Registration Dossier
Registration Dossier
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EC number: 228-291-1 | CAS number: 6219-71-2
Skin irritation / corrosion
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:
- 2 010
- 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:
- 2 017
- 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
- 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 substance name:
- 2-methyl-p-phenylenediamine sulfate
- EC Number:
- 210-431-8
- EC Name:
- 2-methyl-p-phenylenediamine sulfate
- Cas Number:
- 615-50-9
- Molecular formula:
- C7H10N2.H2O4S
- IUPAC Name:
- 2-methyl-p-phenylenediamine sulfate
- 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
Constituent 1
- 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 or test system 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.
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