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Toxicity to soil macroorganisms except arthropods

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Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
In accordance with Column 2 of REACH, Annex IX, section 9.4, the short-term testing on invertebrates study (required in section 9.4.1.) 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.
Endpoint:
toxicity to soil macroorganisms except arthropods: long-term
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
In accordance with Column 2 of REACH Annex X, information requirement 9.4.4, the long term toxicity to invertebrates study does not need to be conducted as the results of the chemical safety assessment do not indicate the need to further investigate the effects of the substance on terrestrial organisms. Furthermore, 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 in 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). Moreover, the substance is not classified as hazardous for environmental effects and the chemical safety assessment concludes that the substance is of no immediate concern to the environment. The available data is adequate for classification and labelling purposes and PBT assessment is not required for inorganic substances so no further testing is required.

Description of key information

In accordance with Column 2 of REACH, information requirement section 9.4, testing on invertebrates 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 in 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).
Furthermore, the results of the chemical safety assessment do not indicate the need to further investigate the effects of the substance on terrestrial organisms.

Key value for chemical safety assessment

Additional information