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EC number: 225-876-3 | CAS number: 5131-58-8
- 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
Gene mutation toxicity study was performed to determine the mutagenic nature of p-nitro-m-phenylenediamine (p-NO2-m-PD). The study was performed by the Ames method with the suspension assay using Salmonella typhimurium strain TA98 with and without of S9 activation system. The test chemical dissolved in DMSO was used at dose levels of 0, 10 or 30 µg/plate in triplicate. Concurrent solvent and positive controls were included in the study.
p-nitro-m-phenylenediamine (p-NO2-m-PD) did not induce a dose dependent increase in the number of revertnats/plate as compared to controls using Salmonella typhimurium strain TA98 in the presence and absence of S9 activation system and hence the 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Gene mutation toxicity study was performed to determine the mutagenic nature of p-nitro-m-phenylenediamine (p-NO2-m-PD)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- - Name of test material : 4-nitro-m-phenylenediamine
- IUPAC name: 4-nitrobenzene-1,3-diamine
- Molecular formula : C6H7N3O2
- Molecular weight : 153.14 g/mol
- Substance type: organic
- Physical state: No data
- Purity: No data available
- Impurities (identity and concentrations): No data available - Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium TA 98
- 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 postmitochondrial fraction (S9) was prepared from the liver of male Sprague-Dawley rats induced with PCB.
- Test concentrations with justification for top dose:
- 0, 10 or 30 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The chemical was soluble 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:
- 2-acetylaminofluorene
- 4-nitroquinoline-N-oxide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension
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: 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 - Rationale for test conditions:
- No data
- Evaluation criteria:
- The plates were observed for a dose dependent increase in the number of revertants/plate
- Statistics:
- No data
- Species / strain:
- S. typhimurium TA 98
- 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
- Additional information on results:
- No data
- Conclusions:
- p-nitro-m-phenylenediamine (p-NO2-m-PD) did not induce a dose dependent increase in the number of revertnats/plate as compared to controls using Salmonella typhimurium strain TA98 in the presence and absence of S9 activation system and hence the chemical is not likely to classify as a gene mutant in vitro.
- Executive summary:
Gene mutation toxicity study was performed to determine the mutagenic nature of p-nitro-m-phenylenediamine (p-NO2-m-PD). The study was performed by the Ames method with the suspension assay using Salmonella typhimurium strain TA98 with and without of S9 activation system. The test chemical dissolved in DMSO was used at dose levels of 0, 10 or 30 µg/plate in triplicate. Concurrent solvent and positive controls were included in the study.
p-nitro-m-phenylenediamine (p-NO2-m-PD) did not induce a dose dependent increase in the number of revertnats/plate as compared to controls using Salmonella typhimurium strain TA98 in the presence and absence of S9 activation system and hence the chemical is not likely to classify as a gene mutant in vitro.
Reference
Table: Mutagenicity for the test compoundp-nitro-m-phenylenediamine (p-NO2-m-PD)
Sample |
Histidine revertants/dose |
|
-S9 |
+S9 |
|
p-NO2-m-PD |
17/10 |
25/10 |
28/30 |
32/30 |
|
DMSO |
18 |
21 |
4NQO |
411 |
- |
AAF |
- |
470 |
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:
Various peer reviewed publications were reviewed to determine the mutagenic nature of . The studies are as mentioned below:
Gene mutation toxicity study was performed by Watanabe et al (Mutation Research, 1989) to determine the mutagenic nature of p-nitro-m-phenylenediamine (p-NO2-m-PD; CAS no 5131 -58 -8; IUPAC name: 4-nitrobenzene-1,3-diamine). The study was performed by the Ames method with the suspension assay using Salmonella typhimurium strain TA98 with and without of S9 activation system. The test chemical dissolved in DMSO was used at dose levels of 0, 10 or 30 µg/plate in triplicate. Concurrent solvent and positive controls were included in the study. p-nitro-m-phenylenediamine (p-NO2-m-PD) did not induce a dose dependent increase in the number of revertnats/plate as compared to controls using Salmonella typhimurium strain TA98 in the presence and absence of S9 activation system and hence the chemical is not likely to classify as a gene mutant in vitro.
Watanabe et al (Mutation Research, 1991) also performed gene mutation toxicity study to determine the mutagenic nature of p-nitro-m-phenylenediamine (p-nitro-m-PD; CAS no 5131 -58 -8; IUPAC name:4-nitrobenzene-1,3-diamine). The study was performed by the Ames method using Salmonella typhimurium strain TA98 with and without of S9 activation system. p-nitro-m-phenylenediamine (p-nitro-m-PD) failed to induce gene mutation in Salmonella typhimurium strain TA98 in the presence and absence of S9 activation system and hence the chemical is not likely to classify as a gene mutant in vitro.
Based on the data available for the target chemical, p-nitro-m-phenylenediamine did not induce gene mutation in vitro. Hence the chemical is not likely to classify as a gene mutant in vitro.
Justification for classification or non-classification
Based on the data available for the target chemical, p-nitro-m-phenylenediamine did not induce gene mutation in vitro. Hence the chemical is not likely to classify as a gene mutant in vitro.
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