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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 Oct - 01 Dec 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 guidelineopen allclose all
- 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:
- adopted in 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EURL ECVAM DB-ALM Method Summary No. 164: EpiOcular™ Eye Irritation Test - Summary
- Version / remarks:
- adopted in 2015
- 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
Test animals / tissue source
- Species:
- human
- Strain:
- other: EpiOcular™ (OCL-200-EIT); Keratinocyte strain: 4F1188
- Details on test animals or tissues and environmental conditions:
- - Justification of the test method and considerations regarding applicability
The EpiOcular™ Eye Irritation Test (EIT) was validated by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) and cosmetics Europe.
This in vitro method is recommended to identify chemicals that do not require classification for eye irritation or serious eye damage according to UN GHS (UN GHS “No Category”) without further testing within a tiered testing strategy from those requiring classification and labelling (UN GHS categories 1 and 2). It therefore can be used for regulatory purposes as an initial step in the Bottom-Up approach or as one of the last steps in a Top-Down approach. It is not intended to differentiate between UN GHS “Category 1” (serious eye damage) and UN GHS “Category 2” (eye irritation) which would require additional testing.
- Description of the cell system used, incl. certificate of authenticity and the mycoplasma status of the cell live
This test uses the three-dimensional RhCE EpiOcular™ (MatTek). It consists of normal, human-derived epidermal keratinocytes and mimics the histological, morphological, biochemical and physiological properties of the human corneal epithelium. The EpiOcular™ RhCE tissue construct consists of at least 3 viable layers of cells and a non-keratinized surface, showing a cornea-like structure analogous to that found in vivo. All biological components of the used tissue and the kit culture medium have been tested and are free of the presence of viruses, bacteria and mycoplasma. Analysis for tissue functionality and quality was performed and passed.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 50 mg (83.3 mg/cm2) - Duration of treatment / exposure:
- 6 ± 0.25 h
- Duration of post- treatment incubation (in vitro):
- 25 ± 2 h (Post-soak immersion incubation)
18 ± 0.25 h (Post-treatment incubation) - Number of animals or in vitro replicates:
- 2 replicates
- Details on study design:
- - Details of the test procedure used
Ocular irritation potential is predicted by the relative viability of the tissue after a single exposure to the test substance. Relative viability is determined by measuring the 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) dye conversion by the EpiOcular™ tissue construct after topical exposure to the test substance. The percent reduction of cell viability in comparison to untreated negative controls is used to predict eye irritation potential.
- RhCE tissue construct used, including batch number
The EpiOcular™ human cell construct (e.g. OCL-200-EIT, MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia, Lot number: 27015)
- Doses of test chemical and control substances used
50 mg test item; 50 μL positive control (methyl acetate) and 50 μL negative control (destilled water)
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods
exposure: 6 ± 0.25 h at 37 ± 1 °C
post-exposure immersion (post-soak): 25 ± 2 min at room temperature
post-exposure incubation: 18 ± 0.25 h at 37 ± 1 °C
- Number of tissue replicates used per test chemical and controls
2 replicates each
- Wavelength and band pass used for quantifying MTT formazan, and linearity range of measuring device (e.g. spectrophotometer)
570 nm; filter band pass of maximum ± 30 nm
- Description of the method used to quantify MTT formazan
Inserts were removed from the 24-well plate after the incubation time in MTT solution (3 h ± 10 min), the bottom of the insert was blotted on absorbent material and transferred to a 6-well "extraction plates" containing 2 mL isopropanol per well. The plate was sealed to inhibit evaporation. MTT was extracted overnight at 2 - 8 °C in the dark or by shaking on an orbital plate shaker for 2 - 3 h at room temperature. After the extraction the inserts were discarded and 200 μL samples (in duplicate) of the extract were transferred into the wells of a 96-well plate and the absorbance/ optical density was measured in a plate spectrophotometer to determine cell viability.
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model
If the test item-treated tissue viability is > 60% relative to the negative control treated tissue viability, the test substance is predicted to be non-irritant.
If the test item-treated tissue viability is ≤ 60% relative to negative control treated tissue viability, the test substance is predicted to be irritant or corrosive.
- Reference to historical positive and negative control results demonstrating suitable run acceptance criteria
Historical positive and negative control results are provided in the report and meet the acceptance criteria.
- Complete supporting information for the specific RhCE tissue construct used
A copy of the certificate of analysis provided by the manufacturer is included in the study report.
- Demonstration of proficiency in performing the test method before routine use by testing of the proficiency chemicals
No information is provided in the report.
Acceptance criteria:
- Mean absolute OD570 nm of negative control is in the range of 0.8 - 2.5.
- Mean relative viability of positive control is < 50%.
- relative tissue viability difference of replicate tissues is < 20%.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: mean viability (%)
- Run / experiment:
- test substance (exposure: 6 ± 0.25 h)
- Value:
- 102.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes, as the mean OD value (1.819) of the two negative control tissues is between 0.8 and 2.5.
- Acceptance criteria met for positive control: Yes, as the mean relative viability for the positive control (19.1%) is below 50% of the control viability.
- Acceptable variability between tissue replicates for positive (PC) and negative controls (NC): Yes, as the difference of % viability was 2.3% and 6.3% for the PC and NC, respectively and thus < 20%.
- Acceptable variability between tissue replicates for the test chemical: Yes, as the variability for the test chemical was 7.4%, and thus < 20%.
- Positive and negative control means based on historical data
historical negative control (mean OD ± SD): 1.664 ± 0.311
historical positive control (mean relative viability [%] ± SD): 28.9 ± 12.0
Any other information on results incl. tables
Table 1: Absorbance values and relative viability of the test substance, negative and positive controls
|
Negative control |
Positive control |
Test substance |
|||
Tissue No. |
1 |
2 |
1 |
2 |
1 |
2 |
OD570(blank-corrected) |
1.818 |
1.737 |
0.312 |
0.365 |
1.851 |
1.751 |
1.847 |
1.704 |
0.328 |
0.356 |
1.912 |
1.751 |
|
Mean OD570of the duplicates |
1.833 |
1.720 |
0.320 |
0.360 |
1.882 |
1.751 |
Mean OD570of 2 replicate tissues |
1.776 ± 0.07 |
0.34 ± 0.20 |
1.816 ± 0.08 |
|||
Relative tissue viability [%] |
103.2 |
96.8 |
18.0 |
20.3 |
105.9 |
98.6 |
Relative tissue viability difference [%] |
6.3 |
2.3 |
7.4 |
|||
Mean relative tissue viability [%] |
100.0 |
19.1 |
102.2 |
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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