4'-aminoazobenzene-4-sulphonic acid

Skin sensitisation

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:

Skin sensitization of test chemical.

Author:

Thierbach MA et. al..

Year:

1992

Bibliographic source:

Contact Dermatitis

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

A patch test for test chemical was performed in 32 patients with an established p-aminoazobenzene allergy.

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate

EC Number:

217-699-5

EC Name:

Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate

Cas Number:

1934-21-0

Molecular formula:

C16-H12-N4-O9-S2.3Na

IUPAC Name:

trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate

Test material form:

solid

Details on test material:

- Name of test material (IUPAC name): trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Common name: Acid Yellow 23,Tartrazine
- Molecular formula: C16H9N4Na3O9S2
- Molecular weight:534.3681 g/mol
- Smiles notation: n1(c2ccc(cc2)S(=O)(=O)[O-])c(c(c(n1)C(=O)[O-])/N=N/c1ccc(cc1)S(=O)(=O)[O-])O.[Na+].[Na+].[Na+]
-InChl:1S/C16H12N4O9S2.3Na/c21-15-13(18-17-9-1-5-11(6-2-9)30(24,25)26)14(16(22)23)19-20(15)10-3-7-12(8-4-10)31(27,28)29;;;/h1-8,13H,(H,22,23)(H,24,25,26)(H,27,28,29);;;/q;3*+1/p-3/b18-17+;;;
- Substance type: Organic
- Physical state:Soild

In vivo test system

Test animals

Species:

other: Human

Strain:

other: Not applicable

Sex:

male/female

Details on test animals and environmental conditions:

The test was conducted on a group of 32 patients with presumable allergic contact dermatitis and all with a positive patch teat reaction to p-aminoazobenzene (0.25% pet). The group consisted of 20 women (mean age 39.9 years) and men (mean age 46.6 years). 11 patients had previously also shown sensitization to PPD (Para-phenyldiamine).

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

other: White petrolatum

Concentration / amount:

2%

Day(s)/duration:

2 days

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

other: White petrolatum

Concentration / amount:

2%

Day(s)/duration:

2 days

Adequacy of challenge:

not specified

No. of animals per dose:

32 patients

Details on study design:

A patch contain test chemical was placed in a small squares (about 1.0 cm2) and wetted with 1 drop of tap water, water was used to imitate the circumstances (wet hands or sweating of hands). By this procedure a slight but visible yellow stain on the skin was found at the test site after 2 days of application, indicating liberation of the dyes.

Challenge controls:

30 patients with an allergic contact dermatitis but negative to p- p-aminoazobenzene and PPD were also tested with the same patch test series.

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

72

Group:

test chemical

Dose level:

2%

No. with + reactions:

0

Total no. in group:

32

Clinical observations:

The chemical did not elicit a positive patch test reaction in any one of the 32 patients’ positive to p-aminoazobenzene nor in the 30 control subjects.

Remarks on result:

no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:

The chemical did not elicit a positive patch test reaction in any one of the 32 patients’ positive to p-aminoazobenzene nor in the 30 control subjects.

Applicant's summary and conclusion

Interpretation of results:

other: not sensitizing

Conclusions:

The chemical did not elicit a positive patch test reaction in any one of the 32 patients’ positive to p-aminoazobenzene nor in the 30 control subjects. Hence was considered to be not sensitizing.

Executive summary:

A patch test for test chemical was performed in 32 patients with an established p-aminoazobenzene allergy.

 

The test was conducted on a group of 32 patients with presumable allergic contact dermatitis and all with a positive patch teat reaction to p-aminoazobenzene (0.25% pet). The group consisted of 20 women (mean age 39.9 years) and men (mean age 46.6 years). 11 patients had previously also shown sensitization to PPD (Para-phenyldiamine). 30 patients with an allergic contact dermatitis but negative to p-aminoazobenzene and PPD were also tested with the same patch test series.

 

A patch with test chemical was placed in small squares (about 1.0 cm²) and wetted with 1 drop of tap water, water was used to imitate the circumstances (wet hands or sweating of hands). By this procedure a slight but visible yellow stain on the skin was found at the test site after 2 days of application, indicating liberation of the dyes.

 

The chemical did not elicit a positive patch test reaction in any one of the 32 patients’ positive to p-aminoazobenzene nor in the 30 control subjects. Hence the chemical was considered to be not sensitizing.