Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate

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 Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalene sulphonate (CAS No. 3567-69-9). Also the predicted data for target chemical using the Danish QSAR database has also been compared with the experimental data. Based on the above summarized studies for target chemical 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:

calculation (if not (Q)SAR)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

accepted calculation method

Justification for type of information:

Data is from Danish QSAR.

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

The data is predicted using Danish QSAR database.

GLP compliance:

not specified

Justification for non-LLNA method:

Allergic Contact Dermatitis in Guinea Pig and Human

Species:

other: Guinea Pig and Human

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

No data available.

Route:

other: No data available.

Route:

other: No data available.

No. of animals per dose:

No data available.

Details on study design:

No data available.

Challenge controls:

No data available.

Positive control substance(s):

not specified

Reading:

1st reading

Group:

test chemical

Clinical observations:

No sensitization observed

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

other: Not sensitizing

Conclusions:

According to Danish QSAR database, skin sensitization effects were estimated by using four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra for test chemical. Based on estimation, no Allergic Contact Dermatitis effects were observed when test chemical was exposed to human and guinea pig skin. Hence, the test chemical can be considered as not sensitizing to skin.

Executive summary:

According to Danish QSAR database, skin sensitization effects were estimated by using four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra for test chemical. Based on estimation, no Allergic Contact Dermatitis effects were observed when test chemical was exposed to human and guinea pig skin. Hence, the test chemical can be considered as not sensitizing to skin.

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 Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalene sulphonate (CAS No. 3567-69-9). Also the predicted data for target chemical using the Danish QSAR database has also been compared with the experimental data and summarized as below:

 

According to Danish QSAR database, skin sensitization effects were estimated by using four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra for test chemical. Based on estimation, no Allergic Contact Dermatitis effects were observed when test chemical was exposed to human and guinea pig skin. Hence, the test chemical can be considered as not sensitizing to skin.

 

The above predicted data was supported by skin sensitization study conducted for similar read across substance 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.

 

Another skin sensitization study was conducted for read across chemical by performing patch test on human patients. This study was conducted by the same principle and method as mentioned in above study. The dye was applied on 14 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 test chemical can be considered as non-sensitizer to human skin.

 

The last sensitization study was carried out in guinea pigs to determine the sensitizing potential of 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 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 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 test chemical Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalene sulphonate (CAS No. 3567-69-9) is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.