A mixture of isomers of: 1,1'-[(3,5(or 2,4 or 4,6 or 2,6)-dihydroxy-o(or m or p)-phenylene)bis(azo-meta-phenyleneazo{1-[3-(dimethylamino)propyl]-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl})]dipyridinium-dichloride-dihydrochloride; 1-(1-[3-(dimethylamino)propyl]-5-{3-[x-(4-{1-[3-(dimethylamino)propyl]-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-5-pyridinio-3-pyridylazo}phenylazo)-2,4(or 2,6 or 3,5 or 4,6)-dihydroxyphenylazo]phenylazo}-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-3-pyridyl)pyridinium-dichloride-dihydrochloride (where x is variable)

Endpoint summary

Description of key information

Acute oral toxicity: LD50 > 5000 mg/kg bw
Acute dermal toxicity: LD50 > 2000 mg/kg bw 
Acute inhalation toxicity: waiving.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Only one reliable key study is available. This study was performed according to OECD TG 401 under GLP.

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

Quality of whole database:

Only one reliable key study is available. This study was performed according to OECD TG 402 under GLP.

Additional information

Oral

A fully reliable study was designed according to OECD TG 401. The oral LD50 value of tet substance in rats of both sexes was estimated to exceed 5000 mg/kg body weight.

Inhalation

Relevant human exposure to the substance via inhalation route is deemed to be unlikely due to the following:

1) the substance has a negligible vapour pressure, based on the high melting point > 300 °C;

2) the particle size distribution shows D90 76.7 µm, D50 37 µm and less than 5 % < 10 µm, thus most particles belong to the inhalable fraction (10-100 µm). If inhaled, particles remain in the high part of the respiratory tract, from which they could be cleared out or enter the gastrointestinal tract. Possible toxic effects may be assessed in the oral acute toxicity study;

3) the use of the substance is in the form of aqueous solutions as a dye.

The inhalation route was thus considered as not relevant to human exposure and the study proposed to get waived.

Dermal

A fully reliable study was designed according to OECD TG 402. The dermal LD50 value of test substance in rats of both sexes, was estimated to exceed 2000 mg/kg body weight.

Justification for classification or non-classification

- oral toxicity:

based on the above stated assessment of the acute oral toxicity, the test item does not need to be classified according to the CLP Regulation (EC 1272/2008).

- dermal toxicity:

based on the above stated assessment of the acute dermal toxicity, the test item does not need to be classified according to the CLP Regulation (EC 1272/2008).

- inhalation toxicity:

no inhalation studies are available and due to exposure considerations the conduct of studies and the classification and labelling for this endpoint is deemed not to be necessary.