is an alternative testing method for the evaluation of the skin sensitization potential of a test compound. It quantifies phenotypic changes, such as cell surface marker expression in cell lines following 24 h treatment with chemicals. The human leukemia cell line THP-1 is used as surrogate for human myeloic dendritic cells, which show enhanced CD86 and CD54 surface protein expression when treated with sensitiziers.
The dose for the h-CLAT assay was determined in two preliminary cytotoxicity test, yielding 75% cell viability (CV75). For the main assay, THP-1 cells were incubated for 24 ± 1 hours at 37 °C with the test compound, as well as the negative and positive controls. Changes of CD86 and CD54 expression were analyzed by flow cytometry, using fluorescently labelled antibodies against the two surface proteins. Relative fluorescence intensities compared to solvent controls are calculated and used in a prediction model to discriminate between sensitizing and non-sensitizing compounds.
TESTS SUBSTANCE PREPARATION:
The test item was dissolved in culture medium.
CONCENTRATIONS:
Pre-experimental dose-finding study: 5000, 2500, 1250, 625, 312.5, 156.25, 78.13, 39.06 µg/mL
Main experiment (h-CLAT): based on the results obtained in the pre-experimental dose-finding study: 595.25, 496.04, 413.37, 344.47, 287.06, 239.22, 199.35, 166.12 µg/mL.
VEHICLE CONTROL: Complete Roswell Park Memorial Institute (RPMI) culture medium containing 10% Human Serum and 0.05 mM 2-mercaptoethanol
POSITIVE CONTROL CV75: 2,4-Dinitrochlorobenzene (DNCB) prepared as 8 µg/mL in DMSO
POSITIVE CONTROL CD54 and CD86 expression: Nickel Sulphate prepared as 100 µg/mL in RPMI medium
TEST CELL LINE: THP-1 cells
- Source: ATCC, #TIB-202
CELL CULTURE CONDITIONS:
- Type and identity of media: RPMI supplemented with 10% Human Serum and 0.05 mM 2-mercaptoethanol
EXPOSURE CONDITIONS:
- Method of application: in medium
- Exposure duration: 24 ± 0.5 h
NUMBER OF REPLICATES: Each concentration was tested in two independent runs
DETERMINATION OF CYTOTOXICITY:
- Method: Propidium iodide, 24 ± 0.5 h exposure with test item, two independent experiments
- Determination of cell viability (= relative aborbance) for calculation of the CV75, which corresponds to the concentration needed to reduce the relative absorbance to 75% of the solvent control.
DETERMINATION OF FLUORESCENCE:
- Flow cytometry
- Antibodies: fluorochrome-tagged CD86 and CD54
Results and discussion
- Positive control results:
- Relative fluorescence intensities first experiment:
100 µg/mL: CD54 = 212% (93.69% viability), CD86 = 152% (93.04% viability)
Relative fluorescence intensities, second experiment:
100 µg/mL: CD54 = 377% (88.95% viability), CD86 = 210% (86.58% viability)
In vitro / in chemico
Resultsopen allclose all
- Run / experiment:
- other: 24 h incubation
- Parameter:
- other: RFI in % for CD54 in µg/mL
- Value:
- 150
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: in 2/2 independent experiment data
- Run / experiment:
- other: 24 h incubation
- Parameter:
- other: RFI in % for CD86 in µg/mL
- Value:
- 200
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: in 2/2 independent experiment data
- Other effects / acceptance of results:
- - Acceptance criteria met for CV75 determination: Yes, cell viability is ≥ 75% at the lowest dose and the highest test item concentration produces cytotoxicity (< 90% cell viability)
- Acceptance criteria met for negative control: yes, medium and solvent control RFI values do not exceed the positive criteria CD86 ≥ 150% and CD54 ≥ 200% and cell viability is > 90%
- Acceptance criteria met for positive control: yes, RFI values CD86 ≥ 150% and CD54 ≥ 200% and cell viability is > 50%
Any other information on results incl. tables
Table 1: Results of the h-CLAT test, first experiment:
Test Item Dose [µg/mL) |
Cell Viability (%) | Average cell viability |
CD54 RFI | CD86 RFI | ||
Isotype | CD54 | CD86 | ||||
595.25 | 55.95 | 60..92 | 58.46 | 58.44 | -335 | -871 |
496.04 | 51.28 | 53.04 | 53.36 | 52.56 | -239 | -625 |
413.37 | 57.3 | 52.62 | 53.8 | 54.57 | -145 | -425 |
344.47 | 60.74 | 55.92 | 56.7 | 57.79 | 135 | 120 |
287.06 | 71.13 | 65.12 | 65.53 | 67.26 | 124 | 126 |
239.22 | 78.66 | 75.32 | 75.64 | 76.54 | 114 | 105 |
199.35 | 86.92 | 83.85 | 82.52 | 84.43 | 87 | 87 |
166.12 | 85.81 | 85.22 | 85.14 | 85.39 | 82 | 65 |
Table 2: Results of the h-CLAT test, second experiment:
Test Item Dose [µg/mL) |
Cell Viability (%) | Average cell viability |
CD54 RFI | CD86 RFI | ||
Isotype | CD54 | CD86 | ||||
595.25 | 66.59 | 62.05 | 61.5 | 63.38 | 131 | 141 |
496.04 | 25.18 | 24.39 | 25.36 | 24.98 | 180 | 3 |
413.37 | 23.39 | 24.96 | 25.42 | 24.59 | 81 | -236 |
344.47 | 81.07 | 84.13 | 85.74 | 83.64 | 2073* | 2085* |
287.06 | 42.93 | 45.66 | 38.86 | 42.48 | 191 | 173 |
239.22 | 64.97 | 63.79 | 61.91 | 63.56 | 140 | 81 |
199.35 | 81.3 | 80.15 | 79.64 | 80.36 | 116 | 89 |
166.12 | 89.72 | 88.53 | 87.3 | 88.51 | 67 | 90 |
* artefact, large amount of cell debris (and not live cells) that were picked up by the flow cytometer | ||||||
Applicant's summary and conclusion
- Interpretation of results:
- other: negative in the hCLAT
- Conclusions:
- The data generated with this method may not be sufficient to conclude on the absence of skin sensitisation potential of chemicals and should be considered in the context of an integrated approach such as integrated approaches to testing and assessment (IATA).
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