2-ethylhexanoic acid, monoester with propane-1,2-diol

Biodegradation in water and sediment: simulation tests

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

biodegradation in water: sediment simulation testing

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is readily biodegradable

the study does not need to be conducted because direct and indirect exposure of sediment is unlikely

Justification for type of information:

Reliable measured data for simulation testing on ultimate degradation in surface water or sediment for FX511 is not available. However, a waiver is being applied for simulation testing on ultimate degradation in surface water and ultimate degradation in sediment. In accordance with Column 2 of REACH Annex IX, the simulation test on ultimate degradation in surface water, the soil simulation test and the sediment simulation test (required in Sections 9.2.1.2 and 9.2.1.4 respectively) do not need to be conducted as direct or indirect exposure of soil is unlikely or if the substance is readily biodegradable. Testing is waived as potential for exposure is low as the substance is readily biodegradable. In the environment, ready biodegradability means it can be assumed that FX511 will be biodegraded within the STP process and as a consequence a transfer to the terrestrial compartment via STP effluent is not expected. Furthermore, for substances not passing the STP-process but being readily biodegradable, it can be assumed that they will be also biologically degraded in the surface water within a short time. Additionally, the partition coefficient of FX511 was determined in a reliable study (Walker 2012) where the measured log Kow is 2.98. Therefore, FX511 is considered to have low potential for absorption to soil and sediment. Based on the readily biodegradability and low absorption potential of the test substance, exposure to aquatic or sediment organisms is unlikely.

Transformation products:

not measured

Reference 2

Endpoint:

biodegradation in water: simulation testing on ultimate degradation in surface water

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is readily biodegradable

Justification for type of information:

Reliable measured data for simulation testing on ultimate degradation in surface water or sediment for FX511 is not available. However, a waiver is being applied for simulation testing on ultimate degradation in surface water and ultimate degradation in sediment. In accordance with Column 2 of REACH Annex IX, the simulation test on ultimate degradation in surface water, the soil simulation test and the sediment simulation test (required in Sections 9.2.1.2 and 9.2.1.4 respectively) do not need to be conducted as direct or indirect exposure of soil is unlikely or if the substance is readily biodegradable. Testing is waived as potential for exposure is low as the substance is readily biodegradable. In the environment, ready biodegradability means it can be assumed that FX511 will be biodegraded within the STP process and as a consequence a transfer to the terrestrial compartment via STP effluent is not expected. Furthermore, for substances not passing the STP-process but being readily biodegradable, it can be assumed that they will be also biologically degraded in the surface water within a short time. Additionally, the partition coefficient of FX511 was determined in a reliable study (Walker 2012) where the measured log Kow is 2.98. Therefore, FX511 is considered to have low potential for absorption to soil and sediment. Based on the readily biodegradability and low absorption potential of the test substance, exposure to aquatic or sediment organisms is unlikely.

Description of key information

Waiver based on ready biodegradability

Additional information

Reliable measured data for simulation testing on ultimate degradation in surface water or sediment for FX511 is not available. However, a waiver is being applied for simulation testing on ultimate degradation in surface water and ultimate degradation in sediment.

 

In accordance with Column 2 of REACH Annex IX, the simulation test on ultimate degradation in surface water, the soil simulation test and the sediment simulation test (required in Sections 9.2.1.2 and 9.2.1.4 respectively) do not need to be conducted as direct or indirect exposure of soil is unlikely or if the substance is readily biodegradable. Testing is waived as potential for exposure is low as the substance is readily biodegradable. In the environment, ready biodegradability means it can be assumed that FX511 will be biodegraded within the STP process and as a consequence a transfer to the terrestrial compartment via STP effluent is not expected. Furthermore, for substances not passing the STP-process but being readily biodegradable, it can be assumed that they will be also biologically degraded in the surface water within a short time. Additionally, the partition coefficient of FX511 was determined in a reliable study (Walker 2012) where the measured log Kow is 2.98. Therefore, FX511 is considered to have low potential for absorption to soil and sediment. Based on the readily biodegradability and low absorption potential of the test substance, exposure to aquatic or sediment organisms is unlikely.