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Ecotoxicological information

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 section 1 of REACH Annex XI (testing does not appear scientifically necessary), the short-term testing on invertebrates study (required in section 9.4.1.) does not need to be conducted as the hazard assessment performed during the chemical safety assessment concludes that the substance is not classified and 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. Furthermore, any ionic metal leaching out of the substance in environmental conditions is predicted to bind strongly to soil and sediments. On this basis the bioavailable concentration of manganese from the substances to terrestrial organisms is predicted to be much 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).
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 section 1 of REACH Annex XI (testing does not appear scientifically necessary), the long-term toxicity testing on invertebrates (required in section 9.4.4.) does not need to be conducted as the hazard assessment performed during the chemical safety assessment concludes that the substance is not classified and 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. Furthermore, any ionic metal leaching out of the substance in environmental conditions is predicted to bind strongly to soil and sediments. On this basis the bioavailable concentration of manganese from the substances to terrestrial organisms is predicted to be much 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).

Description of key information

In accordance with section 1 of REACH Annex XI (testing does not appear scientifically necessary), the short-term testing on invertebrates study (required in section 9.4.1.) and long-term toxicity testing (required in section 9.4.4) does not need to be conducted as the hazard assessment performed during the chemical safety assessment concludes that the substance is not classified and 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. Furthermore, any ionic metal leaching out of the substance in environmental conditions is predicted to bind strongly to soil and sediments. On this basis the bioavailable concentration of manganese from the substances to terrestrial organisms is predicted to be much 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).

Key value for chemical safety assessment

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