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

Endpoint summary

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 for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

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 chemical

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.