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EC number: 258-964-5 | CAS number: 54079-53-7
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
AMES Assay
Test chemical did not induce gene mutation in the Salmonella typhimurium TA98, TA100, TA1535, TA1537, and TA1538 with and without of metabolic activation system and hence is not likely to classify as a gene mutant in vitro.
In vitro gene mutation study in mammalian cell
Test chemical was evaluated for its mutagenic potential in mammalian cells by in vitro mammalian cell gene mutation. The test result was considered to be negative both in the presence and absence of metabolic activation.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data from handbook or collection of data
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- Weight of evidence prepared from various publication mention below
Salmonella/Mammalian-Microsome Mutagenicity Assay was performed to determine the mutagenic nature of the test chemical. - GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537, and TA1538
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium, other: TA1538, TA98 and TA100
- Details on mammalian cell type (if applicable):
- Not specified
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 homogenate was prepared from male Sprague-Dawley rats and Syrian golden hamsters that had been injected with Aroclor 1254 at 500 mg/kg body weight
- Test concentrations with justification for top dose:
- 1,0.3- 100 µg/plate
2,0.1 mg/plate or 1 mg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: No data
- Justification for choice of solvent/vehicle: No data - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Remarks:
- No data
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: No data
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: Five doses of test chemical were tested in triplicate on each tester strain without and with metabolic activation.
NUMBER OF CELLS EVALUATED: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data
OTHER: No data - Rationale for test conditions:
- No data
- Evaluation criteria:
- For a test article to be considered positive, it had to induce at least a doubling (TA98, TA100, and TA1535) in the mean number of revertants per plate of at least one tester strain. This increase in the mean revertants per plate had to be accompanied by a dose response to increasing concentrations of the test chemical. If the study showed a dose response with a less than 3-fold increase on TA1537 or TA1538, the response had to be confirmed in a repeat experiment.
- Statistics:
- No data
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537, and TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium, other: TA1538, TA98 and TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: No data
- Other confounding effects: No data
RANGE-FINDING/SCREENING STUDIES: The doses that were tested in the mutagenicity assay were
selected based on the levels of cytotoxicity observed in a preliminary dose range-finding study using strain TA100. Ten dose levels of the chemical, one plate per dose, were tested in both the presence and the absence of induced hamster S9. If no toxicity was observed, a total maximum dose of 10 mg of test chemical per plate was used.
COMPARISON WITH HISTORICAL CONTROL DATA: No data
ADDITIONAL INFORMATION ON CYTOTOXICITY: No data - Remarks on result:
- other: No mutagenic potential
- Conclusions:
- Test chemical did not induce gene mutation in the Salmonella typhimurium TA98, TA100, TA1535, TA1537, and TA1538 with and without of metabolic activation system and hence is not likely to classify as a gene mutant in vitro.
- Executive summary:
Data for test chemicals was reviewed to determine the mutagenic nature of [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]malononitrile (54079-53-7). The studies are as mentioned below:
AMES Assay
Salmonella/Mammalian-Microsome Mutagenicity Assay was performed to determine the mutagenic nature of test substance. The study was performed at dose levels of 0.3-100 µg/plate using Salmonella typhimurium TA98, TA100, TA1535, TA1537, and TA1538 with and without S9 metabolic activation system. Concurrent solvent and positive controls were used in the study. Test chemical did not induce gene mutation in the Salmonella typhimurium TA98, TA100, TA1535, TA1537, and TA1538 with and without S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
Gene mutation study was performed to evaluate the mutagenic nature of test substance using Salmonella typhimurium strain TA1538 and TA100. Bacteria were grown overnight in Oxoid nutrient broth, then refrigerated at 4-5OC for a few hours before use. 0.1 ml of bacterial culture was added to 2 ml of 45°C molten top agar containing 0.01 mg histidine HCI and 0.012 mg biotin/ml, followed by the test sample in ≤0.2 ml DMSO. Finally, 0.5 ml of sodium phosphate buffer, pH 7.4 (no activation), or 0.5 ml of Aroclor-induced rat S9 mixture was added, and the mixture was poured on minimal glucose agar plates. Histidine revertant colonies were counted on a Biotran II automated colony counter after 2-day incubation at 37°C. A sample was judged mutagenic if it produced greater than twice the spontaneous background colonies at more than one dose or at the highest dose tested. In the above mentioned study, test substance failed to induce gene mutation in the Salmonella typhimurium strains TA1538 and TA100 with and without metabolic activation. Hence, test substance, is not likely to be a gene mutant in vitro.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data from handbook or collection of data.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- Weight of evidence prepared from various publication mention below
1,To evaluate the mutagenic potential of test substance in CHINESE HAMSTER V-79 by in vitro mammalian cell gene mutation assay.
2,To evaluate the mutagenic potential of test substance in Chinese hamster ovary by In vitro mammalian cell gene mutation assay - GLP compliance:
- not specified
- Type of assay:
- other: in vitro mammalian cell gene mutation assay
- Target gene:
- HGPRT locus (6-thioguanine resistance)
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- not specified
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- An Kanechlor 400 induced rat liver S9 fraction
- Test concentrations with justification for top dose:
- 1,0.3-33µg/mL
2,4.64-215 µg/mL - Vehicle / solvent:
- Yes, not specified
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- 1,METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 5 hour
NUMBER OF CELLS EVALUATED: 3 x 106
SELECTION AGENT (mutation assays): 6-TG, 60 µM
DETERMINATION OF CYTOTOXICITY
- Method: other: not specified
2,METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4hour
NUMBER OF CELLS EVALUATED: 5 x 105
SELECTION AGENT (mutation assays): 6-TG, 10 µM
DETERMINATION OF CYTOTOXICITY
- Method: other: not specified - Evaluation criteria:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 5 hour
NUMBER OF CELLS EVALUATED: 3 x 106
SELECTION AGENT (mutation assays): 6-TG, 60 µM
DETERMINATION OF CYTOTOXICITY
- Method: other: not specified
The mammalian cells were observed for mutagenic effects. - Statistics:
- Yes SD± Mean was observed.
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: No toxic potential was observed
- Conclusions:
- Test chemical was evaluated for its mutagenic potential in mammalian cells by in vitro mammalian cell gene mutation. The test result was considered to be negative both in the presence and absence of metabolic activation.
- Executive summary:
Genetic toxicity in vitro study was assessed for test chemical. For this purpose in vitro mammalian cell gene mutation was performed in Chinese hamster cells. The test chemical was exposed to the Chinese hamster cell sin the presence and absence of metabolic activation. Different concentration of test material used on cells were in µg/mL. No mutagenic frequency were observed in the mammalian cells in the presence and absence of metabolic activation. Therefore test chemical was considered to be non-mutagenic in Chinese hamster cells by in vitro mammalian cell gene mutation. Hence the substance cannot be classified as mutagenic in vitro.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data for test chemicals was reviewed to determine the mutagenic nature of [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]malononitrile (54079-53-7). The studies are as mentioned below:
AMES Assay
Salmonella/Mammalian-Microsome Mutagenicity Assay was performed to determine the mutagenic nature of test substance. The study was performed at dose levels of 0.3-100 µg/plate using Salmonella typhimurium TA98, TA100, TA1535, TA1537, and TA1538 with and without S9 metabolic activation system. Concurrent solvent and positive controls were used in the study. Test chemical did not induce gene mutation in the Salmonella typhimurium TA98, TA100, TA1535, TA1537, and TA1538 with and without S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
Gene mutation study was performed to evaluate the mutagenic nature of test substance using Salmonella typhimurium strain TA1538 and TA100. Bacteria were grown overnight in Oxoid nutrient broth, then refrigerated at 4-5OC for a few hours before use. 0.1 ml of bacterial culture was added to 2 ml of 45°C molten top agar containing 0.01 mg histidine HCI and 0.012 mg biotin/ml, followed by the test sample in ≤0.2 ml DMSO. Finally, 0.5 ml of sodium phosphate buffer, pH 7.4 (no activation), or 0.5 ml of Aroclor-induced rat S9 mixture was added, and the mixture was poured on minimal glucose agar plates. Histidine revertant colonies were counted on a Biotran II automated colony counter after 2-day incubation at 37°C. A sample was judged mutagenic if it produced greater than twice the spontaneous background colonies at more than one dose or at the highest dose tested. In the above mentioned study, test substance failed to induce gene mutation in the Salmonella typhimurium strains TA1538 and TA100 with and without metabolic activation. Hence, test substance, is not likely to be a gene mutant in vitro.
In vitro gene mutation study in mammalian cell
Genetic toxicity in vitro study was assessed for test chemical. For this purpose in vitro mammalian cell gene mutation was performed in Chinese hamster V-79 cells. The test chemical was exposed to the Chinese hamster V-79 cell sin the presence and absence of metabolic activation. The concentration of test material used on cells were 0.3-33µg/mL. No mutagenic frequency were observed in the mammalian cells in the presence and absence of metabolic activation. Therefore test chemical was
considered to be non-mutagenic in Chinese hamster V-79 calls by in vitro mammalian cell gene mutation. Hence the substance cannot be classified as mutagenic in vitro.
Genetic toxicity in vitro study was assessed for test chemical. For this purpose in vitro mammalian cell gene mutation was performed in Chinese hamster ovary cells. The test chemical was exposed to the Chinese hamster V-79 cells in the presence and absence of metabolic activation. The concentration of test material used on cells were 4.64-215 µg/mL. No mutagenic frequency were observed in the mammalian cells in the presence and absence of metabolic activation. Therefore test chemical was
considered to be non-mutagenic in Chinese hamster ovary cells by in vitro mammalian cell gene mutation. Hence the substance cannot be classified as mutagenic in vitro.
Based on the data summarized, [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]malononitrile (54079-53-7)is expected to not induce gene mutation In vitro. Hence it is not likely to be mutagenic in vitro.
Justification for classification or non-classification
Thus based on the above annotation and CLP criteria for target substance [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]malononitrile (54079-53-7) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.
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