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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 publication

Data source

Reference
Reference Type:
publication
Title:
contact dermatitis study of test chemical
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:
Skin sensitization study was performed in human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R for test substance 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
Reference substance name:
Sodium 2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate
EC Number:
214-998-2
EC Name:
Sodium 2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate
Cas Number:
1248-18-6
IUPAC Name:
sodium 2-[(2-hydroxy-1-naphthyl)diazenyl]naphthalene-1-sulfonate
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Lithol Red
- Molecular formula: C20H13N2NaO4S
- Molecular weight : 400.389 g/mol
- Substance type:Organic
- Physical state:Solid
-Smiles: c12c(c(\N=N\c3c4c(ccc3O)cccc4)ccc1cccc2)S(=O)(=O)[O-].[Na+] :
-InChI: 1S/C20H14N2O4S.Na/c23-18-12-10-13-5-1-3-7-15(13)19(18)22-21-17-11-9-14-6-2-4-8-16(14)20(17)27(24,25)26;/h1-12,23H,(H,24,25,26);/q;+1/p-1/b22-21+;

In vivo test system

Test animals

Species:
other: Human
Strain:
other: Not applicable
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:
2 days
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1%
Day(s)/duration:
2 days
Adequacy of challenge:
not specified
No. of animals per dose:
28 healthy female volunteers
Details on study design:
The test was 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:
Healthy female volunteers which were used as a control are of age 20 and 21.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
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

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
As none of the patients showed positive reactions, the test material 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 to detect its contact sensitivity.

 

The patch of test chemical 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 chemical was considered to be not sensitizingin human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R.