Sodium 4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonate

Endpoint summary

Description of key information

Eye irritation: not irritating
Skin irritation: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No data on Acid Yellow 049 sodium salt is available. Thus, a read across approach was followed, using available data on the acid form. Details on the read-acoss approach are reported in section 13.

Skin irritation

In the key study (1994), the skin irritation potential of the Acid Yellow 049 acid form was determined following OECD guideline 404. 0.5 g of test substance were placed on both intact and scarified skin, as aqueous paste. Three rabbits were used. The primary irritation score was 0. Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema and oedema reactions (in both intact and scarified skin).

In a second experiment (1976), two New Zealand White rabbits, both sexes, were treated with 500 mg/µl/animal of Acid Yellow 049, acid form. The irritation degree was evaluated on the basis of the recommended methods for the toxicological investigation of dyes and auxiliaries. The Primary Irritation Index resulted to be equal to 0, thus the susbtance can be considered as not skin irritating (1976). Unfortunately, only a summary sheet is available, thus details on testing procedures and results are lacking.

Eye irritation

In the key study (1994), the eye irritation potential of the Acid Yellow 049 acid form was determined following OECD guideline 405. 0.1 g of test substance were placed into conjunctival sac of three rabbits. After 24 hours of exposure the substance was removed using drinking water. The primary irritation score was 2. The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for irtitis, lower than 2 for both conjunctival redness and oedema, in all animals.

Based on the raw tables data, redness was not disappeared after 72 hours in one animal; unfortunately, there are no information about the successive period. However, based on the severity degree and based on the trend demonstrated, a complete recovery is expected within 21 days. Therefore, this effect has been judged as reversible.

In a second experiment, two rabbits were treated with 50 mg/100 μl/animal of Acid Yellow 049, acid form. The irritation degree was evaluated on the basis of the recommended methods for the toxicological investigation of dyes and auxiliaries. The Primary Irritation Index resulted to be 7 and the substance has been judged as not eye irritating. Unfortunately, only a summary sheet is available, thus details on testing procedures and results are lacking.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.2 Skin corrosion/irritation section, skin Irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

Based on the available information, Acid Yellow 049 can be considered as not skin irritating.

According to the CLP Regulation (EC 1272/2008), 3.3 serious eye damage/eye irritation section, eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.

Based on the available information, Acid Yellow 049 can be considered as not eye irritating.

In conclusion, the substance is not classified for the eye/skin irritation, according to the CLP Regulation (EC 1272/2008).