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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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-07-19 to 2013-08-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD and EU guideline and in accordance with 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 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
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
Method
- Target gene:
- missing Histidine synthesis
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium LT2: TA1535, TA 97a, TA98, TA 100, TA 102
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Nutrient broth for overnight culture (Merck 5443)
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: no data
- Genotype confirmation was performed once a quarter
- Periodically checked for karyotype stability: yes/no
- Periodically "cleansed" against high spontaneous background: yes/no - Additional strain / cell type characteristics:
- other: all with mutation in histidine gene
- Metabolic activation:
- with and without
- Metabolic activation system:
- produced from the livers of male Sprague-Dawley rats treated with 500 mg Aroclor 1254/kg b.w. intraperitoneally
- Test concentrations with justification for top dose:
- nominal concentrations:
- first experiment (plate incorporation method):
5002 µg/plate , 1501 µg/plate, 502 µg/plate, 152 µg/plate and 51 µg/plate (= 50.02; 15.01 ;5.02; 15.2 and 0.51 g/L)
- second experiment (pre-incubation method):
5002 µg/plate , 2500 µg/plate, 1254 µg/plate, 624 µg/plate, 313 µg/plate, 157 µg/plate and 76 µg/plate (= 50.02; 25 ; 12.54; 6.24; 3.13; 1.57 and 0.76 g/L) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:DMSO
- Justification for choice of solvent/vehicle:
The test item was not sufficiently soluble in deionised water, dimethyl sulfoxide (DMSO) or ethanol. In DMSO, the test item showed the best homogenous suspension under permanent shaking in the highest required concentration.
Therefore, the test item was weighed directly. The weighed amounts were autoclaved and filled up with sterile DMSO.
The suspensions were shaken for 24 hours and stirred during application.
In both experiments, the two highest concentrations were tested as suspension (in the first experiment: 5002 µg/plate and 1501 µg/plate; in the second experiment: 5002 µg/plate and 2500 µg/plate).
Complete dissolution was observed at the following nominal concentrations:
Experiment I: 502 µg/plate, 152 µg/plate and 51 µg/plate.
Experiment II: 1254 µg/plate, 624 µg/plate, 313 µg/plate, 157 µg/plate and 76 µg/plate.
Controls
- Untreated negative controls:
- yes
- Remarks:
- H2O
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro- 1,2-phenylene diamine, 2-Amino-anthracene
- Remarks:
- NPD (TA97a, TA98, TA102; no metabolic activation); Na-azide (TA 100, TA 1535, no metabolic activation), 2AA (TA 97a, TA100, TA 102, TA 1535, +S9), BaP (TA 98, + S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
experiment 1: in agar (plate incorporation);
experiment 2: preincubation
DURATION:
- Preincubation period: 20min
- Exposure duration:48h (second experiment no data)
- Expression time (cells in growth medium): at least 1E+09 cells/ml
NUMBER OF REPLICATIONS:
4 plates for each concentration, strain, metabolic activation/no metabolic activation
NUMBER OF CELLS EVALUATED: see Table 1a (experiment 1) and Table 1b (experiment 2) below
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth (The test item is considered non-toxic, if the quotient titre/tox is below 2.) - Evaluation criteria:
- The colonies were counted visually, the numbers were recorded. A spreadsheet software (Microsoft Excel®) was used to calculate mean values and standard deviations of each treatment, solvent control and positive control.
The increase factor f(I) of revertant induction (mean revertants divided by mean spontaneous revertants) and the absolute number of revertants (“Rev. abs.”, mean revertants less mean spontaneous revertants) were also calculated.
A test item is considered to have mutagenic potential, if a significant, reproducible increase of revertant colonies per plate (increase factor 2) in at least one strain can be observed. A concentration-related increase over the range tested can also be taken as a sign of mutagenic activity.
All calculations are performed with unrounded values. - Statistics:
- calculation of mean values and standard deviations, calculation of increase factor, no documentation of significance determination
Results and discussion
Test results
- Species / strain:
- other: TA1535, TA97a, TA98, TA100 and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: test item not completely soluble in DMSO (undissolved particles have been observed) at the two highest tested concentrations (5002 and 1501 µg/plate) and were tested as suspensions in these concentrations
- Precipitation: undissolved substance particles have been observed at the highest tested concentrations
RANGE-FINDING/SCREENING STUDIES: no data
COMPARISON WITH HISTORICAL CONTROL DATA: only marginal differences compared to historical cotrol data
OTHER CONTROL DATA:
Genotype Confirmation: ok
Histidine Requirement: ok
UV-Sensitivity (uvrB): ok
Crystal Violet Sensitivity (deep rough/rfa): ok - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 3: Results of experiment 1 (negative controls, positive controls, values for FC-131)
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
H2O |
Mean |
150 |
125 |
15 |
15 |
110 |
123 |
180 |
184 |
22 |
22 |
sd |
9.9 |
16.4 |
5.9 |
3.6 |
5.1 |
13.6 |
25.2 |
15.2 |
4.4 |
2.2 |
|
DMSO |
Mean |
126 |
103 |
16 |
14 |
113 |
140 |
174 |
169 |
22 |
20 |
sd |
12.3 |
7.9 |
5.4 |
2.6 |
6.9 |
13.9 |
18.2 |
23.9 |
5.5 |
6.2 |
|
Positive |
Mean |
600 |
552 |
139 |
110 |
619 |
520 |
683 |
895 |
468 |
112 |
sd |
81 |
84 |
17 |
14 |
55 |
84 |
54 |
76 |
39 |
17 |
|
f(I) |
4.76 |
5.36 |
8.69 |
7.86 |
5.63 |
3.71 |
3.93 |
5.30 |
21.27 |
5.60 |
|
5002 µg/pl. |
Mean |
107 |
109 |
18 |
14 |
128 |
116 |
179 |
196 |
20 |
21 |
sd |
7 |
16 |
1 |
2 |
19 |
18 |
13 |
12 |
3 |
3 |
|
f(I) |
0.85 |
1.06 |
1.13 |
1.00 |
1.13 |
0.83 |
1.03 |
1.16 |
0.91 |
1.05 |
|
1501 µg/pl. |
Mean |
112 |
102 |
16 |
18 |
109 |
131 |
190 |
175 |
22 |
20 |
sd |
8 |
5 |
3 |
2 |
18 |
25 |
21 |
15 |
3 |
3 |
|
f(I) |
0.89 |
0.99 |
1.00 |
1.29 |
0.96 |
0.94 |
1.09 |
1.04 |
1.00 |
1.00 |
|
502 µg/pl. |
Mean |
120 |
121 |
13 |
13 |
119 |
136 |
167 |
178 |
21 |
23 |
sd |
9 |
20 |
3 |
2 |
20 |
20 |
15 |
19 |
7 |
4 |
|
f(I) |
0.95 |
1.17 |
0.81 |
0.93 |
1.05 |
0.97 |
0.96 |
1.05 |
0.95 |
1.15 |
|
152 µg/pl. |
Mean |
127 |
120 |
16 |
13 |
122 |
122 |
185 |
189 |
22 |
24 |
sd |
13 |
26 |
3 |
2 |
7 |
7 |
14 |
17 |
2 |
2 |
|
f(I) |
1.01 |
1.17 |
1.00 |
0.93 |
1.08 |
0.87 |
1.06 |
1.12 |
1.00 |
1.20 |
|
51 µg/pl. |
Mean |
112 |
116 |
13 |
13 |
116 |
122 |
193 |
192 |
24 |
23 |
sd |
21 |
9 |
3 |
1 |
19 |
3 |
19 |
18 |
3 |
3 |
|
f(I) |
0.89 |
1.13 |
0.81 |
0.93 |
1.03 |
0.87 |
1.11 |
1.14 |
1.09 |
1.15 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
negative with metabolic activation
Under the test conditions, the test item FC-131 is not mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium, strains TA 97a, TA 98, TA 100, TA 102 and TA 1535 with or without metabolic activation. Cytotoxicity of the test item at the concentrations tested was not detected.
No complete dissolution in DMSO/ Ethanol/water was possible for the two highest concentrations in the first and in the second experiment; hence undissolved particles were visible on the plates and substance was tested as suspension. - Executive summary:
The mutagenic potential of FC-131 was tested according to the OECD guideline 471 with the Bacterial Reverse Mutation Test using five strains of Salmonella typhimurium TA 97a, TA 98, TA 100, TA 102 and TA 1535 with and without metabolic activation (using S9) and applying both the plate incorporation and pre-incubation method. The tests and all included controls were valid. FC-131 was tested with a concentration range between 76 µg/plate (= 0.76 g/L) and 5002 µg/plate (= 50 g/L). Concentrations above 1501 µg/plate showed precipitation. No cytotoxicity was observed upto and including the highest concentration of 5002 µg/plate.
For all strains and all conditions tested, the test item FC-131 showed negative results and can be considered as not mutagenic under the conditions of the test.
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