Sodium 3-(p-anilinophenylazo)benzenesulphonate

Endpoint summary

Description of key information

Skin sensitisation:
The substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate was observed to show positive reactions in Human patch test for skin sensitization.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed journal

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To evaluate the skin sensitizing potential of substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate in human by patch test.

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

Case report of contact dermatitis proceeded by patch test.

Specific details on test material used for the study:

- Name of test material : sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate
- Molecular formula : C18H14N3O3S.Na
- Molecular weight: 375.383 g/mol
- Smiles notation : c1(Nc2ccccc2)ccc(\N=N\c2cc(ccc2)S(=O)(=O)[O-])cc1.[Na+]
- InChl : 1S/C18H15N3O3S.Na/c22-25(23,24)18-8-4-7-17(13-18)21-20-16-11-9-15(10-12-16)19-14-5-2-1-3-6-14;/h1-13,19H,(H,22,23,24);/q;+1/p-1/b21-20+;
- Substance type: Organic
- Physical state: Solid

Species:

other: human

Strain:

other: not applicable

Sex:

female

Details on test animals and environmental conditions:

No data

Route:

other: dermal

Vehicle:

not specified

Concentration / amount:

not specified

Day(s)/duration:

4 days

Adequacy of induction:

not specified

No. of animals per dose:

1 human female

Details on study design:

Not specified

Challenge controls:

Not specified

Positive control substance(s):

not specified

Key result

Reading:

1st reading

Hours after challenge:

96

Group:

test chemical

Dose level:

not specified

No. with + reactions:

3

Clinical observations:

lesions were observed

Remarks on result:

positive indication of skin sensitisation

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Conclusions:

The substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate was observed to show positive reactions in Human patch test for skin sensitisation.

Executive summary:

A female patient worked in a leather (and paper) shop, selling various leather items, such as purses, pocket books, photo albums, document portfolios, wallets and writing cases. Whenever she worked in this shop, which was usually for 2 days a week, she developed dermatitis on left side of the neck. Hence the patch test was carried out for the test substance. Patch test with the scrapings of the material remained negative. However, patch testing with the leather series gave a +++ reaction to the test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (acid yellow/metanil yellow) at 2, 3 and 4 days. On giving up working in this shop, and subsequent avoidance of contact with leather articles, her lesions healed completely. Therefore, the test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate was considered to be a skin sensitiser and can be classified as Skin sensitiser category 1 according to CLP criteria.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Skin sensitisation:
In different studies, sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (CAS No. 587-98-4) has been investigated for potential of skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in guinea pig and human for target and its structurally similar read across substance. The predicted data Danish QSAR database has also been compared with the experimental data of target and read across.

In a case study obtained from Contact Dermatitis 31: 117–118, 1994, a female patient worked in a leather (and paper) shop, selling various leather items, such as purses, pocket books, photo albums, document portfolios, wallets and writing cases. Whenever she worked in this shop, which was usually for 2 days a week, she developed dermatitis on left side of the neck. Hence the patch test was carried out for the test substance. Patch test with the scrapings of the material remained negative. However, patch testing with the leather series gave a +++ reaction to the test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (acid yellow/metanil yellow) at 2, 3 and 4 days. On giving up working in this shop, and subsequent avoidance of contact with leather articles, her lesions healed completely.

Supporting above study, QSAR prediction done using the Danish (Q)SAR Database, the skin sensitization was estimated to be positive on guinea pig and human for sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate. Thus it can be concluded that the substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate has positive skin sensitization effects.

 

Further, the above data for target is supported by a case report of structurally similar substance 1-phenylazo-2-naphthol (CAS No. 842-07-9), from Contact Dermatitis 12: 15-17; 1985, in which a 51-year-old man had been working in dye factory for 25 years and had noticed itching and pigmentation on the extremities for the past 5 years. On examination there were erythematous lesions, lichenification and pigmentation, diffusely and symmetrically over the dorsa of the hands, feet and legs. Patch test was performed having concentration of Sudan I is 1%. They were applied on the back for 48 hours, and the test read 1h and 24 h after removal according to the ICDRG Classification. Positive reaction was observed for to 1-phenylazo-2-naphthol (Sudan I).Therefore 1-phenylazo-2-naphthol (Sudan I) was considered to be a skin sensitizer.

Thus, based on the above data of sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (CAS 587-98-4)as well as its read across and applying weight of evidence, it can be concluded that sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate may cause skin sensitisation. Thus comparing the above annotations with the criteria of CLP regulation, sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate can be considered as a skin sensitiser under category 1.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Thus, based on the above data of sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (CAS 587-98-4)as well as its read across and applying weight of evidence, it can be concluded that sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate may cause skin sensitisation. Thus comparing the above annotations with the criteria of CLP regulation, sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate can be considered as a Skin Sensitiser under category 1.