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Diss Factsheets

Ecotoxicological information

Toxicity to terrestrial arthropods

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Administrative data

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Endpoint:
toxicity to terrestrial arthropods: long-term
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with Section 9.4 of Column 2 of REACH Annex X, it is considered justified to omit the testing on effects on terrestrial organisms, specifically the long-term testing on invertebrates (9.4.4.), as the results of the chemical safety assessment indicate there is no need to investigate further effects on terrestrial organisms as there is no release to the environment and direct and indirect exposure of the soil compartment is unlikely. The available data are adequate for classification and labelling purposes and PBT assessment. Furthermore, in accordance with section 3 of REACH Annex XI, it is considered justified to omit this study based on the exposure scenarios developed in the chemical safety report, which indicate there is no release to the environment. As such, comparison of the derived PNEC with the results of the exposure assessment yield a risk characterisation ratio well below a value of 1. Therefore, overall, the chemical safety assessment does not indicate the need to investigate further effects on terrestrial organisms and hence it is considered justified to omit the study.
Endpoint:
toxicity to terrestrial 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 Section 9.4 of Column 2 of REACH Annex IX, it is considered justified to omit the testing on effects on terrestrial organisms, specifically the short-term toxicity to invertebrates test (9.4.1.), as direct and indirect exposure of the soil compartment is unlikely. Furthermore, in accordance with section 3 of REACH Annex XI, it is considered justified to omit the study based on consideration of the exposure scenarios developed in the chemical safety report. The comparison of the derived PNEC with the results of the exposure assessment yield a risk characterisation ratio well below a value of 1.

Description of key information

In accordance with Section 9.4 of Column 2 of REACH Annex IX, it is considered justified to omit the testing on effects on terrestrial organisms, specifically the short-term toxicity to invertebrates test (9.4.1.), as direct and indirect exposure of the soil compartment is unlikely.

In accordance with Section 9.4 of Column 2 of REACH Annex X, it is considered justified to omit the testing on effects on terrestrial organisms, specifically the long-term testing on invertebrates (9.4.4.), as the results of the chemical safety assessment indicate there is no need to investigate further effects on terrestrial organisms as there is no release to the environment and direct and indirect exposure of the soil compartment is unlikely. F

Key value for chemical safety assessment

Additional information