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Diss Factsheets

Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

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Endpoint:
biodegradation in water: sediment simulation testing
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint:
biodegradation in water: simulation testing on ultimate degradation in surface water
Type of information:
other: Expert assessment
Adequacy of study:
weight of evidence
Study period:
2022
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Expert assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
A weight of evidence approach was used in the expert assessment to address simulation testing on
ultimate degradation in surface water.
GLP compliance:
no
Inoculum or test system:
other: Expert assessment
Remarks on result:
other: Expert assessment
Transformation products:
not measured
Conclusions:
Based on the fact that bis(2-ethoxyethyl) ether is not readily biodegradable and data is not available to reach a conclusion on its persistence, a worst case scenario approach has been followed to classify the substance as Persistent in section 2.3 PBT assessment.
We conclude that a simulation test in surface water is not expected to reveal any new
findings, therefore, testing is considered scientifically not necessary.
Executive summary:

A weight of evidence approach was used to address simulation testing on ultimate degradation in surface water of bis(2-ethoxyethyl) ether.


An assessment of the degradability potential of bis(2-ethoxyethyl) ether has been undertaken in a GLP complaint screening test conducted according to the OECD TG 301F. The substance was not considered to be readily biodegradable under the conditions of this test.
Degradation is an important endpoint to fulfil regulatory needs for persistence assessment. As such, a worst case scenario approach has been followed to classify the substance as Persistent in section 2.3 PBT assessment.
None of the ecotoxicological studies identified a need for classification and the substance is not considered bioaccumulative based on Log Kow <=4.5 (log P for the substance was determined to be 0.39 at 25°C) or toxic based on available data.


Therefore, we concluded that a simulation test in surface water is not expected to reveal any new findings, therefore, testing is considered scientifically not necessary.

Description of key information

In accordance with Column 2 adaptation statement of REACH Annex IX, sediment simulation testing, information requirement 9.2.1.4 does not need to be conducted as direct and indirect exposure to sediment is unlikely. The test substance entering the water is not likely to sorb onto suspended solids and sediment based upon the calculated Kow (CSR section 1.3 Physico-Chemical Properties), mitigating exposure to sediment. See supporting sorption data (CSR section 4.2.1 Adsorption/desorption) and exposure assessment information (CSR Chapter 9).


Based on the fact that bis(2-ethoxyethyl) ether is not readily biodegradable and data is not available to reach a conclusion on its persistence, a worst case scenario approach has been followed to classify the substance as Persistent in section 2.3 PBT assessment. We concluded that a simulation test in surface water is not expected to reveal any new findings, therefore, testing is considered scientifically not necessary.


 

Key value for chemical safety assessment

Additional information