3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea

Endpoint summary

Description of key information

Experimental data for the mammalian toxicity Annex VII and VIII endpoints have been generated on the test item and on the read-across source substance N,N''-(methylenedi-4,1-phenylene)bis[N'-octylurea] (EC # 451-060-3).

 

The following conclusions can be drawn on the basis of a review of available key experimental data from physico-chemical and toxicological studies on the isolated substances performed according to international technical guidelines:

 

 - The registered substance does not appear to be absorbed via the gastrointestinal tract. This is supported by the lack of systemic toxicity at a single doses of 5000 mg/kg bw, as suspension via oral gavage in the acute oral toxicity study with Wistar rats and in the repeat dose oral toxicity studies with Wistar rats at concentrations up to 1000 mg/kg bw/day.

 

- The substance 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 skin irritation study. Similarly, the substance showed no classifiable response following topical application in a guinea-pig maximisation test or in a Buehler test conducted with the test item. There was also a lack of systematic toxicity in acute dermal toxicity studies with the substance. 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 test item in the marketed grease base.