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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-07-30 to 2013-09-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well documented study according to a OECD guideline and GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- 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
- Reference substance name:
- 453.62 g/mol
- IUPAC Name:
- 453.62 g/mol
- 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
Constituent 3
Test animals
- Species:
- other: in vitro test
- Strain:
- other: EpiDerm TM tissue
- Details on test animals or test system and environmental conditions:
- Commercially available Epi-200-SIT-Kit:
The EpiDermTM tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized 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 EpiDermTM tissues are cultured on specially prepared cell cultures inserts.
Origin:
- Epi-200 tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava
- Day of delivery: 20. Aug. 2013
- Batch: 18361
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: positive and negative controls included
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
1: 25.7 mg FC-131
2: 26.3 mg FC-131
3: 25.0 mg FC-131
direct exposure of substance to Epi-200 tissues in 6-well-plates - Duration of treatment / exposure:
- 60 min
- Observation period:
- 24 hours (after rinsing of the plates)
- Number of animals:
- in vitro method applied
- Details on study design:
- - preincubation of tissues in 6-well-plates containing 0.9 ml assay medium
- tissues wetted with 25 µL DPBS buffer before applying the test item
- after dosing, tissues rinsed immediatly
- transfer into new 6-well-plates
- evaluation of tissue surfaces with stereo microscope
- incubation for 24h
Control details:
- one plate: (three wells) negative control (Dulbecco’s Phosphate Buffered Saline)
- one plate: (three wells) positive control (5% SDS solution in deionised H20)
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: cell viability
- Value:
- ca. 109.2
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 24h. Reversibility: other: not applicable. Remarks: in vitro test, score is related to relative absorbance (indicator for cell viability); the threshold of relative absorbance for irritation potential is 50 %; the observed value of 109% is well above this treshold. (migrated information)
In vivo
- Irritant / corrosive response data:
- After treatment, relative absorbance values and thus cell viability values were not reduced compared to the untreated negative controls (see Table 1 and 2). Relative absorbance in a mean was about 109% (see Table 3) and well above the treshold for irritation. Hence, no skin irritation potential of FC-131 was observed with the applied test conditions.
Any other information on results incl. tables
Table 1: Absorption Values negative control, test item and positive control (OD at 570 nm)
Designation |
Measurement |
Negative Control |
FC-131 |
Positive Control |
Tissue 1 |
1 |
2.004 |
2.151 |
0.093 |
2 |
2.116 |
2.335 |
0.087 |
|
Tissue 2 |
1 |
2.131 |
2.397 |
0.100 |
2 |
2.127 |
2.367 |
0.094 |
|
Tissue 3 |
1 |
2.250 |
2.403 |
0.084 |
2 |
2.226 |
2.362 |
0.086 |
Table 2: Mean absorption values
Designation |
Negative Control |
FC-131 |
Positive Control |
Mean – blank (Tissue 1) |
2.022 |
2.205 |
0.052 |
Mean – blank (Tissue 2) |
2.091 |
2.344 |
0.059 |
Mean – blank (Tissue 3) |
2.200 |
2.345 |
0.047 |
Mean of the three Tissues |
2.104 |
2.298 |
0.053 |
Relative Standard Deviation |
4.3 % |
3.5 % |
11.4 % |
Table 3: Absoprtion in % related to untreated control for FC-131 treated cells and cells treated with the positive control (values related to formazan production)
Designation |
FC-131 |
Positive Control |
% Formazan production (Tissue 1) |
104.8 % |
2.5 % |
% Formazan production (Tissue 2) |
111.4% |
2.8 % |
% Formazan production (Tissue 3) |
111.5 % |
2.2 % |
% Formazan production Mean |
109.2 % |
2.5 % |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Using the in vitro human skin model test (OECD 439) for testing of the skin irritation potential of FC-131, no irritation potential for the test item could be observed under the test conditions applied.
- Executive summary:
The skin irritation potential of FC-131 was determined using the in vitro human skin model test in accordance with the OECD guideline 439 and the EU-Method B.46 under GLP. As the relative absorption value (correlating with the cell viability) with 109% was well above the treshold for irritation potential (50%), FC-131 is considered as not irritant in the human skin model test.
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