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EC number: 943-080-0 | 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
- 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
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 July 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to international guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidelines for the Testing of Chemicals, adopted 25. Jul. 2014, DRAFT PROPOSAL FOR A NEW TEST GUIDELINE , Reconstructed Human Cornea-like Epithelium (RhCE)
- Qualifier:
- according to guideline
- Guideline:
- other: “EpiOcular TM Eye Irritation Test (OCL-200-EIT) for the prediction of acute ocular irri-tation of chemicals” by MatTek Corporation, document no. MK‐24‐007‐0055, dated 10. Dec. 2012
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction product of: stearyl-diethanol-amine with C16-C18 saturated fatty acids
- EC Number:
- 943-080-0
- Molecular formula:
- Not applicable, UVCB
- IUPAC Name:
- Reaction product of: stearyl-diethanol-amine with C16-C18 saturated fatty acids
- Test material form:
- other: pastilles
- Details on test material:
- Name SABOSTAT A 300
Batch no. 20085596
Appearance whitish pastilles
Composition Reaction product of stearyl-diethanol-amine with C16-C18 saturated fatty acids
CAS No. not applicable
(CAS No. of main compound 2-[(2-hydroxyethyl)octadecylamino]ethyl stearate: 52497-24-2)
EINECS-No. not stated
Molecular formula not applicable
Molecular weight 668 g/mol (calculated based on average UVCB composi-tion)
Purity 100%
Homogeneity homogeneous
Vapour pressure 5.85E-21 Torr Calculated using Advanced Chemistry De-velopment (ACD/Labs) Software V11.02 (© 1994-2015 ACD/Labs) h Pa at 25°C
Stability H2O; EtOH; acetone; CH3CN; DMSO: unknown
Solubility H2O: not soluble DMSO: soluble at 50 °C; EtOH, acetone, CH3CN: unknown
Production date 16. Apr. 2015
Expiry date 10. Apr. 2016
Storage Room temperature (20 ± 5 °C), keep away from light/ hu-midity
Constituent 1
Test animals / tissue source
- Species:
- other: 3D human cornea tissue model
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Commercially available EpiOcularTM kit.
The EpiOcularTM tissue consists of normal, human-derived keratinocytes which have been cultured to form a stratified squamous epithelium similar to that found in the human cornea. It consists of highly organized basal cells. These cells are not transformed or transfected with genes to induce an extended life span. The EpiOcularTM tissues are cultured in specially prepared cell culture inserts with a porous membrane through which nutrients can pass to the cells. The tissue surface is 0.6 cm2.
EpiOcularTM tissues were procured from MatTek In Vitro Life Science Laboratories, Mylnské Nivy 73, 82105 Bratislava, Slovakia.
Day of delivery: 14. Jul. 2015
Batch no.: 21562
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: negative and positive control vessels (in vitro study)
- Amount / concentration applied:
- The following amounts were applied to the tissues:
Tissue 1 51.5 mg
Tissue 2 49.4 mg - Duration of treatment / exposure:
- 6 hours
- Observation period (in vivo):
- Not applicable
- Number of animals or in vitro replicates:
- Not applicable
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Relative absorbance (%)
- Basis:
- mean
- Score:
- 107.5
- Remarks on result:
- other: Absorbance of test item compared to negative control
Any other information on results incl. tables
Findings and Results
Measured Values
As blank, the optical density of isopropanol was measured in eight wells of the 96-well-plate. The measured values and their mean are given in the following table:
Table 1.Absorbance Values Blank Isopropanol (OD at 570 nm)
Replicate |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
Mean |
Absorbance |
0.035 |
0.038 |
0.035 |
0.035 |
0.034 |
0.036 |
0.036 |
0.036 |
0.036 |
The absorbance values of negative control, test item and positive control are given in the following table:
Table 2. Absorbance Values Negative Control, Positive Control and Test Item (OD at 570 nm)
Designation |
Measurement |
Negative Control |
Positive Control |
SABOSTAT A 300 |
Tissue 1 |
1 |
1.289 |
0.453 |
1.440 |
2 |
1.368 |
0.457 |
1.438 |
|
Tissue 2 |
1 |
1.358 |
0.456 |
1.446 |
2 |
1.360 |
0.456 |
1.447 |
From the measured absorbances, the mean of each tissue was calculated, subtracting the mean absorbance of isopropanol as given in table 1 (= corrected values).
Table3 Mean Absorbance Negative Control, Positive Control and Test Item
Designation |
Negative Control |
Positive Control |
SABOSTAT A 300 |
Mean – blank (Tissue 1) |
1.293 |
0.419 |
1.403 |
Mean – blank (Tissue 2) |
1.323 |
0.420 |
1.411 |
Comparison of Formazan Production
For the test item and the positive control, the following percentage values of formazan production were calculated in comparison to the negative control:
Table 4 % Viability Positive Control and Test Item
Designation |
Positive Control |
SABOSTAT A 300 |
% Viability (Tissue 1) |
32.0% |
107.3% |
% Viability (Tissue 2) |
32.1% |
107.8% |
% Viability Mean |
32.1% |
107.5% |
Assessment
Eye irritation is assessed using the criteria given in the following table (source: MatTek Corporation):
Table 5 Assessment of Eye Irritation
% Viability |
Assessment |
GHS classification |
> 60 % |
Non eye irritant |
No GHS category |
≤60 % |
Eye irritant |
GHS category 1 or 2 |
Validity
Validity criteria and results are stated in the following table:
Table 6 Validity
Criterion |
Demanded |
Found |
OD of negative control |
≥1.0 and≤ 2.6 |
1.3 |
% Formazan production of positive control |
< 60% of negative control |
32.1% |
Variation within replicates |
< 20% |
2.3% (negative control) |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test system, the substance is considered as
not eye irritant in the EpiOcularTM Eye Irritation Test.
After treatment with the test item, the relative absorbance values increased to 107.5 %.
This value is well above the threshold for eye irritation potential (60%).
All validity criteria were met. The criterion for optical density of the negative control was fulfilled: The OD value was 1.3 (> 1.0 and < 2.6).
The positive control induced a decrease in the relative absorbance as compared to the negative control to 32.1% (< 60%). Variation within the replicates was acceptable (<20 %).
For these reasons, the result of the test is considered as valid. - Executive summary:
The substance was applied to a three-dimensional human cornea tissue model in duplicate for a 6 h exposure.
In average, 50.5 mg of the solid test item were applied to each tissue.
After treatment, the respective substance was rinsed from the tissue; then, cell viability of the tissues was evaluated by addition of MTT which can be reduced to a blue formazan. Formazan production was measured by measuring the optical density (OD) of the resulting solution.
Deionised water was used as negative control, Methyl acetate was used as positive control.
The controls showed the expected results. After treatment with the negative control, the absorbance values were within the required acceptability criterion of 1.0 ≤ mean OD ≤ 2.6, OD was 1.3. The positive control showed clear eye irritating effects, the relative absorbance value was reduced to 32.1 %. Variation within tissues was acceptable (< 20%).
After treatment with the test item, the relative absorbance values increased to 107.5 %.
This value is well above the threshold for eye irritation potential (60%).
Under the conditions of the test system, the substance is considered as
not eye irritant in the EpiOcularTMEye Irritation Test.
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