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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 26 June 2020
- 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
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia containing: 24 EPI-200 tissues
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epiderm 200 kit, EPI-200
- Tissue batch number(s): 34145
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 25 minutes at room temperature and for 35 minutes in the incubator at 37°C
- Temperature of post-treatment incubation (if applicable): 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: washing occurred after incubation and post-incubation
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 ml
- Incubation time: 3 hours
- Spectrophotometer: SunriseTM Absorbance Reader
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: three tissues are treated in parallel. The inter-tissue variability is considered to be acceptable if the SD of % viability is >= 18%.
- Negative and positive controls: OD570 of the negative control between 0.8 and 2.8 and of the positive control (5% SDS) ≤ 20%
- Barrier function: lower acceptance limit: ET50 = 4.0 hours; upper acceptance limit: ET50 = 8.7 hours; both for Triton X-100 (1%)
Further information are given below in the section "Any other information"
NUMBER OF REPLICATE TISSUES: 3
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test chemical is identified as requiring classification and labelling according to UN GHS (Category 2 or Category 1) if the mean percent tissue viability after exposure and posttreatment incubation is less than or equal (≤) to 50%.
- The test substance is considered to be non-corrosive to skin if after exposure is greater than or equal to 50%.
- 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.
- Justification for the selection of the cut-off point:
A borderline range (50 ± 5%) was statistically determined by using historic BASF data and hence considers the variance of the test method. This evaluation is confirming the borderline range provided in OECD Guideline 439. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 μL undiluted test substance were applied using a pipette
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- Concentration (if solution): 5% (w/v) - Duration of treatment / exposure:
- 25 minutes at room temperature and for 35 minutes in the incubator at 37°C
- Duration of post-treatment incubation (if applicable):
- 18 ± 2 hour
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean value from three tissues out of one experiment
- Value:
- 101.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: The test substance ist not able to reduce MTT directly.
Any other information on results incl. tables
Individual and mean OD570 values, individual and mean viability values, standard deviations and coefficient of variation
Test substance identification |
|
Tissue 1 |
Tissue 2 |
Tissue 3 |
Mean |
SD |
CV[%] |
NC |
mean OD570 |
1.879 |
1.950 |
2.030 |
1.953 |
|
|
|
viability [% of NC] |
96.2 |
99.9 |
104.0 |
100.0 |
3.9 |
3.9 |
Test substance |
mean OD570 |
2.089 |
1.880 |
1.957 |
1.975 |
|
|
|
viability [% of NC] |
106.9 |
96.3 |
100.2 |
101.1 |
3.4 |
5.3 |
PC |
mean OD570 |
0.061 |
0.052 |
0.052 |
0.055 |
|
|
|
viability [% of NC] |
3.1 |
2.7 |
2.6 |
2.8 |
0.3 |
9.7 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- 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 a skin irritation potential in the EpiDerm™ in vitro skin irritation test under the test conditions chosen.
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