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EC number: 246-115-1 | CAS number: 24271-12-3
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 - 11 Aug 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted in 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU method B.40 BIS. (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- adopted in 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayrisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany
Test material
- Reference substance name:
- Octadecyl docosanoate
- EC Number:
- 246-115-1
- EC Name:
- Octadecyl docosanoate
- Cas Number:
- 24271-12-3
- Molecular formula:
- C40H80O2
- IUPAC Name:
- octadecyl docosanoate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Source strain:
- other: EpiDerm™ (keratinocyte strain: 00267)
- Justification for test system used:
- This test uses the EpiDerm™ Skin Model is a well established organotypic, three-dimensional model of the human epidermis and is used for in vitro experiments since many years. It is known for its similarity to human skin.
- Vehicle:
- water
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ Kit (Epi-200, MatTek In vitro Life Science Laboratories (Bratislava, Slovakia)
- Tissue batch number(s): 25835
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1 °C (for both exposures)
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: rinsed about 20 times with DPBS
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: plate spectrophotometer
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD = 1.474 ± 0.093 (acceptance range. 1.0 - 3.0)
- Barrier function: ET-50: 5.93 h (acceptance range: 4.77 - 8.72 h)
- Morphology: functional stratum corneum, a viable basal cell layer and an intermediate spinous and granular layers
- Contamination: no
NUMBER OF REPLICATE TISSUES: 2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
No MTT interference of the test item.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%. A viability after 3 minutes exposure of greater than or equal to 50 % and the viability after 1 hour exposure of less than 15% is considered to be corrosive (combination of optional sub-categories 1B and 1C).
Subcategorisation (optional): A viability after 3 minutes exposure of less than 25% will lead to subcategory 1A. A viability after 3 minutes exposure of greater than or equal to 25% will lead to sub-categories 1B and 1C.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 25 mg + 25 μL H2O
VEHICLE
- Amount(s) applied: 50 μL
POSITIVE CONTROL
- Amount(s) applied: 50 μL
- Concentration: 8 N - Duration of treatment / exposure:
- 3 min and 60 min
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- (mean value)
- Run / experiment:
- test substance, 3 min exposure
- Value:
- 92.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- (mean value)
- Run / experiment:
- test substance, 60 min exposure
- Value:
- 105.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
not reported
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, as the mean OD 570 (3 min exposure) = 1.724 and the mean OD 570 (60 min exposure) = 1.767 (acceptance range for both exposure times: mean OD 570 = 0.8 - 2.8)
- Acceptance criteria met for positive control: yes, as the mean relative tissue viability (%) of PC after 60 min exposure: 8.9 % (acceptance range: mean relative tissue viability <15 %)
- Acceptance criteria met for variability between replicate measurements: yes as the coefficients of variation were between 2.3 and 7.8% (acceptance criteria ≤ 30%)
Any other information on results incl. tables
Table 1: Results after 3 min exposure for the test substance, positive and negative controls.
Negative control |
Positive control |
Test item |
||||
Tissue sample |
1 |
2 |
1 |
2 |
1 |
2 |
OD570 (blank corrected) |
1.619 |
1.803 |
0.223 |
0.205 |
1.568 |
1.653 |
1.633 |
1.800 |
0.233 |
0.207 |
1.557 |
1.629 |
|
1.634 |
1.857 |
0.231 |
0.205 |
1.540 |
1.627 |
|
OD570 (mean) ± SD |
1.629 ± 0.008 |
1.820 ± 0.038 |
0.229 ± 0.025 |
0.205 ± 0.025 |
1.555 ± 0.028 |
1.636 ± 0.028 |
OD570 (mean values of replicates) ± SD |
1.724 ± 0.135 |
0.217 ± 0.017 |
1.596 ± 0.057 |
|||
Relative viability (%) |
100.0 |
12.6 |
92.5 |
|||
CV (%) |
7.8 |
7.7 |
3.6 |
CV = coefficient of variation
SD = standard deviation
Table 2: Results after 60 min exposure for the test substance, positive and negative controls.
Negative control |
Positive control |
Test item |
||||
Tissue sample |
1 |
2 |
1 |
2 |
1 |
2 |
OD570 (blank corrected) |
1.63 |
1.866 |
0.145 |
0.167 |
1.859 |
1.909 |
1.712 |
1.855 |
0.153 |
0.162 |
1.82 |
1.862 |
|
1.686 |
1.854 |
0.154 |
0.163 |
1.810 |
1.902 |
|
OD570 (mean) ± SD |
1.676 ± 0.042 |
1.859 ± 0.025 |
0.151 ± 0.025 |
0.164 ± 0.025 |
1.830 ± 0.034 |
1.891 ± 0.034 |
OD570 (mean values of replicates) ± SD |
1.767 ± 0.129 |
0.157 ± 0.009 |
1.860 ± 0.043 |
|||
Relative viability (%) |
100.0 |
8.9 |
105.3 |
|||
CV (%) |
7.3 |
5.9 |
2.3 |
CV = coefficient of variation
SD = standard deviation
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 test substance was shown to have no corrosive potential towards reconstructed human epidermis tissue in the Epiderm™ skin 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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