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Diss Factsheets
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EC number: 202-810-1 | CAS number: 100-01-6
- 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
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: Parent fertility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Data is from RTECS database
- GLP compliance:
- not specified
- Species:
- mouse
- Strain:
- not specified
- Sex:
- female
- Route of administration:
- oral: unspecified
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 6-13 day(s) after conception
- Control animals:
- not specified
- Litter observations:
- litter size (e.g. # fetuses per litter; measured before birth)
- Dose descriptor:
- LOEL
- Effect level:
- 9 600 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Reproductive - Fertility - litter size (e.g. # fetuses per litter; measured before birth) Reproductive - Effects on Newborn - live birth index (measured after birth) Reproductive - Effects on Newborn - growth statistics (e.g.%, reduced weight gain)
- Reproductive effects observed:
- not specified
- Conclusions:
- Reproductive toxicity LOEL (low observed effect level) of 4-nitroaniline was observed at dose concentration of 9600 mg/kg. in a 6-13 day(s) after conception to female mouse by the oral route. There was reduced weight gain observed in new borns.
- Executive summary:
Reproductive toxicity LOEL (low observed effect level) of 4-nitroaniline was observed at dose concentration of 9600 mg/kg. in a 6-13 day(s) after conception to female mouse by the oral route. There was reduced weight gain observed in new borns.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- 9 600 mg/kg bw/day
- Study duration:
- subacute
- Species:
- mouse
Additional information
Reproductive toxicity LOEL (low observed effect level) of 4-nitroaniline was observed at dose concentration of 9600 mg/kg. in a 6-13 day(s) after conception to female mouse by the oral route. This indicates that 4-nitroaniline shall not exhibit toxic effects to mouse by the oral route below the
above mention dose.
Justification for selection of Effect on fertility via oral route:
LOEL value of 4-nitroaniline observed was 9600 mg/kg/day. Therefore NOAEL value of 4-nitroaniline is bound to be less than 9600 mg/kg/day.
Effects on developmental toxicity
Description of key information
Mammal rat foetus 6-19 day(s) after conception show Developmental Abnormalities - musculoskeletal system if subatance 4-nitroaniline reaches at LOEL (lowest observed effect concentration) concentration 3500 mg/kg.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Data is from RTECS database
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- not specified
- Route of administration:
- oral: unspecified
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 6-19 day(s) after conception
- Control animals:
- not specified
- Dose descriptor:
- LOEL
- Effect level:
- 3 500 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- Mammal rat foetus 6-19 day(s) after conception show Developmental Abnormalities - musculoskeletal system if subatance 4-nitroaniline reaches a LOEL (lowest observed effect concentration) concentration of 3500 mg/kg.
- Executive summary:
Mammal rat foetus 6-19 day(s) after conception show Developmental Abnormalities - musculoskeletal system if subatance 4-nitroaniline reaches at LOEL (lowest observed effect concentration) concentration 3500 mg/kg.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- subacute
- Species:
- rat
Additional information
LOEL value of 4-nitroaniline observed was 3500 mg/kg/day. Therefore NOAEL value of 4-nitroaniline is bound to be less than 3500 mg/kg/day.
Justification for classification or non-classification
4- nitro aniline do not have reproductive toxcity properties as per th studies mentioned in the end point. Regarding the developmental toxicity effect; abnormalities have been observed in the study in the form of musculoskeletal system. Thus we can consider the substance for reproductive toxicity in developemental category but will require more studies to prove the same.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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