Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

There is no evidence from the experimental studies to indicate that Diurea 8 in a grease base is absorbed systemically.  No information on distribution, metabolism or excretion can be derived from the experimental data.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

Experimental data for the mammalian toxicity Annex VII and VIII endpoints have been generated on Diurea 8.

The following conclusions can be drawn on the basis of a review of available key experimental data from physico-chemical and toxicological studies on Diurea 8 in a grease base performed according to international technical guidelines and in compliance with GLP in internationally recognised contract research organisations:

- Diurea 8 in a grease base does not appear to be absorbed via the gastrointestinal tract. This is supported by the lack of systemic toxicity at single doses of up to 2000 mg/kg bw, as a suspension in arachis oil via oral gavage in an acute oral toxicity study in female Wistar rats and also, following repeated daily oral gavage dosing at lower concentrations to male and female rats for at least 42 days. Alternatively the lack of toxicity via the oral route may also be indicative of high-threshold toxicity for the substance over the relatively short-term exposures examined.

- Diurea 8 in a grease base does not appear to be absorbed via the skin. This is supported by the lack of any systemic effects following semi-occluded application of 0.5 g to rabbit skin in an in vivo study. Similarly there was no dose dependent increase in stimulation index following topical application of Diurea 8 in a grease base concentration in 1% pluronic L92 in distilled water in a local lymph node assay. Although lack of dermal absorption is the likely scenario for the absence of systemic effects via this route of exposure, the alternative explanation of high threshold toxicity over the short-term exposure examined cannot be ruled out.

No available data from these studies allows conclusions to be drawn regarding distribution, metabolism or excretion of the polyurea, Diurea 8 in a grease base.