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Diss Factsheets

Ecotoxicological information

Toxicity to soil microorganisms

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Reference
Endpoint:
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
Justification for type of information:
No experimental study on toxicity to soil microorganisms is available. According to Guidance Document R.7c (v3.0; 2017) it is stated, that for readily biodegradable substances which are not directly applied to soil it is generally assumed that the substance will not enter the terrestrial environment and as such there is no need for testing of soil organisms is required. Additionally, the substance cannot be regarded as adsorptive with a log Kow of 4 (logKow < 5) and logKoc of 3.8 (log Koc < 5). It will not be present in ionized form at environmentally relevant pH (4-9) as does not contain any ionic structure.
According to column 2 of REACH Annex IX the study does not need to be conducted if direct and indirect exposure of the soil compartment is unlikely. The results of the chemical safety assessment indicates no need to investigate further the effects of the substance. In the absence of any ecotoxicological data for terrestrial organisms, a provisional PNEC soil is derived by calculations based on the equilibrium partitioning method in accordance to the Guidance Document R.10. A Koc of 6310, a Henrys Law constant of 0.284 Pa m³/mole, and the PNEC aqua (fresh water) of 3.23 µg/l were used for calculation.
A PNECsoil of 0.4069 mg/kg ww is obtained.

Based on the PNECsoil derived via EPM, the following risk characterization rates have been found:
Scenario 1: RCR 0.570
Scenario 2: RCR 0.565
Scenario 3: RCR 0.032
Scenario 4: RCR 1.58E-03
Scenario 5: RCR 4.63E-03
Scenario 6: RCR 1.66E-03
Scenario 7: RCR 0.094
Scenario 8: RCR 0.094
Scenario 9: RCR 0.018
Scenario 10: RCR 0.033
Scenario 11: RCR 0.033
Scenario 12: RCR 0.033
Scenario 13: RCR 0.033

No risk has been identified for the soil compartment and the RCRs are sufficiently lower than 1. Therefore, the performance of sediment toxicity tests is considered unnecessary.

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Key value for chemical safety assessment

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