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EC number: 241-644-4 | CAS number: 17671-26-0
- 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:
- 17 July - 30 Jan 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- 9 October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Test material
- Reference substance name:
- Dodecyl nonan-1-oate
- EC Number:
- 241-644-4
- EC Name:
- Dodecyl nonan-1-oate
- Cas Number:
- 17671-26-0
- Molecular formula:
- C21H42O2
- IUPAC Name:
- dodecyl nonanoate
Constituent 1
Test animals / tissue source
- Species:
- human
- Strain:
- other: EpiOcularTM (OCL-200-EIT)
- Details on test animals or tissues and environmental conditions:
- - Justification of the test method and considerations regarding applicability
The EpiOcularTM Eye Irritation Test (EIT) predicts the acute ocular irritation potential of chemicals by measurement of its irreversible tissue damage caused by cytotoxic effects in the human cornea model. The EpiOcular ™ Eye Irritation Test (EIT) was validated by the European Union Reference laboratory for Alternatives to Animal Testing (EURL ECVAM) and cosmetics Europe between 2008 and 2013. It is utilized for the classification and labelling of chemicals concerning their eye irritation potential. The EpiOcularTM EIT is intended to differentiate substances that require “no classification" as eye irritant from those that require labelling as either GHS category 1 or 2 for serious eye damage respective eye irritation potential.
- Description of the cell system used, incl. certificate of authenticity and the mycoplasma status of the cell live
The EpiOcularTM tissue consists of normal, human-derived keratinocytes which have been cultured to form a stratified squamous epithelium similar to that found in the human cornea. It consists of highly organized basal cells, which progressively flatten out as the apical surface of the tissue is approached, analogous to the normal in vivo corneal epithelium. The EpiOcularTM tissues (surface 0.6 cm²) were cultured on specially prepared cell culture inserts (MILLICELL®, 10 mm Ø). 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: undiluted - Duration of treatment / exposure:
- 30 min
- Duration of post- treatment incubation (in vitro):
- 120 min
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- - Details of the test procedure used
:
EpiOcularTM tissue model was used. After the assessment and exclusion of direct MTT reduction and colouring potential of the test substance, the well plates were prepared and the tissues were pre-incubated in warm medium under standard culture conditions (37 ± 1.5 °C, 5 ± 0.5 % CO2 and 95 % relative humidity). After overnight incubation, the tissues were pre-wetted with 20 μL DPBS buffer (Ca2+ Mg2+ free) and then incubated at standard culture conditions for 30 min. 50 μL of the controls and the neat test substance were then applied and incubated for 30 min at standard culture conditions. After exposure the tissue constructs were thoroughly rinsed and transferred to fresh medium for an immersion incubation at room temperature. Afterwards, the tissues were transferred to fresh medium and incubated for 120 min 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: 27002
- Doses of test chemical and control substances used :
50 μL of undiluted test substance, 50 μL of demineralised water (negative control), 50 μL of methyl acetate (positive control)
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods:
30 min at 37.0 ± 1.5 °C, 12 min immersion incubation at room temperature, 120 min at 37 ± 1.5 °C post-exposure incubation
- Number of tissue replicates used per test chemical and controls (positive and negative control) : 2
- Wavelength used for quantifying MTT formazan : 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 a plate reader (Versamax® Molecular Devices, Ismaning, Germany). Then the mean OD of the blank isopropanol (OD Blk) was calculated, followed by the subtraction of mean OD Blk of each value of the same experiment (corrected values).
The mean OD of the two replicates for each tissue the mean OD of the two relating tissues for controls and test substance were then calculated.
To calculate the relative absorbance, the following equation was used: viability (%) = (OD corrected of test substance or positive control/ OD corrected of mean negative control)*100
- 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 valid if it meets the following criteria:
a) mean OD570 of the negative control: > 0.8 and < 2.5
b) mean relative tissue viability of the positive control: < 50% relative to the negative control.
c) variation within replicates: <20%
If the test item-treated tissue viability is > 60% relative to the negative control treated tissue viability, the test item is labeled non-irritant (no Category according to UN GHS).
If the test item-treated tissue viability is ≤ 60% relative to negative control treated tissue viability, the test item is labeled irritant (Category 2 or Category 1 according to UN GHS; no differentiation between the categories possible).
- Reference to historical positive and negative control results demonstrating suitable run acceptance criteria : negative contrtol range: 1.27 - 2.16; positive control range: 6.9 - 43.4%
- Complete supporting information for the specific RhCE tissue construct used :
Tissue viability: 1.269 ± 0.039 (accepted range: 1.1 - 3.0)
Barrier function: ET-50: 24.36 min (accepted range: 12.2 - 37.5)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: mean viability (%)
- Run / experiment:
- mean value of test substance
- Value:
- 95
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: mean viability (%)
- Run / experiment:
- mean value of positive control
- Value:
- 36.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
yes, but not in this report
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, mean OD = 1.691 (> 0.8 and < 2.5)
- Acceptance criteria met for positive control: yes, % viability = 36.5% (< 50%)
- Range of historical values if different from the ones specified in the test guideline: 0.6 - 2.1% (< 20%)
Any other information on results incl. tables
Table 1: Results of MTT assay
|
Tissue No. |
OD570 |
Mean (OD570) |
Mean (OD570) - blank |
Mean tissue viability (% of negative control) |
|
Negative control |
1 |
1.674 |
1.714 |
1.676 |
99.1 |
100 |
1.753 |
||||||
2 |
1.735 |
1.744 |
1.706 |
100.9 |
||
1.753 |
||||||
Positive control |
1 |
0.626 |
0.660 |
0.622 |
36.8 |
36.5 |
0.693 |
||||||
2 |
0.647 |
0.649 |
0.611 |
36.2 |
||
0.652 |
||||||
Test substance |
1 |
1.614 |
1.626 |
1.588 |
93.9 |
95.0 |
1.638 |
||||||
2 |
1.676 |
1.662 |
1.624 |
96.1 |
||
1.649 |
OD = optical density
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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