Sodium 3-(p-anilinophenylazo)benzenesulphonate

Endpoint summary

Description of key information

Skin irritation:
The test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (Acid yellow 36) was determined to be negative for skin irritation test on application of 0.5 g to rabbits.

Eye irritation:
The test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (Acid yellow 36) was determined to be negative in eye irritation test on application of 0.1 ml of a 0.25% solution in water/propylene glycol (1:1) to rabbits eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from Scientific Committee on Cosmetology

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

A skin irritation test in rabbits were carried out with colourant test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (Acid yellow 36) in vivo.

GLP compliance:

not specified

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:

rabbit

Strain:

not specified

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

0.5 g of a 50% aqueous suspension

Duration of treatment / exposure:

not specified

Observation period:

not specified

Number of animals:

not specified

Details on study design:

not specified

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: not specified

Score:

0

Reversibility:

not specified

Remarks on result:

other: no ither details mentioned

Interpretation of results:

other: not irritating

Conclusions:

The test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (Acid yellow 36) was determined to be negative for skin irritation test on application of 0.5 g to rabbits.

Executive summary:

A skin irritation test in rabbits were carried out with colourant test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (Acid yellow 36) in vivo. The concentration used was 0.5 g of a 50% aqueous suspension. The results were determined to be negative for skin irritation test on rabbits. This indicates that the test substance can be considered as a Not classified under Skin Irritation category as per CLP classification criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from Scientific Committee on Cosmetology report

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Eye irritation test in rabbits were carried out to measure the effects of the test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (Acid Yellow 36).

GLP compliance:

not specified

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:

rabbit

Strain:

not specified

Vehicle:

other: water/propylene glycoL (1:1)

Controls:

not specified

Amount / concentration applied:

0.25%

Duration of treatment / exposure:

not specified

Observation period (in vivo):

not specified

Duration of post- treatment incubation (in vitro):

not specified

Number of animals or in vitro replicates:

not specified

Details on study design:

not specified

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: not specified

Score:

0

Reversibility:

not specified

Remarks on result:

other: no other details available

Interpretation of results:

other: not irritating

Conclusions:

The test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (Acid yellow 36) was determined to be negative in eye irritation test on application of 0.1 ml of a 0.25% solution in water/propylene glycol (1:1) to rabbits eye.

Executive summary:

In vivo eye irritation test in rabbits were carried out with colourant test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (Acid yellow 36). 0.1 ml of a 0.25% solution in water/propylene glycol (1:1) was applied. It was found to be not irritating. This indicates that the test substance can be considered as a Not classified under Eye irritation category as per CLP classification criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation
In different studies, sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate has been investigated for potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with study for its structurally similar read across substances. These are presented as weight of evidence as below:

Two different studieswere cited in Report of Scientific Committee on Cosmetology; Seventh series; 1988 by Commission of European Communities, to assess the skin irritation in rabbits.

A skin irritation test in rabbits were carried out with colourant test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (Acid yellow 36) in vivo. The concentration used was 0.5 g of a 50% aqueous suspension. The results were determined to be negative for skin irritation test on rabbits.

In vivo skin irritation test in rabbits were carried out with colourant test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (Acid yellow 36). The concentration applied was 0.5 ml of a 0.25% solution in water/propylene glycol (1:1). No signs of irritation were observed in rabbits.

These studies are further supported by the experimental study conducted by BASF Aktiengesellschaft Gewerbehygiene und Toxikologie, 6700 Ludwigshafen, 2015 (Sustainability Support Services (Europe) AB has the letter of access), for structurally related substance 1-phenylazo-2-naphthol (CAS No. 842-07-9; 50-60% similar). Primary skin irritation test of 1-(phenylazo)-2-napthol in rabbits was performed according to Guidelines mentioned in Federal Register 38 No 187 § 1500 .41 (skin). 6 rabbits were used for the study. 50% of the substance in aqueous solution was applied on the intact and scarfied skin of rabbits and the effects were observed at 24 and 72 hours. The reactions were scored according to Draize method. Due to substance-induced coloration of the skin no reading and no exact calculation of the primary irritation was possible at 24 hours. Skin lesions were also observed after 8 days of testing. No lesions were observed in case of intact skin, but dandruff formation was recorded in 4 of 6 rabbits in case of scarified skin. The Primary Skin Irritation Score of 1-phenylazo-2-naphthol was 0.17. On the basis of the scores and observations, 1-phenylazo-2-napthol can be considered as not irritating to skin.

Based on the available data for the target as well as read across substances and applying the weight of evidence approach, sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate was determined to be not irritating to skin. Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified” for Skin irritation.

Eye irritation:
In different studies, sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate has been investigated for potential for eye irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with study for its structurally similar read across substances. These are presented as weight of evidence as below:

Two different studieswere cited in Report of Scientific Committee on Cosmetology; Seventh series; 1988 by Commission of European Communities, to assess the eye irritation in rabbits.

In vivo eye irritation test in rabbits were carried out with colourant test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (Acid yellow 36). 0.1 ml of a 0.25% solution in water/propylene glycol (1:1) was applied. It was found to be not irritating.

 

In an eye irritation test, the rabbits with a 1.25% suspension of the test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate in saline no changes were observed. While with higher concentrations (up to 33%) moderate conjunctival reactions occurred. However, for the purpose of classification the lower concentration is considered.

These studies are further supported by the experimental study conducted by BASF Aktiengesellschaft Gewerbehygiene und Toxikologie, 6700 Ludwigshafen, 2015 (Sustainability Support Services (Europe) AB has the letter of access), for structurally related substance 1-phenylazo-2-naphthol (CAS No. 842-07-9; 50-60% similar). Primary eye irritation of 1-(phenylazo)-2-napthol was evaluated in rabbits according to Federal Register 38 § 15 .00 42 (Eye), p. 27019 of 27 .09 .73. guidelines. 6 rabbits were used for the study. Undiluted test chemical was instilled into the right eye of the rabbit and the effects were observed. The reactions were observed at 24, 48 and 72 hours and scored according to Draize method. Conjunctival redness and secretion was observed in all the rabbits till 72 hours. The Primary Irritation Score for eye irritation in rabbits was 1.34. Based on the scores, 1-(phenylazo)-2-napthol can be considered as not irritating to rabbit eyes.

Based on the available data for the target as well as read across substances and applying the weight of evidence approach, sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate was determined to be not irritating to eye. Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified” for Eye irritation.

Justification for classification or non-classification

Based on the available data for the target as well as read across substances and applying the weight of evidence approach, sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate was determined to be not irritating to skin and eye. Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified” for Skin as well as Eye irritation.