Registration Dossier
Registration Dossier
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EC number: 234-679-1 | CAS number: 12023-27-7
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
Description of key information
In accordance with section 1.2 of Annex XI to Regulation (EC) No 1907/2006 (REACH) no study on toxicity to soil macroorganisms (except arthropods) has to be conducted as there is sufficient supporting data from several independent sources of information for the read across source substances leading to the conclusion that the target substance diiron titanium pentaoxide is not toxic soil organisms.
Furthermore, in accordance with section 1 of REACH Annex XI, studies on terrestrial organisms do not need to be conducted, as the substance is inert mixture of inorganic oxides of iron and titanium and based upon the physic-chemical properties and low bioavailability of the substance. The substances is, according to the transformation and dissolution test highly insoluble in water and does not have a potential for adsorption. Furthermore, oxides of iron or titanium from natural sources, occur in sediments. Synthetic diiron titanium pentaoxide have no relevant effect on the levels and bioavailabilities of these elements. Even under worst case conditions an inhibitory effect of diiron titanium pentaoxide is not likely to be exerted on soil organisms.
In accordance with section 1 of REACH Annex XI, the study does not need to be conducted. Iron and titanium are common elements in the earth's crust and can be found in both the terrestrial as sediment environment. The relative contribution of anthropogenic sources to the existing natural pools in soils and sediments are therefore not relevant, neither in terms of added amounts nor in terms of toxicity. Based on these exposure considerations additional sediment and/or soil testing is not warranted.
Key value for chemical safety assessment
Additional information
Non-submission justification for diiron titanium pentaoxide
In accordance with section 1.2 of Annex XI to Regulation (EC) No 1907/2006 (REACH) no study on toxicity to soil macroorganisms (except arthropods) has to be conducted as there is sufficient weight of evidence from several independent sources of information for the read across source substances leading to the conclusion that the target substance diiron titanium pentaoxide is not toxic soil organisms including microbes, plants and invertebrates.
Information available for the read across source substances titanium dioxide (TiO2, CAS 13463-67-7) and diiron trioxide (FE2O3, CAS 1309-37-1) is summarized below.
Supporting information
Titanium dioxide
Data on one non-guideline laboratory test with tinanium dioxide (bulk form) is available. No toxicity of titanium dioxide to C. elegans was observed up to a concentration of 95.9 mg/L. The 24-hour LC50 was determined to be 135.8 mg/L (reference 6.3.1-1).
Key information on toxicity to soil macroorganisms provided in public ECHA REACH dossiers for the read across substances titanium dioxide and diiron trioxide
Titanium dioxide
In the public ECHA REACH dossier for titanium dioxide (last accessed on: 18 March 2020) nano- and microsized titanium dioxide (rutile, anatase and mixed forms) was assessed in a weight of evidence approach and found not to affect survival, reproduction and growth of soil annelids based on data available for different earthworm species indicating that no toxic effects occur up to at least 1000 mg/kg dw soil.
Diiron trioxide
According to the public ECHA REACH dossier for diiron trioxide (last accessed on: 18 March 2020) no data are available on the effects of iron oxides to terrestrial organisms. However, it is pointed out that the substance is an inert inorganic oxide of iron resembling naturally occurring iron oxides. It is also stressed that the environmental concentration of iron depends on several factors as e.g. the presence of siderophores, humic substances, contact time and temperature. Hence, it appears unlikely that the input of iron oxides significantly affects the ion contents in the soil matrix and soil water. Therefore, inhibitory effects of synthetic iron oxide pigments to soil organisms have not to be expected.
Conclusion
In the public ECHA REACH dossier for the structural analogues titanium dioxide (CAS 13463-67-7) and diiron trioxide (CAS 1309-37-1) it is concluded that the substances are not toxic to soil organisms including microbes, plants and invertebrates. The target substance diiron titanium pentaoxide is a mixed oxide of titanium dioxide and diiron trioxide. The source substances share the common atoms Ti, O and Fe with the target substance and have very similar physico-chemical properties (for further information please refer to the read across justification attached to IUCLID section 13). Therefore, by applying an analogue approach, diiron(III) titanium pentaoxide is not considered to be toxic to terrestrial macroorganisms and additional studies are thus scientifically not necessary.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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