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EC number: 288-538-4 | CAS number: 85750-13-6
- 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
Gene mutation in vitro:
Ames assay:
Gene mutation toxicity studies of the read across chemicals were reviewed to determine the mutagenic nature of the target chemical 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline. The studies are as mentioned below:
Ames assay was performed to determine the mutagenic nature of the given 50 -60% structurally and functionally similar test chemical. The study was performed using Salmonella typhimurium strains TA98 and TA100 in the presence and absence of metabolic activation system. The study was performed as per the princubation assay. The test chemical was preincubated with the bacterial strains for 1 hr and studied at dose levels of 0-100 µg/plate. The test chemical did not induce gene mutation in Salmonella typhimurium strains TA98 and TA100 in the presence and absence of metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
In another study, bacterial gene mutation assay was performed to determine the mutagenic nature of another 50 -60% structurally and functionally similar test chemical. The study was performed using Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 in the presence and absence of S9 metabolic activation system. The study was performed as per the standard plate incorporation assay. The test chemical did not induce gene mutation in Salmonella typhimurium strains TA100, TA1535, TA1537 in the presence and absence of S9 metabolic activation system. It however induced gene mutation in Salmonella typhimurium strain TA98 in the presence of S9 metabolic activation system.
The given test chemical is therefore predicted to not induce gene mutation in Salmonella typhimurium strains in the presence and absence of metabolic activation system on the basis of the data available from the read across chemicals and hence it 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
- 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:
- bacterial reverse mutation assay
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium, other: TA98 and TA100
- Remarks:
- RA 1
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA1537, TA98 and TA100
- Remarks:
- RA 2
- 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:
- 10% (v/v) microsomal fractions (25% w/v) from Aroclor 1254-treated animals and supplemented with glucose 6-phosphate dehydrogenase (1 unit/plate).
- Test concentrations with justification for top dose:
- 1. 0-100 µg/plate
2. No data - Vehicle / solvent:
- 1. No data
1. 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:
- RA 1
- Details on test system and experimental conditions:
- 1. METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 1 hr in shaking water bath at 37˚C
- Exposure duration: No data
- Expression time (cells in growth medium): No data
- 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: Triplicate
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
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
- 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: No data
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:
- 1. No data
- Evaluation criteria:
- 1. The plates were observed for an increase in the number of revertants/plate
2. The plates were observed for an increase in the number of revertants/plate - Statistics:
- 1. Statistical analysis was carried out using Student's t-test.
2. No data - Species / strain:
- S. typhimurium, other: TA98 and TA100
- 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: TA100, TA1535, TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- 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:
- 1. No data
2. No data - Remarks on result:
- other: No mutagenic potential
- Conclusions:
- The given test chemical is predicted to not induce gene mutation in Salmonella typhimurium strains in the presence and absence of metabolic activation system on the basis of the data available from the read across chemicals and hence it is not likely to classify as a gene mutant in vitro.
- Executive summary:
Gene mutation toxicity studies of the read across chemicals were reviewed to determine the mutagenic nature of the target chemical 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline. The studies are as mentioned below:
Ames assay was performed to determine the mutagenic nature of the given 50 -60% structurally and functionally similar test chemical. The study was performed using Salmonella typhimurium strains TA98 and TA100 in the presence and absence of metabolic activation system. The study was performed as per the princubation assay. The test chemical was preincubated with the bacterial strains for 1 hr and studied at dose levels of 0-100 µg/plate. The test chemical did not induce gene mutation in Salmonella typhimurium strains TA98 and TA100 in the presence and absence of metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
In another study, bacterial gene mutation assay was performed to determine the mutagenic nature of another 50 -60% structurally and functionally similar test chemical. The study was performed using Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 in the presence and absence of S9 metabolic activation system. The study was performed as per the standard plate incorporation assay. The test chemical did not induce gene mutation in Salmonella typhimurium strains TA100, TA1535, TA1537 in the presence and absence of S9 metabolic activation system. It however induced gene mutation in Salmonella typhimurium strain TA98 in the presence of S9 metabolic activation system.
The given test chemical is therefore predicted to not induce gene mutation in Salmonella typhimurium strains in the presence and absence of metabolic activation system on the basis of the data available from the read across chemicals and hence it is not likely to classify as a gene mutant in vitro.
Reference
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:
Gene mutation toxicity studies of the read across chemicals were reviewed to determine the mutagenic nature of the target chemical 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline. The studies are as mentioned below:
Ames assay was performed to determine the mutagenic nature of the given 50 -60% structurally and functionally similar test chemical. The study was performed using Salmonella typhimurium strains TA98 and TA100 in the presence and absence of metabolic activation system. The study was performed as per the princubation assay. The test chemical was preincubated with the bacterial strains for 1 hr and studied at dose levels of 0-100 µg/plate. The test chemical did not induce gene mutation in Salmonella typhimurium strains TA98 and TA100 in the presence and absence of metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
In another study, bacterial gene mutation assay was performed to determine the mutagenic nature of another 50 -60% structurally and functionally similar test chemical. The study was performed using Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 in the presence and absence of S9 metabolic activation system. The study was performed as per the standard plate incorporation assay. The test chemical did not induce gene mutation in Salmonella typhimurium strains TA100, TA1535, TA1537 in the presence and absence of S9 metabolic activation system. It however induced gene mutation in Salmonella typhimurium strain TA98 in the presence of S9 metabolic activation system.
The given test chemical is therefore predicted to not induce gene mutation in Salmonella typhimurium strains in the presence and absence of metabolic activation system on the basis of the data available from the read across chemicals and hence it is not likely to classify as a gene mutant in vitro.
Justification for classification or non-classification
Based on the data available for the read across chemicals, 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline does not exhibit gene mutation in vitro. Hence the test chemical is not likely to be mutagenic 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.
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