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Ecotoxicological information

Toxicity to soil microorganisms

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toxicity to soil microorganisms
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

Description of key information

According to Annex X. 9.4., column 2 of the REACH regulation no data on terrestrial organisms are needed, if direct or indirect exposure of the soil 
compartment is unlikely. There is no indication that there is a relevant route of exposure with respect to soil.

Key value for chemical safety assessment

Additional information

Due to the lack of ecotoxicological data for terrestrial organisms an estimation of the PNEC for soil was performed using the equilibrium partitioning method (EPM) as recommended in the Guidance on information requirements and chemical safety assessment Chapter R.10 (ECHA, 2008).

On this basis the chemical safety assessment demonstrates that direct and indirect exposure is prevented and all exposure levels estimated for the terrestrial compartment do not exceed the appropriate PNEC values , the resulting RCR values are all below 0.01 providing a high margin of safety for a potential underestimation of risk.