Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate

Endpoint summary

Description of key information

The substance Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF) was found to be not irritating in skin and eye category.

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)

Principles of method if other than guideline:

The skin irritation study was conducted to evaluate the irritating effects of administration of sunset yellow FCF to rabbits.

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

other: petrolatum or water

Controls:

not specified

Duration of treatment / exposure:

no data

Observation period:

no data

Number of animals:

no data

Irritation parameter:

overall irritation score

Basis:

mean

Reversibility:

no data

Remarks on result:

other: not irritating

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF)in petrolatum or in aqueous solutions was found to be not irritating to rabbit skin.

Executive summary:

Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF)in petrolatum or in aqueous solutions was found to be not irritating to rabbit skin.

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)

Principles of method if other than guideline:

The eye irritation study was conducted to evaluate the irritating effects of administration of sunset yellow FCF to eye of rabbits.

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Vehicle:

not specified

Controls:

not specified

Irritation parameter:

overall irritation score

Basis:

mean

Reversibility:

not specified

Remarks on result:

other: minimally irritant to the rabbit eye

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF) was found to be minimally irritant to the rabbit eye which is not enough to classify as eye irritant thus test substance was considered to be non irritant to eye of rabbit.

Executive summary:

Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF) was found to be minimally irritant to the rabbit eye which is not enough to classify as eye irritant thus test substance was considered to be non irritant to eye of rabbit.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

Weight of evidence studies were reviewed for skin irritation from reliable sources having Klimish rating 2 and 4.

The summary of the results are presented below

 

Sr.No	Irritation Parameter	Species	Interpretation of results	Conclusions	Sources
1.	overall irritation score	Rabbit	Not irritating	Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF)in petrolatum or in aqueous solutions was found to be not irritating to rabbit skin.	Experimental data from ‘BIBRA report’ for target CAS:2783-94-0
2.	overall irritation score	Rabbit	Not irritating	Test material produced very slight redness of abraded skin in some of the rabbits when observed at only 24 hours after application. The overall result concluded that this was a false positive reaction. Under the conditions in this experiment the material Acid Orange 7 is classified as non-irritant to the skin.	Experimental data from ‘Journal of Pharmacology and Experimental Therapeutics’ for read across CAS:633-96-5
3.	overall irritation score	Rabbit	Not irritating	The test substance disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate (ALLURA RED AC) did not produce any skin irritation effect on rabbit skin.	Experimental data from study report of ‘Joint FAO/WHO Expert Committee on Food Additives’ for read across CAS:25956-17-6

 

Based on the above experimental data, it is concluded that the substance Disodium 6-hydroxy-5-[(4-sulphonatophenyl) azo] naphthalene-2-sulphonate (sunset yellow FCF)was found to be not irritating to the skin of rabbit.

Eye irritation:

Weight of evidence studies were reviewed for eye irritation from reliable sources having Klimish rating 2 and 4.

The summary of the results are presented below

 

Sr.No	Irritation Parameter	Species	Interpretation of results	Conclusions	Sources
1.	overall irritation score	Rabbit	Not irritating	Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF) was found to be minimally irritant to the rabbit eye which is not enough to classify as eye irritant thus test substance was considered to be non irritant to eye of rabbit.	Experimental data from ‘BIBRA report’ for target CAS:2783-94-0
2.	MMAS(modified maximum average score (MMAS))	Rabbit	Not irritating	The modified maximum average score (MMAS) from QSAR toolbox eye irritation score of Disodium 6-hydroxy-5-[(4-sulphonatophenyl) azo] naphthalene-2-sulphonate is estimated as 18. This score indicates that test substance is not irritating to the eye of rabbit.(as the criteria MMAS ≤ 25 is not irritating).	Predicted data from QSAR for target CAS:2783-94-0
3.	overall irritation score	Rabbit	Not irritating	During experimental study 100 mg of test compound (Acid Orange 7)was administered to eye of 3 male rabbits no sign of irritation was observed during experiment thus it is concluded that Acid Orange 7 dose not classify as eye irritant.	Experimental data from publication for read across CAS: 633-96-5

  

Based on the above experimental data, it is concluded that the substance Disodium 6-hydroxy-5-[(4-sulphonatophenyl) azo] naphthalene-2-sulphonate (sunset yellow FCF)was found to be not irritating to the eye of rabbit.

Justification for selection of skin irritation / corrosion endpoint:

Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF)in petrolatum or in aqueous solutions was found to be not irritating to rabbit skin.

Justification for selection of eye irritation endpoint:

Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF) was found to be minimally irritant to the rabbit eye which is not enough to classify as eye irritant thus test substance was considered to be non irritant to eye of rabbit.

Justification for classification or non-classification

The available studies indicate that the substance Disodium 6-hydroxy-5-[(4-sulphonatophenyl) azo] naphthalene-2-sulphonate (sunset yellow FCF) is not classified as a skin and eye irritant according to CLP regulation.