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Long-term toxicity to fish

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fish life cycle toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
Referencing ECHA's Read-Across Assessment Framework (RAAF) as basis, an analogue approach is used to assess the read-across potential for the target substance, Reaction mass of dialuminium titanium pentaoxide and strontium calcium aluminosilicate (triclinic feldspar, Slawsonite), from the source substance Dialuminium titanium pentoxide (CAS 12004-39-6, EC 234-456-9).

For this assessment, the defined Read-Across Approach used in RAAF Scenario 1 was deemed to be the most appropriate. This involves comparison of two chemically and structurally-related substances displaying (Bio)transformation to common compound(s). This prediction is supported by toxicological data on the source substance and on the dissolution products of both source and target substances, which are minimal.
Validity criteria fulfilled:
Long-term toxicity testing in fish and the concomitant expenditure of vertebrate test animals is considered scientifically unjustified, as exposure arising from dialuminium titanium pentaoxide (the source substance) is expected to be negligible compared to natural background levels of aluminium and titanium present in surface waters. In addition, aquatic toxicity tests conducted on all three aquatic trophic levels do not indicate any toxic effect associated with the source substance. In an acute (96-h) fish toxicity assay on medaka (Oryzias latipes) conduced as a limit test, neither mortality nor any abnormal symptoms were observed at the measured test concentration of 0.360 mg/L (corresponding to a loading rate of 100 mg/L). In an acute (48-h) daphnid immobilisation assay conducted on Daphnia magna as a limit test, neither immobilisation nor abnormal appearance or behaviour were observed at the measured test concentration of 0.687 mg/L (corresponding to a loading rate of 100 mg/L). In an algal toxicity mitigation test conducted in association with an algal growth inhibition test, growth inhibition on Pseudokirchneriella subcapitata was not observed at the test concentration. The No Observed Effects Concentration based on growth rate (NOErC) for the algal study of 0.210 mg/L (measured) corresponded to a No Observed Effects Loading Rate (NOErLR) of 100 mg/L. The NOErC/NOErLR from an algal growth inhibition study is an evaluation of toxicity over multiple generations, and the absence of any observed growth inhibition is an indicator of the absence of long-term effects. Therefore, the absence of any observed toxic effect in the available short-term tests on fish and invertebrates and the long-term test on algal growth inhibition indicate that the source substance does not exhibit toxic effects upon aquatic organisms, and that long-term toxicity test in fish is not indicated (thereby obviating the need for additional toxicity testing in vertebrate animals).
Executive summary:

This reaction mass mixture of Dialuminum titanium pentaoxide (Al2TiO5), SrAl2Si2O8 (general CAS for Feldspar group), CaAl2Si2O8, and Residual Al2O3 is insoluble in water and has no known toxicity to fish or other aquatic wildlife. The major constituent has been accepted as being non-toxic long term to fish within its REACH registration and the other constituents are naturally occurring substances. When the substance does dissolve its dissociated elements are very common ions already found in abundance within the soil and water.

Description of key information

In accordance with Column 2 of REACH Annex IX, the study does not need to be conducted as all identified uses of the substance are assessed as safe for the environment.

Key value for chemical safety assessment

Additional information

This data point has been waived for dialuminium titanium pentaoxide on the grounds that the exposure potential in the aquatic environment is expected to be negligible. Under these circumstances, data for the long-term effects of dialuminium titanium pentaoxide on fish and the concomitant expenditure of vertebrate test organisms are considered unnecessary.