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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
Reference
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:
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 group
Clinical observations:
Sensitization effects were observed.
Remarks on result:
positive indication of skin sensitisation

A test on the skin-sensitizing effects of the substance on guinea pigs yielded positive results and confirmed a moderate allergic potential

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.

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.