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

LD50 (rat, oral) > 2000 mg/kg bw

LD50 (rat, dermal) > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

ACUTE ORAL TOXICITY

The substance was tested for acute administration by oral route according to the OECD guideline 423 and the EU method B.1 tris of theDirective 96/54/EEC. Three male and three femal Wistar rats were treated with test substance by oral gavage administration at a dosage of 2000 mg/kg body weight.

No deaths and no clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy.

The LD50 (rat, oral) was found to be greater than 2000 mg/kg body weight.

ACUTE DERMAL TOXICITY

The substance was tested for acute toxicity by dermal route according to the OECD Guidelines 402 (1987) and the method B.3 of Directive 92/69/EEC. Five male and five female Wistar rats were treated with test item at 2000 mg/kg by dermal application. The application period was 24 hours.

No deaths occurred during the study. No systemic signs of toxicity were observed during the study period. A slight violet discoloration was present at the test site of all animals from study day 2 to 6. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.

The LD50 (rat, dermal) was found to be greater than 2000 mg/kg body weight.

Justification for classification or non-classification

In the CLP Regulation (EC 1272/2008) acute toxicity is defined as “those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours”. A substance can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route. The numeric criteria based on the acute toxicity estimates (ATE) in mg/kg bodyweight are presented in Annex I, Part 3, Table 3.1.1. For acute oral and dermal toxicity: "Category 4: 300 < ATE ≤ 2 000".

Based on the results of acute oral and dermal toxicity studies performed on the test substance (LD50 (rat, oral) > 2000 mg/kg bw and LD50 (rat, dermal) > 2000 mg/kg bw), no classification for acute toxicity is warranted under the CLP Regulation (EC 1272/2008).