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Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

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Endpoint:
biodegradation in water: sediment simulation testing
Data waiving:
exposure considerations
Justification for data waiving:
the study does not need to be conducted because direct and indirect exposure of sediment is unlikely
Transformation products:
not measured
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:
other:
Transformation products:
not measured

Description of key information

Not applicable.

Key value for chemical safety assessment

Additional information

Biodegradation in water

In accordance with column 2 of REACH Annex IX, the simulation test in ultimate biodegradation in water does not need to be conducted as the substance insoluble in water.

Biodegradation in sediment

The performance of simulation tests for biodegradation in water and sediment is scientifically unjustified.

REACH Regulation (EC) No 1907/2006, Annex IX, Sect. 9.2.1.2, Col. 2, states as follows:

“9.2.1.2: The study need not to be conducted:

- if the substance is readily biodegradable, or

- if direct and indirect exposure of sediment is unlikely. ”

Direct and indirect exposure of the test item to sediment and water is unlikely. It can be assumed that upon contact with sediment and organic matter, the test item undergoes rapid degradation (hydrolysis) resulting in the formation of respective degradation products. Furthermore, the test item is not soluble in water and was considered to be inherently biodegradable. Therefore, simulation testing for biodegradation in sediment and water was considered not scientifically justified.