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EC number: 457-890-2 | CAS number: 860399-11-7
- 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:
- 2013-07-30 to 2013-09-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- well documented study according to GLP; Up to now, no internationally accepted guidelines are available for the EpiOcular eye irritation test. But the EpiOcular Test has been already used in pre-validation studies and validation by ECVAM is in progress.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EpiOcular (TM) guideline from MatTek in vitro life science laboratories, Bratislava
- Deviations:
- no
- Principles of method if other than guideline:
- Guideline Reference: Ocular Irritation Protocol: Neat Method (MTT ET-50) for use with EpiOcular Tissues, Rev:17.Jan.2012 by MatTek in vitro life science laboratories; Bratislava
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- FC-131
- IUPAC Name:
- FC-131
- Reference substance name:
- -
- EC Number:
- 457-890-2
- EC Name:
- -
- Cas Number:
- 860399-11-7
- Molecular formula:
- C27H39N3O3
- IUPAC Name:
- (2E,5Z)-3-cyclohexyl-2-(cyclohexylimino)-5-{[4-(diethylamino)-2-methoxyphenyl]methylidene}-1,3-oxazolidin-4-one
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report):FC-131
- Physical state: yellow crystalline powder
- Analytical purity: 99.8% (area HPLC)
- Impurities (identity and concentrations): about 0.1% 4-diethylamino-2-methoxy-benzaldehyde
- Isomers composition:No data
- Purity test date:03.07.2013
- Lot/batch No.:30610045
- Expiration date of the lot/batch:12.06.2015
- Homogeneity: yes
- Storage condition of test material: Room temperature (20+-5 °C), no humidity
- Production date: Jun. 2013
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- other: in vitro test
- Strain:
- other: in vitro test
- Details on test animals or tissues and environmental conditions:
- - EpiOcular (TM) tissue: normal, human-derived epidermal keratinocytes cultured to form a stratified squamous epithelium similar that of human cornea
- tissue surface: approx. 0.6 square cm
-origin: OCL-200 tissues produced from MatTek in vitro life science laboratories, Bratislava
- day of delivery: 20.08.2013
- Batch: 18627
- Buffer for tissue rinsing: DPBS
- plates: 6-well plates
- temperature: 37+-1°C
- CO2: 5+-1%
Cell viability test:
-measured after exposure of tissues with test substance
-for calculation of the ET50 value (time needed for 50% reduction of cell viability)
- measured by dehydrogenase conversion of MTT, present in cell mitochondria, into blue formazan, which is quantitatively measured after tissue extraction
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: in vitro test with tissues: positive and negative controls included
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100+-10mg of FC-131 in duplicate (2 tissues each) - Duration of treatment / exposure:
- 3,30 and 60 min
positive control: 15 ad 45 min
negative control: 60 min - Observation period (in vivo):
- three hours in MTT medium, and thereafter overnight at room temperature (tissues covered by isopropanol) for formazan production
- Number of animals or in vitro replicates:
- number of tissues: 2 tissues for each time point and two replicates each
- Details on study design:
- - first step: substance exposure to tissues
- second step: cell viability test based on MTT coversion to formanzan
- Positive control: 0.3% Triton X 100 solution
- Negative control: Deionised H2O
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing of tissues with DPBS buffer and soaking in medium for 10min
SCORING SYSTEM: Formanzan relative absorption for calculation of ET50 (time needed for 50% reduction of absorption (cell viability)
ET50 > 60: non/minimal irritant
ET50 31-60: mild irritant
ET50 3-30: moderate irritant
ET50 < 3: severe/extreme irritant
TOOL USED TO ASSESS SCORE: plate spectral photometer at 570m
Results and discussion
In vivo
Results
- Irritation parameter:
- other: ET50
- Basis:
- mean
- Time point:
- other: 60min
- Score:
- > 60
- Reversibility:
- other: not applicable
- Remarks on result:
- other: determination of time leading to a reduction of relative formanzan absorption, mean formanzan production in tissues was 96.5% after 60 min compared to controls
- Irritant / corrosive response data:
- Values for absorption and relative absorption (in % compared to negative controls) are shown in tables 1-3. After 60 min of treatment with the test substance relative absorbance values were marginal reduced to 96.5%. Hence, the ET50 value is stated as "> 60min" and FC-131 according to this test can be considered as not/minimal irritant.
- Other effects:
- The ET50 for the positive controls was 29.55 (min). Marginal deviations from historical controls of tested negative controls were observed.
Any other information on results incl. tables
Table 1: Absorption values for negative controls, positive controls and test item
Substance |
Tissue 1 |
Tissue 2 |
Incubation Time |
Negative Control |
1.969 |
1.856 |
60 minutes |
1.969 |
1.833 |
||
1.970 |
1.842 |
||
Positive Control |
1.513 |
1.426 |
15 minutes |
1.507 |
1.438 |
||
1.517 |
1.433 |
||
Positive Control |
0.436 |
0.450 |
45 minutes |
0.434 |
0.449 |
||
0.438 |
0.445 |
||
Test Item |
1.860 |
1.780 |
3 minutes |
1.857 |
1.800 |
||
1.843 |
1.792 |
||
Test Item |
1.810 |
1.806 |
30 minutes |
1.829 |
1.814 |
||
1.836 |
1.813 |
||
Test Item |
1.894 |
1.801 |
60 minutes |
1.871 |
1.813 |
||
1.888 |
1.783 |
Designation |
Negative control |
Positive control |
Positive control |
Test item |
Test Item |
Test item |
Incubation time |
60 min. |
15 min |
45 min. |
3 min. |
30 min. |
60 min. |
Mean – blank (Tissue 1) |
1.931 |
1.474 |
0.398 |
1.815 |
1.787 |
1.846 |
Mean – blank (Tissue 2) |
1.806 |
1.394 |
0.410 |
1.753 |
1.773 |
1.761 |
Mean of the two Tissues |
1.869 |
1.434 |
0.404 |
1.784 |
1.780 |
1.804 |
Relative Standard Deviation of the two tissues |
0.047 |
0.039 |
0.021 |
0.025 |
0.006 |
0.033 |
Designation |
Positive control |
Positive control |
Test item |
Test Item |
Test item |
Incubation time |
15 min |
45 min. |
3 min. |
30 min. |
60 min. |
% Formazan production (Tissue 1) |
78.9% |
21.3% |
97.1% |
95.6% |
98.8% |
% Formazan production (Tissue 2) |
74.6% |
21.9% |
93.8% |
94.9% |
94.2% |
% Formazan production Mean |
76.7% |
21.6% |
95.5% |
95.2% |
96.5% |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: from EpiOcular guideline
- Conclusions:
- FC-131 reduced cell viability of EpiOcular tissue only marginal. The estimated ET50 value was > 60min. Hence, FC-131 can be considered as not/minimal irritant in the Human Cornea Model test under the conditions of the test.
- Executive summary:
The eye irritation potential of FC-131 was determined using an in vitro Human Cornea Model (EpiOcular Test). Up to now, no internationally accepted guidelines are available for this test but the validation by ECVAM is in progress. About 100 mg of the test substance was tested for 3, 30 ad 60 min. The irritation potential was measured as reduction of cell viability within the tissue by applying a cell viability test after exposure based on formanzan production of the cells. FC-131 lead to 95.5% formanzan production (cell viability) compared to untreated controls after 60 min treatment. Hence, an ET50 value (time needed for a 50% reduction of cell viability) of ">60 min" could be estimated and FC-131 was considered to be not/mild irritant.
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