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Administrative data

Link to relevant study record(s)

Description of key information

no study available

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

There are no studies available in which the toxicokinetic properties of the substance were investigated.

 

The test item is a solid and organic substance, and it hydrolyses only in small amounts (less than 10 % after 5 days). The water solubility is 139 mg/L (see chapter 5.12). The octanol water partition coefficient (Log Pow) for the substance was determined to be 1.12 (see IUCLID chapter 4.7). Due to the limited water solubility a general potential of bioaccumulation might be excluded.

 

Absorption

With reference to the low solubility in water and its complex structure the absorption of the substance is considered to be very poor (please refer to ECHA Guidance on information requirements and chemical assessment, Chapter R.7c, Table R.7.12-1, p. 152). Furthermore, even if low amounts of the substance are dissolved in aqueous solutions it will dissociate into its ionic compounds. Ionisation does not contribute to a readily diffusion across biological membranes (please refer to ECHA Guidance on information requirements and chemical assessment, Chapter R.7c, p. 150). Therefore, an excessive absorption of the substance can be excluded. This assumption is strengthened by the results of several oral toxicity studies in rats (acute oral toxicity study: LD501,253 mg/kg bw; 28 d oral toxicity: NOAEL 1000 mg/kg bw/d, 90 day oral toxicity: NOAEL 450 mg/kg bw/d; reproductive toxicity study (one generation): NOEL 540 mg/kg bw/d). However, since some (unspecific) effects were observed in the course of the acute study at high doses a small amount of the substance might be bioavailable.

 

Distribution

The substance is only limited water soluble. Therefore, it will not migrate into cells and concentrate in adipose tissues or other systemic compartments (please refer to ECHA Guidance on information requirements and chemical assessment, Chapter R.7c, pp. 159-160).

 

Metabolism

Taking into account the very limited water solubility and the results of several oral toxicity studies, an uptake of considerable amounts of this substance is not considered to occur. However, absorption of small amounts can not be excluded.

Studies on genotoxicity performed with the test item (Ames-Test; chromosome aberration test and MLA) were negative, i.e. there is no indication of a reactivity of the substance under the test conditions. With reference to its chemical composition and structure the cleavage of the amidic bindings might be considered as possible metabolic pass way.

 

Excretion

With reference to the limited solubility the biliary excretion might be considered as the most favorable excretion route. Therefore, enterohepatic recycling resulting in a prolonged biological half-life can not be excluded (please refer to ECHA Guidance on information requirements and chemical assessment, Chapter R.7c, p. 161).