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EC number: 298-078-6 | CAS number: 93777-46-9
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 - 12 Aug 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- / No demonstration of technical proficiency
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 28 July 2015
- Deviations:
- yes
- Remarks:
- / No demonstration of technical proficiency
- GLP compliance:
- yes
Test material
- Reference substance name:
- Decyl 2-ethylhexanoate
- EC Number:
- 298-078-6
- EC Name:
- Decyl 2-ethylhexanoate
- Cas Number:
- 93777-46-9
- Molecular formula:
- C18H36O2
- IUPAC Name:
- decyl 2-ethylhexanoate
- 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: at room temperature
Test animals / tissue source
- Species:
- human
- Strain:
- other: Keratinocyte strain: 4F1188
- Details on test animals or tissues and environmental conditions:
- - Justification of the test method and considerations regarding applicability
In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimise the need of in vivo testing. One of the validated in vitro eye irritation tests is the EpiOcular test, which is recommended in international guidelines and scientific publications (e.g. OECD).
- Description of the cell system used, incl. certificate of authenticity and the mycoplasma status of the cell live
The EpiOcular tissue construct is a non-keratinized epithelium (0.6 cm2) prepared from normal human keratinocytes (MatTek Corporation, Ashland MA, U.S.A.). It models the cornea epithelium with progressively stratified, but not cornified cells. These cells are not transformed or transfected with genes to induce an extended life span in culture.
Analysis for tissue functionality and for potential contaminants was passed.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µL
- Concentration (if solution): neat/ undiluted - Duration of treatment / exposure:
- 30 ± 2 minutes
- Duration of post- treatment incubation (in vitro):
- 2 h
- Number of animals or in vitro replicates:
- 2 replicates
- Details on study design:
- - Details of the test procedure used
EpiOcularTM cornea epithelial model was used. The test item was applied undiluted (50 μL) directly on top of the tissue for 30 ± 2 minutes at 37.0 ± 1.0 °C. After exposure the cornea epithelial construct was thoroughly rinsed to remove the test item and transferred to fresh medium for an immersion incubation. Afterwards, the tissues were transferred to fresh medium and incubated for 2 hours at standard culture conditions, prior to determination of the cytotoxic (irritancy) effect. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) at the end of the treatment.
- RhCE tissue construct used, including batch number
Keratinocyte strain: 4F1188, Lot Number: 23438
- Doses of test chemical and control substances used
50 µL of undiluted test chemical, 50 µL of MilliQ water, 50 µL of Methyl Acetate
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods (where applicable)
30 ± 2 minutes at 37.0 ± 1.0 °C, 12 ± 2 minutes immersion incubation at room temperature, 120 ± 15 minutes at 37 °C post-exposure incubation
- Number of tissue replicates used per test chemical and controls (positive control, negative control)
2
- Wavelength and band pass (if applicable) used for quantifying MTT formazan, and linearity range of measuring device (e.g. spectrophotometer)
570 nm
- Description of the method used to quantify MTT formazan
The amount of extracted formazan was determined spectrophotometrically at 570 nm in duplicate with the TECAN Infinite® M200 Pro Plate Reader.
- Description of the qualification of the HPLC/UPLC-spectrophotometry system (if applicable)
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model
The in vitro eye irritation test is considered acceptable if it meets the following criteria:
a) The absolute mean OD570 of the two tissues of the negative control should reasonably be > 0.8 and < 2.5.
b) The mean relative tissue viability of the positive control should be <50% relative to the negative control.
c) The SD calculated from individual % tissue viabilities of the two identically treated replicates should be <20.
A test item is considered to be positive in the in vitro eye irritation test if:
The relative mean tissue viability of two individual tissues after exposure to the test item is ≤ 60% of the mean viability of the negative controls, requiring classification for eye irritation or serious eye damage.
- Acceptable variability between tissue replicates for positive and negative controls
The SD calculated from individual % tissue viabilities of the two identically treated replicates should be <20
- Acceptable variability between tissue replicates for the test chemical
The SD calculated from individual % tissue viabilities of the two identically treated replicates should be <20
Results and discussion
In vitro
Results
- Irritation parameter:
- other: mean viability (%)
- Run / experiment:
- mean value of test item
- Value:
- 88
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: no information provided
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
Any other information on results incl. tables
Table 1: MTT assay (30 ± 2 min exposure)
Tissue No. |
OD570* |
Mean (OD570) |
Standard Deviation |
Mean tissue viability (% of negative control) |
Standard Deviation |
|
Negative |
1 |
1.713 |
1.778 |
0.091 |
100 |
5.1 |
2 |
1.842 |
|||||
Positive Control |
1 |
0.589 |
0.589 |
0.001 |
33 |
0.6 |
2 |
0.588 |
|||||
Test |
1 |
1.580 |
1.572 |
0.010 |
88 |
0.03 |
2 |
1.565 |
OD = optical density
SD = Standard deviation
* The values represent the mean values of two OD570 measurements per well and are corrected for background absorption (0.041).
Isopropanol was used to measure the background absorption.
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:
- CLP: not classified
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