reaction mass of: pentasodium bis[6-anilino-3,5'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato]cobaltate(III);tetrasodium [6-anilino-3,5'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato][6-anilino-5'-sulfamoyl-3-sulfonatonaphthalene-2-azobenzene-1,2'-diolato]cobaltate(III);trisodium bis[6-anilino-5'-sulfamoyl-3-sulfonatonaphthalene-2-azobenzene-1,2'-diolato]cobaltate(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 g of test item were applied (semi-occlusive system) to the intact left flank of 3 young adult New Zealand White rabbits. The duration of treatment was 4 hours.

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 a marked violet coloured staining at the test site of all animals 1 hour after removal of the dressing. A light violet staining continued to be observed in one animal up to the 72-hour examination and in the remaining two animals up to the 7-day examination. Thus this effect was reversable within the study period (10 days).

No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals.

EYE IRRITATION/CORROSION

The eye irritation test was performed to the rabbit eye according to OECD Guidelines 405 (2002) 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. 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.

Mean values at 24, 48 and 72 hours for iris were 0.00 in all animals. The other mean values for corneal opacity were 0.00, 0.00 and 1.00; for the conjunctivae were 1.33, 1.00 and 1.33 (redness) and 0.00, 0.00 and 0.33 (chemosis), respectively in animals #1, #2 and #3. These effects were reversible and were no longer evident 21 days after treatment, the end of the observation period for all animals.

No corrosion was observed at any of the measuring intervals.

A slight opacity of the cornea was noted in one animal due to the staining produced by the test item. Marked violet staining caused by the test item was evident in all animals at the 1-hour reading. Light to marked violet staining was then observed in all animals up to 7 days. Light violet staining persisted in one animal up to termination.

Thus, the test item induced irreversible damage to the rabbit eye: the violet coloured staining which persisted in one animal throughout the observation period.

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 substance was found to cause light violet staining persisted in one animal up to study period termination (21 days). Therefore, the test substance should be classified according to the CLP Regulation (EC n. 1272/2008) Eye Dam. 1.