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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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

Constituent 1
Chemical structure
Reference substance name:
1-(4-methyl-2-nitrophenylazo)-2-naphthol
EC Number:
219-372-2
EC Name:
1-(4-methyl-2-nitrophenylazo)-2-naphthol
Cas Number:
2425-85-6
Molecular formula:
C17H13N3O3
IUPAC Name:
1-(4-Methyl-2-nitrophenylazo)-2-naphthol
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 chemical
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.