Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Short description of key information on bioaccumulation potential result:

absorption: ~ 2 % via intestine

distribution: mainly localised within central compartment (minimal tissue distribution)

metabolism: no metabolites detectable

excretion: 92-96 % by renal excretion; 0.35 ml/h

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

Pharmacokinetics indicate that ethylenediamine, +4PO is poorly absorbed from the GI tract (less than 2 %), almost exclusively localized in the central compartment (plasma water) with negligible binding to albumin or erythrocytes, minimally biotransformed if at all and removed from the plasma in a simple first order process. 92 - 96 % ethylenediamine, +4PO is eliminated via renal excretion with a rate of 0.35 ml/h by simple glomerular filtration in the absence of tubular reabsorption. The remaining percentages of Ethylenediamine, +4PO may be removed from the body by the biliary pathway.

The logPow of -2.08 and the available data of basic toxicokinetics and acute dermal toxicity (LD50 > 2000 mg/kg bw) do not support a significant absorption through the skin. Most likely, ethlenediamine, +4PO will not difíuse through cellular membranes with ease.

Discussion on bioaccumulation potential result:

Ethylenediamine, +4PO's pharmacokinetics indicate that it is rapidly though poorly absorbed from the GI tract (less than 2 %), almost exclusively localized in the central compartment (plasma water) with negligible binding to albumin or erythrocytes and removed from the plasma in a simple first order process. Ethylenediamine, +4PO is completely eliminated from the bloodstream within the first 24 h.

Discussion on absorption rate:

The available data of basic toxicokinetics (minimal absorption through the GI tract), a LogPow of -2.08 and the data on acute dermal toxicity (LD50 > 2000 mg/kg bw) indicate a negligible absorption through the skin. The available data support the notion that ehtylenediamine, +4PO will not difíuse through cellular membranes with ease.