Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Data on the toxicokinetics of the registration substance are not available. However, toxicity data indicate that this compound and/or metabolites are absorbed from the gastro-intestinal tract. For structural related alkylguanidinium acetats (e.g 1-dodecylguanidinium acetate, n-dodecylguanidin hydrochloride)  dermal penetration rates of about 50% have been demonstrated, which is assumed to be also valid for the registration substance. This view of limited dermal penetration of the registration substance is supported by the molecular weight (approximately 500) and log Pow of about 4 (in line with appendix R.7.12-4 of REACH endpoint guidance R7c) as well as by data from dermal toxicity studies with structural related alkylguanidinium acetates which revealed no specific systemic toxicity at doses which resulted in toxicity after oral administration. Therefore, a significant dermal absorption is not to be expected.
Guanidine,C12-C16(even numbered),N,N'''-1,3-propanediylbis derivatives acetate consists mainly of cocosalkyl mono- and cocosalkyl diguanidine derivatives. In accordance with the general metabolic scheme of such guanidine derivatives, at least two metabolic degradation pathways are conceivable with respect to the registration substance. This includes either the formation of a hydroxyalkylguanidine derivative via desamination and ω-oxidation which may be further degraded via ω- and ß-oxidation in mitochondria and/or lysosomes as well as the integration into catabolic pathways catalysed by ureohydrolases like arginase and agmatinase. Potential endproducts include acidic hydroxyalkylguanidine compounds, urea, CO2, as well as 1,3-diaminopropan. Published toxicological data revealed for the most common guanidine derivatives, i.e. dodecylguanidine acetate and dodecylguanidine hydrochloride, as well as the potential metabolic degradation products guanidine and diaminopropan are in good agreement with the available toxicity of the registration substance, which supports common toxicokinetics.

Key value for chemical safety assessment

Absorption rate - oral (%):
100
Absorption rate - dermal (%):
50
Absorption rate - inhalation (%):
100

Additional information