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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
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 journals

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Pigmented cosmetic dermatitis and coal tar dyes.
Author:
T Sugai, Y Takahashi, T Takagi.
Year:
1977
Bibliographic source:
Contact Dermatitis, 3 249-256 (1977).
Reference Type:
secondary source
Title:
OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID YELLOW 23
Author:
SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS -SCCNFP
Year:
2004
Bibliographic source:
Evaluation and opinion on Acid Yellow 23, SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS -SCCNFP, adopted on 23 April 2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the dermal sensitization potential of Tartrazine Aluminium lake in humans
GLP compliance:
not specified
Type of study:
patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material: Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex- IUPAC name: aluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulfonate)- Molecular formula: C48H33AlN12O27S6- Molecular weight: 1429.19 g/mole- Smiles : C1=CC(=CC=C1N=NC2C(=NN(C2=O)C3=CC=C(C=C3)S(=O)(=O)O)C(=O)O)S(=O)(=O)[O-].C1=CC(=CC=C1N=NC2C(=NN(C2=O)C3=CC=C(C=C3)S(=O)(=O)O)C(=O)O)S(=O)(=O)[O-].C1=CC(=CC=C1N=NC2C(=NN(C2=O)C3=CC=C(C=C3)S(=O)(=O)O)C(=O)O)S(=O)(=O)[O-].[Al+3]- Inchl: 1S/3C16H12N4O9S2.Al/c3*21-15-13(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;/h3*1-8,13H,(H,22,23)(H,24,25,26)(H,27,28,29);/q;;;+3/p-3- Substance type: Organic- Physical state: Solid Red powder
Specific details on test material used for the study:
- Name of test material: Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex- Common Name: Tartrazine Aluminium lake- IUPAC name: aluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulfonate)- Molecular formula: C48H33AlN12O27S6- Molecular weight: 1429.19 g/mole- Smiles : C1=CC(=CC=C1N=NC2C(=NN(C2=O)C3=CC=C(C=C3)S(=O)(=O)O)C(=O)O)S(=O)(=O)[O-].C1=CC(=CC=C1N=NC2C(=NN(C2=O)C3=CC=C(C=C3)S(=O)(=O)O)C(=O)O)S(=O)(=O)[O-].C1=CC(=CC=C1N=NC2C(=NN(C2=O)C3=CC=C(C=C3)S(=O)(=O)O)C(=O)O)S(=O)(=O)[O-].[Al+3]- Inchl: 1S/3C16H12N4O9S2.Al/c3*21-15-13(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;/h3*1-8,13H,(H,22,23)(H,24,25,26)(H,27,28,29);/q;;;+3/p-3- Substance type: Organic- Physical state: Solid Red powder

In vivo test system

Test animals

Species:
other: humans
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Source: Patch test were performed in 53 patients with pigmented cosmetic dermatitis who had visited the authors clinic over the past 2 years

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: 88 % polyethylene glycol 400 and 12 % polyethylene glycol 6000
Concentration / amount:
5 % in vehicle
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: 88 % polyethylene glycol 400 and 12 % polyethylene glycol 6000
Concentration / amount:
5% in vehicle
Day(s)/duration:
48 and 72 hours
Adequacy of challenge:
not specified
No. of animals per dose:
28 patients
Details on study design:
OTHER:Patch tests were performed according to the standardized method recommended by the ICDRGPatients had pigmented cosmetic dermatitis. The test substance was mixed at 5 % in a vehicle composed of 88 % polyethylene glycol 400 and 12 % polyethylene glycol 6000. The test were fixed with A1-test on Dermicel tape.Scoring pattern for dermal reactions:No reaction: -Slight erythema: +Erythema with slight papules: ±Erythema with edema: ++Erythema with vesicles and/or papules: +++
Challenge controls:
no data available
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
5% in vehicle
No. with + reactions:
0
Total no. in group:
53
Clinical observations:
no reactions observed
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
72
Group:
test group
Dose level:
5% in vehicle
No. with + reactions:
0
Total no. in group:
53
Clinical observations:
no reactionns observed
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Table: Results of the skin tests to representative coal tar dyes in patients with pigmented dermatitis

Name of the dye

Legal name in USE

PATCH TEST

TOTAL NUMBER OF PATIENTS

+

 

++

 

+++

 

Tartrazine aluminium lake

FDC- Y5

0

0

0

53

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
Tartrazine Aluminium Lake in a patch test performed according to ICDRG Guidelines did not produce any dermal reactions in the human volunteers. Hence, Tartrazine Aluminum lake was considered to be not sensitizing to skin.
Executive summary:

Patch tests were performed to assess the dermal sensitization potential of Tartrazine Aluminium lake in humans. Patch tests were performed according to the standardized method recommended by the ICDRG. The test was performed in 53 patients with pigmented cosmetic dermatitis who had visited the author’s clinic over the past 2 years. The test substance was mixed at 5 % in a vehicle composed of 88 % polyethylene glycol 400 and 12 % polyethylene glycol 6000. The test patches were fixed with A1 -test on Dermicel tape. The skin reactions were scored at 48 and 72 hours according to the following standards:

No reaction: -; Slight erythema: +; Erythema with slight papules: ±; Erythema with edema: ++; Erythema with vesicles and/or papules: +++

Tartrazine Aluminium Lake in a patch test performed according to ICDRG Guidelines did not produce any dermal reactions in the human volunteers. Hence, Tartrazine Aluminum lake was considered to be not sensitizing to skin.