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Diss Factsheets
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EC number: 201-924-9 | CAS number: 89-62-3
- 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
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- KemI-Riskline database
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 4-week
- Remarks:
- Doses / Concentrations:
0 (controls), 40, 200 and 1000 mg/kg body weight
Basis:
no data - Control animals:
- yes
- Details on results:
- 2-nitro-4-methylaniline caused minor anaemia in the females and males, starting at doses of 200 mg/kg body weight and 1000 mg/kg body weight, respectively.In the highest dose group there was an increase in the liver weights in both sexes and the females also had increased kidney weights, but there was no histopathological correlate in either case
- Dose descriptor:
- NOEL
- Effect level:
- 200 other: mg/kg body weight
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- NOEL
- Effect level:
- 40 other: mg/kg body weight
- Based on:
- test mat.
- Sex:
- female
- Critical effects observed:
- not specified
- Conclusions:
- Repeated dose toxicity (4 weeks) value of 2-nitro-p-toluidine to male rat is found to be NOEL: 200 mg/kg body weight while to female rat it is found to be NOEL: 40 mg/kg body weight.
- Executive summary:
On 4-week oral administration of 0 (controls), 40, 200 and 1000 mg/kg body weight to rats, 2-nitro-4-methylaniline (2-nitro-p-toluidine) caused minor anaemia in the females and males, starting at doses of 200 mg/kg body weight and 1000 mg/kg body weight, respectively. In the highest dose group there was an increase in the liver weights in both sexes and the females also had increased kidney weights, but there was no histopathological correlate in either case. The no effect levels (NOEL) are 200 mg/kg body weight and 40 mg/kg body weight for male and female rats, respectively.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The Kemi database is considered to be a reliable database.
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- QSAR prediction: migrated from IUCLID 5.6
- Qualifier:
- according to guideline
- Guideline:
- other: estimated data
- Principles of method if other than guideline:
- Prediction is done using QSAR Toolbox version 2.3.
- GLP compliance:
- no
- Species:
- rat
- Strain:
- other: Albino, not further specified;Wistar;Crl:CD(SD)BR;F344/N;F344;Sprague-Dawley;Crl:(Wi)BR;Charles River;no data;CD
- Sex:
- male/female
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Control animals:
- not specified
- Dose descriptor:
- other: "Effect LOEL"
- Effect level:
- 205.871
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Effect: Body weight decreased
- Critical effects observed:
- not specified
- Conclusions:
- The repeated dose toxicity LOEL (Lowest observed effect level) of 5-nitro-o-anisidine in rat was observed at a dose concentration of 205.8714 mg/kg bw/day by the inhalative route.This indicates that 5-nitro-o-anisidine shall not exhibit toxic effect to rat by the inhalative route below the above mentioned dose.
- Executive summary:
The repeated dose toxicity LOEL (Lowest observed effect level) of 5-nitro-o-anisidine in rat was observed at a dose concentration of 205.8714 mg/kg bw/day by the inhalative route.This indicates that 5-nitro-o-anisidine shall not exhibit toxic effect to rat by the inhalative route below the above mentioned dose.
Reference
The prediction was based on dataset comprised from the following descriptors: "effect LOEL"
Estimation method: Taking average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
("a" and ("b" and "c" ) )
Domain logical expression index: "a"
Similarity boundary:Target: c1(OC)c(N)cc(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 >= 0.872
Domain logical expression index: "c"
Parametric boundary:The target chemical should have a value of log Kow which is <= 2.17
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Study duration:
- subacute
- Species:
- rat
Additional information
The Kemi database is considered to be a reliable database. The results indicated increase in the weight of liver and kidneys in male and female rats on repeated exposure to 2-nitro-p-toluidine in a 4 week study. The effects were observed above the dose of 200 mg/kg body weight.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
Model considered reliable by OECD. Decrease in the body weight was observed at the LOEL dose ranging between 117 to 205 mg/kg/day.
Justification for classification or non-classification
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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