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EC number: 225-876-3 | CAS number: 5131-58-8
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- data is from experimental reports
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- To assess the ocular irritation potential of 4-nitro-m-phenylenediamine in rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-nitro-m-phenylenediamine
- EC Number:
- 225-876-3
- EC Name:
- 4-nitro-m-phenylenediamine
- Cas Number:
- 5131-58-8
- Molecular formula:
- C6H7N3O2
- IUPAC Name:
- 4-nitro-m-phenylenediamine
- Test material form:
- solid
- Details on test material:
- - Name of test material : 4-Nitro-m-phenylenediamine
- Molecular formula : C6H7N3O2
- Molecular weight : 153.14 g/mol
- Smiles notation : c1(c(cc(N)cc1)N)[N+](=O)[O-]
- InChl (if other than submission substance): 1S/C6H7N3O2/c7-4-1-2-6(9(10)11)5(8)3-4/h1-3H,7-8H2
- Substance type: Organic
- Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material : 4-Nitro-m-phenylenediamine
- Molecular formula : C6H7N3O2
- Molecular weight : 153.14 g/mol
- Smiles notation : c1(c(cc(N)cc1)N)[N+](=O)[O-]
- InChl (if other than submission substance): 1S/C6H7N3O2/c7-4-1-2-6(9(10)11)5(8)3-4/h1-3H,7-8H2
- Substance type: Organic
- Physical state: Solid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: Male
- Source: Hacking & Churchill ltd, Huntingdon, UK
- Age at study initiation: Not reported
- Weight at study initiation: average about 3 kg
- Housing: The animals were housed individually
- Diet (e.g. ad libitum): "muemmel Z-222" (Hoeing Kraftfutterwerk Lower Saxony, Verden / Aller), ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: Not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 40-50%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hours light / dark cycle (artificial lighting. 7 - 19 h)
IN-LIFE DATES: From: To: Not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 g of the solid test sample was applied by single injection in the conjunctival sac of an eyelid.
- Duration of treatment / exposure:
- 24 hrs
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
After application, the eyelids for about 1 sec were gently held together. The other eye remained untreated as a control. After 24 hours the treated eye was rinsed with physiological saline solution.
SCORING SYSTEM: As per the method of Draize
The sum of the weighted vote degrees in all animals at 24, 48 and 72 h (s, 4.1, a + b + c) was divided by the sum of the number of animals and observation time points (9) and yielded the-primary irritation score.
TOOL USED TO ASSESS SCORE: ophthalmoscope
The observations on the cornea after 24 hours was secured by application of 1 drop of 1% fluorescein solution in ophthalmic formulation and subsequent rinsing with saline solution under UV light.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 9
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Of the controls differing findings were not charged. The animals were followed up until the 7th day of the experiment.Primary irritation score: 0/9
Any other information on results incl. tables
Table 1:Irritation Scores
Reading |
1 hr |
24 hr |
48 hr |
72 hr |
||||||||
Animal No. |
18 |
19 |
10 |
18 |
19 |
10 |
18 |
19 |
10 |
18 |
19 |
10 |
CORNEA |
||||||||||||
A. Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
B. Area affected |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
a=AxBx5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
IRIS |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
b=Ax5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
CONJUNCTIVA |
||||||||||||
A. Redness |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
B. Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
C. |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
c=(A+B+C)x2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total = a+b+c |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- The primary eye irritation score for 4-nitro-m-phenylenediamine was determined to be 0.0 .
From the above results, the classification of 4-nitro-m-phenylene diamine was considered to be not irritating according to the E.C Commission's proposal on criteria for effects and irritants as set out in Annex VI II B 6 Directive. - Executive summary:
The primary eye irritation of 4-nitro-m-phenylenediamine was assessed in rabbits in a study conducted as per OECD Guideline 405.
0.1 g of the solid 4 -nitro-m-phenylenediamine was applied by single injection in the conjunctival sac of 3 male New Zealand White rabbits. The untreated eye served as a control. After 24 hours the treated eye was rinsed with physiological saline solution.The observations on the cornea after 24 hours were secured by application of 1 drop of 1% fluorescein solution in ophthalmic formulation and subsequent rinsing with saline solution under UV light. The animals were observed for signs of irritation at 1, 24, 48 and 72 hours. The animals were followed up until the 7th day of the experiment.
The reactions were scored as per Draize method.The sum of the weighted vote degrees in all animals at 24, 48 and 72 h (s, 4.1, a + b + c) was divided by the sum of the number of animals and observation time points (9) and yielded the-primary irritation score.
The primary eye irritation score of for 4-nitro-m-phenylenediamine was determined to be 0.0 . From the above results, the classification of 4-nitro-m-phenylene diamine was considered to be not irritating according to the E.C Commission's proposal on criteria for effects and irritants as set out in Annex VI II B 6 Directive.
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