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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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No reliable chronic toxicity data are available for aquatic invertebrates and the requirement for new test results is waived. Indeed, REACH Regulation (EC) No. 1907/2006, Annex XI, section 2 states that testing for a specific endpoint may be omitted if it is technically not possible to conduct the study as a consequence of the properties of the substance. The physico-chemical characteristics of a chemical may limit the possibility for performing certain (eco)toxicity assays such as low solubility. For highly insoluble substances such as synthetic rutile (solubility < 5 µg Ti/L, Strom, 2010), it may neither be possible nor relevant to try and conduct certain ecotoxicological tests, as it is difficult to maintain a high enough and constant concentration of the substance in the water.

Column 2 of Annex IX of REACH Regulation (EC) No. 1907/2006 also states that "Long-term (aquatic) toxicity studies shall be proposed by the registrant if the CSA according to Annex I indicates the need to investigate further the effects on aquatic organisms". Because all acute tests for the read-across substance TiO2 show the absence of toxic effects and therefore the absence of a classification for the environment, there is no need for further investigation of effects on aquatic organisms.

It is therefore proposed to waive further chronic testing of synthetic rutile with fish/invertebrates based on the following arguments:

- Significantly higher solubility of synthetic rutile between acute & chronic test set-ups is not expected to occur.

- All of the acute toxicity tests for the read-across substance TiO2 with the invertebrate and fish resulted in the absence of any ecotoxicological signal (EC50 > 100 mg/L).

- The most sensitive organism to TiO2, i.e. the alga P. subcapitata, was used in the chronic test set up and resulted in the absence of any ecotoxicological signal (NOEC > 1 mg/L).