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Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

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Endpoint:
toxicity to soil macroorganisms except arthropods: long-term
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely
other:
Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Data waiving:
exposure considerations
Justification for data waiving:
the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACH Annex IX, information requirement 9.4.1 (effects on terrestrial organisms - short term toxicity to invertebrates), the study does not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.
Direct and indirect exposure of the soil compartment is unlikely and so it is considered justified to omit this study.

Description of key information

In accordance with column 2 of REACH Annex IX, information requirement 9.4.1 (effects on terrestrial organisms - short term toxicity to invertebrates), the study does not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.

Direct and indirect exposure of the soil compartment is unlikely and so it is considered justified to omit this study.

According to column 2 of REACH Annex X, information requirement 9.4.4 (Effects on terrestrial organisms - Long-term toxicity testing on invertebrates), long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment according to Annex I indicates the need to investigate further the effects of the substance and/or degradation products on terrestrial organisms. The chemical safety assessment does not indicate a need  to investigate further the effects of the substance and/or degradation products on terrestrial organisms. The available data are adequate for classification and labelling purposes and PBT assessment and show that the substance does not need to be classified for environmental effects. The data further shows that neither the substance, nor its degradation product, are considered to be persistent, bioaccumulative or toxic to the environment. Moreover, the environmental exposure assessment - as reported in the Chemical Safety Report - provides environmental risk characterisation ratios << 1 (BPA-DA local assessment RCR 5.45E-09 to 4.76E-03; BPA-DA regional assessment RCR 1.17E-09 to 5.53E-08; BPA-TA local assessment RCR 8.43E-12 to 3.34E-05, BPA-TA regional assessment RCR 7.63E-09 to 1.18E-08). Moreover, direct and indirect exposure of the soil compartment is unlikely. It is therefore considered appropriate to omit this study.

Key value for chemical safety assessment

Additional information