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EC number: 292-124-9 | CAS number: 90552-04-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-Propenoic acid, 2-methyl-, C13-15-branched and linear alkyl esters
- EC Number:
- 292-124-9
- EC Name:
- 2-Propenoic acid, 2-methyl-, C13-15-branched and linear alkyl esters
- Cas Number:
- 90552-04-8
- Molecular formula:
- C(17-19)H(32-36)O2
- IUPAC Name:
- 2-Propenoic acid, 2-methyl-, C13-15-branched and linear alkyl esters
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 0023067499
Test animals / tissue source
- Species:
- human
- Strain:
- other: non-keratinized tissue construct composed of normal human-derived epidermal keratinocytes
- Details on test animals or tissues and environmental conditions:
- SOURCE OF RECONSTRUCTED CELLS
- Source: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
- Model used: EpiOcular model (OCL-200)
- Tissue batch number: 34906
- Certificate of analysis/authenticity: provided by the supplier
- Verification of tissue functionality and quality (performed by the supplier):
- Tissue viability: acceptance criteria met
- Barrier function: acceptance criteria met
- Sterility: no contamination
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
- Concentration (if solution): undiluted test substance
- Duration of treatment / exposure:
- - pre-treatment with 20 μL PBS and incubated at standard culture conditions for 30 min
- 30 min of test substance treatment - Duration of post- treatment incubation (in vitro):
- incubation for 12 min + 120 min at room temperature in culture medium
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- Two tissues were treated with each the test substance, the PC and the NC.
Pre-incubation of the tissues
On the day of arrival in the laboratory, the tissues were transferred to sterile 6-well plates with 1 mL assay medium and preconditioned in the incubator at 37°C. After 1 hour, the pre-incubation medium was replaced with fresh medium, and preconditioning continued in the incubator at standard culture conditions for 16 – 24 hours.
Pretreatment of the tissues
After pre-incubation, the tissues were pretreated with 20 μL PBS in order to wet the tissue surface. The tissues were incubated at standard culture conditions for 30 minutes
Application of the test substance
Ffifty microliters (50 μL) undiluted liquid test substance were applied covering the whole tissue surface. Control tissues were applied concurrently with 50 μL sterile deionized water (NC) or with 50 μL
methyl acetate (PC). After application, the tissues were placed into the incubator until the total exposure time of 30 minutes was completed.
Removal of the test substance and postincubation period
In order to remove the test substance, the tissues were washed with sterile PBS. For this purpose, the tissues were immersed and swiveled three times in each of three beakers filled with PBS. Washed tissues were immersed immediately into 12-well plates pre-filled with 5 mL/well pre-warmed medium (post-soak immersion) to remove residual test substance. After 12 minutes of post-soak immersion, each tissue was dried on absorbent paper and transferred to fresh 6-well plates filled with 1 mL/well pre-warmed medium. Subsequently, the tissues were incubated at standard culture conditions for 2 hours (postincubation period).
MTT incubation
After the post-incubation period, the assay medium was replaced with 0.3 mL MTT solution, and the tissues were incubated in the incubator for 3 hours. After incubation, the tissues were washed with PBS to stop the MTT incubation. The optical density at a wavelength of 570 nm (OD570) of the extracts was spectrophotometrically determined.
EVALUATION
The test substance is considered as "non-irritant” (no UN GHS Category) if the mean relative tissue viability with a test material is greater than 60%.
A single test composed of at least two tissue replicates should be sufficient for a test chemical when the result is unequivocal. However, in case of borderline results such as non-concordant replicate measurements and/or mean percent tissue viability equal to ± 5% of the cut-off value, a second test should be considered as well as a third one in case of discordant results between the first two tests.
A “borderline“ evaluation (60 ± 5%) was determined statistically using historic data and hence considers the variance of the test method. This evaluation is confirming the borderline range provided in OECD Guideline 492.
ACCEPTANCE CRITERIA
NC: Tissue viability is acceptable if the mean OD570 of the NC is > 0.8. The mean OD570 of the NC should not exceed 2.8.
PC: Methyl acetate used as PC usually leads to a tissue viability of approx. 25%. A viability of < 50% is acceptable.
Variability: Two tissues were treated under the same conditions. A variability between the tissues is considered to be acceptable if the relative difference of the viability is < 20%.
Results and discussion
In vitro
Results
- Irritation parameter:
- mean percent tissue viability
- Remarks:
- [%]
- Value:
- 114.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Individual and mean OD570 values, individual and mean viability values and inter-tissue variability
Test substance identification |
|
Tissue 1 |
Tissue 2 |
Mean |
Inter-tissue variability [%] |
NC |
mean OD570 |
1.977 |
1.841 |
1.909 |
|
|
viability [% of NC] |
103.5 |
96.5 |
100.0 |
7.1 |
Test substance |
mean OD570 |
2.162 |
2.207 |
2.184 |
|
|
viability [% of NC] |
113.3 |
115.6 |
114.4 |
2.3 |
PC |
mean OD570 |
0.738 |
0.761 |
0.750 |
|
|
viability [% of NC] |
38.7 |
39.9 |
39.3 |
1.2 |
Applicant's summary and conclusion
- Conclusions:
- Based on the results observed and by applying the evaluation criteria, it was concluded that 2-Propenoic acid, 2-methyl-, C13-15-branched and linear alkyl esters does not show an eye irritation potential in the EpiOcular™ in vitro eye irritation test under the test conditions chosen.
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