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Ecotoxicological information

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The aquatic toxicity of the test substance has been assessed using reliable, GLP short term or long term studies on three trophic levels: Algae (Weber, 2010), aquatic Invertebrates (Marshall, 1996 and Sewell, 2001) and fish (Marshall, 1993). As the test substance is extremely poorly soluble, the test substance was previously dissolved in a vehicle (methanol or tetrahydrofuran) in each case when preparing test solutions. This allowed a stable emulsion far higher than the water solubility to be used in the tests. Vehicles were dosed at lower than recommended final concentrations and a solvent control was included in each test. Chemical analysis by GC-FID was performed in nearly all studies allowing to the actual exposure concentrations of organisms to the test substance to be ascertained. In the short term daphnid study (Sewell, 2001), test solutions were analysed before and after centrifugation in order to measure dissolved substance. No acute effect was observed on Algae below saturation limit of 100 µg/L (Zippertiz, 2010). Test substance showed no effect at all after 48h of exposure on immobilization of daphnids below the saturation limit of 130 µg/L (Sewell, 2001) and no chronic effect at all was observed on reproductive endpoints after 21 d of exposure at the saturation limit of 79.7 µg/L measured in the chronic daphnid study (Marshall, 1996). Finally, no effect on growth rate of juvenile fish was measured over a 28 day period at the saturation limit of 105 µg/L (Marshall, 1993). In conclusion, no lethal or sub-lethal effects were observed on any recommended organisms tested and measured at the highest stable emulsion of the test substance. No further testing is considered necessary.