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Toxicity to soil microorganisms

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In accordance with Column 2 of REACH, Annex IX, section 9.4, the effects on soil microorganisms study (required in section 9.4.2) does not need to be conducted since direct and indirect exposure of the soil compartment is unlikely. This understanding is confirmed in the TDp test (IUCLID section 5.6). Here, manganese is only seen at a concentration of 15.9 µg/L (after 28 days from 1 mg/L loading). Since the registered substance is a metal oxide, any ionic metal leaching out of this matrix is predicted to bind strongly to soil and sediments. On this basis the bioavailable concentration of Mn from the substance to terrestrial organisms is predicted to be less than the background concentration of manganese in European soils (428.6 mg Mn/kg, according to “Probabilistic Distribution of Manganese in European Surface Water, Sediment and Soil and Derivation of Predicted Environmental Concentrations (PEC)”, Parametrix, 2009 and supported by GEMAS data). Furthermore, the substance is not classified as hazardous for environmental effects and the available data are adequate for classification and labelling purposes. Moreover, a PBT assessment is not required for inorganic substances so no further testing is required.

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