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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 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:
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 to evaluate whether the test substance Sudan II is a potential skin sensitizer or not.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
Skin sensitization study was performed in human patients suffering from pigmented contact dermatitis.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Sudan II
- Molecular formula (if other than submission substance): C18H16N2O
- Molecular weight (if other than submission substance): 276.337 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: No data available
- Impurities (identity and concentrations): No data available
Specific details on test material used for the study:
- Name of test material (as cited in study report): C.I. Solvent orange 7
- Molecular formula: C18H16N2O
- Molecular weight : 276.337 g/mol
- Substance type: Organic
- Physical state: Solid
- Smiles : Cc1ccc(N=Nc2c(O)ccc3ccccc23)c(C)c1
- InChI: 1S/C18H16N2O/c1-12-7-9-16(13(2)11-12)19-20-18-15-6-4-3-5-14(15)8-10-17(18)21/h3-11,21H,1-2H3/b20-19+

In vivo test system

Test animals

Species:
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% in petrolatum
Challenge
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1% in petrolactum
No. of animals per dose:
8
Details on study design:
OTHER: 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:
No data available
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Group:
test group
Dose level:
1%
No. with + reactions:
2
Total no. in group:
8
Clinical observations:
Positive effects observed
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

Other details not known

Applicant's summary and conclusion

Interpretation of results:
other: sensitising
Conclusions:
Positive reactions were seen in 2 out of total 8 cases. Thus the test chemical 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6) was considered to be sensitizing 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 to evaluate the skin sensitizing potential of the test substance 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6).

 

The patch of 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol was applied onto the back of each patient for 24 hours by usingFinn Chambers® on Scanpor® (Epitest, Ltd. Oy). 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 to

 

Since thepositive reactions were seen in 2 out of total 8 cases,the test chemical1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (CAS No: 3118-97-6)was considered to be sensitizingin human patients suffering from pigmented contact dermatitis caused by the commercial Brilliant Lake Red R.