Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

There are no studies available for the determination of toxicokinetics or dermal absorption.

(5-ethyl-1,3-dioxan-5-yl)methyl acrylate is a liquid with a molecular weight of 200 g/mol and a low vapour pressure of 0.6Pa at 20 °C. In agreement with its logPow of 1.9, up to 9.3g can be dissolved in one liter of water. Due to its low vapour pressure, exposure to vapor is unlikely. Acute dermal toxicity tests as well as oral acute and repeated dose studies showed no signs of systemic toxicity, but irritation at the site of entry. In the acute toxicity study one female died due to extensive bleeding in the glandular stomach after a single dose of 2000mg/kg. The remaining animals showed an impaired general state mostly up to 5 hours after dosing, probably also due to the irritant properties of the test substance. In a test study to select the doses for the OECD 422 study, 1 of 3 animals died on day 13 after daily exposure to 1000mg/kg. All animals of this group had erosions / ulcers in the glandular and/or forestomach. Even after 14 day exposure to 500mg/kg, ulcers observed in one animal were considered severe enough to cause death after prolonged exposure. In the main study performed with 250mg/kg at the top dose, hyperkeratosis was observed in the forestomach of 7 out of 10 males, while no signs of systemic toxicity were found.

Based on the moderate logPow (between -1 and 4) of the test substance and its low molecular weight, absorption through the GI-tract seems likely, but the substance is not expected to bioaccumulate. It is assumed, that the molecule is metabolized via hydrolyzation of the ester bond into acrylic acid and 5 -ethyl-1,3 -dioxane-5 -methanol. Since severe irritation occured at doses at and above 500mg/kg in the stomach after oral exposure (the substance itself has a pH value of 7 and is not irritating on mucosal surfaces), generation of acrylic acid and 5 -Ethyl-1,3-dioxane-5-methanol might already take place in the stomach. Acrylic acid is rapidly exhaled as CO2, while 5-Ethyl-1,3-dioxane-5-methanol is even more hydrophilic than the parent compound (logPow = 0.08) and probably excreted via urine.

No mutagenicity or chromosomal aberration was observed for the parent compound (Ames, HPRT, MNT), or the proposed metabolic products, so no reactivity with macromolecules is expected prior to excretion.