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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:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: 1 % carboxymethylcellulose solution; prepared with bi-distilled water
Concentration / amount:
intradermal induction : 5 % solutionepidermal induction : 50 % solutionchallenge : 25 % solution
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 1 % carboxymethylcellulose solution; prepared with bi-distilled water
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 group
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.