4-aminoazobenzene-3,4'-disulphonic acid

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Data source

Reference

Reference Type:

publication

Title:

Evaluation and opinion on Acid Yellow 23

Author:

SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS

Year:

2004

Bibliographic source:

OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID YELLOW 23 COLIPA n° C29

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

as per OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

no

Type of study:

other: Maximisation (Magnusson and Kligman) 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

IUPAC Name:

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

Constituent 2

Reference substance name:

Tartrazine

IUPAC Name:

Tartrazine

Details on test material:

- Name of test material (as cited in study report): Tartrazine- Molecular formula (if other than submission substance): C16-H12-N4-O9-S2.3Na- Molecular weight (if other than submission substance): 534.3681- Substance type: Organic

In vivo test system

Test animals

Species:

guinea pig

Strain:

Himalayan

Sex:

not specified

Details on test animals and environmental conditions:

No data available

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

other: 1 % carboxymethylcellulose solution; prepared with bi-distilled water

Induction 2

Concentration / amount:

intradermal induction : 5 % solutionepidermal induction : 50 % solutionchallenge : 25 % solution

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: 1 % carboxymethylcellulose solution; prepared with bi-distilled water

Challenge 2

Concentration / amount:

intradermal induction : 5 % solutionepidermal induction : 50 % solutionchallenge : 25 % solution

No. of animals per dose:

15 (10 test, 5 control female animals)

Details on study design:

Details on study designRANGE FINDING TESTS:MAIN STUDY- Exposure period: an emulsion of Freund´s Complete Adjuvant- Concentrations:5% of test chemical for intradermal inductionB. CHALLENGE EXPOSURE- No. of exposures:No data- Day(s) of challenge:No data (2 wk later the animals were challenged)- Site:No data(Epidermal application under occlusive dressing)- Evaluation (hr after challenge): at 24 and 48 h after removal of the dressingOTHER: 1 week later the induction exposure, following treatment with sodium lauryl sulfate (SLS) the epidermal induction was conducted for 48 h under occlusion with a 50 % Acid Yellow 23 solution.

Challenge controls:

For challenge reading, all animals were depilated 3 h before examination to remove the discolouration

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Reading:

other: Non-sensitising

Hours after challenge:

48

Group:

test chemical

Dose level:

5,50 and 25% solution

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

None of the control and test animals showed skin reactions after the challenge treatment with Acid Yellow 23. The 50 % test item stained the skin orange, therefore it was not possible to determine whether erythema were present or not.

Remarks on result:

other: see Remark

Remarks:

Reading: other: Non-sensitising. . Hours after challenge: 48.0. Group: test group. Dose level: 5,50 and 25% solution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None of the control and test animals showed skin reactions after the challenge treatment with Acid Yellow 23. The 50 % test item stained the skin orange, therefore it was not possible to determine whether erythema were present or not..

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Non-sensitising effects were known skin sensitisation test of chemical tartrazine Maximisation (Magnusson and Kligman) Test.

Executive summary:

Maximisation test was conducted according to OECD guideline 406 to the skin of Albino guinea pigs.A 5 % Acid Yellow 23 solution was applied in an emulsion of Freund´s Complete Adjuvant (FCA) for the intradermal induction. 1 week later, following treatment with sodium lauryl sulfate (SLS) the epidermal induction was conducted for 48 h under occlusion with a 50 % Acid Yellow 23 solution. 2 wk later the animals were challenged by epidermal application of Acid Yellow 23 (25

% solution) under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 h after removal of the dressing. For challenge reading, all animals were depilated 3 h before examination to remove the discolouration.

None of the control and test animals showed skin reactions after the challenge treatment with Acid Yellow 23. The 50 % test item stained the skin orange, therefore it was not possible to determine whether erythema were present or not. However, no oedema was observed.

Hence, Non-sensitising effects were known skin sensitisation test of chemical tartrazineMaximisation (Magnusson and Kligman) Test.