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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Description of key information

No observed effect at limit of solublity of 0.048 mg/l

Key value for chemical safety assessment

Additional information

Two studies are reports; one from 1996 by Safepharm which show some effects at levels greater than the reported water solubility and a later study in 2008 showing no effect at the limit of solubility.

In the 2008 study, 1 mg was added to 1 litre of water and subjected to ultrasonic bath to attempt to maximise dissolution in the water. Efforts were made to remove any undissolved material by filtration. This method needs to be compared with the earlier 1996 study with 100 mg added to a 10 ml stock solution (10 g / litre) in solvent to provide a nominal dose concentration greater than the limit of solubility.

Although performed to high standards, the 1996 Safepharm study had no confirmatory analysis performed. It is also worth noting that the reported effect levels are higher than the reported water solubility of 0.048 mg/l. As a co-solvent was used and in view of high levels used in preparing the media, other factors such as the presence of impurities or particulates from micro-emulsion formation could have led to the effects seen. The replicates tested at lower than the limit of solubility showed no adverse effects, confirming there is no acute toxicity at the limit of solubility.

It is considered that the 2007 should be used to determine the classification and confirms the fish and algal data to demonstrate no effect at limits of solubility.