Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

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).