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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
Experimental study conducted by IFA (GESTIS- Substance Database, 2011) to evaluate the skin sensitizing potential of target substance 4-Nitro-m-phenylenediamine (5131-58-8) in guinea pig.4-nitrobenzene-1,3-diamine( 5131-58-8) was assessed for its possible contact allergenic potential. A test on the skin-sensitizing effects of the substance on guinea pigs yielded positive results and confirmed a moderate allergic potential. Therefore 4-nitrobenzene-1,3-diamine( 5131-58-8) was considered to be sensitizing in Guinea pig.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from authoritative database.
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- To evaluate the skin sensitizing potential of 4-nitrobenzene-1,3-diamine in Guinea pig.
- GLP compliance:
- not specified
- Type of study:
- other: Not specified.
- Justification for non-LLNA method:
- 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:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available.
- Route:
- other: No data available.
- Route:
- other: No data available.
- No. of animals per dose:
- No data available.
- Details on study design:
- No data available.
- Challenge controls:
- No data available.
- Positive control substance(s):
- not specified
- Statistics:
- No data available.
- Reading:
- 1st reading
- Group:
- test chemical
- Clinical observations:
- Sensitization effects were observed.
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- other: Sensitizing
- Conclusions:
- 4-nitrobenzene-1,3-diamine( 5131-58-8) was observed for its skin sensitizing potential in guinea pig. The test material 4-nitrobenzene-1, 3-diamine was considered to non sensitizing in Guinea pig.
- Executive summary:
4-nitrobenzene-1,3-diamine( 5131-58-8) was assessed for its possible contact allergenic potential. A test on the skin-sensitizing effects of the substance on guinea pigs yielded positive results and confirmed a moderate allergic potential. Therefore 4-nitrobenzene-1,3-diamine( 5131-58-8) was considered to be sensitizing in Guinea pig.
Reference
A test on the skin-sensitizing effects of the substance on guinea pigs yielded positive results and confirmed a moderate allergic potential
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensitization
In different studies, 4-Nitro-m-phenylenediamine (5131-58-8) has been investigated for potential of skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in guinea pig and human for target chemical4-nitrobenzene-1,3-diamine,4-Nitro-m-phenylenediamine (5131-58-8) and its structurally similar read across substances2-nitrobenzene-1,4-diamine (5307-14-2).The predicted data using the Danish QSAR has also been compared with the experimental data of target chemical and read across.
Experimental study conducted by IFA (GESTIS- Substance Database, 2011) to evaluate the skin sensitizing potential of target substance 4-Nitro-m-phenylenediamine (5131-58-8) in guinea pig.4-nitrobenzene-1,3-diamine( 5131-58-8) was assessed for its possible contact allergenic potential. A test on the skin-sensitizing effects of the substance on guinea pigs yielded positive results and confirmed a moderate allergic potential. Therefore 4-nitrobenzene-1,3-diamine( 5131-58-8) was considered to be sensitizing in Guinea pig.
Another prediction done using the Danish (Q) SAR Database, the skin sensitization was estimated to be positive on guinea pig and human for 4-Nitro-m-phenylenediamine.Using Battery algorithm model of Danish QSAR, Allergic Contact Dermatitis for 4-Nitro-m-phenylenediamine (5131-58-8) estimated to be sensitizing when applied to human and guinea pig skin.
It is further supported by an experimental study conducted by COSMETIC INGREDIENT REVIEW (JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY, 1985)on structurally similar read across substance 2-nitrobenzene-1,4-diamine (5307-14-2)on guinea pigs.The read across substances share high similarity in structure and log kow .Therefore, it is acceptable to derive information on skin sensitization from the analogue substance. 2-nitrobenzene-1,4-diamine (5307-14-2) was assessed for its possible contact allergenic potential. 20 guinea pigs received topical applications of 3 percent test material in an aqueous solution containing 2 percent Natrosol250 HR, 2 percent Tween 80, 0.05 percent sodium sulfite, and 10 percent isopropanol, and adjusted to pH 7. The compounds were applied daily 6 days a week for 3 weeks on a 6 cm2shaved area of the flank. A 2-week rest period was followed by application of the compounds on the opposite, previously untreated flanks of the guinea pigs. Four of 20 guinea pigs were sensitized to test material; the total reaction intensity for all the animals was 4 (scores added for all animals; possible total of 60).Therefore2-nitrobenzene-1,4-diamine (5307-14-2) can be considered as weakly sensitizing to guinea pigs.
Thus based on the above experimental study and prediction on 4-Nitro-m-phenylenediamine (5131-58-8)andapplying weight of evidence, it can be concluded that4-Nitro-m-phenylenediamine is a skin sensitizer. Thus comparing the above annotations with the criteria of CLP regulation, 4-Nitro-m-phenylenediamine (5131-58-8) can be considered as ‘classified ‘for skin sensitization.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Thus comparing the above annotations with the criteria of CLP regulation, 4-Nitro-m-phenylenediamine (5131-58-8) can be considered as ‘classified ‘for skin sensitization.
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