3-dodecyl-1-(2,2,6,6-tetramethyl-4-piperidyl)pyrrolidine-2,5-dione

Endpoint summary

Link to relevant study record(s)

Reference

Endpoint:

basic toxicokinetics, other

Type of information:

other: expert statement

Description of key information

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

 

The test item is a clear, medium viscous and organic substance. It does not hydrolyse at pH 7, at pH 9 only a slow hydrolysis was observed (see IUCLID chapter 5.1.2). The water solubility is 6.3 mg/L (see IUCLID chapter 4.8). The octanol water partition coefficient (Log P_ow) for the substance was determined to be greater than 5.7 (see IUCLID chapter 4.7). Due to the very limited water solubility a general potential of bioaccumulation can be excluded.

 

Absorption

With reference to the low solubility in water and its complex structure the absorption of the substance is considered to be restricted (please refer to ECHA Guidance on information requirements and chemical assessment, Chapter R.7c, Table R.7.12-1, p. 168). Furthermore, even if low amounts of the substance are dissolved in aqueous solutions it might dissociate into ionic species (i.e. N⁺). 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. 167). Therefore, an excessive absorption of the substance can be excluded. However, based on the results of several oral toxicity studies in rats (acute oral toxicity study: LD₅₀ 2000 mg/kg bw; 28 d oral toxicity: NOAEL 25 mg/kg bw/d) effects were observed especially in the course of the subacute study that prove the bioavailability of at least a small amount of the substance.

 

Distribution

The substance is only very 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. 176-177).

 

Metabolism

Taking into account the very limited water solubility and the results of several oral toxicity studies, a moderate uptake of this substance is considered to occur.

Studies on genotoxicity performed with the test item (Ames-Test; HPRT test and chromosome aberration 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 the cleavage of the carbonyl-nitrogen binding 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. 178).

Key value for chemical safety assessment

Bioaccumulation potential:

low bioaccumulation potential

Additional information

none