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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
Remarks:
in vivo
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: data from OECD QSAR toolbox v 3.3
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: predicted data
Principles of method if other than guideline:
Prediction was done using OECD QSAR toolbox v 3.3
GLP compliance:
not specified
Type of study:
other: predicted data
Justification for non-LLNA method:
not specified
Test material information:
Composition 1
Species:
guinea pig
Strain:
Himalayan
Sex:
male
Route:
intradermal and epicutaneous
Vehicle:
petrolatum
Concentration / amount:
Induction:Concentration for intradermal injection: 5% Concentration for epicutaneous application: 25% Challenge:Concentration for epicutaneous application: 15 and 25%
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
Induction:Concentration for intradermal injection: 5% Concentration for epicutaneous application: 25% Challenge:Concentration for epicutaneous application: 15 and 25%
No. of animals per dose:
20 animals
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test group
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation

The prediction was based on dataset comprised from the following descriptors: "Skin Sensitisation"
Estimation method: Takes mode value from the 5 nearest neighbours
Domain  logical expression:Result: In Domain

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

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 Fused carbocyclic aromatic AND Naphtalene AND Phenol 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 Fused carbocyclic aromatic AND Naphtalene AND Overlapping groups AND Phenol AND Sulfonic acid by Organic Functional groups (nested)

Domain logical expression index: "d"

Referential boundary: The target chemical should be classified as Alcohol, olefinic attach [-OH] AND Aliphatic Nitrogen, one aromatic attach [-N] AND Aromatic Carbon [C] AND Azo [-N=N-] AND Hydroxy, aromatic attach [-OH] AND Hydroxy, sulfur attach [-OH] AND Miscellaneous sulfide (=S) or oxide (=O) AND Olefinic carbon [=CH- or =C<] AND Oxygen, one aromatic attach [-O-] 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 Hydroxy compound AND Phenol 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 Anilines (Acute toxicity) by US-EPA New Chemical Categories

Domain logical expression index: "g"

Referential boundary: The target chemical should be classified as Dianilines OR Not categorized OR Phenols (Acute toxicity) by US-EPA New Chemical Categories

Domain logical expression index: "h"

Parametric boundary:The target chemical should have a value of log Kow which is >= -0.613

Domain logical expression index: "i"

Parametric boundary:The target chemical should have a value of log Kow which is <= 2.27

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance, Aluminum, tris(5-amino-4-hydroxy-3-(2-phenyldiazenyl)-2,7-naphthalenedisulfonato(2-))di- was estimated to be not sensitizing to guinea pigs
Executive summary:

The skin sensitization potential of Aluminum, tris(5-amino-4-hydroxy-3-(2-phenyldiazeyl)-2,7-naphthalenedisulfonato(2-)di- was predicted using OECD QSAR toolbox v 3.3 The substance, Aluminum, tris(5-amino-4-hydroxy-3-(2-phenyldiazenyl)-2,7-naphthalenedisulfonato(2-))di- was estimated to be not sensitizing to guinea pigs

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

Skin sensitization

The skin sensitization potential of Aluminum, tris(5-amino-4-hydroxy-3-(2-phenyldiazeyl)-2,7-naphthalenedisulfonato(2-)di- was predicted using OECD QSAR toolbox v 3.3 The substance, Aluminum, tris(5-amino-4-hydroxy-3-(2-phenyldiazenyl)-2,7-naphthalenedisulfonato(2-))di- was estimated to be not sensitizing to guinea pigs.

 

In other study by (COMMISSION OF THE EUROPEAN COMMUNITIES; Directorate-General Telecommunications, Information Industries and Innovation 1988) with similar substance (3567-66-6) was observed in guinea pigs. A maximization test in guinea pigs was carried out with an induction treatment by intradermal injection of 5% aqueous solution of the test chemical and by topical application of 10% aqueous solution. The challenge was made by topical application of 10% and 5% aqueous solution 2 weeks later. There were no positive reactions. It was concluded that 10% aqueous solution of the test substance was not sensitizing to guinea pig skin. Based on the above result the test chemical was concluded to be non sensitizing.

In other study by (Scientific Committee on Consumer Safety, 2007) with similar substance (3567-66-6) was observed inguinea pigs.The maximisation test was performed in 15 (10 test and 5 control) female guinea pigs. The intradermal induction of sensitisation in the test group was performed in the nuchal region with a 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitisation was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction and following pre-treatment of the test areas with 10% sodium-laureth- sulfate (SLS), 24 hours prior to application of the test item. The animals of the control group were intradermally induced with 1% CMC and FCA/physiological saline and epidermally induced with 1% CMC under occlusion following pre-treatment with 10% SLS. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. The study concluded that the test substance was not a skin sensitizer.

In other study by (Commission of the European Communities, 1988) with similar substance (1064-48-8) was observed in. The skin studyof D+C Black No. 1(CAS No: -1064-48-8)wascarried out inguinea pigsto determine its sensitization potency by maximization test. During induction phase, animals were induced with 5% aqueous suspension and 5% in Vaseline. After 14 days rest period, animals were challenged with 25% in Vaseline. Since the animals showed no signs of sensitization, the test chemicalD+C Black No. 1(CAS No: -1064-48-8) was found to be non sensitizing on guinea pigs.

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 of Aluminum, tris(5-amino-4-hydroxy-3-(2-phenyldiazeyl)-2,7-naphthalenedisulfonato(2-)di- was predicted using OECD QSAR toolbox v 3.3 The substance, Aluminum, tris(5-amino-4-hydroxy-3-(2-phenyldiazenyl)-2,7-naphthalenedisulfonato(2-))di- was estimated to be not sensitizing to guinea pigs.

Justification for selection of skin sensitisation endpoint:
Data is predicted using OECD QSAR toolbox v 3.3.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitization properties ofAluminum, tris(5-amino-4-hydroxy-3-(2-phenyldiazenyl)-2,7-naphthalenedisulfonato(2-))di- was estimated .The substance Aluminum, tris(5-amino-4-hydroxy-3-(2-phenyldiazenyl)-2,7-naphthalenedisulfonato(2-))di-is estimated to be as non sensitizer to skin.