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EC number: 202-057-9 | CAS number: 91-29-2
- 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
Endpoint summary
Administrative data
Description of key information
Repeated dose toxicity: Oral
28 days subacute repeated dose oral toxicity study was performed to determine the oral toxic nature of 4-nitro-4’-aminodiphenylamine-2-sulfonic acid. The study was performed using Wistar rats as per the OECD guideline no 407. 5 male and 5 female rats recieved feed at dosage of 0, 480, 2400 or 12000 mg/Kg containing an average daily substance intake of 0, 50, 243 or 1253 mg/Kg bw in male rats and 0, 47, 234 or 1191 mg/Kg bw in female rats. All animals were observed for clinical symtoms, mortality, hematological and clinical chemistry parameters, urinanalysis, and were subjected to gross and histopathological observations. All animals well tolerated the highest dose and did not show any signs at the highest dose level corresponding to 1253 mg/Kg bw for male rats and 1191 mg/Kg bw for female rats. No changes were noted in hematological and clinical chemistry parameters. Urinanalysis represented brown discoloration of urine in the highest dose group (1253 mg/Kg bw for males and 1191 mg/Kg bw for females). 2 male rats of 2400 mg/Kg bw feed group and all male rats of 12000 mg/Kg feed group exhibited ocherous kidneys. No cases of histopathological observations were made. On the basis of observations made, the No Observed Adverse Effect level for the test substance 4-nitro-4’-aminodiphenylamine-2-sulfonic acid is considered to be 1253 mg/Kg bw in male rats and 1191 mg/Kg bw in female rats.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary literature
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- Repeated dose oral toxicity study was performed to determine the toxic nature of 4-nitro-4’-aminodiphenylamine-2-sulfonic acid upon repeated exposure by oral route
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material: 4-nitro-4’-aminodiphenylamine-2-sulfonic acid
- IUPAC name: 2-[(4-aminophenyl)amino]-5-nitrobenzenesulfonic acid
- Molecular formula: C12H11N3O5S
- Molecular weight: 309.301 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: 58.9% , 40.2% water
- Impurities: No data - Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data available
- Age at study initiation: 6 weeks old
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available - Route of administration:
- oral: feed
- Details on route of administration:
- No data
- Vehicle:
- other: Feed
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The test compound was mixed with feed (0, 480, 2400 or 12000 mg/Kg feed) to give an average daily intake of 0, 50, 243 or 1253 mg/Kg bw in male rats and 0, 47, 234 or 1191 mg/Kg bw in female rats
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): Feed
- Concentration in vehicle:
Male rats: 0, 50, 243 or 1253 mg/Kg bw
Female rats: 0, 47, 234 or 1191 mg/Kg bw
- Amount of vehicle (if gavage): 0, 480, 2400 or 12000 mg/Kg feed
- Lot/batch no. (if required): No data
- Purity: No data - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Daily
- Remarks:
- Male rats: 0, 50, 243 or 1253 mg/Kg bw
Female rats: 0, 47, 234 or 1191 mg/Kg bw - No. of animals per sex per dose:
- Total: 40
0 mg/Kg bw: 5 male and 5 female
50 mg/Kg bw: 5 males
243 mg/Kg w: 5 males
1253 mg/Kg bw: 5 males
47 mg/Kg bw: 5 females
234 mg/Kg bw: 5 females
1191 mg/Kg bw: 5 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The doses were selected on the basis of a preliminary toxicity study conducted on rats. The dosage level for the study was 2000 or 10000 mg/ Kg feed suring a period of 14 days. No changes in the body weight and food consumption were observed during the study. No unusual hematological findings were observed. Also the animals did not exhibit any macroscopic changes during the study. On this basis, the doses selected for the study were 0, 480, 2400 or 12000 mg/Kg feed containing an average daily intake of 0, 50, 243 or 1253 mg/Kg bw in male rats and 0, 47, 234 or 1191 mg/Kg bw in female rats
- Rationale for animal assignment (if not random): No data
- Rationale for selecting satellite groups: No data
- Post-exposure recovery period in satellite groups: No data
- Section schedule rationale (if not random): No data - Positive control:
- No data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Throughout the treatment period
- Cage side observations checked in table [No.?] were included. The animals were observed for any symptoms and mortality
DETAILED CLINICAL OBSERVATIONS: Not specified
- Time schedule: Not specified
BODY WEIGHT: Not specified
- Time schedule for examinations: Not specified
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified
FOOD 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: Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
- Time schedule for examinations: Not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
- Time schedule for examinations: Not specified
- Dose groups that were examined: Not specified
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Not specified
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- How many animals: Not specified
- Parameters checked in table [No.?] were examined. Not specified
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Not specified
- Animals fasted: Not specified
- How many animals: Not specified
- Parameters checked in table [No.?] were examined. Not specified
URINALYSIS: Yes
- Time schedule for collection of urine: Not specified
- Metabolism cages used for collection of urine: Not specified
- Animals fasted: Not specified
- Parameters checked in table [No.?] were examined. the animals were checked for discoloration of urine
NEUROBEHAVIOURAL EXAMINATION: Not specified
- Time schedule for examinations: Not specified
- Dose groups that were examined: Not specified
- Battery of functions tested: sensory activity / grip strength / motor activity / other: Not specified
IMMUNOLOGY: Not specified
- Time schedule for examinations: Not specified
- How many animals: Not specified
- Dose groups that were examined: Not specified
- Parameters checked in table [No.?] were examined. Not specified
OTHER: Not specified - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, the animals were subjected to gross pathology findings
HISTOPATHOLOGY: Yes, the animals were subjected to histopathological findings - Other examinations:
- No data
- Statistics:
- No data
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- 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:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- Clinical signs and mortality
Clinical signs: All animals tolerated the treatment without any symptoms even at the highest dosage (1253 mg/Kg bw for males and 1191 mg/Kg bw for females).
Mortality: No mortality was noted at the highest dosage (1253 mg/Kg bw for males and 1191 mg/Kg bw for females)
Body weight and weight gain: No data available
Food consumption and compound intake: No data available
Food efficiency: No data available
Water consumption and compound intake: No data available
Opthalmoscopic examination: No data available
Haematology: The hematological parameters remained unchanged during the study period
Clinical chemistry: The clinical chemistry parameters remained unchanged during the study period
Urinanalysis: Urine of the animals in the highest dose group (1253 mg/Kg bw for males and 1191 mg/Kg bw for females) showed brown discoloration. Urinary starus and sediments were not unusual
Neurobehaviour: No data available
Organ weights: No data available
Gross pathology: 2 male rats of 2400 mg/Kg bw dose group and all male rats of 12000 mg/Kg dose group exhibited ocherous kidneys
Histopathology: Histology revealed no cases of pathological findings. - Dose descriptor:
- NOAEL
- Effect level:
- 1 253 mg/kg bw (total dose)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No significant alterations were noted at the mentioned dose level
- Dose descriptor:
- NOAEL
- Effect level:
- 1 191 mg/kg bw (total dose)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No significant alterations were noted at the mentioned dose level
- Critical effects observed:
- not specified
- Conclusions:
- The No Observed Adverse Effect level for the test substance 4-nitro-4’-aminodiphenylamine-2-sulfonic acid is considered to be 1253 mg/Kg bw in male rats and 1191 mg/Kg bw in female rats.
- Executive summary:
28 days subacute repeated dose oral toxicity study was performed to determine the oral toxic nature of 4-nitro-4’-aminodiphenylamine-2-sulfonic acid. The study was performed using Wistar rats as per the OECD guideline no 407. 5 male and 5 female rats recieved feed at dosage of 0, 480, 2400 or 12000 mg/Kg containing an average daily substance intake of 0, 50, 243 or 1253 mg/Kg bw in male rats and 0, 47, 234 or 1191 mg/Kg bw in female rats. All animals were observed for clinical symtoms, mortality, hematological and clinical chemistry parameters, urinanalysis, and were subjected to gross and histopathological observations. All animals well tolerated the highest dose and did not show any signs at the highest dose level corresponding to 1253 mg/Kg bw for male rats and 1191 mg/Kg bw for female rats. No changes were noted in hematological and clinical chemistry parameters. Urinanalysis represented brown discoloration of urine in the highest dose group (1253 mg/Kg bw for males and 1191 mg/Kg bw for females). 2 male rats of 2400 mg/Kg bw feed group and all male rats of 12000 mg/Kg feed group exhibited ocherous kidneys. No cases of histopathological observations were made. On the basis of observations made, the No Observed Adverse Effect level for the test substance 4-nitro-4’-aminodiphenylamine-2-sulfonic acid is considered to be 1253 mg/Kg bw in male rats and 1191 mg/Kg bw in female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 253 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Data is from K4 secondary literature
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity: Oral
Data available for the target chemical 4-nitro-4’-aminodiphenylamine-2-sulfonic acid was reviewed to determine its toxic nature upon repeated exposure by oral route. The summary is as mentioned below:
28 days subacute repeated dose oral toxicity study was performed to determine the oral toxic nature of 4-nitro-4’-aminodiphenylamine-2-sulfonic acid. The study was performed using Wistar rats as per the OECD guideline no 407. 5 male and 5 female rats recieved feed at dosage of 0, 480, 2400 or 12000 mg/Kg containing an average daily substance intake of 0, 50, 243 or 1253 mg/Kg bw in male rats and 0, 47, 234 or 1191 mg/Kg bw in female rats. All animals were observed for clinical symtoms, mortality, hematological and clinical chemistry parameters, urinanalysis, and were subjected to gross and histopathological observations. All animals well tolerated the highest dose and did not show any signs at the highest dose level corresponding to 1253 mg/Kg bw for male rats and 1191 mg/Kg bw for female rats. No changes were noted in hematological and clinical chemistry parameters. Urinanalysis represented brown discoloration of urine in the highest dose group (1253 mg/Kg bw for males and 1191 mg/Kg bw for females). 2 male rats of 2400 mg/Kg bw feed group and all male rats of 12000 mg/Kg feed group exhibited ocherous kidneys. No cases of histopathological observations were made. On the basis of observations made, the No Observed Adverse Effect level for the test substance 4-nitro-4’-aminodiphenylamine-2-sulfonic acid is considered to be 1253 mg/Kg bw in male rats and 1191 mg/Kg bw in female rats.
Based on the data available for the target chemical, 4-nitro-4’-aminodiphenylamine-2-sulfonic acid does not exhibit toxic nature upon repeated exosure by oral route. Hence the test chemical is likely to be non toxic.
Justification for classification or non-classification
Based on the data available for the target chemical, 4-nitro-4’-aminodiphenylamine-2-sulfonic acid does not exhibit toxic nature upon repeated exosure by oral route. Hence the test chemical is likely to be non toxic.
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