title: Saving two birds with one stone: using active substance avian acute toxicity data to predict formulated plant protection product toxicity.
abstract: Environmental safety assessments for exposure of birds require the provision of acute avian toxicity data for both the pesticidal active substance and formulated products. As an example, testing on the formulated product is waived in Europe using an assessment of data for the constituent active substance(s). This is often not the case globally, because some countries require acute toxicity tests with every formulated product, thereby triggering animal welfare concerns through unnecessary testing. A database of 383 formulated products was compiled from acute toxicity studies conducted with northern bobwhite (Colinus virginianus) or Japanese quail (Coturnix japonica) (unpublished regulatory literature). Of the 383 formulated products studied, 159 contained only active substances considered functionally nontoxic (median lethal dose [LD50] > highest dose tested). Of these, 97% had formulated product LD50 values of >2000 mg formulated product/kg (limit dose), indicating that no new information was obtained in the formulated product study. Furthermore, defined (point estimated) LD50 values for formulated products were compared with LD50 values predicted from toxicity of the active substance(s). This demonstrated that predicted LD50 values were within 2-fold and 5-fold of the measured formulated product LD50 values in 90% and 98% of cases, respectively. This analysis demonstrates that avian acute toxicity testing of formulated products is largely unnecessary and should not be routinely required to assess avian acute toxicity. In particular, when active substances are known to be functionally nontoxic, further formulated product testing adds no further information and unnecessarily increases bird usage in testing. A further analysis highlights the fact that significant reductions (61% in this dataset) could be achieved by using a sequential testing design (Organisation for Economic Co-operation and Development test guideline 223), as opposed to established single-stage designs.
authors.affiliation: Product Safety, Jealott's Hill International Research Centre, Syngenta, Bracknell, Berkshire, United Kingdom.
authors.forename: Samuel K
authors.initials: SK
authors.lastname: Maynard
authors.forename: Peter
authors.initials: P
authors.lastname: Edwards
authors.forename: James R
authors.initials: JR
authors.lastname: Wheeler
mesh_terms: D000818:Animals; D003088:Colinus / Q000502:physiology*; D003370:Coturnix / Q000502:physiology*; D005060:Europe; D007928:Lethal Dose 50; D010575:Pesticides / Q000633:toxicity*; D023382:Toxicity Tests, Acute
chemical_list: D010575:Pesticides
keywords: Avian toxicology; Ecological risk assessment; Ecotoxicology; Hazard/risk assessment; Pesticide regulation