Pentasodium bis{7-[4-(1-butyl-5-cyano-1,2-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo)phenylsulfonylamino]-5'-nitro-3,3'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato} chromate (III)

Endpoint summary

Description of key information

Not skin irritant

Category 1 (irreversible effects on the eye)

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 (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

SKIN IRRITATION

The skin irritation test was performed to rabbit skin according to the OECD Guidelines 404 (1992) and the method B.4 of EEC-Directive 92/69 EEC. 0.5 gof the test item was topically appliedonto 6 cm^2 intact dorsal skin of each of 3 young adult New Zealand rabbits. The duration of treatment was 4 hours and the scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.

The test substance was found to be not irritant when applied to intact rabbit skin: local signs (mean values 24/48/72 hours) consisted of grade 0 erythema and grade 0 oedema in all animals. The test item caused green staining (after 1 and 24 hours) and pale green staining (after 48 and 72 hours) of the treated skin area in all animals. No corrosive effect occurred on the treated skin of any animal at any measuring interval.

EYE IRRITATION/CORROSION

The eye irritation test was performed to the rabbit eye according to OECD Guidelines 405 (1987) and the method B.5 of EEC-Directive 92/69 EEC. 0.1 g of test item were installed into the left eye of 3 young adult New Zealand White rabbits (1 male and 2 females). The treated eyes were not rinsed after the application. Scoring of irritation effects was performed after test item application at 1, 24, 48 and 72 hour, as well as 7, 10, 14, 17 and 21 day.

Animal #1 was found dead on day 7, but the death was considered to be not treatment-related. Mean values at 24, 48 and 72 hours for iris, corneal opacity and the conjunctivae (redness and chemosis) were 0.00 in all animals. No corrosion was observed at any of the measuring intervals. The test item caused dark green staining of cornea, conjunctivae and sclera in all animals at the 1-hour reading. Light green staining was then observed in the following readings. For animal #1 staining of cornea, conjunctivae and sclera persisted until its death. For animals #2 and #3 staining of the conjunctivae persisted up to 21 days. Staining of the sclera was reversible within 14 days (animal #2) and 24 hours (animal #3). Staining of the cornea was still present in animal #2 after 21 days, whereas in animal #3 was reversible on day 21.

Justification for classification or non-classification

SKIN IRRITATION

In the CLP Regulation (EC 1272/2008), skin irritation is defined as "the production of reversible damage to the skin following the application of a test substance for up to 4 hours." A single irritant category (Category 2) is defined and, using the results of animal testing, the classification criteria are presented in Annex I, Part 3, Table 3.2.2.

Based on the results of Acute Dermal Irritation/Corrosion study conducted on the test substance, the mean score (24/48/72h) of erythema and edema was not in the range of ≥ 2.3 - ≤ 4.0; therefore the substance is not classified for skin irritation according to the CLP Regulation (EC 1272/2008).

EYE IRRITATION/CORROSION

The CLP Regulation (EC 1272/2008) defines Serious eye damage as “the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application”. A substance that has the potential to seriously damage the eyes is classified in Category 1 (irreversible effects on the eye).

On the basis of the results of animal testing, the classification criteria are presented in Annex I, Part 3, Table 3.3.1.

Based on the results of Acute Eye Irritation/Corrosion study conducted, the test substance was found to cause light green staining of the conjunctivae that persisted up to study period termination (21 days). Therefore, the test substance should be classified Eye Dam. 1, according to the CLP Regulation (EC 1272/2008).