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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 peered 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: Guinea pig maximisation test
Principles of method if other than guideline:
To evaluate skin sensitization potential of 2-methyl-p-phenylenediamine sulphate on Hartley albino guinea pigs
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
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

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1%
Day(s)/duration:
48 hrs exposure for 3 times per week
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.1% or 1%
Day(s)/duration:
48 hrs
Adequacy of challenge:
not specified
No. of animals per dose:
Total=10
Details on study design:
A. INDUCTION EXPOSURE
- No. of exposures: 6
- Exposure period: 48 hrs
- Test groups: 10
- Control group: no data
- Site: nape
- Frequency of applications: 3 times per week for 2 weeks
- Duration: 48 hrs
- Concentrations: 1%

B. CHALLENGE EXPOSURE
- No. of exposures: not specified
- Day(s) of challenge: not specified
- Exposure period: 48 hrs
- Test groups: 10
- Control group: not specified
- Site: flank
- Concentrations:0.1 % or 1%
- Evaluation (hr after challenge): 48 hrs

OTHER: the animals were given 2 weeks non treatment period after the induction treatment and before challenge treatment.
Challenge controls:
Not specified
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
0.1 and 1%
Total no. in group:
10
Clinical observations:
Sensitization rate for 0.1% test solution was 10% and 1% test solution was 40%
Remarks on result:
positive indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
Sensitization rate for 0.1% test solution was 10% and 1% test solution was 40%

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
2-methyl-p-phenylenediamine sulphate was applied occlusively on the skin of Hartley albino guinea pigs in the concentration 1% and ) 0.1% in induction and challenge treatment . Sensitization rate for 0.1% test solution was 10% and 1% test solution was 40%. Positive skin sensitization reactions were observed. Hence, 2-methyl-p-phenylenediamine sulphate was considered to be sensitizing to guinea pig’s skin.
Executive summary:

2-methyl-p-phenylenediamine sulphate was used as attest material to evaluate skin sensitization potential on the Hartley albino guinea pigs skin

  In the induction treatment the test material was applied in the concentration 1% in white petrolatum under occlusive patch to the nape of 10 guinea pigsfor 48 hrs three times per week for 2 weeks.The animals were given 2 weeks non treatment period after the induction treatment and before challenge treatment .

  The challenge treatment was givenunder occlusive patch to the flanks of the test animals for 48 hrs and the animals were observed for 24 and 48 hrs after the removal of test material.

  Sensitization rate for 0.1% test solution was 10% and 1% test solution was 40%. Positive skin sensitization reactions were observed. Hence,2-methyl-p-phenylenediamine sulphate  was considered to be sensitizing to guinea pig’s skin.