Chemical name: 5-amino-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-[(1R,S)-(trifluoromethyl)sulfinyl]-1H-pyrazole-3-carbonitrile Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: All uses and formulations of Fipronil are severely restricted The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: All products containing Fipronil are restricted because of their high potential of toxicity to human beings and to the environment. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: Fipronil belongs to class II of WHO (moderately dangerous) (US-EPA, 1998; PAN, 2014). Toxicological studies provide data showing clear risks of toxicity to human health. Expected effect of the final regulatory action in relation to human health: The reduction of risks from the use of fipronil. Summary of known hazards and risks to the environment: Birds: Fipronil is highly toxic to northern bobwhites and pheasants with an acute oral LD50 of 11,3 mg/kg and 31,0 mg/kg, respectively (Footprint PPDB, 2014). Fipronil has also a high sub-acute toxicity with a 5 day dietary LC50 of 49 mg/kg in Virginie quail. It is practically non toxic for mallard ducks without documented acute, sub acute or chronic effects. Fish: Fipronil is highly toxic to sea and freshwater fish. 96 hour LC50 is 0,246 mg/L for rainbow trout (Footprint PPDB, 2014). According to GHS classification, fipronil is extremely dangerous to this species of fish (LC50 < 0,1mg/L). It accumulates in fish with a bio concentration factor of 321 for the whole fish (Footprint PPDB, 2014), 164 for edible tissues and 575 for non edible tissues. (see Annex) Expected effect of the final regulatory action in relation to the environment: The preservation of the environment, above all. Date of entry into force of the final regulatory action: 08/04/2015 |