Reaction mass of Fatty acids, tallow, Guerbet reaction Products, Ca salts and Fatty acids, tallow, Guerbet reaction Products, Na salts and Fatty acids, tallow, Guerbet reaction Products

Endpoint summary

Description of key 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 in form of flakes. The water solubility is 0.01 mg/L (see IUCLID chapter 4.8). The octanol water partition coefficient (Log P_ow) for the substance was determined to be 2.6 (see IUCLID chapter 4.7). Due to the restricted water solubility a general potential of bioaccumulation can be excluded.

 

Absorption

With reference to the restricted 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. O^-). 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. This assumption is strengthened by the result of an acute oral toxicity study in rats (acute oral toxicity study: LD₅₀> 5,000 mg/kg bw).

 

Distribution

The substance is not highly 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 restricted water solubility and the results of oral toxicity studies, an uptake of excessive amounts of this substance is not considered to occur. However, absorption of marginal amounts can not be excluded, as indicated by the occurrence of unspecific adaptive liver changes.

Studies on genotoxicity performed with the test item (Ames-Test; HPRT test and chromosome aberration study) 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 no cleavage of the molecule is likely.

 

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).