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EC number: 226-164-5 | CAS number: 5307-14-2
- 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
The substance is found to be non irritating to skin and eyes of rabbits
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- The procedure for the skin tests was based upon that prescribed for testing primary irritant substances by the Consumer Product Safety Commission of the USA (Code of Federal Regulations, Title 16, Sec. 1500.41).
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- No data available
- Type of coverage:
- not specified
- Preparation of test site:
- other: intact and abraded skin
- Vehicle:
- other: Suspension in 0.5% aqueous gum tragacanth, containing 0.05% Na2SO3
- Controls:
- not specified
- Amount / concentration applied:
- 2.5% (w/v) Suspension in 0.5% aqueous gum tragacanth, containing 0.05% Na2SO3.
- Duration of treatment / exposure:
- no data
- Observation period:
- 72-hr observation period
- Number of animals:
- 3
- Details on study design:
- SCORING SYSTEM: Based on the definition of skin irritation given in the (Code of Federal Regulations, Title 16, Sec. 1500.41).
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hrs
- Score:
- 0
- Reversibility:
- no data
- Remarks on result:
- other: No irritation was observed
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The irritant effects on rabbit skin, was assessed for 2 nitro p phenylene diamine.According to the Code of Federal Regulations, Test for Skin Irritants, the primary irritation index for 2 nitro p phenylene diamine was scored as 0 , due to the no irritation observed during the 72 hour observation period.
- Executive summary:
The irritant effects on rabbit skin, was assessed for 2 nitro p phenylene diamine. The albino rabbits used for the assessment of irritation potential were of the New Zealand White strain.
The procedure for the skin tests was based upon that prescribed for testing primary irritant substances by the Consumer Product Safety Commission of the USA (Code of Federal Regulations, Title 16, Sec. 1500.41). Each of the twelve compounds to be tested was applied as a 2.5% (w/v) preparation to the intact and abraded skin of three animals.
The primary irritation index was estimated to be 0 for test material as it showed no response to treatment during the 72-hr observation period.Based on the above information the test substancecan be classified as "not irritating: ,in accordence with CLP criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- The procedure for the eye tests was based on that prescribed in the Code of Federal Regulations (Title 16, Sec. 1500.42).
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- other: Suspension in 0.5% aqueous gum tragacanth, containing 0.05% Na2SO3.
- Controls:
- other: Other eye acted as control in all the groups
- Amount / concentration applied:
- 2.5%(w/v) Suspension in 0.5% aqueous gum tragacanth, containing 0.05% Na2SO3.
- Duration of treatment / exposure:
- 10 seconds
- Observation period (in vivo):
- No data
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Categorized as + or - according to whether extrapolation of the result would be expected to give a positive or negative test for eye irritation based on the definition in the Code of Federal Regulations, Test for Eye Irritants (Title 16, Sec. 1500.42).REMOVAL OF TEST SUBSTANCEWashing (if done): 50 ml of lukewarm water (37°C) Time after start of exposure: 10 seconds after instillation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hrs
- Reversibility:
- fully reversible
- Remarks on result:
- other: occasional transient mild conjunctival inflammation
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The irritant effects on rabbit eye mucosa, was assessed for 2 nitro p phenylene diamine.None of the three animals treated with the test material showed any response to treatment, and although occasional transient mild conjunctival inflammation was observed. The reactions did not persist for more than 24 hr.Thus, the substance is considered to be non irritating to eyes.
- Executive summary:
The irritant effects on rabbit eye mucosa, was assessed for 2 nitro p phenylene diamine.
The procedure for the eye tests was based on that prescribed in the Code of Federal Regulations (Title 16, Sec. 1500.42). 2 nitro p phenylenediamine was prepared as a 2.5% (w/v) solution or suspension. (Suspension in 0.5% aqueous gum tragacanth, containing 0.05% Na2SO3). Eleven groups of three rabbits were used to test solutions, each of which was instilled into one eye of each of three rabbits.
None of the three animals treated with the test material showed any response to treatment, and although occasional transient mild conjunctival inflammation was observed. The reactions did not persist for more than 24 hr.
Thus, the substance is consudered to be non irritating to eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
The irritant effects on rabbit skin, was assessed for 2 nitro p phenylene diamine. The albino rabbits used for the assessment of irritation potential were of the New Zealand White strain.
The procedure for the skin tests was based upon that prescribed for testing primary irritant substances by the Consumer Product Safety Commission of the USA (Code of Federal Regulations, Title 16, Sec. 1500.41). Each of the twelve compounds to be tested was applied as a 2.5% (w/v) preparation to the intact and abraded skin of three animal
The primary irritation index was estimated to be 0 for test material as it showed no response to treatment during the 72-hr observation period. In supporting study by (Danish (Q)SAR Database 2016),the skin irritation was observed . Skin irritation effects were estimated by three different models i.e, Battery and SciQSAR used within Danish QSAR database for chemical 2-nitro-p-phenylenediamine.Based on estimation No severely skin irritation effect were known when test chemical2-nitro-p-phenylenediamine exposed to rabbit skin.
In another suppoting study by (KEMI Swedish Chemical Agency ,2011) with similar substance(89 -62 -3),the skin irritation was observed in rabbit. 2-nitro-p-toluidine is found to be non-irritating to skin of the rabbit.
On the basis of available information for the target and read across substance , the test substance can be considered as not irritating tothe skin, inaccordance with the CLP criteria.
Eye Irritation:
The irritant effects on rabbit eye mucosa, was assessed for 2 nitro p phenylene diamine.The procedure for the eye tests was based on that prescribed in the Code of Federal Regulations (Title 16, Sec. 1500.42). 2 nitro p phenylenediamine was prepared as a 2.5% (w/v) solution or suspension. (Suspension in 0.5% aqueous gum tragacanth, containing 0.05% Na2SO3). Eleven groups of three rabbits were used to test solutions, each of which was instilled into one eye of each of three rabbits. None of the three animals treated with the test material showed any response to treatment, and although occasional transient mild conjunctival inflammation was observed. The reactions did not persist for more than 24 hr.Thus, the substance is consudered to be non irritating to eyes.
In another suppoting study by (ACTOR,2007) with similar substance(100 -01 -6),the eye irritation was observed in rabbit.
In-vivo studies on rabbits indicate that 4-nitroaniline was not irritating to eyes of rabbit.
Inanother suppoting study by ( KEMI,2011) with similar substance(89 -62 -3),the eye irritation was observed in rabbit.
2-nitro-p-toluidine is found to be non-irritating to eye of the rabbit as per the information available in the database of the Swedish chemical agency.
On the basis of available information for the target and read across substance , the test substance can be considered as not irritating tothe eye, inaccordance with the CLP criteria.
Justification for selection of skin irritation / corrosion endpoint:
The irritant effects on rabbit skin, was assessed for 2 nitro p phenylene diamine.
According to the Code of Federal Regulations, Test for Skin Irritants, the primary irritation index for 2 nitro p phenylene diamine was scored as 0 , due to the no irritation observed during the 72 hour observation period.
Justification for selection of eye irritation endpoint:
The irritant effects on rabbit eye mucosa, was assessed for 2 nitro p phenylene diamine.
None of the three animals treated with the test material showed any response to treatment, and although occasional transient mild conjunctival inflammation was observed. The reactions did not persist for more than 24 hr.
Thus, the substance is considered to be non irritating to eyes.
Justification for classification or non-classification
On the basis of available information, the substance, 2 nitro p phenylene diamine, is likely to be non irritating to skin and eyes.
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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