Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

No specific studies are available however based on physicochemical data, toxicity data and theoretical assessment, the basic toxicokinetics of Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine can be adequately characterised.  According to Lipinski’s Rule of Five (OECD QSAR Toolbox prediction using a representative structure), Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine will not be bioavailable, therefore oral absorption is not predicted.  Dermal absorption is also considered to be unlikely.  No reliable quantitative prediction of the extent of inhalation absorption can be made; however inhalation absorption is also likely to be low.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential
Absorption rate - oral (%):
50
Absorption rate - dermal (%):
50
Absorption rate - inhalation (%):
100

Additional information

No specific studies are required. According to Column 1 of Annex VIII of the REACH regulation, assessment of the toxicokinetic behaviour of the substance (to the extent that can be derived from the relevant available information) is required and this is provided. An adequate assessment of the basic toxicokinetics of the substance can be made from the existing toxicity data and theoretical considerations, without the need for specific testing.

Absorption

According to Lipinski’s Rule of Five, Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine will not be bioavailable (OECD QSAR Toolbox). The long chain fatty acid derivative has a high molecular weight (~823), limiting oral and dermal absorption and is of low water solubility. No deaths occurred and no signs of toxicity were observed in an acute oral toxicity study. No signs of systemic toxicity were observed in a combined repeated dose and reproductive and developmental toxicity screening study in the rat with the read-across substance Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine, up to a dose level of 1000 mg/kg bw/day consistent with a lack of systemic absorption following oral administration.

Vapour pressure was calculated to be low for Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine, therefore exposure by inhalation is not expected.

Distribution

According to Lipinski’s Rule of Five, Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine will not be bioavailable, therefore consideration of systemic distribution is not relevant.

Metabolism

The OECD QSAR Toolbox predicts a total of 17 potential hepatic metabolites based on the functional groups present in the molecule, however as the substance is not bioavailable hepatic metabolism is not predicted in vivo.

Excretion

Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine is not bioavailable therefore the substance is expected to be excreted unchanged in the faeces and will not bioaccumulate.