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

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 toxicity by oral administration according to the OECD Guideline 401 (1987) and the EU method B.1 of the Directive 92/69/EEC. The test substance was administered to a group of 5 male and 5 female rats by oral gavage, at a single dose of 2000 mg test article/kg body weight. There were no deaths as a result of treatment with the test substance. The clinical sign noted during the observation period (14 days after the treatment) was diarrhoea in all animals. No other clinical signs were observed. There was no effect on body weight gain during the observation period. No organ abnormalities were observed 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. The test substance was administered to a group of 5 male and 5 female rats by dermal application at a single dose of 2000 mg test article/kg body weight. No deaths occurred during the study period. Yellow discoloration was observed at the application site after the removal of the dressing until study termination (14 days after the treatment). However in one male animal this observation was noted until test day 12. There were no test substance-related effects on the body weight of the animals during the observation period. The minimal to slight loss of body weight in one female animals during the first observation week was considered to be a consequence of the semi-occlusive dressing. Commonly female animals prove to be more sensitive in relation to the effects on body weight caused by semi-occlusive dressing than males. The macroscopic examination at study termination revealed no organ abnormalities.

The LD50 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).