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EC number: 947-835-5 | CAS number: -
- 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
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- Endpoint summary
- Stability
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- 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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: B.40 BIS (In vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-ethyl-2-[[(1-oxononyl)oxy]methyl]propane-1,3-diyl dinonan-1-oate
- EC Number:
- 204-793-6
- EC Name:
- 2-ethyl-2-[[(1-oxononyl)oxy]methyl]propane-1,3-diyl dinonan-1-oate
- Cas Number:
- 126-57-8
- Molecular formula:
- C33H62O6
- IUPAC Name:
- 2,2-bis[(nonanoyloxy)methyl]butyl nonanoate (non-preferred name)
- Test material form:
- other: oil
Constituent 1
In vitro test system
- Test system:
- other: Commercially available Epi-200-Kit
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on test system:
- Epi-200 tissues were procured from MatTek In Vitro Life Science Laboratories.
Day of delivery: 08 Oct 2013
Batch EPI-200-CORR: 18381
Chemicals and Media:
- MTT reagent: Contains 1mg/mL 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide, which can be reduced to a blue formazan. Prepared as concentrate (5mg/mL in DPBS buffer, stored at -20 °C).
For the pre-test, the concentration was thawed and diluted with serum-free MEM medium directly before use.
For the main study, the concentrate was thawed and diluted with assay medium directly before use.
Isopropanol 99,9%, batch 3100602 used as exctracting solvent for formazan
The EpiDerm tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epiderms. It consists of organised basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues are cultured on specially prepared cell cultures inserts. Negative control: Deionised H2O Positive control: KOH, solution in deionised H2O containing 8.0 mol/L.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- dye content (µg/disc)
- Value:
- ca. 98.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The photometric absorption of the negative controls was considered as 100%. For the mean of the three replicates of test item and positive control. formazan production was calculated as % photometric absorption compared with the negative control.
See table below for assessment
Any other information on results incl. tables
Assessment:
% Formazan productionafter 3 min. incubation time | % Formazan productionafter 1 h incubation time | Assessment |
< 50% of negative control | irrelevant | Corrosive! |
> = 50% of negative control | < 15% of negative control | Corrosive! |
>= 50% of negative control | >= 15% of negative control | not corrosive |
Results:
The absorption values of negative control, test item and positive control are given in the following table:
Negative Control | Test Item | Positive Control | Incubation time | |||||
Tissue 1 | Tissue 2 | Tissue 1 | Tissue 2 | Tissue 1 | Tissue 2 | |||
2.202 | 1.956 | 2.067 | 2.075 | 0.443 | 0.472 | 3 min | ||
2.199 | 1.975 | 2.048 | 2.026 | 0.452 | 0.465 | 3 min | ||
2.166 | 2.074 | 2.038 | 2.079 | 0.452 | 0.459 | 3 min | ||
1.948 | 2.014 | 1.716 | 1.875 | 0.199 | 0.205 | 1 hour | ||
1.986 | 1.924 | 1.750 | 1.916 | 0.198 | 0.203 | 1 hour | ||
1.986 | 2.016 | 1.756 | 1.909 | 0.194 | 0.204 | 1 hour | ||
Mean | Mean | Mean | ||||||
2.095 | 2.056 | 0.457 | 3 min | |||||
1.979 | 1.820 | 0.201 | 1 hour |
Validity:
The criterion for optical density of the negative control (> 0.8) was fulfilled: optical density was 2.095 (3 minutes) resp. 1.979 (1 hour). The positive control showed a clear corrosive effect: the value of the three-minuteexperiment was 21.8% and the value of the one-hour-experiment was 10.1%. Values for negative control and for positive control were within the range of historical data of the test facility (see Annex 2: Comparison with Historical Data, page 17). Therefore, the experiment is considered valid.
Discussion:
The test item is considered not corrosive. After three minutes treatment, the relative absorbance values were decreased to 98.1%. This value is well above the threshold for corrosivity (50%). After one hour treatment relative absorbance values were reduced to 92.0%. This value is well above the threshold for corrosivity (15%). In the guideline, values greater or equal to the threshold are considered as “non-corrosive to skin”. The values of the negative control were well above the required acceptability criterion of mean OD > 0.8 for both treatment intervals thus showing the quality of the tissues. The positive control induced a decrease in the relative absorbance as compared to the negative control to 21.8% for the three minutes treatment interval and 10.1% for the one hour treatment interval thus ensuring the validity of the test system. For these reasons, the result of the test is considered valid.
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive (Skin Irrit. 2 or not classified according to Regulation (EC) No 1272/2008)
- Conclusions:
- Under the conditions of the test, the source substance (CAS 126-57-8) was shown to have no corrosive potential towards reconstructed human epidermis tissue in the EpiDerm model. The result does not allow for the non-classification or classification as irritant of the test substance and therefore further evaluation and/or data generation is required.
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