Registration Dossier

Administrative data

Description of key information

Based on the available data for the structurally similar read across chemicals and applying the weight of evidence approach, it can be concluded that2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium saltwill also behave in similar manner that of the read across chemicals.2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium saltwas estimated to be sensitizing to skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Weight of evidence approach structurally similar chemicals
Justification for type of information:
Weight of evidence approach structurally similar chemicals
Reason / purpose:
read-across: supporting information
Related information:
Composition 1
Reason / purpose:
read-across: supporting information
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: Weight of evidence approach based on similar chemicals
Principles of method if other than guideline:
The weight of evidence report has been prepared based on the read across substances identified based
on structural and functional similarity to assess the dermal sensitization potential of 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium salt
GLP compliance:
not specified
Type of study:
other: Weight of evidence report
Test material information:
Composition 1
Specific details on test material used for the study:
2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium salt / 503155-49-5 / 610-522-6
- Name of test material: 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium salt
- Molecular formula: C28H25N5Na4O20S6
- Molecular weight: 1035.87 g/mol
- Smiles notation : Cc1cc(N=Nc2c(S(=O)(=O)O{}.[Na]{+})cc3c(ccc(N)c3N=Nc3ccc(S(=O)(=O)CCOS(=O)(=O)O{}.[Na]{+})cc3S(=O)(=O)O{-}.[Na]{+})c2O)c(OC)cc1S(=O)(=O)CCOS(=O)(=O)O{-}.[Na]{+}
- Substance type: Organic
- Physical state: Solid
Species:
other: humans
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
no data available
Route:
other: epicutaneous
Vehicle:
not specified
Concentration / amount:
0.1, 1, 2, 5, and 10 mg in the provocation- test, at increasing concentrations until a reaction was noted.
Day(s)/duration:
14 hours
Adequacy of induction:
not specified
Route:
other: epicutaneous
Vehicle:
not specified
Concentration / amount:
0.1, 1, and 2 mg/ dose
Day(s)/duration:
14 hours
Adequacy of induction:
not specified
No.:
#1
Route:
other: epicutaneous
Vehicle:
not specified
Concentration / amount:
0.1, 1, 2, 5, and 10 mg in the provocation- test, at increasing concentrations until a reaction was noted.
Day(s)/duration:
14 hours
Adequacy of challenge:
not specified
No.:
#1
Route:
other: epicutaneous
Vehicle:
not specified
Concentration / amount:
0.1, 1, and 2 mg/ dose
Day(s)/duration:
14 hours
Adequacy of challenge:
not specified
No. of animals per dose:
25 patients
7 patients
Details on study design:
The study is based on weight of evidence approach from the read across values
Challenge controls:
not mentioned
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test group
No. with + reactions:
0
Clinical observations:
no signs of sensitization observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: sensitizing
Conclusions:

Based on the available data for the structurally similar read across chemicals and applying the weight of evidence approach, it can be concluded that 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium saltwill also behave in similar manner that of the read across chemicals.2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium salt was estimated to be sensitizing to skin.
Executive summary:

Based on the available studies for the structurally similar read across substances, the weight of evidence approach was applied to determine the extent of dermal sensitization caused by 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium salt in living organisms.

A Provocation test was conducted for the structurally similar chemical on 25 patients suffering from recurrent urticaria or angio-oedema.

Provocation tests were performed when the patients had slight or no symptoms at a dose of 0.1, 1, 2, 5, and 10 mg and at increasing concentrations until a reaction was noted.Thirty-three healthy persons served as controls. Two of them have a moderate allergic rhinitis and one sometimes has an itching of unknown cause.

Both objective and subjective symptoms were carefully noted after each test. The provocation results were judged as positive when the patient developed an unquestionable urticaria or angio-oedema after having had an inactive period before provocation. The reaction, especially angio-oedema, sometimes occurred within the first few hours after provocation, whereas the urticaria often did not develop until 6-14 h afterwards.

Of the 25 patients studied, 9 evidenced urticaria and 1 showed other objective signs; 6 patients evidenced only subjective symptoms and 9 had no reaction. A control group of 33 subjects did not develop urticaria.

Therefore on the basis of observed reactions, the chemical was considered as skin sensitizing.

This is supported by the results of similar Provocation test performed for other structurally similar test chemical on 7 patients suffering with recurrent urticaria or angio-oedema.

Provocation tests were performed when the patients had slight or no symptoms at 0.1, 1, and 2 mg/ dose. Thirty-three healthy persons served as controls. Two of them have a moderate allergic rhinitis and one sometimes has an itching of unknown cause. Both objective and subjective symptoms were carefully noted after each test.

The provocation results were judged as positive when the patient developed an unquestionable urticaria or angio-oedema after having had an inactive period before provocation. The reaction, especially angio-oedema, sometimes occurred within the first few hours after provocation, whereas the urticaria often did not develop until 6-14 h afterwards.

Of the 7 patients studied, two had no reactions, three had only subjective symptoms, one had urticaria, and one had other objective signs of a "take." A control group of 33 subjects did not develop urticaria.

Therefore on the basis of observed reactions, the chemical was considered as skin sensitizing.

Based on the available data for the structurally similar read across chemicals and applying the weight of evidence approach, it can be concluded that 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium saltwill also behave in similar manner that of the read across chemicals.2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium salt was estimated to be sensitizing to skin.

 

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Based on the available studies for the structurally similar read across substances, the weight of evidence approach was applied to determine the extent of dermal sensitization caused by2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium salt in living organisms.

A Provocation test was conducted for the structurally similar chemical on 25 patients suffering from recurrent urticaria or angio-oedema.

Provocation tests were performed when the patients had slight or no symptoms at a dose of 0.1, 1, 2, 5, and 10 mg and at increasing concentrations until a reaction was noted.Thirty-three healthy persons served as controls. Two of them have a moderate allergic rhinitis and one sometimes has an itching of unknown cause.

Both objective and subjective symptoms were carefully noted after each test. The provocation results were judged as positive when the patient developed an unquestionable urticaria or angio-oedema after having had an inactive period before provocation. The reaction, especially angio-oedema, sometimes occurred within the first few hours after provocation, whereas the urticaria often did not develop until 6-14 h afterwards.

Of the 25 patients studied, 9 evidenced urticaria and 1 showed other objective signs; 6 patients evidenced only subjective symptoms and 9 had no reaction. A control group of 33 subjects did not develop urticaria.

Therefore on the basis of observed reactions, the chemical was considered as skin sensitizing.

This is supported by the results of similar Provocation test performed for other structurally similar test chemical on 7 patients suffering with recurrent urticaria or angio-oedema.

Provocation tests were performed when the patients had slight or no symptoms at 0.1, 1, and 2 mg/ dose. Thirty-three healthy persons served as controls. Two of them have a moderate allergic rhinitis and one sometimes has an itching of unknown cause. Both objective and subjective symptoms were carefully noted after each test.

The provocation results were judged as positive when the patient developed an unquestionable urticaria or angio-oedema after having had an inactive period before provocation. The reaction, especially angio-oedema, sometimes occurred within the first few hours after provocation, whereas the urticaria often did not develop until 6-14 h afterwards.

Of the 7 patients studied, two had no reactions, three had only subjective symptoms, one had urticaria, and one had other objective signs of a "take." A control group of 33 subjects did not develop urticaria.

Therefore on the basis of observed reactions, the chemical was considered as skin sensitizing.

Based on the available data for the structurally similar read across chemicals and applying the weight of evidence approach, it can be concluded that2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium saltwill also behave in similar manner that of the read across chemicals.2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium saltwas estimated to be sensitizing to skin.

 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The results of the experimental studies from the structurally similar read across substances indicate a possibility that 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium salt can be sensitizing to skin.

Hence, by applying the weight of evidence approach, 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium salt can be considered to be sensitizing to skin.