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Toxicity to soil macroorganisms except arthropods

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Endpoint:
toxicity to soil macroorganisms except arthropods: long-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 X, long-term testing to terrestrial invertebrates (required in section 9.4.4) does not need to be conducted as the results of the chemical safety assessment do not indicate the need to investigate further the effects of the substance and/or degradation products on terrestrial organisms. Additionally, direct and indirect exposure of the soil compartment is unlikely.
Indeed, direct exposure of soil will not occur from the use of MOTE and indirect exposure will be low. The assessment performed in Chapter 9 of the CSR confirms this low indirect environmental exposure and an acceptable risk to terrestrial organisms is demonstrated with the use of relevant risk mitigation measures. In addition in environmental monitoring data shows that environmental levels of octyl tins were demonstrated to be extremely low. Therefore in accordance with Annex XI of the Regulation EC 1907/2006 the study is not necessary.
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, short-term testing to terrestrial invertebrates (required in section 9.4.1) does not need to be conducted as direct and indirect exposure of the soil compartment is unlikely, and additionally, since the equilibrium partitioning method has found no hazard to soil organisms.
Indeed, direct exposure of soil will not occur from the use of MOTE and indirect exposure will be low. The assessment performed in Chapter 9 of the CSR confirms this low indirect environmental exposure and an acceptable risk to terrestrial organisms is demonstrated with the use of relevant risk mitigation measures. In addition in environmental monitoring data shows that environmental levels of octyl tins were demonstrated to be extremely low. Therefore in accordance with Annex XI of the Regulation EC 1907/2006 the study is not necessary.

Description of key information

Short-term

In accordance with column 2 of REACH Annex IX, short-term testing to terrestrial invertebrates (required in section 9.4.1) does not need to be conducted as direct and indirect exposure of the soil compartment is unlikely, and additionally, since the equilibrium partitioning method has found no hazard to soil organisms.

Indeed, direct exposure of soil will not occur from the use of MOTE and indirect exposure will be low. The assessment performed in Chapter 9 of the CSR confirms this low indirect environmental exposure and an acceptable risk to terrestrial organisms is demonstrated with the use of relevant risk mitigation measures. In addition in environmental monitoring data shows that environmental levels of octyl tins were demonstrated to be extremely low. Therefore in accordance with Annex XI of the Regulation EC 1907/2006 the study is not necessary.

Long-term

In accordance with column 2 of REACH Annex X, long-term testing to terrestrial invertebrates (required in section 9.4.4) does not need to be conducted as the results of the chemical safety assessment do not indicate the need to investigate further the effects of the substance and/or degradation products on terrestrial organisms. Additionally,  direct and indirect exposure of the soil compartment is unlikely.

Indeed, direct exposure of soil will not occur from the use of MOTE and indirect exposure will be low. The assessment performed in Chapter 9 of the CSR confirms this low indirect environmental exposure and an acceptable risk to terrestrial organisms is demonstrated with the use of relevant risk mitigation measures. In addition in environmental monitoring data shows that environmental levels of octyl tins were demonstrated to be extremely low. Therefore in accordance with Annex XI of the Regulation EC 1907/2006 the study is not necessary.

Key value for chemical safety assessment

Additional information