Disodium 3,3'-[[6-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]bis[imino(3-methoxy-4,1-phenylene)azo]]bis[benzenesulphonate]

Endpoint summary

Description of key information

Direct Yellow 142 is a orange organic powder. It is characterized by an appreciable molecular weight and carries ionic charges.

The substance is expected to possess a low potential for bioaccumulation, based on the screening evaluation taken into account the experimental log Pow. Due to the molecular mass greater than 700 and due to the steric hindrance, the possible passage of gill membranes or cell membranes of respiratory organs is expected to be negligible.

Direct Yellow 142 is not toxic/harmful for short-term exposures and it is not skin/eye irritating. It is not able to cause skin sensitization. No genotoxic activity has been observed in specific experiments performed. The subacute repeated dose toxicity study and the screening on reproductive toxicity did not evidence any reason of concern.

There is no specific studies or specific literature data on toxicokinetics and metabolism, thus available information about the substance and analogues has been taken into account, avoiding further tests.

Because of the physical state and the physicochemical properties of Direct Yellow 142, inhalation is not an appropriate route of exposure; in addition, the substance dermal absorption is expected to be low.  

During the acute oral toxicity experiments, the treatment did not produce changes detected in health condition. During the subacute oral tests, no significant effect due to the treatment with Similar Substance 01 and Similar Substance 02 were recorded, up to the appreciable high dose of 1000 mg/kg bw/day; one of the explanation may be the limited absorption of the substance, due to the high molecular weight and considering that it is very water soluble

In addition, the sulphonation degree is expected to contribute to increased solubility and to decreased absorption.

Although on the basis of the available information a definitive conclusion about possible metabolism and metabolites cannot be traced, neither from qualitative, either from rate point of view, the absence of significant effects directly attributable to the test item administration lets to suppose that only few rates of substance can be absorbed or that it can be metabolised into a easily eliminable compound(s). In any case, processes of bioactivation, which may increase the substance toxicity, can be excluded.