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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Data is from study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Studies on the acute oral toxicity of 4-nitro-1,3-phenylenediamine in female Wistar rats
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4-nitro-m-phenylenediamine
- EC Number:
- 225-876-3
- EC Name:
- 4-nitro-m-phenylenediamine
- Cas Number:
- 5131-58-8
- Molecular formula:
- C6H7N3O2
- IUPAC Name:
- 4-nitro-m-phenylenediamine
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): 4-nitro-m-phenylenediamine
- Molecular formula (if other than submission substance): C6H7N3O2
- Molecular weight (if other than submission substance): 153.14 g/mole
- Substance type: Organic
- Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 4-nitro-m-phenylenediamine
- Molecular formula (if other than submission substance): C6H7N3O2
- Molecular weight (if other than submission substance): 153.14 g/mole
- Substance type: Organic
- Physical state: Solid
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SPF rats (Wistar strain TNO W 74, Ztichter: Winkelmann, Borchen)
- Age at study initiation: approximately 14 weeks old
- Weight at study initiation: average initial weight of 171 g.
- Fasting period before study: Not reported
- Housing: Conventional cages in Makrolon type III in a dust-free wood pellets in groups of 5 animals
- Diet (e.g. ad libitum): altromin R 1324, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: Not reported
- Identification: The identification of the animals was performed by picric acid marker of the skin and cage labeling
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1.5 ° C
- Humidity (%): 60 ± 5 %
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hour light / dark cycle (artificial lighting 7-19 hours)
IN-LIFE DATES: From: To: Not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The substance was formulated at room temperature in water and administered by means of a rigid metal gavage at constant volume administered (20 ml / kg body weight) to 10 female animals/dose administered once.
- Doses:
- 1000, 1500, 2000, 2500, 3100 mg/kg bw
- No. of animals per sex per dose:
- Totel: 50
1000 mg/kg bw: 10 female
1500 mg/kg bw: 10 female
2000 mg/kg bw: 10 female
2500 mg/kg bw: 10 female
3100 mg/kg bw 10 female - Control animals:
- not specified
- Details on study design:
- On the day of application and in the following 14-day observation period, the animals were repeatedly inspected twice a day (once on weekends and holidays), for the nature, onset, duration and intensity of the clinical symptoms and possibly death.
Deaths and conclusion of the test animals slaughtered were randomly dissected
During the application and at the end of the 14 day observation period, the animals were weighed individually about living. - Statistics:
- The calculation of the LD50 with the confidence interval for p <0.05 was carried out with the programmed probit analysis by Fink and Hund
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 650 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 380 - 1 800
- Remarks on result:
- other: 50 % mortality observed
- Mortality:
- when treated with 3100 mg/kg bw, all animals died
when treated with 2500 mg/kg bw, 9 female rats were died.
when treated with 2000 mg/kg bw, 7 female rats were died.
when treated with 1500 mg/kg bw, 5 female rats were died.
when treated with 1000 mg/kg bw, No mortality were observed. - Clinical signs:
- other: Anesthesia, tremors, shaggy coat, stomach side position, reduction of the general condition, sedation were observed in treated female rats.
- Gross pathology:
- No macroscopically specific findings were observed in treated rats died during the experiment and some at the end of the experiment killed animals.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- LD50 was considered to be 1650 mg/kg (1380-1800) when SPF Wistar female rats were treated with 4-nitrobenzene-1,3-diamine orally by gavage.
- Executive summary:
In a acute oral toxicity study, SPF Wistar female rats were treated with 4-nitrobenzene-1,3-diamine in the concentration of 1000, 1500, 2000, 2500, 3100 mg/kg bw orally by gavage. All animals died at 3100 mg/kg bw, 9 female rats were died at 2500 mg/kg bw, 7 female rats were died at 2000 mg/kg bw, 5 female rats were died at 1500 mg/kg bw and No mortality were observed at 1000 mg/kg bw. In addition, Anesthesia, tremors, shaggy coat, stomach side position, reduction of the general condition, sedation and weight loss were observed in treated female rats. No macroscopically specific gross findings were observed treated female rats. Therefore, LD50 was considered to be 1650 mg/kg (1380-1800) when SPF Wistar female rats were treated with 4-nitrobenzene-1,3-diamine orally by gavage.
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