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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 journal.

Data source

Reference
Reference Type:
publication
Title:
Pigmented contact dermatitis from azo dyes. I. Cross-sensitivity in humans.
Author:
TAKEHITO KGZUKA, MINORU TASHIR0, SHIGEHARU SANO, KEIICHI FUJIMOTO,YUMI NAKAMURA, SEIICHI HASHIMOTO AND GEN NAKAMINAM.
Year:
1980
Bibliographic source:
Contact Dermatitis; Volume 6; Pg. no. 330-336; 1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Skin sensitization study was performed in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R for test substance Toluidine Red (CAS No: 2425-85-6) to detect its contact sensitivity.
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 ( IUPAC): 1-(4-Methyl-2-nitrophenylazo)-2-naphthol
- Name of test material (as cited in study report): pigment red-3
- Molecular formula: C17H13N3O3
- Molecular weight: 307.308 g/mol
- Smiles notation: c12c(\N=N\c3c(cc(C)cc3)[N+](=O)[O-])c(ccc1cccc2)O
- InChl : 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+
- Substance type: Organic
-Physical state: yellowish red powder
Specific details on test material used for the study:
- 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
Details on test animals and environmental conditions:
A commercial sample of Toluidine Red was recrystallized from chloroform and then from benzene, mp 277.6-278.9°C; electronic spectrum (toluene), AmaxH, 4.26; C, 66.44; N, 13.68. Found: H, 4.22; C, 66.38; N, 13.54.

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
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:
As none of the patients showed positive reactions, the test material Toluidine Red (CAS No: 2425-85-6) was not considered to be a potent sensitizer in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R.
Executive summary:

Skin sensitization study was performed in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R for test substance Toluidine Red (CAS No: 2425-85-6) to detect its contact sensitivity.

 

The patch of Toluidine Red was applied onto the back of each patient for24 hours by usingFinn Chambers® on Scanpor® (Epitest, Ltd. Oy) at a dose of 1% in petrolatum. After removal of patch, skin reactions were assessedaccording 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.

 

The negative skin sensitizing effects were observed in all treated patients. Thusthe test chemicalToluidine Red(CAS No: 2425-85-6)was considered to be not sensitizingin human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R.