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Long-term toxicity to fish

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In Annex XI of Regulation (EC) No 1907/2006, it is laid down that there may be sufficient weight of evidence from several independent sources of information leading to the assumption/conclusion that a substance has or has not a particular dangerous property, while the information from each single source alone is regarded insufficient to support this notion. In the mentioned case further testing on vertebrate animals for that property shall be omitted. In this case the present substance was tested in short-term aquatic tests (algae, daphnia and fish). All None of the test showed acute or chronic toxic effects (aquatic invertebrates, algae). No adverse effects have been observed in acute studies at the highest recommended concentrations/doses tested, therefore, it can be concluded that all none of the test showed acute or chronic toxic effects (see IUCLID Ch. 6.1).

In ECHA’s Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.11: PBT/vPvB assessment it is stated that information on molecular size can be an indicator to strengthen the evidence for a limited bioaccumulation potential of a substance. For consideration of its nano-material properties its particle size distribution was determined using Transmission Electron Microscopy (TEM) provided in Chapter 1.4. Based on these measurements, no particle found was smaller than 10 nm. This size is above the threshold of 1.7 nm given in ECHA’s Guidance document mentioned above. Taking this into account additional to the low logKow and the low octanol solubility, a transportation of the substance in its particulate nano form through biological membranes and a resulting toxic effect due to lacking exposure is unlikely

Therefore, and for reasons of animal welfare a long-term toxicity test in fish is not provided.