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EC number: 607-240-0 | CAS number: 23511-73-1
- 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:
- 27 - 28 Nov 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- adopted 2004
- Deviations:
- yes
- Remarks:
- interference with MTT not determined
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted 2016
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.40 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- adopted May 2008
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-phenoxyethyl octanoate
- EC Number:
- 607-240-0
- Cas Number:
- 23511-73-1
- Molecular formula:
- C16H24O3
- IUPAC Name:
- 2-phenoxyethyl octanoate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Source strain:
- other: EpiDerm™; reconstructed three-dimensional human epidermis (EPI-200)
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- HUMAN SKIN MODEL TEST
- Model used: EpiDerm™ (Epi-200)
- Tissue batch number(s): 11208 kit H
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37.0 ± 1.0 °C (actual range 35.9 - 37.2 °C)
REMOVAL OF TEST MATERIAL AND CONTROLS
-Number of washing steps: 1
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 1 h
- Spectrophotometer: Multiskan Spectrum (Thermo Labsystems)
- Wavelength: 540 nm
REDUCTION OF MTT BY THE TEST SUBSTANCE
To assess the ability of the test substance to reduce MTT, approximately 100 µL of the test substance was added to a 24-well plate filled with 1 mL MTT medium. The mixture was incubated for approximately 1 h at room temperature in the dark. A negative control (sterile Milli-Q water) was tested concurrently.
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability:
Negative control: 3 min treatment (range: 1.153 - 2.003; mean: 1.61; SD: 0.22; n = 36); 1 h treatment (range: 1.298 - 2.007; mean: 1.60; SD: 0.19; n = 36)
Positive control: 3 min treatment (range: 0.075 - 0.156; mean: 0.11; SD: 0.02; n = 36); 1 h treatment (range: 0.059 - 0.178; mean: 0.09; SD: 0.02; n = 36)
NUMBER OF REPLICATE TISSUES: duplicates per incubation time and for controls
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 min exposure is less than 50%, or if the viability after 3 min exposure is greater than or equal to 50% and the viability after 1 h exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 min exposure is greater than or equal to 50% and the viability after 1 h exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µL
NEGATIVE CONTROL
- Amount(s) applied: 50 µL
POSITIVE CONTROL
- Amount(s) applied: 50 µL
- Concentration: 8N - Duration of treatment / exposure:
- 3 min and 1 h
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min application with the test substance
- Value:
- 93
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 h application with the test substance
- Value:
- 113
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The relative mean tissue viability obtained after the 3-min and 1-h treatments with the test substance was 93% and 113%, respectively, compared with the negative control tissues.
Any other information on results incl. tables
In Table 1 the raw data are presented. Table 2 shows the mean tissue viability obtained after 3-min and 1-h treatments compared to the negative control tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance.
Table 1: Mean absorption at 540 nm
|
A |
B |
Mean |
±SD |
A |
B |
Mean |
± SD |
Negative control (water) |
1.613 |
1.815 |
1.714 |
0.143 |
1.558 |
1.443 |
1.501 |
0.082 |
Positive control (8 N KOH) |
0.082 |
0.091 |
0.086 |
0.007 |
0.064 |
0.075 |
0.070 |
0.008 |
Test substance |
1.619 |
1.556 |
1.587 |
0.045 |
1.758 |
1.697 |
1.697 |
0.087 |
Values are corrected for background absorption.
SD: standard deviation
A and B: duplicate cultures
Table 2: Mean tissue viability
|
Viability [% of control] |
|
|
3 min |
1 h |
Negative control (water) |
100 |
100 |
Positive control (8 N KOH) |
5 |
5 |
Test substance |
93 |
113 |
The absolute mean OD540 (optical density at 540 nm) of the negative control tissues was within the laboratory historical control data range. The mean relative tissue viability following 3-min exposure to the positive control was 5%. The maximum inter-tissue variability in viability between two tissues treated identically was less than 15% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 8%. It was therefore concluded that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- Under the conditions of the RHE test method the test substance did not show corrosive properties.
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