Registration Dossier
Registration Dossier
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EC number: 947-618-5 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
The following remarks on the toxicokinetics of EGGE 2806-1 (N,N''-hexane-1,6-diylbis[N'-(2-hydroxyethyl)-N'-methylurea]) are based on physico-chemical properties of the compound and on toxicological data. Experimental toxicokinetic studies were not performed.
The substance is a white organic solid with a very low vapour pressure under normal ambient conditions (3.64 x 10-7 Pa at 20°C), therefore inhalation exposure to the vapour is expected to be negligible. Acute inhalation of a liquid aerosol of EGGE 2806-1 inhalable to rats did not reveal signs of systemic toxicity at the maximum attainable concentration of 3038 mg/m3 (Kopf, 2015). Even subacute (4-week) inhalation of EGGE 2806-1 liquid aerosol to rats revealed no signs of systemic toxicity (Kopf, 2016). Due to the lack of systemic toxicity there is no proof of systemic availability after inhalation exposure.
The physico-chemical characteristics of the substance (high water solubility of 527 g/L at 20°C, moderate log Pow of - 0.81 at 22.5°C and a molecular mass of 318 - 804 g/mol) are favourable for intestinal absorption after oral intake. Since a single oral dose of 2000 mg/kg bw was tolerated in rats without mortalities, clinical signs, effects on body weight development and gross pathological findings no proof of systemic availability after oral administration could be demonstrated in an acute oral toxicity study (Brockes, 2015).
Because of the poor lipophilicity of the substance accumulation of the unchanged compound in fatty tissues is unlikely. The results of a OECD 421 study in rats (Barraclough, 2016), in which oral doses up to 1000 mg/kg bw were applied for 42 days (males) or up to 64 days (females), do not reveal indications of a significant accumulation potential of the substance.
Due to the high water solubility, a log Pow of -0.81 at 22.5°C and a molecular mass of 318 - 804 g/mol no appreciable dermal or mucosal absorption is anticipated. This is confirmed by a study on skin sensitisation (LLNA; Leidenfrost, 2015) in which no signs of systemic toxicity were observed.
Based on the results of three in vitro genotoxicity tests (negative with and without metabolic activation in an Ames test (Sokolowski, 2015a), in a HPRT test (Wollny, 2015) as well as in a mammalian cell micronucleus test (Sokolowski, 2015b)) it is concluded that DNA-reactive metabolites of the substance will most probably not be generated in mammals in the course of hepatic biotransformation.
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