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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:
A case of allergic contact dermatitis due to metanil yellow
Author:
Hausen BM
Year:
1994
Bibliographic source:
Contact Dermatitis 31: 117–118, 1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To evaluate the skin sensitizing potential of substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate in human by patch test.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
Case report of contact dermatitis proceeded by patch test.

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 3-(p-anilinophenylazo)benzenesulphonate
EC Number:
209-608-2
EC Name:
Sodium 3-(p-anilinophenylazo)benzenesulphonate
Cas Number:
587-98-4
Molecular formula:
C18H14N3O3S.Na
IUPAC Name:
sodium 3-(p-anilinophenylazo)benzenesulphonate
Test material form:
solid
Details on test material:
- Name of test material: Ext. D&C Yellow No. 1
- IUPAC name: sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate
- Molecular formula: C18H15N3O3SNa
- Molecular weight: 375.383 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 : sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate
- Molecular formula : C18H14N3O3S.Na
- Molecular weight: 375.383 g/mol
- Smiles notation : c1(Nc2ccccc2)ccc(\N=N\c2cc(ccc2)S(=O)(=O)[O-])cc1.[Na+]
- InChl : 1S/C18H15N3O3S.Na/c22-25(23,24)18-8-4-7-17(13-18)21-20-16-11-9-15(10-12-16)19-14-5-2-1-3-6-14;/h1-13,19H,(H,22,23,24);/q;+1/p-1/b21-20+;
- Substance type: Organic
- Physical state: Solid

In vivo test system

Test animals

Species:
other: human
Strain:
other: not applicable
Sex:
female
Details on test animals and environmental conditions:
No data

Study design: in vivo (non-LLNA)

Induction
Route:
other: dermal
Vehicle:
not specified
Concentration / amount:
not specified
Day(s)/duration:
4 days
Adequacy of induction:
not specified
No. of animals per dose:
1 human female
Details on study design:
Not specified
Challenge controls:
Not specified
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
1st reading
Hours after challenge:
96
Group:
test chemical
Dose level:
not specified
No. with + reactions:
3
Clinical observations:
lesions were observed
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate was observed to show positive reactions in Human patch test for skin sensitisation.
Executive summary:

A female patient worked in a leather (and paper) shop, selling various leather items, such as purses, pocket books, photo albums, document portfolios, wallets and writing cases. Whenever she worked in this shop, which was usually for 2 days a week, she developed dermatitis on left side of the neck. Hence the patch test was carried out for the test substance. Patch test with the scrapings of the material remained negative. However, patch testing with the leather series gave a +++ reaction to the test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (acid yellow/metanil yellow) at 2, 3 and 4 days. On giving up working in this shop, and subsequent avoidance of contact with leather articles, her lesions healed completely. Therefore, the test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate was considered to be a skin sensitiser and can be classified as Skin sensitiser category 1 according to CLP criteria.