Assessment of risk of monepantel faecal residues to dung fauna

To evaluate the safety of monepantel and its major metabolite for dung fauna. Monepantel is a new oral anthelmintic drug for use in sheep at a dose of 2.5 mg active ingredient/kg body weight. Hazard (toxicity) is related to the expected exposure.

The methodology was based on the Organisation for Economic Cooperation and Development (OECD) draft guideline for testing of chemicals, so dung from cattle, not sheep, and eggs of the dung fly, Scathophaga stercoraria and larvae of the dung beetle Aphodius constans were used.

Monepantel or its sulfone metabolite were mixed into bovine faeces in which either dung fly eggs or dung beetle larvae were placed and their development observed. The primary endpoint was survival. Real exposure data (faecal concentrations) for comparison with the generated laboratory data were taken from a kinetics study in sheep dung.

The no-observed effect concentration (NOEC) for monepantel was >1000 mg/kg substrate for dung flies and 250 mg/kg for dung beetles. The sulfone metabolite was slightly more toxic, with a NOEC of 500 mg/kg for dung flies and 125 mg/kg for dung beetles.

A comparison of the results to the maximum concentrations of 15 mg monepantel and 4.5 mg sulfone per kg dung observed under an exaggerated dosing regime in sheep indicates that monepantel poses no risk to insect dung fauna when used as recommended. The study is considered valid because representatives of both genera were able to develop in bovine or ovine dung.