Reaction product of Aminoguanidine bicarbonate and Tall Oil fatty acid

Endpoint summary

Additional information

Toxicity studies have shown some evidence for absorption following oral administration, based upon limited perturbations in haematological and clinical chemistry parameters and some organ weight changes, although these were restricted to liver and spleen, and there were no associated pathological changes. The use of corn oil as a vehicle may have facilitated the absorption of this lipophilic test substance, and absorption would be promoted by bile acids, similarly to other lipids absorbed from diet.

Although there was no evidence of any dermal penetration in the rat and rabbit, following occluded application, the moderate dermal sensitisation result in the guinea pig demonstrated that some material was absorbed through the skin in this species.

An assessment of the potential absorption is also based upon its physio-chemical properties, which suggest that intact molecules would be subject to absorption across the gastrointestinal mucosa following oral administration. The structures and chain lengths of the saturated and unsaturated molecules equate with the predominant fatty acids found in higher plants and animals and are therefore similar to normal endogenous substrates. Whilst the acid amide moiety is likely to be stable, there exists the potential for oxidation to the corresponding fatty acid, with direct incorporation into endogenous metabolism. However, oxidation of the alkyl side chain is more likely and would allow for the progressive breakdown of both the saturated and the unsaturated chains. The absorbed molecules would therefore be expected to be incorporated into cellular lipid metabolism.