Disodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzene-1-sulphonato(4-)]hydroxychromate(2-)

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)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from safety assessment report

Data source

Reference

Reference Type:

secondary source

Title:

OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS

Author:

European Commission (EC) - Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP)

Year:

2004

Bibliographic source:

Opinion concerning: Acid Yellow 23 (Colipa n° C29); European Commission (EC) - Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP) SCCNFP/0786/04; 23 April 2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

A Maximisation (Magnusson and Kligman) Test was conducted on albino Himalayan spotted guinea pigs to determine the skin sensitization potential of chemical Acid Yellow 23 (CAS No: 1934-21-0) in accordance with OECD Guideline No. 406.

GLP compliance:

not specified

Type of study:

guinea pig maximisation 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:

C16H12N4O9S2.3Na

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

Specific details on test material used for the study:

- 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:

guinea pig

Strain:

other: Ibm: GOHI (synonym: Himalayan spotted)

Sex:

female

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

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

Concentration / amount:

5 % solution (in 1 % carboxymethylcellulose solution; prepared with bidistilled water) applied in an emulsion of Freund´s Complete Adjuvant (FCA)

Day(s)/duration:

1 week

Adequacy of induction:

not specified

Induction 2

Route:

epicutaneous, occlusive

Vehicle:

not specified

Concentration / amount:

50 % solution

Day(s)/duration:

48 hours

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

not specified

Concentration / amount:

25 % solution

Day(s)/duration:

48 hours

Adequacy of challenge:

not specified

No. of animals per dose:

15 (10 test, 5 control female animals)

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE: Intradermal
- No. of exposures: 1
- Exposure period: 1 Week
- Test groups: 10
- Control group: 5
- Site: no data
- Frequency of applications: no data
- Duration: 1 week
- Concentrations: 5 % solution

A. II.INDUCTION EXPOSURE: Epidermal
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: 10
- Control group: 5
- Site: no data
- Frequency of applications: no data
- Duration: 48 hours
- Concentrations: 50 % solution


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 2 weeks
- Exposure period: 48 hours
- Test groups: 10
- Control group: 5
- Site: no data
- Concentrations:25 % solution
- Evaluation (hr after challenge): after 24 and 48

Challenge controls:

Yes (No detailed information was available).

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

25 % solution

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

No skin reactions were observed in treated guinea pigs.

Remarks on result:

no indication of skin sensitisation

Results 2

Reading:

other: control group

Hours after challenge:

48

Group:

test chemical

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

no skin reaction was observed.

Remarks on result:

no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / 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. However, no oedema was observed.

Applicant's summary and conclusion

Interpretation of results:

other: not sensitizing

Conclusions:

The test material Acid Yellow 23 (CAS No: 1934-21-0) was considered to be not sensitizing to the skin of albino Himalayan spotted guinea pigs in a Maximisation (Magnusson and Kligman) Test conducted according to OECD Guideline No. 406.

Executive summary:

A Maximisation (Magnusson and Kligman) Test was conducted on albino Himalayan spotted guinea pigs to determine the skin sensitization potential of chemical Acid Yellow 23 (CAS No: 1934-21-0) in accordance with OECD Guideline No. 406.

 

During the induction, a 5 % Acid Yellow 23 solution (in 1 % carboxymethylcellulose solution; prepared with bidistilled water) 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.

 

Animals were challenged after 2 week 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.

 

Since none of the control as well as test animals showed any signs of contact sensitization at after challenge treatment , the chemical Acid Yellow 23 (CAS No: 1934-21-0) was considered to be not sensitizing to the skin ofalbino Himalayan spotted guinea pigs.