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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
Description of key information
Though the supporting studies for acute oral toxicity for 4-nitroaniline indicate toxicity category IV, since 4-nitroaniline has a harmonized classification of acute oral Category III; therefore for the purpose of this dossier and chemical safety assessment the value of the key study shall be used.
For acute toxicity by the inhalation route; the key study does not indicate that 4-nitroaniline shall have toxic effect by the inhalation route. However since 4-nitroaniline has a harmonized classification of acute inhalation Category III; this dossier agrees to the harmonized classification though a key study is not available supporting the classification.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- 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:
- standard acute method
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- other: Bird - wild bird species
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 75 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- Toxicity Category III
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The lethal dose value (LD50) causing acute oral toxicity to wild bird species is 75 mg/kg body weight. This value indicates that 4-nitroaniline shall exhibit acute oral toxicity Category III to birds as per the CLP criteria. This is in agreement with the harmonized system of classification for 4-Nitroaniline.
- Executive summary:
The lethal dose value (LD50) causing acute oral toxicity to wild bird species is 75 mg/kg body weight. This value indicates that 4-nitroaniline shall exhibit acute oral toxicity of the level of Category III to birds as per the CLP criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 75 mg/kg bw
- Quality of whole database:
- The key study is from an authoritative database. Supporting studies indicte that 4-nitroaniline shall exhibit acute oral toxicity in the Category IV. However, since this chemical has a harmonized classification within CLP, for the purpose of chemical safety report the key study LD50 value shall be used.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- QSAR prediction: migrated from IUCLID 5.6
- Qualifier:
- according to guideline
- Guideline:
- other: Not Applicable;OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- no
- Test type:
- other: Acute Rodent Inhalation Toxicity Test
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Route of administration:
- inhalation
- Type of inhalation exposure:
- other: Inhalation: Vapor
- Vehicle:
- other: Unchanged (No Vehicle/Air)
- Duration of exposure:
- 4 h
- No. of animals per sex per dose:
- 6 animals
- Control animals:
- not specified
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 47.485 ppm
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Inhalation toxicity (LC50 value) of 4-nitroaniline vapours was examined for 4 hrs.in male Wistar rat at a dose concentration (LC50) of 47.48475 ppm.This value suggests that the chemical 4-nitroaniline is non toxic to Wistar rat by the inhalation route.
- Executive summary:
Inhalation toxicity (LC50 value) of 4-nitroaniline vapours was examined for 4 hrs.in male Wistar rat at a dose concentration (LC50) of 47.48475 ppm.This value suggests that the chemical 4-nitroaniline is non toxic to male Wistar rat by the inhalation route.
Reference
The prediction was based on dataset comprised from the following descriptors: LC50
Estimation method: Taking average value from the 4 nearest neighbours
Domain logical expression:Result: In Domain
("a" and ("b" and "c" ) )
Domain logical expression index: "a"
Similarity boundary:Target: c1(N)ccc(N(=O)=O)cc1
Threshold=50%,
Dice(Atom pairs)
Domain logical expression index: "b"
Parametric boundary:The target chemical should have a value of log Kow which is >= 0.348
Domain logical expression index: "c"
Parametric boundary:The target chemical should have a value of log Kow which is <= 2.58
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 47.485 mg/m³ air
- Quality of whole database:
- SSS QSAR generated data
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- 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:
- standard acute method
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 500 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- Toxicity Category III
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 4-nitroaniline when administered onto the skin of guinea pig in the standard acute toxicity test by the dermal route gave a LD50 value of >500 mg/kg body weight. This result indicates that 4-nitroaniline is acutely toxic to guinea pig by the dermal route in Toxicity Category III.
- Executive summary:
4-nitroaniline when administered onto the skin of guinea pig in the standard acute toxicity test by the dermal route gave a LD50 value of >500 mg/kg body weight. This result indicates that 4-nitroaniline is acutely toxic to guinea pig by the dermal route in Toxicity Category III.
Reference
4-nitroaniline when administered onto the skin of guinea pig in the standard acute toxicity test by the dermal route gave a LD50 value of >500 mg/kg body weight. This result indicates that 4-nitroaniline is acutely toxic to guinea pig by the dermal route according to Toxicity Category III.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 500 mg/kg bw
- Quality of whole database:
- 4-nitroaniline when administered onto the skin of guinea pig in the standard acute toxicity test by the dermal route gave a LD50 value of >500 mg/kg body weight. This result indicates that 4-nitroaniline is acutely toxic to guinea pig by the dermal route in Toxicity Category III.
Additional information
Acute oral toxicity:
The lethal dose value (LD50) causing acute oral toxicity to wild bird species is 75 mg/kg. This value indicates that 4-nitroaniline shall exhibit acute oral toxicity of the level of Category III to birds as per the CLP criteria.
Acute toxicity inhalation:-
Inhalation toxicity (LC50) of 4-nitroaniline vapours was examined for 4 hrs.in male Wistar rat at a dose concentration of 47.48475 ppm.This value
suggest that the chemical 4-nitroaniline is non toxic by inhalation route.
Acute dermal toxicity:
4-nitroaniline when administered onto the skin of guinea pig in the standard acute toxicity test by the dermal route gave a LD50 value of >500 mg/kg body weight. This result indicates that 4-nitroaniline is acutely toxic to guinea pig by the dermal route in Toxicity Category III.
Justification for selection of acute toxicity – oral endpoint
The result is from an authoritative database and therefore was selected as a key study.
Justification for selection of acute toxicity – inhalation endpoint
The results obtained through QSAR do not indicate 4-nitroaniline to be toxic by the inhalation route. However, since this chemical has a harmonized classification within CLP, this chemical shall be considered to exhibit acute toxicity category 3 (by the inhalation route)
Justification for selection of acute toxicity – dermal endpoint
The result is from an authoritative database and therefore was selected as a key study.
Justification for classification or non-classification
All the values in the toxicity end point for the 4 nitro aniline indicate that the substance will certainly qualify for acute toxicity in category 3 for all the three routes of exporsure that is oral, dermal and inhalation.
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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