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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
Endpoint summary
Administrative data
Description of key information
Skin Irritation:
The sum of the average stimulus values after 24 h (erythema = 1.3, edema = 0) and 72 h (erythema = 0.7, edema = 0) obtained by dividing by the number of these time points (by 2) gave a primary irritation score of 1.0.
From the above results, the classification of 4-nitro-m-phenylene diamine was considered to be 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.
Eye Irritation:
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.
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- data is from experimental reports
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- To assess the dermal irritation potential of 4-nitrobenzene-1,3-diamine in rabbits
- GLP compliance:
- not specified
- 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 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- 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 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- 0.5 g of creamed with water test substance were applied.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 h after removal of the lobules and conclusion of the test after 10 test day.
- Number of animals:
- 3 male animals
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: full
- Type of wrap if used: Gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
SCORING SYSTEM: As per the method of Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hrs
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hrs
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- After one hour, a yellowish discoloration of the skin was found. Discoloration held until the 9th day of the experiment at (Animal No. 4). The animals were followed up until the 10th day of the experiment,
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The sum of the average stimulus values after 24 h (erythema = 1.3, edema = 0) and 72 h (erythema = 0.7, edema = 0) obtained by dividing by the number of these time points (by 2) gave a primary irritation score of 1.0.
From the above results, the classification of 4-nitro-m-phenylene diamine was considered to be 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 skin irritation of 4-nitro-m-phenylenediamine was assessed in a study conducted on rabbits as per OECD Guideline 404.
The flank skin of 3 male New Zealand White rabbits was depilated on both sides on an area of approximately 6 x 6 cm with an electric clipper with suction for 24 hours before starting the test. In the experiment only animals with intact skin were taken. 0.5 g of 4 -nitro-m-phenylenediamine was applied under occlusion to clipped intact skin of the flank. The untreated side served as a control.The survey findings was performed 1, 24, 48 and 72 h after removal of the lobules and conclusion of the test after 10 test day. The stimulus values after 24 and 72 h were averaged over the experimental animals and dividing the resultant sum of the averages by 2.
After one hour, a yellowish discoloration of the skin was found. Discoloration held until the 9th day of the experiment at (Animal No. 4). The animals were followed up until the 10th day of the experiment.
The sum of the average stimulus values after 24 h (erythema = 1.3, edema = 0) and 72 h (erythema = 0.7, edema = 0) obtained by dividing by the number of these time points (by 2) gave a primary irritation score of 1.0.
From the above results, the classification of 4-nitro-m-phenylene diamine was considered to be 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.
Reference
Time after patch removal |
Skin irritation Animal No. |
Total |
Average |
|||
3 |
4 |
5 |
||||
Erythema |
1 hr |
1 |
3 |
1 |
- |
- |
24 hr |
1 |
2 |
1 |
4 |
1.3 |
|
48 hr |
1 |
2 |
1 |
- |
- |
|
72 hr |
1 |
1 |
0 |
2 |
0.7 |
|
Experimental end |
0 |
0 |
0 |
- |
- |
|
|
||||||
Edema |
1 hr |
0 |
0 |
0 |
- |
- |
24 hr |
0 |
0 |
0 |
0 |
0 |
|
48 hr |
0 |
0 |
0 |
- |
- |
|
72 hr |
0 |
0 |
0 |
0 |
0 |
|
Experimental end |
0 |
0 |
0 |
- |
- |
The sum of the average stimulus values after 24 h (erythema = 1.3, edema = 0) and 72 h (erythema = 0.7, edema = 0) obtained by dividing by the number of these time points (by 2) gave a primary irritation score of 1.0
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- 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
- 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
- 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 - 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 - 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. - 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
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
The primary skin irritation of 4-nitro-m-phenylenediamine was assessed in rabbits in a study conducted at Bayer AG Institute for Toxicology (Sustainability Support Service (Europe) AB has Letter of Access). The study was performed as per OECD Guideline 404.
The flank skin of 3 male New Zealand White rabbits was depilated on both sides on an area of approximately 6 x 6 cm with an electric clipper with suction for 24 hours before starting the test. In the experiment only animals with intact skin were taken. 0.5 g of 4 -nitro-m-phenylenediamine was applied under occlusion to clipped intact skin of the flank. The untreated side served as a control. The survey findings was performed 1, 24, 48 and 72 h after removal of the lobules and conclusion of the test after 10 test day. The stimulus values after 24 and 72 h were averaged over the experimental animals and dividing the resultant sum of the averages by 2. After one hour, a yellowish discoloration of the skin was found. Discoloration held until the 9th day of the experiment at (Animal No. 4). The animals were followed up until the 10th day of the experiment.
The sum of the average stimulus values after 24 h (erythema = 1.3, edema = 0) and 72 h (erythema = 0.7, edema = 0) obtained by dividing by the number of these time points (by 2) gave a primary irritation score of 1.0.
From the above results, the classification of 4-nitro-m-phenylene diamine was considered to be 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.
Eye Irritation:
In different studies, 4-nitro-m-phenylenediamine has been investigated for potential for ocular irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with predicted data for target chemical and its structurally similar read across substances, 2 nitro p –phenylene diamine [CAS: 5307-14-2] and 4-nitroaniline [CAS: 100-01-6].
The primary eye irritation of 4-nitro-m-phenylenediamine was assessed in rabbits in a study conducted at Bayer AG Institute for Toxicology (Sustainability Support Service (Europe) AB has Letter of Access). The study was performed 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 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.
This result is supported by the experimental study summarized in Fd Cosmet. Toxicol. Vol. 15, pp. 607-610. 1977; for the structurally similar read across substance, 2 nitro p –phenylene diamine [CAS: 5307-14-2]..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. The reactions were scored and 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).
None of the three animals treated with 2 nitro p phenylene diamine 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, 2 nitro p phenylene diamine was considered to be not irritating to rabbit eyes.
These results are further supported by the experimental study summarized in ACTor (Aggregated Computational Toxicology Resource) - ACToR EPA database, 2011; for the structurally similar read across substance, 4-nitroaniline [CAS: 100-01-6].4 -nitroaniline was instilled into rabbit eyes and observed for signs of irritation (dose and duration not specified).
No signs of irritation were observed. Hence, 4-nitroaniline was considered not irritating to rabbit eyes.
Based on the available data for the target as well it’s read across substances, 4-nitro-m-phenylene diamine can be considered not irritating to eyes.Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”.
Justification for classification or non-classification
Available studies for 4-nitro-m-phenylenediamine indicate that it is not likely to cause any irritation to eyes, but causes moderate irritation to skin.
Hence, 4-nitro-m-phenylene diamine can be classified under the category “Not Classified” for eyes and “Category 2” for skin as per CLP.
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