No abstract

The veterinary parasiticide ivermectin was selected as a case study compound within the project ERAPharm (Environmental Risk Assessment of Pharmaceuticals). Based on experimental data generated within ERAPharm and additional literature data, an environmental risk assessment (ERA) was performed mainly according to international and European guidelines. For the environmental compartments surface water, sediment, and dung, a risk was indicated at all levels of the tiered assessment approach. Only for soil was no risk indicated after the lower tier assessment. However, the use of effects data from additional 2-species and multispecies studies resulted in a risk indication for collembolans. Although previously performed ERAs for ivermectin revealed no concern for the aquatic compartment, and transient effects on dung-insect populations were not considered as relevant, the present ERA clearly demonstrates unacceptable risks for all investigated environmental compartments and hence suggests the necessity of reassessing ivermectin-containing products. Based on this case study, several gaps in the existing guidelines for ERA of pharmaceuticals were shown and improvements have been suggested. The action limit at the start of the ERA, for example, is not protective for substances such as ivermectin when used on intensively reared animals. Furthermore, initial predicted environmental concentrations (PECs) of ivermectin in soil were estimated to be lower than refined PECs, indicating that the currently used tiered approach for exposure assessment is not appropriate for substances with potential for accumulation in soil. In addition, guidance is lacking for the assessment of effects at higher tiers of the ERA, e.g., for field studies or a tiered effects assessment in the dung compartment.

Veterinary parasiticides are administered to livestock to control a wide range of parasites. Following excretion, these substances may persist in the environment and impact nontarget organisms. This paper describes a simple screening-based index for predicting the effects of veterinary parasiticides on dung flies using data on parasiticide toxicity, animal husbandry, and parasiticide use. The utility of the index has been assessed, at the farm scale for a number of dipteran species, using data from a survey of farms in England and insect ecology and ecotoxicological data. The results indicate that a large proportion (35%) of parasiticide treatments in England will have no impact on dung fly populations. In terms of individual parasiticides, the macrocyclic lactone doramectin was predicted to have the highest impact on English dipteran populations with a maximum reduction in the population of horn flies on one farm of 28%. Ivermectin pour-on had the next highest impact (6.8%), followed by eprinomectin (6.4%), and ivermectin injection (4.1%). Due to a lack of data, it was not possible to assess the effects of the benzimidazole parasiticides (oxfendazole and fenbendazole), morantel and permethrin. The approach is simple, nondata-intensive and has the potential to be a valuable tool for use in environmental risk assessment or management of new and existing veterinary parasiticides.

The effect of ivermectin on soil organisms was assessed in Terrestrial Model Ecosystems (TMEs). Intact soil cores were extracted from a pasture in England and kept for up to 14 weeks in the laboratory. Ivermectin was applied to the soil surface via spiked cow dung slurry at seven concentration rates ranging from 0.25 to 180 mg/TME, referring to concentrations of 0.19-227 mg ivermectin/kg soil dry weight in the uppermost (0-1 cm) soil layer. After 7, 28 and 96 days following the application soil cores were destructively sampled to determine ivermectin residues in soil and to assess possible effects on microbial biomass, nematodes, enchytraeids, earthworms, micro-arthropods, and bait-lamina feeding activity. No significant effect of ivermectin was found for microbial respiration and numbers of nematodes and mites. Due to a lack of dose-response patterns no effect concentrations could be determined for the endpoints enchytraeid and collembolan numbers as well as total earthworm biomass. In contrast, EC50 values for the endpoint feeding rate could be calculated as 0.46, 4.31 and 15.1 mg ivermectin/kg soil dry weight in three soil layers (0-1, 0-5 and 0-8 cm, respectively). The multivariate Principal Response Curve (PRC) was used to calculate the NOEC(community), based on earthworm, enchytraeid and collembolan abundance data, as 0.33 and 0.78 mg ivermectin/kg soil dw for day 7 and day 96, respectively. The results shown here are in line with laboratory data, indicating in general low to moderate effects of ivermectin on soil organisms. As shown by the results of the bait-lamina tests, semi-field methods such as TMEs are useful extensions of the battery of potential test methods since complex and ecologically relevant endpoints can be included.