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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 peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
Pigmented contact dermatitis from azo dyes -I
Author:
TAKEHITO KGZUKA et. al
Year:
1980
Bibliographic source:
Contact Dermatitis, 1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
A study was performed in human volunteers to determine the degree of allergic reactions caused by the test chemical
GLP compliance:
not specified
Type of study:
patch test
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 (as cited in study report): Toluidine Red- Molecular formula: C17H13N3O3- Molecular weight : 307.308g/mol- Substance type:Organic- Physical state:Solid-Smiles: c12c(\N=N\c3c(cc(C)cc3)[N+](=O)[O-])c(ccc1cccc2)O : c12c(\N=N\c3ccc(\N=N\c4ccccc4)cc3)c(ccc1cccc2)O- InChI: 1S/C17H13N3O3/c1-11-6-8-14(15(10-11)20(22)23)18-19-17-13-5-3-2-4-12(13)7-9-16(17)21/h2-10,21H,1H3/b19-18+

In vivo test system

Test animals

Species:
other: human
Strain:
other: Not applicable
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: Petrolatum
Concentration / amount:
1%
Day(s)/duration:
2
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: Petrolatum
Concentration / amount:
1%
Day(s)/duration:
2
Adequacy of challenge:
not specified
No. of animals per dose:
8
Details on study design:
The tests were performed with Finn Chambers® on Scanpor® (Epitest, Ltd. Oy). The application was performed on the back for 2 days. Readings were made according to the ICDRG classification 24 h after the patches were removed.
Challenge controls:
28 healthy female volunteers

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
72
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
8
Clinical observations:
Skin sensitizing effects were not observed.
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
Skin sensitizing effects were not observed.None of the control volunteers gave a positive reaction

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
No dermal reactions were observed in all treated patients. Thus the test material was not considered to be a potent  sensitizer in human patients suffering from pigmented contact dermatitis.
Executive summary:

A study was performed  in human volunteers to determine the degree of allergic reactions caused by the test chemical.

The test chemical 1% in petrolatum was applied onto the back of 8 healthy patients for 24 hours by using Finn Chambers® on Scanpor® (Epitest, Ltd. Oy). After removal of patch, skin reactions were assessed according to the ICDRG classification for 2 days. Twenty-eight healthy female volunteers, aged 20 and 21, were also tested with the sample as controls. None gave a positive reaction.

No dermal reactions were observed in all treated patients. Thus the test material was not considered to be a potent  sensitizer in human patients suffering from pigmented contact dermatitis.