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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 inorganic substance, which is considered to dissociate into its ionic compounds after dissolution. The water solubility is nearly not detectable at pH 4, 7 and 9(see IUCLID chapter 5.12).The octanol water partition coefficient (Log Pow) for the substance was not determined(see IUCLID chapter 4.7)but since the substance is an anorganic salt a Log Pow< 3 is expected. Due to the very minimal water solubility in combination with the assumed insolubility in organic solvents a general potential of bioaccumulation might be excluded.

Absorption

With reference to the insolubility in water and organic solvents 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, a large-scale 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: LD50> 2,000 mg/kg bw; reproduction toxicity screening: NOAEL 1000 mg/kg bw/d, 28 day oral toxicity: NOAEL 1000 mg/kg bw/d). However, since some (unspecific) effects were observed in the course of repeated dose studies at high doses a small amount of the substance might be bioavailable.

Distribution

The substance is neither water soluble nor soluble in organic solvents. 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 HPRT test) 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 metabolism of the substance might be excluded. This conclusion is supported by the low water solubility. However, the dissociation into the ionic components when dissolved is supposed.

Excretion

With reference to the insolubility 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).

For further details please refer to attached document.