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EC number: 451-060-3 | CAS number: 122886-55-9
- 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:
- 07 October, 2003 - 05 November 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study has been performed according to OECD and/or EC guidelines and according to GLP principles. As the suspension in ethanol showed white particles which may interfere with the scoring, the supernatant has been tested but the concentration of the substance is unknown. No information on the solubility of the test substance in ethanol has been reported. As the Competent Authority of France accepted the study in 2004 (notification no. 04-00-0000-02), the study is considered reliable with restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- yes
- Remarks:
- As the suspension in ethanol showed white particles which may interfere with the scoring, the supernatant has been tested but the conc. of the substance is unknown. Competent Authority of France accepted the study in 2004 (notification no. 04-00-0000-02).
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- (2000)
- Deviations:
- yes
- Remarks:
- As the suspension in ethanol showed white particles which may interfere with the scoring, the supernatant has been tested but the conc. of the substance is unknown. Competent Authority of France accepted the study in 2004 (notification no. 04-00-0000-02)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 451-060-3
- EC Name:
- -
- Cas Number:
- 122886-55-9
- Molecular formula:
- C31H48N4O2
- IUPAC Name:
- 3-octyl-1-[4-({4-[(octylcarbamoyl)amino]phenyl}methyl)phenyl]urea
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): KY-UN
- Stability under test conditions: not stated
- Storage condition of test material: at room temperature and protected from light
Constituent 1
Method
- Target gene:
- - S. typhimurium: Histidine gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced by Aroclor 1254
- Test concentrations with justification for top dose:
- Preliminary test (without and with S9) TA98: 0.1, 1, 5, 10, 25 and 50 µL/plate
Main study 1 and 2: TA1535, TA1537, TA98, TA100 and TA102:
Without and with S9-mix: 3.13, 6.25, 12.5, 25 and 50 µL/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: The test substance was insoluble in most vehicle used in this type of study (water, dimethylsulfoxide,
ethanol, acetone and tetrahydrofuran), an extract in ethanol was used for treatment.
The test item was suspended in the vehicle at a concentration of 50 mg/mL. This suspension was incubated for approximately 14 hours, at 37°C under shaking. Then the suspension was centrifuged at approximately 2500 rpm during 6 minutes. The supernatant was removed and used for treatment.
The preparations were made inunediately before use.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- Positive controls:
- yes
- Positive control substance:
- other: 9-aminoacridine 50 µg/plate in DMSO for TA1537
- Remarks:
- without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- Positive controls:
- yes
- Positive control substance:
- other: 2-nitrofluorene 0.5 µg/plate in DMSO for TA98
- Remarks:
- without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- Positive controls:
- yes
- Positive control substance:
- other: Mitomycin C 0.5 µg/plate in distilled water for TA102
- Remarks:
- without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide 1 µg/plate in DMSO for TA1535 and TA100
- Remarks:
- without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthramino 2 µg/plate in DMSO for TA1535, TA1537, TA98, TA100 and 10 µg/plate in DMSO for TA102
- Remarks:
- with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: first experiment: in agar (plate incorporation); second experiment with S9-mix: preincubation
DURATION
- Exposure duration: 48 to 72 hours
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
NUMBER OF CELLS EVALUATED: no data
DETERMINATION OF CYTOTOXICITY
- Method: The reduction of the bacterial background lawn and the reduction of the revertant colonies.
OTHER EXAMINATIONS:
- The presence of precipitation of the test compound on the plates was determined. - Evaluation criteria:
- Acceptance criteria:
This study is considered valid if the following criteria are fully met:
- the number of revertants in the vehicle controls is consistent with the historical data of the testing facility,
- the number of revertants in the positive controls is higher than that of the vehicle controls and is consistent with the historical data of the testing facility.
Evaluation criteria:
A reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the data obtained.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- As the suspension in ethanol showed white particles which may interfere with the scoring, the supernatant has been tested but the conc. of the substance is unknown. No information on the solubility of the test substance in ethanol has been reported.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed up to and including the top dose of 50 µL/plate
RANGE-FINDING/SCREENING STUDIES:
- A moderate toxicity was observed at the dose-level of 50 µL/plate of test item extract in ethanol/plate, in TA 98 strain without S9 mix.
COMPARISON WITH HISTORICAL CONTROL DATA:
- The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered valid.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- No toxicity or mutagenicity was observed up to and including the top dose of 50 µL/plate.
Applicant's summary and conclusion
- Conclusions:
- An extract of KY-UN in ethanol was tested in the Salmonella typhimurium assay according to OECD 471 guideline and GLP principles. Based on the results KY-UN is not mutagenic.
- Executive summary:
An extract of KY-UN in ethanol was tested in the Salmonella typhimurium assay in strains TA98, TA100, TA1535, TA1537 and TA102 with and without S9 -mix, according to OECD 471 guideline and GLP principles. As the suspension in ethanol showed white particles which may interfere with the scoring, the supernatant has been tested but the concentration of the substance is unknown. No information on the solubility of the test substance in ethanol has been reported. No precipitation and no toxicity was observed up to and including the top dose of 50 µL/plate. Based on the study results, KY-UN is not mutagenic. As the Competent Authority of France accepted the study in 2004 (notification no. 04-00-0000-02), the study is considered reliable with restrictions.
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