Sodium 6-amino-5-[[4-chloro-3-[[(2,4-dimethylphenyl)amino]sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate

Endpoint summary

Description of key information

Not skin irritating

Eye Irrit. 2 (H319), according to CLP Regulation (EC) No 1272/2008

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:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

SKIN IRRITATION

There are no information about skin irritation potential to aquatic invertebrates of Acid Red 336, thus the available data on structural analogous Similar Substance 01 have been taken into account (details and explanations are included in the report attached to the IUCLID section 13).

The key study was performed using New Zealand White rabbit, according to the OECD 404 testing guidelines. Application of the test material to the intact skin produced very slight to well-defined erythema and very slight to slight oedema. Skin reactions noted at all treated skin sites seven days after treatment were crust formation and desquamation. No corrosive effects were noted. The mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions, thus the test item does not meet the criteria to be classified as irritating, according to the CLP (EC) No 1272/2008 Regulation.

EYE IRRITATION

There are no information about the eye irritation potential of Acid Red 336, thus the available data on structural analogous Similar Substance 01 have been taken into account (details and explanations are included in the report attached to the IUCLID section 13).

The key study was performed in accorcance with OECD Guideline 405. A single application of the test material to the non-irrigated eye of three rabbits produced areas of diffuse corneal opacity, iridial inflammation and moderate to severe conjunctival irritation. Vascularisation of the cornea was confined to one treated eye. No ocular effects were noted seven or fourteen days after treatment. The test material produced a maximum group mean score in the range of 34.3 - 42.7 and was classified as a moderate irritant (class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system (Allen, 1993). The mean values from gradings at 24, 48 and 72 hours were equal to 1 for corneal opacity and iritis in all rabbits, equal/higher than 2 for conjunctival redness in two out of three rabbits and lower than 2 for chemosis in two out of three rabbits; all the reactions recorded were fully reversible within 14 days. The substance can be considered as irritating to eye and a classification in category 2, Eye. Irrit. 2 (H319), of the CLP Regulation (EC) No 1272/2008 can be considered as appropriated.

Justification for classification or non-classification

In the key study, the mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions, thus the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.

The mean values from gradings at 24, 48 and 72 hours were equal to 1 for corneal opacity and iritis in all rabbits, equal/higher than 2 for conjunctival redness in two out of three rabbits and lower than 2 for chemosis in two out of three rabbits; all the reactions recorded were fully reversible within 14 days. The substance can be considered as irritating to eye and a classification in category 2 (Eye. Irrit. 2 H319) of the CLP Regulation (EC) No 1272/2008 can be considered as appropriated.