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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 vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: comparable to guideline study with acceptable restrictions (e.g. no documentation of systemic toxicity)
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
- Reference Type:
- secondary source
- Title:
- In Vivo - In Vitro Hepatocyte DNA Repair (UDS) and DNA Replication Assay with 4-NDPA, 4-ADPA, DADPE & DNDPE. Study SR-86-175
- Author:
- Monsanto Co.
- Year:
- 1 988
- Bibliographic source:
- Short report with cover letter dated 10/18/88; NTIS/OTS 516609, Doc I.D. 89-890000009 (1988)
Materials and methods
- Principles of method if other than guideline:
- Method: other: in vivo-in vitor UDS comparable to current guidelines
- GLP compliance:
- yes
- Type of assay:
- unscheduled DNA synthesis
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:
- IUCLID4 Test substance: other TS: purity: 95-97%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- single dose
- Frequency of treatment:
- once
- Post exposure period:
- 16 hrs (UDS), 48 hrs (DNA replication)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50, 100, 250 mg/kg bw
Basis:
- No. of animals per sex per dose:
- 3
- Control animals:
- yes, concurrent vehicle
Examinations
- Tissues and cell types examined:
- liver tissue
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
RS-Freetext:
UDS study:
All doses of 4-ADPA and the vehicle control yielded mean values ranging
from -4 to -4,1 and 4 net grain/nucleus (NG) whereas the positive control
yielded 14.6 (NG). All animals receiving doses of 4-ADPA or vehicle
control had less than 2% of cells undergoing repair compared with 70% for
the positive control.
Induction of DNA replication:
4-ADPA yielded a mean value of 2,68% in S-phase at 250 mg/kg compared to
the vehicle control with 0.06% in S-phase. On the basis of the criteria
for a positive response it is concluded that 4-ADPA induces DNA
replication in male rat liver.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
- Executive summary:
The test substance 4-ADPA induced no significant increase of unscheduled DNA synthesis in hepatocytes of Fischer-344 rats that had received single dosage of 50, 100 and 250 mg/kg bw by gavage. It induced DNA replication at 250 mg/kg bw (2.68 % compared to vehicle control 0.06%). The study was performed according to current international standard methods but no information is available on systemic toxicity in the high dose animals except the information that the highest dose had to be reduced to 250 mg/kg bw because at 400 mg/kg bw one of the two rats died prior to the 16-hour sacrifice and another yielded unscorable slides (Monsanto Co. 1986).
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