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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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 peer reviewed journal

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Final amended report of the safety assessment of Toluene-2,5-Diamine, Toluene-5,5-Diamine, Toluene-2,5-Diamine Sulfate , and Toluene-3, 4- Diamine as used in cosmetics.
Author:
Christina L. Burnett, Wilma F.Bergfeld , Donald V.Belsito , Curtis D.Klaassen , James G.Marks Jr, Ronald C. Shank , Thomas J. Slaga, Paul W. Snyder, F. Alan Andersen
Year:
2010
Bibliographic source:
International Journal of Toxicology 29 ( supplement 2) 2010
Reference Type:
other: authorative database
Title:
Hazardous Substances Data Bank (HSDB) for 2,5-DIAMINOTOLUENE SULFATE
Author:
U.S National Library of Medicine
Year:
2017
Bibliographic source:
Hazardous Substances Data Bank (HSDB) for 2,5-DIAMINOTOLUENE SULFATE ,U.S National Library of Medicine 2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To evaluate skin irritation potential of 2-methyl-p-phenylenediamine sulphate on Hartley albino guinea pigs
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
-IUPAC name:2-methyl-p-phenylenediamine sulphate
- Name of test material : Toluene-2,5-diamine sulphate
- Molecular formula : C7H12N2O4S
- Molecular weight : 220.2478 g/mol
- Substance type: Organic
- Physical state: Off-white powder
InChI:1S/C7H10N2.H2O4S/c1-5-4-6(8)2-3-7(5)9;1-5(2,3)4/h2-4H,8-9H2,1H3;(H2,1,2,3,4)
Smiles:Cc1cc(ccc1N)N.OS(=O)(=O)O
Specific details on test material used for the study:
-IUPAC name:2-methyl-p-phenylenediamine sulphate
- Name of test material : Toluene-2,5-diamine sulphate
- Molecular formula : C7H12N2O4S
- Molecular weight : 220.2478 g/mol
- Substance type: Organic
- Physical state: Off-white powder
InChI:1S/C7H10N2.H2O4S/c1-5-4-6(8)2-3-7(5)9;1-5(2,3)4/h2-4H,8-9H2,1H3;(H2,1,2,3,4)
Smiles:Cc1cc(ccc1N)N.OS(=O)(=O)O

Test animals

Species:
guinea pig
Strain:
Hartley
Details on test animals and environmental conditions:
No data available

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: White petrolatum
Controls:
not specified
Amount / concentration applied:
0.1%, 0.2%, 0.5%, 1%, 2%, 5% and 10%
Duration of treatment / exposure:
48 hrs
Observation period:
48 hrs
Number of animals:
Total=10
Details on study design:
Area of exposure: Flank

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No skin reaction were observed in any of the test animals in any of the test concentrations.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
2-methyl-p-phenylenediamine sulphate was applied on the skin of Hartley albino guinea pigs in the concentrations 0.1%, 0.2%, 0.5%, 1%, 2%, 5% and 10% in petrolatum for 48 hrs. No skin reaction were observed in any of the test animals in any of the test concentrations. Hence, 2-methyl-p-phenylenediamine sulphate was considered as not skin irritant
Executive summary:

2-methyl-p-phenylenediamine sulphate was used as a test material to evaluate skin irritation potential on 10 Hartley albino guinea pigs.

The test material was applied on the flanks of test animal in the concentrations of0.1%, 0.2%, 0.5%, 1%, 2%, 5% and 10% in petrolatum for 48 hrs under occlusion .

No skin reaction were observed in any of the test animals in any of the test concentrations. Hence,2-methyl-p-phenylenediamine sulphate was considered as not skin irritant.