Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 945-065-4 | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation in vitro:
Ames test:
Data available for the read across chemicals was reviewed to determine the mutagenic nature of N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo] naphthalen-2-amine. The studies are as mentioned below:
Salmonella/microsome test in the absence of exogenous metabolic activation and in the presence of liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters was performed to evaluate the mutagenic nature of the test chemical usingS. typhimuriumtester strains TA1535, TA97, TA98 and TA100. The study was performed as per the preincubation assay and the preincubation time was 20 mins and the plates were incubated for 48 hrs. The test compound was dissolved in DMSO and was used at a dosage level of 0, 0.03, 0.1, 0.3, 1.0, 3.0, 10, 33, 100 or 333 µg/plate in the preincubation assay of 48 hrs. Concurrent solvent and positive control chemicals were included in the study. The test chemical did not induce a reproducible, dose-related increase in his+revertants over the corresponding solvent in the S. typhimurium tester strains TA100, TA97, TA1535 and TA98 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
Ames assay in the absence of exogenous metabolic activation and in the presence and absence of liver S-9 was performed to evaluate the mutagenic nature of the test chemical using S. typhimurium tester strains TA100, TA98, TA102 and TA97. The study was performed as per the plate incorporation assay. The test compound was dissolved in DMSO and was used at a dosage level of 0, 5, 25, 50, 75, 100 or 200µg/plate for strains TA98, TA97 and TA100 and at dose levels of 0, 0.25, 0.5, 1, 75, 50, 100 or 200µg/plate. Concurrent solvent control was also included in the study. The test chemical did not induce a reproducible, dose-related 2- fold increase in his+revertants over the corresponding solvent in the S. typhimurium tester strains TA100, TA98, TA102 and TA97 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
Based on the data available for the read across chemicals, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine (CAS no 93964 -07 -9) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.
Chromosome aberration test:
Gene mutation in vitro was predicted for the target chemical N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo] phenyl]azo] naphthalen-2-amine on the basis of the data from read across chemicals. The studies are as mentioned below:
The gene mutation study was conducted according to L5178Y TK+/-Mouse Lymphoma Mutagenicity Assay to determine the mutagenic nature of 60 -70% and 50 -60% structurally and functionally similar test chemical. The Cells at a concentration of 6 X 105/mL (6 X106cells total) were exposed for 4 h to a range of concentrations from 1 -349 µg/mL of the test chemical 1 and 1 -19 µg/mL for test chemical 2. The cells were then washed, resuspended in growth medium, and incubated at 37°C for 48 h. The rate of cell growth was determined for each of the treated cultures and compared to the rate of growth of the solvent controls.Results 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. The test chemical 1 did not induce a doubling of the mutant frequency both in the presence and absence of S9 activation system. Another test chemical 2 did not induce a doubling of the mutant frequency in the presence of S9 activation system and an equivocal response was noted in the absence of S9 metabolic activation system and based on these observations, the test chemical 1 and 2 are not likely to be gene mutant in vitro.
Based on the data available for the read across chemicals, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo] phenyl]azo] naphthalen-2-amine (CAS no 93964 -07 -9) does not exhibit gene mutation in vitro. Hence the test chemical is considered to be non-mutagenic as per the criteria mentioned in CLP regulation.
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
- Remarks:
- experimental data of read across substances
- 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: Refer below principle
- Principles of method if other than guideline:
- WoE report is based on gene mutation toxicity study for the read across chemicals-
1. and 2. Bacterial reverse mutation assay was performed to evaluate the mutagenic nature of the test chemicals - GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium, other: TA98, TA100, TA1535, and TA97
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- The S-9 fractions of Aroclor 1254-induced, male Sprague-Dawley rat and male Syrian hamster livers were prepared
- Test concentrations with justification for top dose:
- 1. 0, 0.03, 0.1, 0.3, 1.0, 3.0, 10, 33, 100 or 333 µg/plate
2. Strains TA98. TA97, TA100: 0, 5, 25, 50, 75, 100 or 200 µg/plate
Strain TA102: 0, 0.25, 0.5, 1, 75, 50, 100 or 200 µg/plate - Vehicle / solvent:
- 1. and 2.
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The chemical was soluble and stable in DMSO - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 2-Aminoanthracene (2-AA) (All strains, with S9), 4-nitro-o-phenylenediamine (TA98, -S9)
- Remarks:
- RA 1
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Remarks:
- RA 2
- Details on test system and experimental conditions:
- 1. METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 mins
- 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
SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available
NUMBER OF REPLICATIONS: Triplicate
NUMBER OF CELLS EVALUATED: No data available
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available
OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other:
OTHER: No data available
2. METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: No data
- Exposure duration: No data
- Expression time (cells in growth medium): No data
- 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): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available
NUMBER OF REPLICATIONS: Triplicate
NUMBER OF CELLS EVALUATED: No data available
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available
OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other:
OTHER: No data available - Rationale for test conditions:
- No data
- Evaluation criteria:
- 1. An individual trial was judged mutagenic (+) if a dose-related increase over the corresponding solvent control was seen, and it was judged weakly mutagenic C+W) if a low-level dose response was seen. A trial was considered questionable (?) if a dose-related increase was judged insufficiently high to justify a call of "+W," if only a single dose was elevated over the control, or if a non-dose-related increase was seen.
The chemical was judged to be mutagenic (+), or weakly mutagenic (+W), if it produced a reproducible, dose-related increase in his+ revertants over the corresponding solvent controls in replicate trials.
It chemical was considered to be questionable (?) if a reproducible increase of his+ revertants did not meet the criteria for either a " + " or " + W," or if only single doses produced an increase in his+ revertants in repeat trials.
2. The plates were observed for a 2-fold increase in the number of revertants/plate - Statistics:
- No data
- Species / strain:
- S. typhimurium, other: No data
- Remarks:
- RA 1
- 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: TA98, TA102, TA100, TA97
- Remarks:
- RA 2
- 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
- Additional information on results:
- 1. TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data available
- Effects of osmolality: No data available
- Evaporation from medium: No data available
- Water solubility: No data available
- Precipitation: No data available
- Other confounding effects: No data available
RANGE-FINDING/SCREENING STUDIES: The chemical was tested initially in a toxicity assay to determine the appropriate dose range. The toxicity assay was performed by using TA100 or the system developed by Waleh et al. Toxic concentrations were those at which a decrease in the number of his+ colonies was seen or at which there was a clearing in the density of the background lawn
COMPARISON WITH HISTORICAL CONTROL DATA: No data available
ADDITIONAL INFORMATION ON CYTOTOXICITY: No data available - Remarks on result:
- no mutagenic potential (based on QSAR/QSPR prediction)
- Conclusions:
- N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine (CAS no 93964 -07 -9) does not exhibit gene mutation in vitro in Salmonell tester strains in the presence and absence of S9 metabolic activaton system. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.
- Executive summary:
Data available for the read across chemicals was reviewed to determine the mutagenic nature of N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo] naphthalen-2-amine. The studies are as mentioned below:
Salmonella/microsome test in the absence of exogenous metabolic activation and in the presence of liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters was performed to evaluate the mutagenic nature of the test chemical using S. typhimurium tester strains TA1535, TA97, TA98 and TA100. The study was performed as per the preincubation assay and the preincubation time was 20 mins and the plates were incubated for 48 hrs. The test compound was dissolved in DMSO and was used at a dosage level of 0, 0.03, 0.1, 0.3, 1.0, 3.0, 10, 33, 100 or 333 µg/plate in the preincubation assay of 48 hrs. Concurrent solvent and positive control chemicals were included in the study. The test chemical did not induce a reproducible, dose-related increase in his+revertants over the corresponding solventin the S. typhimurium tester strains TA100, TA97, TA1535 and TA98 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
Ames assay in the absence of exogenous metabolic activation and in the presence and absence of liver S-9 was performed to evaluate the mutagenic nature of the test chemical using S. typhimurium tester strains TA100, TA98, TA102 and TA97. The study was performed as per the plate incorporation assay. The test compound was dissolved in DMSO and was used at a dosage level of 0, 5, 25, 50, 75, 100 or 200µg/plate for strains TA98, TA97 and TA100 and at dose levels of 0, 0.25, 0.5, 1, 75, 50, 100 or 200µg/plate. Concurrent solvent control was also included in the study. The test chemical did not induce a reproducible, dose-related 2- fold increase in his+revertants over the corresponding solvent in the S. typhimurium tester strains TA100, TA98, TA102 and TA97 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
Based on the data available for the read across chemicals, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine (CAS no 93964 -07 -9) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.
- 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
- Remarks:
- experimental data of read across substances
- 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: Refer below principle
- Principles of method if other than guideline:
- WoE derived based on the experimental data from structurally and functionally similar read across chemicals
- GLP compliance:
- not specified
- Type of assay:
- other: Mammalian cell gene mutation assay
- Target gene:
- 1/2. Thymidine kinase
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Remarks:
- TK+/- 3.7.C / RA 1/ 2
- Details on mammalian cell type (if applicable):
- - 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.
- Properly maintained: No data available
- Periodically checked for Mycoplasma contamination: Yes
- Periodically checked for karyotype stability: No data available
- Periodically "cleansed" against high spontaneous background: No data available - Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 fraction was prepared from Aroclor 1254-induced male Sprague- Dawley rats.
- Test concentrations with justification for top dose:
- 1. 1-349 µg/mL
2. 1-19 µg/mL - Vehicle / solvent:
- 1. No data
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- methylmethanesulfonate
- other: 3-methylcholanthrene at 1.86 × 10-5 M (or dimethylbenz[a]- anthracene at 0.5-4 µg/mL) for the test with metabolic activation.
- Remarks:
- RA 1/ RA 2
- Details on test system and experimental conditions:
- 1/2. METHOD OF APPLICATION: in medium;
- Cell density at seeding (if applicable): 6000000 cells
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: Duplicate
NUMBER OF CELLS EVALUATED: 1 X 106 cells/plate for mutant selection and 200
cells/plate for viable count determinations
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: The rate of cell growth was determined for each of the treated cultures
OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available
OTHER: No data available - Rationale for test conditions:
- 1/2. No data
- Evaluation criteria:
- 1/2. Results 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. Doubling of the mutant frequency was previously reported as representing a positive effect. Only doses yielding total growth values of 10% were used in the analysis of induced mutant frequency. Doses yielding less than 10% total growth were used in determining dose response.
- Statistics:
- No data available
- Species / strain:
- mouse lymphoma L5178Y cells
- Remarks:
- TK+/- 3.7.C / RA 1
- 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:
- valid
- Species / strain:
- mouse lymphoma L5178Y cells
- Remarks:
- TK+/- 3.7.C / RA 2
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- mouse lymphoma L5178Y cells
- Remarks:
- TK+/- 3.7.C / RA 2
- Metabolic activation:
- without
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- 1/2. No data
- Remarks on result:
- other: No mutagenic potential
- Conclusions:
- The test chemical did not induce a doubling of the mutant frequency both in the presence and absence of S9 activation system and hence is not likely to be gene mutant in vitro.
- Executive summary:
Gene mutation in vitro was predicted for the target chemical N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo] phenyl]azo] naphthalen-2-amine on the basis of the data from read across chemicals. The studies are as mentioned below:
The gene mutation study was conducted according to L5178Y TK+/-Mouse Lymphoma Mutagenicity Assay to determine the mutagenic nature of 60 -70% and 50 -60% structurally and functionally similar test chemical. The Cells at a concentration of 6 X 105/mL (6 X106cells total) were exposed for 4 h to a range of concentrations from 1 -349 µg/mL of the test chemical 1 and 1 -19 µg/mL for test chemical 2. The cells were then washed, resuspended in growth medium, and incubated at 37°C for 48 h. The rate of cell growth was determined for each of the treated cultures and compared to the rate of growth of the solvent controls.Results 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. The test chemical 1 did not induce a doubling of the mutant frequency both in the presence and absence of S9 activation system. Another test chemical 2 did not induce a doubling of the mutant frequency in the presence of S9 activation system and an equivocal response was noted in the absence of S9 metabolic activation system and based on these observations, the test chemical 1 and 2 are not likely to be gene mutant in vitro.
Based on the data available for the read across chemicals, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo] phenyl]azo] naphthalen-2-amine does not exhibit gene mutation in vitro. Hence the test chemical is considered to be non-mutagenic as per the criteria mentioned in CLP regulation.
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
Gene mutation in vitro:
Ames test:
Data available for the read across chemicals was reviewed to determine the mutagenic nature of N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo] naphthalen-2-amine. The studies are as mentioned below:
Salmonella/microsome test in the absence of exogenous metabolic activation and in the presence of liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters was performed to evaluate the mutagenic nature of the test chemical usingS. typhimuriumtester strains TA1535, TA97, TA98 and TA100. The study was performed as per the preincubation assay and the preincubation time was 20 mins and the plates were incubated for 48 hrs. The test compound was dissolved in DMSO and was used at a dosage level of 0, 0.03, 0.1, 0.3, 1.0, 3.0, 10, 33, 100 or 333 µg/plate in the preincubation assay of 48 hrs. Concurrent solvent and positive control chemicals were included in the study. The test chemical did not induce a reproducible, dose-related increase in his+revertants over the corresponding solventin theS. typhimuriumtester strains TA100, TA97, TA1535 and TA98 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
Ames assay in the absence of exogenous metabolic activation and in the presence and absence of liver S-9 was performed to evaluate the mutagenic nature of the test chemical using S. typhimurium tester strains TA100, TA98, TA102 and TA97. The study was performed as per the plate incorporation assay. The test compound was dissolved in DMSO and was used at a dosage level of 0, 5, 25, 50, 75, 100 or 200µg/plate for strains TA98, TA97 and TA100 and at dose levels of 0, 0.25, 0.5, 1, 75, 50, 100 or 200µg/plate. Concurrent solvent control was also included in the study. The test chemical did not induce a reproducible, dose-related 2- fold increase in his+revertants over the corresponding solvent in theS. typhimuriumtester strains TA100, TA98, TA102 and TA97 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
Based on the data available for the read across chemicals, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine (CAS no 93964 -07 -9) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.
Chromosome aberration test:
Gene mutation in vitro was predicted for the target chemical N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo] phenyl]azo] naphthalen-2-amine on the basis of the data from read across chemicals. The studies are as mentioned below:
The gene mutation study was conducted according to L5178Y TK+/-Mouse Lymphoma Mutagenicity Assay to determine the mutagenic nature of 60 -70% and 50 -60% structurally and functionally similar test chemical. The Cells at a concentration of 6 X 105/mL (6 X106cells total) were exposed for 4 h to a range of concentrations from 1 -349 µg/mL of the test chemical 1 and 1 -19 µg/mL for test chemical 2. The cells were then washed, resuspended in growth medium, and incubated at 37°C for 48 h. The rate of cell growth was determined for each of the treated cultures and compared to the rate of growth of the solvent controls.Results 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. The test chemical 1 did not induce a doubling of the mutant frequency both in the presence and absence of S9 activation system. Another test chemical 2 did not induce a doubling of the mutant frequency in the presence of S9 activation system and an equivocal response was noted in the absence of S9 metabolic activation system and based on these observations, the test chemical 1 and 2 are not likely to be gene mutant in vitro.
Based on the data available for the read across chemicals, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo] phenyl]azo] naphthalen-2-amine (CAS no 93964 -07 -9) does not exhibit gene mutation in vitro. Hence the test chemical is considered to be non-mutagenic as per the criteria mentioned in CLP regulation.
Justification for classification or non-classification
Based on the data available for the its read across, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine (CAS no 93964 -07 -9) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)