Registration Dossier

Administrative data

Description of key information

Skin Sensitization:

Based on the available data for the structurally similar read across chemicals and applying the weight of evidence approach, it can be concluded that tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate will also behave in similar manner that of the read across chemicals and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

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 based on the structrually similar chemicals
Justification for type of information:
Weight of evidence approach based on the structrually similar chemicals
Reason / purpose:
read-across: supporting information
Reason / purpose:
read-across: supporting information
Qualifier:
according to
Guideline:
other: Weight of evidence 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 tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate
GLP compliance:
not specified
Type of study:
other: Weight of evidence report
Justification for non-LLNA method:
not specified
Specific details on test material used for the study:
- Name of test material: tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate- Molecular formula: C29H20ClN9O12S4.4Na- Molecular weight: 938.173 g/mol- Smiles notation : [Na+].[Na+].[Na+].[Na+].c1(c(cc(cc1)S(=O)(=O)[O-])\N=N\c1ccc(c2ccc(cc12)S(=O)(=O)[O-])\N=N\c1ccc(c2c(cccc12)S(=O)(=O)[O-])Nc1nc(nc(n1)N)Cl)S(=O)(=O)[O-]- InChl: 1S/C29H20ClN9O12S4.4Na/c30-27-33-28(31)35-29(34-27)32-22-10-9-20(17-2-1-3-25(26(17)22)55(49,50)51)37-36-19-7-8-21(18-12-14(52(40,41)42)4-6-16(18)19)38-39-23-13-15(53(43,44)45)5-11-24(23)54(46,47)48;;;;/h1-13H,(H,40,41,42)(H,43,44,45)(H,46,47,48)(H,49,50,51)(H3,31,32,33,34,35);;;;/q;4*+1/p-4/b37-36+,39-38+;;;;- Substance type: Organic- Physical state: Solid
Species:
other: humans and guinea pigs
Strain:
not specified
Sex:
not specified
Route:
epicutaneous, occlusive
Vehicle:
not specified
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Adequacy of challenge:
not specified
No. of animals per dose:
1.2002. not specifieid
Details on study design:
The study is based on weight of evidence approach from the read across values
Challenge controls:
no data available
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test group
No. with + reactions:
0
Clinical observations:
no reactions observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not 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 tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate will also behave in similar manner that of the read across chemicals and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation. 
Executive summary:

Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal sensitization potential oftetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate.

Draize- Shelanski Repeat Insult Patch Test was performed on 200 human subjects to determine the degree of dermal sensitization caused by the structurally similar chemical.

The test chemical was applied to the subject's volvar forearms as an aqueous solution for 10 alternate days, for 24-hour periods, followed by a 14-day rest period. Challenge treatment was then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours. The test chemical did not produce any skin allergic reaction in the induction as well as challenge treatment.

Hence, the test chemical was considered to be not sensitizing to skin.

 

This is supported by the results of Modified guinea pig maximization test performed to determine the allergenic potential of the other structurally similar chemical.

The test chemical was applied epicutaneously to the skin of guinea pigs and observed for dermal reactions. The test chemical produced a sensitizing reaction when produced according to a traditional manufacturing process. When the contaminants were isolated, they were identified to be the reason for that reaction, because they showed sensitization effects. The purified test chemical and test chemical produced by modified manufacturing process didn’t cause any sensitization.

 

Hence, it was considered that the purified test chemical was indeed not sensitizing to guinea pig skin

 

Based on the available data for the structurally similar read across chemicals and applying the weight of evidence approach, it can be concluded that tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate will also behave in similar manner that of the read across chemicals and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

 

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

Based on the available studies for the structurally similar read across chemicals, weight of evidence approach was applied to assess the dermal sensitization potential oftetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate.

Draize- Shelanski Repeat Insult Patch Test was performed on 200 human subjects to determine the degree of dermal sensitization caused by the structurally similar chemical.

The test chemical was applied to the subject's volvar forearms as an aqueous solution for 10 alternate days, for 24-hour periods, followed by a 14-day rest period. Challenge treatment was then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours. The test chemical did not produce any skin allergic reaction in the induction as well as challenge treatment.

Hence, the test chemical was considered to be not sensitizing to skin.

 

This is supported by the results of Modified guinea pig maximization test performed to determine the allergenic potential of the other structurally similar chemical.

The test chemical was applied epicutaneously to the skin of guinea pigs and observed for dermal reactions. The test chemical produced a sensitizing reaction when produced according to a traditional manufacturing process. When the contaminants were isolated, they were identified to be the reason for that reaction, because they showed sensitization effects. The purified test chemical and test chemical produced by modified manufacturing process didn’t cause any sensitization.

 

Hence, it was considered that the purified test chemical was indeed not sensitizing to guinea pig skin

 

Based on the available data for the structurally similar read across chemicals and applying the weight of evidence approach, it can be concluded that tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate will also behave in similar manner that of the read across chemicals and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

 

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 tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate can be not sensitizing to skin.

Hence by applying the weight of evidence approach, tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate can be considered to be not sensitizing to skin. It can be classified under the category “Not Classified” as per CLP regulation.