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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6
Qualifier:
according to
Guideline:
other: Given below
Principles of method if other than guideline:
Prediction is done using QSAR Toolbox version 3.3
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Route:
epicutaneous, open
Route:
epicutaneous, open
Reading:
1st reading
Group:
test group
Clinical observations:
Not sensitizing
Remarks on result:
other: Reading: 1st reading. Group: test group. Clinical observations: Not sensitizing .

The prediction was based on dataset comprised from the following descriptors: "S M W N"
Estimation method: Takes highest mode value from the 6 nearest neighbours
Domain  logical expression:Result: In Domain

(((("a" or "b" or "c" or "d" or "e" or "f" )  and ("g" and ( not "h") )  )  and ("i" and ( not "j") )  )  and ("k" and "l" )  )

Domain logical expression index: "a"

Referential boundary: The target chemical should be classified as Anilines (Acute toxicity) by US-EPA New Chemical Categories

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as Aniline AND Aryl AND Azo AND Sulfonic acid by Organic Functional groups

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Aniline AND Aryl AND Azo AND Overlapping groups AND Sulfonic acid by Organic Functional groups (nested)

Domain logical expression index: "d"

Referential boundary: The target chemical should be classified as Aliphatic Nitrogen, one aromatic attach [-N] AND Aromatic Carbon [C] AND Azo [-N=N-] AND Hydroxy, sulfur attach [-OH] AND Miscellaneous sulfide (=S) or oxide (=O) AND Olefinic carbon [=CH- or =C<] AND Suflur {v+4} or {v+6} AND Sulfinic acid [-S(=O)OH] AND Sulfonate, aromatic attach [-SO2-O] by Organic functional groups (US EPA)

Domain logical expression index: "e"

Referential boundary: The target chemical should be classified as Amine AND Aromatic compound AND Azo compound AND Primary amine AND Primary aromatic amine AND Sulfonic acid AND Sulfonic acid derivative by Organic functional groups, Norbert Haider (checkmol)

Domain logical expression index: "f"

Referential boundary: The target chemical should be classified as Aromatic amines AND Sulfonic acids or their salts by Skin irritation/corrosion Inclusion rules by BfR

Domain logical expression index: "g"

Referential boundary: The target chemical should be classified as No Data by Ultimate biodeg

Domain logical expression index: "h"

Referential boundary: The target chemical should be classified as > 100 days OR 1 to 10 days OR 10 to 100 days by Ultimate biodeg

Domain logical expression index: "i"

Referential boundary: The target chemical should be classified as Aromatic amines AND Sulfonic acids or their salts by Skin irritation/corrosion Inclusion rules by BfR

Domain logical expression index: "j"

Referential boundary: The target chemical should be classified as Ketones OR Phenols by Skin irritation/corrosion Inclusion rules by BfR

Domain logical expression index: "k"

Parametric boundary:The target chemical should have a value of log Kow which is >= -1.88

Domain logical expression index: "l"

Parametric boundary:The target chemical should have a value of log Kow which is <= 1.25

Interpretation of results:
not sensitising
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The skin sensitization potential for 4-Aminoazobenzene-3, 4’-disulfonic acid was estimated to be non sensitizing in guinea pig.
Executive summary:

The skin sensitization potential for 4-Aminoazobenzene-3, 4’-disulfonic acid (101-50-8)is estimated using OECD QSAR toolbox version 3.3.The substance 4-aminoazobenzene-3, 4’-disulphonic acid is estimated to be not sensitizing to guinea pig.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization

The skin sensitization potential for4-Aminoazobenzene-3, 4’-disulfonic acid (101-50-8)is estimated using OECD QSAR toolbox version 3.3.The substance 4-aminoazobenzene-3, 4’-disulphonic acid is estimated to be not sensitizing to guinea pig.

In other study by (.SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS, 2004) with similar substance (1934-24-0) was assayed in guineapigs.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(5% 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.

In other study by (.SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS, 2004) with similar substance (1934-24-0) was assayed in human.Human patch test was conducted was conducted to study the skin sensitisation of chemical Acid yellow 23.32 patients (20 women, 12 men) with a positive patch test reaction to paminoazobenzene were tested with dose concentration of 2%.Patch tests were performed using uniform patch tests,Acid Yellow 23 did not elicit an allergic reaction .Hence,Non-sensitising effects were known skin sensitisation test of chemical tartrazinein Human patch test.

In other study by (.S. Pestana, M. Moreira, B. Oleja , 2010) with similar substance (1934-24-0) was assayed . In an in vivo Double-blind placebo controlled challenge test, 26 atopic adults were treated by using Tartrazine in the concentration of 5, 10, 20 and 35 mg and challenged by using placebo (talc) in vice-versa withTartrazine and examined for Erythematous rash, Pruritus and Urticaria/angioedema fifty minutes after the ingestion of each capsule, and 2 h after the last one. No Erythematous rash, Pruritus and Urticaria/angioedema were observed in treated atopic adults. Therefore,Tartrazine was considered to be non sensitizing when atopic adults were tested by using Double-blind placebo controlled challenge.

On the basis of available information for the target as well as read across substance and applying weight of evidence approach, the test substance can be considered as not sensitising to the skin.


Migrated from Short description of key information:
The skin sensitization potential for 4-Aminoazobenzene-3, 4’-disulfonic acid (101-50-8)is estimated using OECD QSAR toolbox version 3.3.The substance 4-aminoazobenzene-3, 4’-disulphonic acid is estimated to be not sensitizing to guinea pig.

Justification for selection of skin sensitisation endpoint:
The skin sensitization potential for 4-Aminoazobenzene-3, 4’-disulfonic acid (101-50-8)is estimated using OECD QSAR toolbox version 3.3.The substance 4-aminoazobenzene-3, 4’-disulphonic acid is estimated to be not sensitizing to guinea pig.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test substance 4-Aminoazobenzene-3, 4’-disulfonic acid can be classified as not sensitizer.