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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 irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 - 08 Mar 2019
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted 29 Jul 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- adopted 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Medicines and Healthcare Products Regulatory Agency, Department of Health, London, United Kingdom
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 the dark
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDermTM reconstituted three-dimensional human epidermis (EPI-200)
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDermTM tissues (MatTek Corporation)
- Tissue batch number: 28646
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C for 3 min and 37 °C for 60 min in the incubator
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Washing was achieved by filling and emptying each tissue under a constant soft stream of Dulbecco’s Phosphate Buffered Saline (DPBS) (without Ca2+ Mg2+) for approximately 40 seconds, to gently remove any residual test item. Excess DPBS was removed by blotting the bottom of the tissue insert with tissue paper. Each tissue was placed into the prepared holding plate until all tissues were rinsed.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h at 31 °C
- Spectrophotometer: Labtech LT-4500 microplate reader
- Wavelength: 570 nm
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
The test item was able to directly reduce MTT. Therefore, an additional test using freeze-killed tissues was performed. The results obtained showed negligible interference due to direct reduction of MTT. It was therefore considered unnecessary to quantitatively correct the results.
PREDICTION MODEL / DECISION CRITERIA
- 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
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 50 µL
NEGATIVE CONTROL
- Amount applied: 50 µL
POSITIVE CONTROL
- Amount applied: 50 µL
- Concentration: 8.0 N in deionised water - Duration of treatment / exposure:
- 3 and 60 min
- Number of replicates:
- duplicates for each treatment and control group (3 and 60 min
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 2 tissues
- Run / experiment:
- 3 min exposure
- Value:
- 34.7
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 2 tissues
- Run / experiment:
- 60 min exposure
- Value:
- 9.4
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Direct-MTT reduction: The test substance was directly reducing MTT. Therefore, an additional test with freeze-killed tissues was performed. The interference was considered negligible, thus a correction of results has not been performed.
- Colour interference with MTT: The test substance was not colour interfering with water. Thus, an additional test with viable tissues was not performed.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD 570 nm of the tissue replicates treated with the negative control is 2.079 for the 3 min exposure and 2.044 for the 60 min exposure and matches the required acceptability criterion.
- Acceptance criteria met for positive control: Mean relative tissue viability is ≤ 20%. Treatment with the positive control for 60 min resulted in a relative mean tissue viability of 2.9% and matches the required acceptability criterion.
- Acceptance criteria met for variability between replicate measurements: In the range 20 to 100% viability the coefficient of variation between the two tissue replicates did not exceed 30% and matches the acceptability criterion.
Any other information on results incl. tables
Table 1: Relative mean viabilities for all treatment groups:
Exposure Period |
Percentage Viability |
||
Negative Control |
Positive Control |
Test Item |
|
3 minute |
100* |
3.0 |
34.7 |
60 minute |
100* |
2.9 |
9.4 |
* The mean viability of the negative control tissues was set to 100%
Table 2: Mean OD570 and viabilities for the negative control, positive control and the test item
Tissue |
Exposure Period |
MeanOD570of individual tissues |
Mean OD570of duplicate tissues |
Standard Deviation |
Coefficient of Variation |
Relative Mean Viability (%) |
Negative Control |
3 Minutes |
2.043 |
2.079 |
0.051 |
5.4 |
100* |
2.115 |
||||||
60 Minutes |
2.042 |
2.044 |
0.002 |
0.1 |
||
2.045 |
||||||
Positive Control |
3 Minutes |
0.061 |
0.063 |
0.003 |
na |
3.0 |
0.065 |
||||||
60 Minutes |
0.059 |
0.060 |
0.001 |
na |
2.9 |
|
0.061 |
||||||
Test Item |
3 Minutes |
0.697 |
0.722 |
0.035 |
4.9 |
34.7 |
0.747 |
||||||
60 Minutes |
0.210 |
0.192 |
0.026 |
13.7 |
9.4 |
|
0.173 |
OD = Optical density
* = The mean percentage viability of the negative control tissue is set at 100%
na = Not applicable
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin corr. 1, H314. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).
- Conclusions:
- CLP: Skin corrosive category 1 (H314). Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).
- Executive summary:
Under the conditions of the test, the test item was shown to have a corrosive potential towards reconstructed human epidermis tissue in the EpiDermTM prediction model. Based on this result, the substance is considered to meet the criteria for classification as Skin corrosive 1, H314, according to the CLP Regulation (EC) No. 1272/2008.
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