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Toxicological information

Skin sensitisation

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Administrative data

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.

Data source

Reference
Reference Type:
other: Authoritative database
Title:
Skin sensitization study of 4-nitrobenzene-1,3-diamine in Guinea pig
Author:
IFA (GESTIS)
Year:
2011
Bibliographic source:
GESTIS - Substance Database (Information system on hazardous substances of the Berufsgenossenschaften)

Materials and methods

Test guideline
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.

Test material

Reference
Name:
Unnamed
Type:
Constituent
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
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

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available.

Study design: in vivo (non-LLNA)

Induction
Route:
other: No data available.
Challenge
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

Study design: in vivo (LLNA)

Statistics:
No data available.

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Clinical observations:
Sensitization effects were observed.
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.