A mixture of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy-1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate

Endpoint summary

Description of key information

not skin irritating

not eye 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

SKIN IRRITATION/CORROSION

The purpose of this study was to assess the possible irritation or corrosion potential of test substance when a single dose was placed on the skin of rabbits. This study was carried out in accordance with OECD Guideline No. 404, "Acute Dermal Irritation / Corrosion" and EEC Directive 84/449/EEC, Part B.4, "Acute Toxicity - Skin Irritation". The substance was applied on the shaved skin using semi-occlusive dressings for 4 hours, followed by four observations at approximately 1, 24, 48 and 72 hours after removal of the dressings and the remaining test substance. Under the conditions of this study, the substance resulted in no skin irritation.

In the area of application, yellowish staining of the treated skin by the test substance was observed. No corrosive effect occurred on the skin in any of the rabbits. No signs of systemic intoxication were observed during the study period.

The mean irritation scores (24,48,72 h) for both erythema and oedema were 0 in all treated animals.

EYE IRRITATION

The purpose of this study was to assess the possible irritation or corrosion potential when a single dose of was placed in the conjunctival sac of a rabbit eye.

This study was carried out in accordance with OECO Guideline No. 405, "Acute Eye Irritation / Corrosion" and EEC Directive 84/449/EEC, Part B.5, "Acute Toxicity - Eye Irritation".

The substance was instilled In one of the eyes of each of the three animals, followed by five observations at approximately 1, 24, 48 and 72 hours and 7 days after test article administration. Under the conditions of this study, the substance resulted in adverse effects of the conjunctivae. The irritation of the conjunctivae was reversible within 72 hours in one animal and within 7 days 1n the other two animals. No ocular corrosion was observed In any of the animals. No signs of systemic intoxication were observed during the study period. The mean eye irritation scores (24, 48, 72 h) for corneal opacity and iritis were 0 in all treted animals; conjunctival redness scores were 1, 2 and 1.33 in animals #1, #2 and #3 and chemosis scores were 0.33 in animals #1 and #3 and 1 in animal #2. Al the effects observed were reversible within 7 -day study period.

Justification for classification or non-classification

SKIN IRRITATION/CORROSION

According to the CLP Regulation (EC) no. 1272/2008 substances that have the potential to induce reversible damage to the skin following the application of a test substance for up to 4 hours are classified in Category 2 (irritating to the skin) if:

-mean value of ≥ 2.3 ≤ 4.0 for erythema/eschar or for oedema in at least 2 of 3 (or 4 out of 6) tested animals from gradings at 24, 48 and 72 h after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

-inflammation that persists to the end of the observation period normally 14 d in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

-in some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

Based on the results of in vivo skin irritation experimental study conducted on the test substance, the mean scores (24/48/72h) of erythema and edema were not in the range of ≥ 2.3 - ≤ 4.0 for all three treated animals; therefore the substance is not classified for skin irritation according to the CLP Regulation (EC) no. 1272/2008.

EYE IRRITATION

According to the CLP Regulation (EC) no. 1272/2008 substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes) if, when applied to the eye of an animal, a substance produces at least in 2 of 3 (or 4 out of 6) tested animals, a positive response of:

-corneal opacity ≥ 1 and/or

-iritis ≥ 1, and/or

-conjunctival redness ≥ 2 and/or

-conjunctival oedema (chemosis) ≥ 2,

calculated as the mean scores following grading at 24, 48 and 72 h after installation of the test material, and which fully reverses within an observation period of 21 d.

Based on the results of in vivo eye irritation study conducted on the test substance, the mean scores (24/48/72h) for corneal opacity and iritis were not ≥ 1 and for conjunctival redness and chemosis were not ≥ 2 for 2 of 3 treated animals and all the effects observed were reversible within the 7 -d study period. Therefore, the substance is not classified for skin irritation according to the CLP Regulation (EC) no. 1272/2008.