Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex

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 peer reviewed journals

Data source

Reference

Reference 1

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 2

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

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

Justification for non-LLNA method:

Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex

EC Number:

235-428-9

EC Name:

Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex

Cas Number:

12225-21-7

Molecular formula:

C48H33AlN12O27S6

IUPAC Name:

aluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulfonate)

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 appearance : Yellow to greenish-yellow powder.
- Purity as per Certificate of Analysis : 40.79%
- Lot No. : FG/16-17/0427
- Manufactured date : 19 May 2016
- Expiry Date : Shelf life of 8 years
- pH : 3.98 at 26.8°C
- Density : 0.283 g/cm3 at 26.8°C
- Storage conditions : Ambient (+15 to +25°C)
- SAFETY PRECAUTIONS: Gloves, cap and face mask were used in addition to protective body garments and shoes, to ensure adequate personal health and safety and to avoid inhalation and skin contact with the test item.

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 ICDRG
Patients 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)

Results

Results 1

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

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

Results 2

Reading:

1st reading

Hours after challenge:

72

Group:

test chemical

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.