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EC number: 226-164-5 | CAS number: 5307-14-2
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from National Cancer Institute Technical report
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- BIOASSAY OF 2·NITRO-p·PHENYLENEDIAMINE FOR POSSIBLE CARCINOGENICITY
- Author:
- National Cancer Institute
- Year:
- 1 979
- Bibliographic source:
- National Cancer Institute, CARCINOGENESIS, Technical Report Series No. 169, 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Subchronic toxicity tests were conducted with rats
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-nitro-p-phenylenediamine
- EC Number:
- 226-164-5
- EC Name:
- 2-nitro-p-phenylenediamine
- Cas Number:
- 5307-14-2
- Molecular formula:
- C6H7N3O2
- IUPAC Name:
- 2-nitrobenzene-1,4-diamine
- Reference substance name:
- 2 nitro p phenylene diamine
- IUPAC Name:
- 2 nitro p phenylene diamine
- Details on test material:
- - Name of test material (as cited in study report): 2 nitro p phenylene diamine- Substance type: Organic - Physical state: Solid
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: A. R. Schmidt, Madison, Wisconsin, and Laboratory Supply Company, Inc., Indianapolis, Indiana.- Age at study initiation: 4 weeks old- Weight at study initiation: No data- Fasting period before study: Housing: polycarbonate cages suspended from aluminum racks. Ab-sorb-dri® hardwood chip bedding- Diet (e.g. ad libitum): Wayne Lab-Blox meal, ad libitum - Water (e.g. ad libitum): Acidulated water (pH 2.5) was supplied to animals in water bottles filled by an automated metering device, ad libitum- Acclimation period: quarantined for 2 weeks prior to initiationENVIRONMENTAL CONDITIONS- Temperature (°C): 22° to 26°C- Humidity (%): 45 and 55 percent- Air changes (per hr): Incoming air was filtered through HEPA filters, at a rate of 12 to 15 complete changes of room air per hour.- Photoperiod (hrs dark / hrs light): Fluorescent lighting was provided 8 hours per day (9:00 a.m. to 5:00 p.m.).IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: basal laboratory diet
- Details on oral exposure:
- DIET PREPARATIONThe chemical was removed from its container and a proper amount was blended with an aliquot of the ground feed using a mortar and pestle. Once visual homogeneity was attained, the mixture was placed in a 6 kg capacity Patterson-Kelley standard model twin-shell stainless steel V-blender along with the remainder of the feed to be prepared. After 20 minutes of blending, the mixtures were placed in double plastic bags and stored in the dark at 4°C. The mixture was prepared once weekly.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Doses were analysed spectrophotometrically
- Duration of treatment / exposure:
- 4 weeks followed by 2 weeks observation
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:31.5, 68.0, 146.5,315.5 and 680.0 mg/kgbwBasis:no data
- No. of animals per sex per dose:
- five males and five females in six dose groups
- Control animals:
- yes
- Details on study design:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes / No / No data: No dataTime schedule: No data- Cage side observations checked in table [No.?] were included. No dataDETAILED CLINICAL OBSERVATIONS: Yes / No / No data: No data Time schedule: No dataBODY WEIGHT: Yes / No / No data: YesTime schedule for examinations: No dataFOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No dataFood consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes / No / No data: No dataCompound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data: No dataFOOD EFFICIENCY:Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data: No dataWATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes / No / No data: No dataTime schedule for examinations: No dataOPHTHALMOSCOPIC EXAMINATION: Yes / No / No data: No dataTime schedule for examinations: No dataDose groups that were examined:No dataHAEMATOLOGY: Yes / No / No data: No dataTime schedule for collection of blood: No dataAnaesthetic used for blood collection: Yes (identity) / No / No data: No dataAnimals fasted: Yes / No / No data: No dataHow many animals:- Parameters checked in table [No.?] were examined.: No dataCLINICAL CHEMISTRY: Yes / No / No dataTime schedule for collection of blood: No dataAnimals fasted: Yes / No / No data: No dataHow many animals: No dataParameters checked in table [No.?] were examined.: No dataURINALYSIS: Yes / No / No dataTime schedule for collection of urine: No dataMetabolism cages used for collection of urine: Yes / No / No data: No dataAnimals fasted: Yes / No / No data: No dataParameters checked in table [No.?] were examined.: No dataNEUROBEHAVIOURAL EXAMINATION: Yes / No / No data: No data
- Sacrifice and pathology:
- No data
- Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No abnormal clinical signs were recorded for any rat group.
- Mortality:
- no mortality observed
- Description (incidence):
- No abnormal clinical signs were recorded for any rat group.
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 680 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Sub-chronic toxicity tests were conducted with both rats and mice. Rats were distributed among six groups, each consisting of five males and five females. 2-Nitro-p-phenylenediamine was incorporated into the basal laboratory diet and supplied ad libitum to five of the six rat groups in concentrations of 31.5, 68.0, 146.5,315.5 and 680.0 mg/kgbw. The remaining rat group served as a control group, receiving only the basal laboratory diet. No abnormal clinical signs were recorded for any rat group.The NOAEL for 2 nitro p phenylenediamine is 680.0mg/kgbw
- Executive summary:
Subchronic toxicity tests were conducted with both rats and mice. Rats were distributed among six groups, each consisting of five males and five females. 2-Nitro-p-phenylenediamine was incorporated into the basal laboratory diet and supplied ad libitum to five of the six rat groups in concentrations of 31.5, 68.0, 146.5,315.5 and 680.0 mg/kg bw. The remaining rat group served as a control group, receiving only the basal laboratory diet.
The dosed dietary preparations were administered for a period of 4 weeks, followed by a 2-week observation period during which all animals were fed the basal laboratory diet. Individual body weights and food consumption data were recorded twice weekly throughout the study. Upon termination of the study all survivors were sacrificed and necropsied.
No abnormal clinical signs were recorded for any rat group. The NOAEL for 2 nitro p phenylenediamine is 680 mg/ kg bw.
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