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Administrative data

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Description of key information

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

No experimental studies regarding toxicokinetics of formaldehyde, reaction products with ethylenediamine are available. Nevertheless available data and information derived from the testing strategy adopted for the chemical permit to evaluate main aspects of the substance toxicokinetics.

Formaldehyde, reaction products with ethylenediamine is expected to be absorbed by oral and inhalation route as, in the acute toxicity studies by these routes, systemic effects have been observed. Although in the inhalation toxicity study a mist of the chemical has been produced by atomization, formaldehyde, reaction products with ethylenediamine is expected to be present in moderate quantities as vapour in the environment, according to the vapour pressure value of 2,176 Pa at 20°C (water: 3,200 Pa at 25°C). Systemic effects were not observed in the dermal acute toxicity study at the dose of 2,000 mg/kg bw, but the chemical produced only local effects linked to slight skin irritation. Results of this study may lead to the conclusion that the chemical is expected to have a low skin absorption. In addition, formaldehyde, reaction products with ethylenediamine is a hydrophilic compound and it is expected to be ionised at the slight acidic pH of the skin (pKa 8.18). Ionised products do not penetrate very much through the skin and, in addition, considering that rat skin is more permeable the human skin, formaldehyde, reaction products with ethylenediamine is expected to have a low percutaneous absorption in humans.

Systemic effects observed in toxicity studies do not permit to make considerations on the distribution of formaldehyde, reaction products with ethylenediamine, however, as no histopathological lesions of the organs, with the exception of kidneys and stomach in the 28-day repeated toxicity study, have been observed, and considering the low calculated logPOWfor the substance, a limited distribution or a low bioaccumulation potential can be expected for formaldehyde, reaction products with ethylenediamine. Low bioaccumulation potential can also be supported by the low predicted BCF (1,41 L/kg ww) of the substance.

As toxicity effects related to formaldehyde, reaction products with ethylenediamine have been observed in kidneys, it can be expected that renal excretion is a probable route of elimination of the substance.