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EC number: 202-951-9 | CAS number: 101-54-2
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- other: assay protocol well documented comparable to current guidelines
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(4-aminophenyl)aniline
- EC Number:
- 202-951-9
- EC Name:
- N-(4-aminophenyl)aniline
- Cas Number:
- 101-54-2
- Molecular formula:
- C12H12N2
- IUPAC Name:
- N1-phenylbenzene-1,4-diamine
- Details on test material:
- purity: 99.28%, lot/batch no.:51
Constituent 1
Method
- Target gene:
- TA98, TA100, TA1535 and TA 1537
Species / strain
- Species / strain / cell type:
- other: TA98, TA100, TA1535 and TA 1537
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from aroclor 1254 induced livers
- Test concentrations with justification for top dose:
- 0, 0.05, 0.15, 0.5, 1.5, 5 mg/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitroquinoline-N-oxide, 2-acetylaminofluorene, benzo(a)pyrene, sodium nitrite, 2-aminoanthracene, 9-aminoacridine
- Details on test system and experimental conditions:
- The Salmonella typhimurium test strains (TA98, TA1 00, TA1 535 and TA1 537) were obtained from the laboratory of Dr. B. N. Ames (Berkeley, CA). The cultures used were inoculated from frozen permanent stocks and grown in nutrient broth at 37°± 1°C in a
shaking incubator. The proper phenotype of each culture was verified by tests for crystal violet sensitivity, ampicillin resistance, requirement for histidine and biotin and spontaneous reversion frequency.
Plate Incorporation Tests
The general procedures used were basically those described by Ames et al. (Ref. 1). Plate incorporation tests were performed by mixing 0.1 ml of bacterial culture and, if appropriate, 0.5 ml of S-9 Mix (as described above) with 2 ml of histidine-biotin top
agar (0.5% (w/v) NaCI, 0.6% (w/v) Difco agar, 0.05 mM L-histidine-HCI, 0.05 mM ( biotin) maintained at 44-48°C. The mixture was poured onto minimal glucose agar plates (Vogel-Bonner medium E of Ref. 2 with 2% glucose and 1.5% Difco agar).
Initially, a toxicity test was conducted with test strain TA100 with and without S-9 Mix to define dose levels for mutagenicity testing. The toxicity screen used the same general r procedures as those described above. Single plates were prepared for each
L S-9/dose level combination for the toxicity test. Toxicity was judged qualitatively by visual examination of the background lawn and consideration of reduction in revertant colonies. Once dose levels were established using information from the toxicity
screen, mutagenicity testing was conducted using plate incorporation assay methods and four test strains (TA98, TA1 00, TA1 535 and TA1 537) both with and without S-9 Mix. In the mutagenicity test, three replicate plates were prepared for each
strain/S-9/test material dose level combination. Concurrent positive and negative controls (solvent and non-solvent) were conducted for all mutagenicity tests to demonstrate strain sensitivity and metabolic activation system capability. Plates were
examined after at least 48 hrs at 37°±1 °C. Solvent control plates used the same solvent and volume per plate as that selected for the test material. Two separate experiments were performed for each strain/S-9 combination to evaluate
reproducibility of results. - Statistics:
- Statistical analysis was performed on plate incorporation assay results after transforming revertant/plate values as 10gb (revertants/plate). Analysis included
Bartlett’s test for homogeneity of variance (Ref. 3) and comparison of treatments with controls using within-levels pooled variance and a one-sided t-test (Ref. 4-6). Grubbs’
test was performed to determine if outliers were present (Ref. 7). Statistical significance of dose response was evaluated by regression analysis for logbO
transformed doses and revertants/plate (Ref. 8). A critical level of p0.01 was used in determining statistical significance. Results with
p0.05 are also indicated to assist in interpretation of results. As a general guide, Li results were considered clearly positive for a strain/microsome combination if
revertants/plate values were significantly elevated over control values (p0.01) at r three or more treatment levels, and there was a statistically significant dose response
L (pO.01). Other evaluation factors included consideration of the reproducibility of increases in revertants/plate, whether data are consistent with a biologically plausible
r r dose response, and the magnitude of the response. The criteria given above provide L guidance for evaluating the data. The study director made the final determination as to
whether a treatment-related mutagenic response was observed based on these general criteria as well as scientific evaluation of the data.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Precipitation: no precipitation of the test material was observed up to the maximum level tested 5 mg/plate
Toxicity: was observed at 1.5 mg/plate or higher without metabolic activation, and at 5 mg/plate with S9 mix.
No significant mutagenicity was observed in either in the inital or the subsequent confirmation assays for TA98, TA100, TA1535 and TA 1537 in the absence or presence of S9 mix.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative - Executive summary:
The test material, 4-ADPA, was tested in Ames/Salmonella plate incorporation assays using test strains TA98, TA100, TA1535 and TA1537 in the presence and absence of an Aroclor 1254-induced rat liver homogenate activation system (S-9 Mix). The maximum dose levels chosen for mutagenicity testing, 1.5 mg/plate without S-9 Mix and 5 mg/plate with S-9 Mix, gave clear indications of toxic responses for all strain/activation combinations. No significant mutagenicity was observed in either the initial or the subsequent confirmation assays for TA98, TA 100, TA1535 and TA1537 in the absence or presence of S-9 Mix. These results indicate that 4-ADPA is not a mutagen in the Ames/Salmonella plate incorporation assay under the experimental conditions.
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