Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

No ADME studies concerning toxicokinetics are available for the registration substance. However, structure related consideration suggests enzymatic degradation in analogy to accepted metabolic pathways for amide hydrolysis and fatty acid  ß-oxidation. The assumed metabolism will not generate metabolites of toxicological concern. Excretion of postulated final metabolic products is considered fast and complete. Due to its solid state, the low water solubility, the moderate molecular weight close to 500  and the ionic nature, only reduced dermal penetration is anticipated.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential
Absorption rate - oral (%):
100
Absorption rate - dermal (%):
20

Additional information

Experimental data on toxicokinetics of the registration substance is not available. From structur relationship considerations, it is anticipated that this compound is absorbed from the gastro-intestinal tract. An absorption rate of 100% is therefore assumed by default. Inhalation exposure is assumed to be equivalent to oral exposure. Due to its solid state, the low water solubility of < 100 microgram per liter, the moderate molecular weight close to 500 and the ionic nature, dermal penetration of the substance is considered to be low in accordance with REACH Guidance (R7.12). An absorption rate of 20% is taken which is in line with an exposure assessment carried out by the US EPA on the registration substance during the establishment of an exemption from the requirement of a tolerance for residues of `sodium N-oleyl-N-methyl taurine` [EPA-HQ-OPP-2008 -075; FRL-8426 -8]. Following accepted metabolic pathways for alkylamides, it can be concluded that degradation of the registration substance sodium oleylmethyltauride by amide hydrolysis and fatty acid ß-oxidation take place. The initial step involves hydrolysis of the amide linkage to generate fatty acid and sodium N-methyltauride by fatty acid amide hydrolase (FAAH, EC 3.5.1.99), the principal catabolic enzyme for fatty acid amides having both, esterase and amidase activity. The resulting anionic sulfonate may be either directly excreted in the urine or converted to a dianionic salt with glucuronic acid that is excreted. The remaining fatty acid is metabolized in a second step via the ß-oxidation pathway. Metabolites of toxicological significance are not to be expected. This metabolic behaviour was demonstrated for sodium N-oleoyl-N-methyltaurine in

Pseudomonas alcaligenes (Denger et al. 2008).

As a conclusion from the available data, no conspicuous toxicokinetic behaviour is attributable to the registration substance. For assessment purposes, a value of 100% for oral uptake and a value of 20% is taken as conservative assumption for dermal penetration. Rapid and complete metabolism is anticipated with no resulting metabolites of significant toxicological concern. A bioaccumulation potential can be excluded.