Fatty acids, tallow, compds. with triethanolamine

Endpoint summary

Description of key information

No experimental studies of the absorption, distribution, metabolism or elimination of Fatty acids, tallow, compounds with triethanolamine in mammals are available. However, the physical chemical properties and the existing toxicology studies on the compound have been used to infer as far as possible, the potential toxicokinetics of the substance.

 

The substance fatty acids, tallow, compounds with triethanolamine is an organic UVCB and a brown liquid. The molecular weight (MW) ranges between 357.54 g/mol for the monosubstituted to 948.60 g/mol for the trisubstituted. The entire substance is poorly water-soluble (< 1 µg/mL).Given the chemical structure and nature of the substance, the partition coefficient (Log Kow/Log Pow) was estimated using Estimation Program Interface EPI ver. 4.1. to range from 4.4225 to 20.7599. The vapour pressure was determined to be 82×10^-4 Pa at 20°C and 119×10^-3 Pa at 25°C.

 

Absorption

The relatively low MW would appear to favour oral absorption at least for the monosubstituted; however, the low water-solubility and the diffuse and high octanol/water partition coefficient may limit the rate of absorption from the gut.

 

In acute oral studies, as well as in repeated dose oral studies, doses up to and including the limit dose of 2000/1000 mg/kg/day were well tolerated without any mortality and no evidence of any target organ of toxicity. This would infer that the substance has a very favourable toxicological profile following oral administration. Alternatively, limited to no oral absorption may be suggested; however this is considered highly unlikely given the nature of components (fatty acids), as also supported by the increased body weights observed in females during pregnancy and lactation, and in their offspring, in the OECD 421 study. In accordance with ECHA guidance, and as a worst-case assumption, oral absorption is assumed to be 50% for risk assessment purposes.

 

With respect to inhalation absorption, in the absence of any quantitative data, and as a worst-case assumption, for risk assessment purposes absorption by inhalation of Fatty acids, tallow, compounds with triethanolamine is assumed to be 100%.

 

A substance must be sufficiently soluble in water to partition from the stratum corneum into the epidermis, and the water solubility of fatty acids, tallow, compounds with triethanolamine is very low. The range of estimated Log Pow values would also suggest that absorption would be favourable for some components, but limited to extremely limited, for other components. In the absence of any quantitative data and in line with latest EC guidance on dermal absorption (EFSA Panel on Plant Protection Products and their Residues (PPR); Guidance on Dermal Absorption. EFSA Journal 2012;10(4):2665), 25% for dermal absorption will be used for risk assessment purposes.

 

Distribution

Repeated dose oral toxicity studies did not identify any target organ. The lower molecular weight components would suggest wider distribution, although this might be counter-acted by the low water solubility. The range of estimated Log Pow values suggests that the intracellular concentration of components may be higher than extracellular concentration, and preferential partition to fatty tissues. However, there was no evidence of bioaccumulation from the available repeated dose toxicity studies and in addition the substance was found to be readily biodegradable. On this basis, no bioaccumulation potential is expected.

 

Metabolism and Excretion

Nothing could be inferred from the results of the Ames test or in vitro genotoxicity studies (chromosome aberration and gene mutations in mammalian cells), because fatty acids, tallow, compounds with triethanolamine was not genotoxic, mutagenic or clastogenic in either the presence or absence of S9 metabolising system. The nature of the components (fatty acids) suggests that most components may be completely metabolised to water and CO₂, through beta-oxidation and citric acid cycle to produce energy.

Key value for chemical safety assessment

Bioaccumulation potential:

no bioaccumulation potential

Absorption rate - oral (%):

50

Absorption rate - dermal (%):

25

Absorption rate - inhalation (%):

100