Registration Dossier
Registration Dossier
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EC number: 293-671-6 | CAS number: 91081-64-0 Slag produced during ilmenite smelting (ore or sand). Consists primarly of TiO2, FeO, Al2O3, SiO2, MgO and other metal oxides.
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Administrative data
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Additional information
UGI products were found to be quite insoluble and hence difficult to test in aquatic media. Therefore the aquatic toxicity of substances such as the UGI products was determined by preparing water-accommodated fractions (WAF).
Acute aquatic toxicity tests on fish, invertebrate and alga have been performed on the WAF of UGI products.
In addition, chronic aquatic toxicity and variability tests with algae have been performed with Pseudokirchneriella subcapitata.
Long-term toxicity tests on invertebrates/fish and birds have not been performed. Justification for waiving is presented in the text below.
Indeed, REACH 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 such poor water soluble substances (e.g. below the detection limit of the analytical method of the test substance) 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 water.
Column 2 of Annex IX of REACH 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 effect to aquatic organisms". Because all acute tests show the absence of toxic effects and therefore the absence of a classification for the environment for these UGI products, there is no need for further investigation of effects to aquatic organisms.
It is therefore proposed to waive further chronic testing with fish/invertebrates based on the following arguments:
- Significantly higher solubility of Ti and Fe between acute & chronic test set-ups is not expected to occur. Indeed, T/Dp using UGI products indicate very low to zero dissolution of Ti and Fe,
- All of the acute toxicity tests with the alga, invertebrate and fish resulted in the absence of any ecotoxicological signal (EC50 > 100 mg/L),
- The most sensitive organism, 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).
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