2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4)

Endpoint summary

Description of key information

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (CAS No: 607724-37-8). The studies are as mentioned below:

 

The sensitization potential of read across chemical was examined to determine the allergic contact dermatitis caused by the chemical via performing patch test on human patients. The dye was applied on 15 patients in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories. None of the treated patients showed any signs of allergic contact dermatitis. Hence the chemical can be considered as non-sensitizer to human skin.

 

The above result was further supported by the guinea pig maximization test conducted for another similar read across chemical. Guinea pigs were given two times 4 intradermal injections of 0.1 ml of a 7.5% solution in saline during the induction phase.14 days after second injection, a challenge exposure was conducted. In the challenge exposure, single intradermal injection of a 3% solution in saline was administered to the guinea pigs. Signs of sensitization were not observed. Hence, the test chemical was considered to be non-sensitizing after challenge exposure in guinea pig.

 

Based on the above summarized studies for target chemical 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (CAS No: 607724-37-8) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

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:

data from handbook or collection of data

Remarks:

experimental data of read across substances

Justification for type of information:

Data for the target chemical is summarized based on the structurally and functionally similar read across chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

WoE report is based on 2 skin sensitization studies as- WoE-2 and WoE-3. Skin sensitization of test chemical was determined by performing ests on humans and guinea pigs.

GLP compliance:

not specified

Type of study:

other: 1.patch test 2.guinea pig maximisation test

Justification for non-LLNA method:

not specified

Specific details on test material used for the study:

- Name of test material: 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4)- Molecular formula: C26H25N5O19S6.4Na- Molecular weight: 995.85 g/mole- Smiles : [Na][Na][Na][Na]Nc1ccc2c(cc(S(O)(=O)=O)c(N=Nc3ccc(S(=O)(=O)CCOS(O)(=O)=O)cc3)c2O)c1N=Nc1ccc(S(=O)(=O)CCOS(O)(=O)=O) cc1S(O)(=O)=O- Substance type: Organic- Physical state: Solid powder

Species:

other: 1.hunan 2.guinea pig

Strain:

other: 1.not applicable 2.not specified

Sex:

not specified

Details on test animals and environmental conditions:

not specified

Route:

other: 1.epicutaneous

Vehicle:

water

Concentration / amount:

20%

Day(s)/duration:

7 days

Adequacy of induction:

not specified

Route:

other: 1.intradermal

Vehicle:

physiological saline

Concentration / amount:

0.1 ml of a 7.5% solution in saline

Day(s)/duration:

not specified

Adequacy of induction:

not specified

No.:

#1

Route:

other: 1.epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

20%

Day(s)/duration:

7 days

Adequacy of challenge:

not specified

No.:

#1

Route:

other: 2.epicutaneous, occlusive

Vehicle:

physiological saline

Concentration / amount:

0.1 ml of a 7.5% solution in saline

Day(s)/duration:

not specified

Adequacy of challenge:

not specified

No. of animals per dose:

1. 15 patients2. no data available

Details on study design:

1.The dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days.The reactions of the patients were graded as ?+. + and ++ categories.2.MAIN STUDYA. INDUCTION EXPOSURENo. of exposures: 2 times 4 intradermal injectionsExposure period: No dataTest groups: No dataControl group: No dataSite: No dataFrequency of applications: 2 timesDuration: No dataConcentrations: 0.1 ml of 7.5% solution in salineB. CHALLENGE EXPOSURENo. of exposures: singleDay(s) of challenge: 14 days after second intradermal injectionExposure period: No dataTest groups: No dataControl group: No dataSite: No dataConcentrations: 3% solution in salineEvaluation (hr after challenge): No data

Challenge controls:

no data availble

Reading:

other: 1.1st reading

Hours after challenge:

168

Group:

test chemical

Dose level:

20%

No. with + reactions:

0

Total no. in group:

15

Clinical observations:

None of the treated patients showed allergic contact dermatitis.

Remarks on result:

no indication of skin sensitisation

Reading:

other: 1st reading

Group:

test chemical

Dose level:

7.5% in saline

Clinical observations:

No sensitization observed

Remarks on result:

no indication of skin sensitisation

Cellular proliferation data / Observations:

1. None of the treated patients showed allergic contact dermatitis.2.The intradermal induction and challenge did not reveal any signs of sensitisation.

Interpretation of results:

other: not sensitizing

Conclusions:

The test material 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (CAS No: 607724-37-8) was considered to be not sensitizing to the skin of guinea pigs and humans.

Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (CAS No: 607724-37-8). The studies are as mentioned below:

 

The sensitization potential of read across chemical was examined to determine the allergic contact dermatitis caused by the chemical via performing patch test on human patients. The dye was applied on 15 patients in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories. None of the treated patients showed any signs of allergic contact dermatitis. Hence the chemical can be considered as non-sensitizer to human skin.

 

The above result was further supported by the guinea pig maximization test conducted for another similar read across chemical. Guinea pigs were given two times 4 intradermal injections of 0.1 ml of a 7.5% solution in saline during the induction phase.14 days after second injection, a challenge exposure was conducted. In the challenge exposure, single intradermal injection of a 3% solution in saline was administered to the guinea pigs. Signs of sensitization were not observed. Hence, the test chemical was considered to be non-sensitizing after challenge exposure in guinea pig.

 

Based on the above summarized studies for target chemical 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (CAS No: 607724-37-8) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (CAS No: 607724-37-8). The studies are as mentioned below:

 

The sensitization potential of read across chemical was examined to determine the allergic contact dermatitis caused by the chemical via performing patch test on human patients. The dye was applied on 15 patients in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories. None of the treated patients showed any signs of allergic contact dermatitis. Hence the chemical can be considered as non-sensitizer to human skin.

 

The above result was further supported by the guinea pig maximization test conducted for another similar read across chemical. Guinea pigs were given two times 4 intradermal injections of 0.1 ml of a 7.5% solution in saline during the induction phase.14 days after second injection, a challenge exposure was conducted. In the challenge exposure, single intradermal injection of a 3% solution in saline was administered to the guinea pigs. Signs of sensitization were not observed. Hence, the test chemical was considered to be non-sensitizing after challenge exposure in guinea pig.

 

Based on the above summarized studies for target chemical 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (CAS No: 607724-37-8) and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The skin sensitization potential of test substance 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (CAS No: 607724-37-8) and its structurally and functionally similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the chemical 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (CAS No: 607724-37-8) is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.