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EC number: 296-117-1 | CAS number: 92257-28-8
- 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
Genetic mutation in vitro;
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Experimental data from read across chemical have been reviewed to determine the mutagenic nature of N-(2-ethylhexyl)-1-[4-(2-phenyldiazen-1-yl)phenyl]naphthalen-2-amine (92257-28-8).The studies are as mentioned below
AMES test
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Salmonella/ mammalian-microsome test was performed to evaluate the mutagenic nature of the test compound Test chemical. The study was performed using Salmonella typhimurium strains TA98, TA1537, TA100, TA1535 with and without S9 metabolic activation system. The test material was dissolved in DMSO and used at dose a level from 10-250 mg. DMSO was used as the solvent control. The 2 ml of liquid top agar was cooled to 45°C and 0.1 ml of a broth culture of microorganism and test substance in volumes of ≤ 0.4 ml of DMSO was added prior to placing on minimal agar plates. After 48 h incubation at 37°C, the colonies which reverted to the prototroph were counted and compared to counts on the control plate (containing no test substance) to demonstrate mutagenicity or toxicity. Materials which caused a 2-fold increase of revertants, as compared to the number of spontaneous revertants on the control plates, were denoted as mutagens. Those which reduced the number of revertants were considered inhibitory. Test chemical did not induce gene mutation in Salmonella typhimuriumTA98, TA1537, TA100, TA1535 in the presence and absence of S9 metabolic activation system and hence it is negative for gene mutation in vitro.
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. Gene mutation toxicity study was performed to determine the mutagenic nature of test chemical. The study was performed using Salmonella typhimurium strains TA97a, TA98, TA100 and TA102 with and without S9 metabolic activation system. The test chemical was dissolved in sterilized distilled water and used at dose levels of 0, 1, 10, 100 or 500µg/plate. Concurrent spontaneous revertants and positive controls were also included in the study. The plates were incubated for 48 hrs and the plates were observed for 2-fold increase in the number of revertants per plate. Test chemical did not induce gene mutation in Salmonella typhimurium strainsTA97a, TA98, TA100 and TA102 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
In vitro Mammalian cell assay;
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance.L5178Y TK+/-Mouse Lymphoma Mutagenicity Assay was conducted on test chemical.L5178Y TK+/- 3.7.C mouse lymphoma cells were grown in Fischer’s medium for leukemic cells of mice supplemented with 10% horse serum and 0.02% pluronic F-68.Cells at a concentration of 6 ×105/mL were exposed for 4 h to a range of concentrations from 200-1000µg/ml.The test chemical showed negative gene toxic effect with andWithout S9 activation inL5178Y TK+/-Mouse Lymphoma Mutagenicity Assay. Hence the test chemical cannot be classified as gene mutant in vitro.
The data available for the target chemical based on its read across substance and applying weight of evidence N-(2-ethylhexyl)-1-[4-(2-phenyldiazen-1-yl)phenyl]naphthalen-2-amine (92257-28-8) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- 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 for the target chemical is summarized based on the structurally similar read across chemicals
- 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:
- WoE derived based on the experimental data from structurally and functionally similar read across chemicals for the target chemical.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium, other: TA98, TA1537, TA100, TA1535
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium, other: TA97a, TA98, TA100 and TA102
- Details on mammalian cell type (if applicable):
- Not applicable.
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- The microsomal fraction (S9) was prepared from male Sprague-Dawley rats weighing approximately 200 g each.
- Test concentrations with justification for top dose:
- 1.10-250 mg
2.0, 1, 10, 100 or 500 µg/plate - Vehicle / solvent:
- 1.DMSO
2.Sterilized distilled water - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- not specified
- Details on test system and experimental conditions:
- 1.Details on test system and conditions
METHOD OF APPLICATION: Plate incorporation assay
DURATION
- Preincubation period: No data available
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available
2.Details on test system and 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):
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays):
NUMBER OF REPLICATIONS: The mutagenicity tests were performed in at least two series of assays with duplicate plates per dose; three plates were used for determinations of spontaneous reversion
NUMBER OF CELLS EVALUATED: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: To estimate the toxic effect, the spareness of the bacterial growth lawn was considered and the relative decline in the mutant values was determined.
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data
OTHER: Revertant colonies were counted
with an automatic counter Biotran II from New Brunswick Scientific Co. Inc., NJ - Rationale for test conditions:
- Not specified
- Evaluation criteria:
- 1.Material which caused a 2-fold increase of revertants, as compared to the number of spontaneous revertants on the control plates, was denoted as mutagens. Those which reduced the number of revertants were considered inhibitory.
2.At least a 2-fold increase in the number of revertants per plate as compared to the number of revertants per control plates (number of spontaneous revertants) was the criterion for judging whether a given compound was a mutagen or not. - Statistics:
- 1.Not specified
2.Not specified - Species / strain:
- S. typhimurium, other: A98, TA1537, TA100, TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium, other: TA97a, TA98, TA100 and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: No mutagenic effect were observed
- Conclusions:
- Gene mutation toxicity study for N-(2-ethylhexyl)-1-[4-(2-phenyldiazen-1-yl)phenyl]naphthalen-2-amine (92257-28-8) as predicted using data from read across chemicals for Salmonella typhimurium bacterial strains in the presence and absence of S9 metabolic activation system is negative and hence the chemical is not likely to classify as a gene mutant in vitro.
- Executive summary:
Genetic mutation in vitro;
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Experimental data from read across chemical have been reviewed to determine the mutagenic nature of N-(2-ethylhexyl)-1-[4-(2-phenyldiazen-1-yl)phenyl]naphthalen-2-amine (92257-28-8).The studies are as mentioned below
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Salmonella/ mammalian-microsome test was performed to evaluate the mutagenic nature of the test compound Test chemical. The study was performed using Salmonella typhimurium strains TA98, TA1537, TA100, TA1535 with and without S9 metabolic activation system. The test material was dissolved in DMSO and used at dose a level from 10-250 mg. DMSO was used as the solvent control. The 2 ml of liquid top agar was cooled to 45°C and 0.1 ml of a broth culture of microorganism and test substance in volumes of ≤ 0.4 ml of DMSO was added prior to placing on minimal agar plates. After 48 h incubation at 37°C, the colonies which reverted to the prototroph were counted and compared to counts on the control plate (containing no test substance) to demonstrate mutagenicity or toxicity. Materials which caused a 2-fold increase of revertants, as compared to the number of spontaneous revertants on the control plates, were denoted as mutagens. Those which reduced the number of revertants were considered inhibitory. Test chemical did not induce gene mutation in Salmonella typhimuriumTA98, TA1537, TA100, TA1535 in the presence and absence of S9 metabolic activation system and hence it is negative for gene mutation in vitro.
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. Gene mutation toxicity study was performed to determine the mutagenic nature of test chemical. The study was performed using Salmonella typhimurium strains TA97a, TA98, TA100 and TA102 with and without S9 metabolic activation system. The test chemical was dissolved in sterilized distilled water and used at dose levels of 0, 1, 10, 100 or 500µg/plate. Concurrent spontaneous revertants and positive controls were also included in the study. The plates were incubated for 48 hrs and the plates were observed for 2-fold increase in the number of revertants per plate. Test chemical did not induce gene mutation in Salmonella typhimurium strainsTA97a, TA98, TA100 and TA102 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
The data available for the target chemical based on its read across substance and applying weight of evidence N-(2-ethylhexyl)-1-[4-(2-phenyldiazen-1-yl)phenyl]naphthalen-2-amine (92257-28-8) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as 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 for the target chemical is summarized based on the structurally similar read across chemical
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Principles of method if other than guideline:
- WoE derived based on the experimental data from structurally similar read across chemcal
- GLP compliance:
- not specified
- Type of assay:
- other: Mammalian cell gene mutation assay
- Specific details on test material used for the study:
- - Name of test material : 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs.
- IUPAC name : N-(2-ethylhexyl)-1-[4-(2-phenyldiazen-1-yl)phenyl]naphthalen-2-amine
- Molecular formula : C30H33N3
- Molecular weight : 435.60 g/mol
- Substance type : Organic
- Physical state : Liquid - Target gene:
- No data available.
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- Details on mammalian cell line
- Type and identity of media:
The cells were grown in Fischer’s
medium for leukemic cells of mice
supplemented with 10% horse serum and 0.02% pluronic
F-68. - Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9mix S9 prepared from Aroclor 1254-induced male Sprague- Dawley rats
- Test concentrations with justification for top dose:
- 200-1000µg/mL
- Vehicle / solvent:
- Yes ,but not specified
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: Ethyl methylsulfonate at 4.7×10-6 M (or methyl methanesulfonate at 10-20 µg/ml mL) for the test without metabolic activation. 3-methylcholanthrene at 1.86 × 10-5 M (or dimethylbenz[a]- anthracene at 0.5-4 µg/mL) for the test with metabolic activation.
- Details on test system and experimental conditions:
- Details on test system and conditions
METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk:
Suspension/plate
DURATION
- Preincubation period: No data available
- Exposure duration: 4-h
- Expression time (cells in growth medium):48-h
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available
SELECTION AGENT (mutation assays): 1×106 cells/plate for mutant selection
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available
NUMBER OF REPLICATIONS: No data available
NUMBER OF CELLS EVALUATED: No data available - Rationale for test conditions:
- Not specified
- Evaluation criteria:
- Only colonies larger than 0.2 mm in diameter were counted. Mutant frequencies were expressed as mutants per 106 surviving cells. Although there are several different
methods for evaluating mouse lymphoma data, results from this study were interpreted using a doubling of the mutant frequency
over the concurrent solvent-treated control value as an indication of a positive effect, together with evidence of a dose-related
increase. - Statistics:
- Yes ,Mean Standard deviation was observed
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: No mutagenic effect were observed
- Conclusions:
- Gene mutation toxicity study for N-(2-ethylhexyl)-1-[4-(2-phenyldiazen-1-yl)phenyl]naphthalen-2-amine (92257-28-8) as predicted using data from read across chemicals for mammmalian cell gene mutation assay.Test chemical did not induced genetoxic effect with and Without S9 activation in L5178Y TK+/- Mouse Lymphoma Mutagenicity Assay.
- Executive summary:
Data available for the read across chemicals was reviewed to determine the mutagenic nature of test chemical . The studies are as mentioned below:
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance.L5178Y TK+/-Mouse Lymphoma Mutagenicity Assay was conducted on test chemical.L5178Y TK+/- 3.7.C mouse lymphoma cells were grown in Fischer’s medium for leukemic cells of mice supplemented with 10% horse serum and 0.02% pluronic F-68.Cells at a concentration of 6 ×105/mL were exposed for 4 h to a range of concentrations from 200-1000µg/ml.The test chemical showed negative gene toxic effect with andWithout S9 activation inL5178Y TK+/-Mouse Lymphoma Mutagenicity Assay. Hence the test chemical cannot be classified as gene mutant in vitro.
On the basis of the data summarized from read across chemicals, the target chemical test chemical is not likely to mutagenic in the Mammalian cells used in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant 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
Genetic mutation in vitro;
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Experimental data from read across chemical have been reviewed to determine the mutagenic nature of N-(2-ethylhexyl)-1-[4-(2-phenyldiazen-1-yl)phenyl]naphthalen-2-amine (92257-28-8).The studies are as mentioned below
AMES test
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Salmonella/ mammalian-microsome test was performed to evaluate the mutagenic nature of the test compound Test chemical. The study was performed using Salmonella typhimurium strains TA98, TA1537, TA100, TA1535 with and without S9 metabolic activation system. The test material was dissolved in DMSO and used at dose a level from 10-250 mg. DMSO was used as the solvent control. The 2 ml of liquid top agar was cooled to 45°C and 0.1 ml of a broth culture of microorganism and test substance in volumes of ≤ 0.4 ml of DMSO was added prior to placing on minimal agar plates. After 48 h incubation at 37°C, the colonies which reverted to the prototroph were counted and compared to counts on the control plate (containing no test substance) to demonstrate mutagenicity or toxicity. Materials which caused a 2-fold increase of revertants, as compared to the number of spontaneous revertants on the control plates, were denoted as mutagens. Those which reduced the number of revertants were considered inhibitory. Test chemical did not induce gene mutation in Salmonella typhimuriumTA98, TA1537, TA100, TA1535 in the presence and absence of S9 metabolic activation system and hence it is negative for gene mutation in vitro.
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. Gene mutation toxicity study was performed to determine the mutagenic nature of test chemical. The study was performed using Salmonella typhimurium strains TA97a, TA98, TA100 and TA102 with and without S9 metabolic activation system. The test chemical was dissolved in sterilized distilled water and used at dose levels of 0, 1, 10, 100 or 500µg/plate. Concurrent spontaneous revertants and positive controls were also included in the study. The plates were incubated for 48 hrs and the plates were observed for 2-fold increase in the number of revertants per plate. Test chemical did not induce gene mutation in Salmonella typhimurium strainsTA97a, TA98, TA100 and TA102 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
In vitro Mammalian cell assay;
The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance.L5178Y TK+/-Mouse Lymphoma Mutagenicity Assay was conducted on test chemical.L5178Y TK+/- 3.7.C mouse lymphoma cells were grown in Fischer’s medium for leukemic cells of mice supplemented with 10% horse serum and 0.02% pluronic F-68.Cells at a concentration of 6 ×105/mL were exposed for 4 h to a range of concentrations from 200-1000µg/ml.The test chemical showed negative gene toxic effect with andWithout S9 activation inL5178Y TK+/-Mouse Lymphoma Mutagenicity Assay. Hence the test chemical cannot be classified as gene mutant in vitro.
The data available for the target chemical based on its read across substance and applying weight of evidence N-(2-ethylhexyl)-1-[4-(2-phenyldiazen-1-yl)phenyl]naphthalen-2-amine (92257-28-8) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.
Justification for classification or non-classification
Thus based on the above annotation and CLP criteria for target substance N-(2-ethylhexyl)-1-[4-(2-phenyldiazen-1-yl)phenyl]naphthalen-2-amine (92257-28-8) 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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