Registration Dossier
Registration Dossier
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EC number: 930-936-3 | CAS number: -
Biodegradation in water and sediment: simulation tests
Administrative data
Link to relevant study record(s)
Description of key information
Simulation tests for evaluating biodegradation in water and sediment are not warranted given the available data that the study substance is found to be inherently biodegradable in the OECD 301F test. Little additional information can be gained since rapid mineralization in the soil environment is assumed for materials that are biodegraded to >60% in the aquatic environment.
Key value for chemical safety assessment
Additional information
Analogous to exceptions allotted for readily biodegradable materials (>60% biodegradation in 28 days)(see Column 2 of Annex IX), simulation testing for biodegradation in water is not expected to be required for the study substance because it is biodegraded to >60% in OECD ready biodegradation test. Also as pointed out in the REACH guidance document, Chapter R7b, pg. 161-163, the simulation testing in water would not be expected to provide any additional information since rapid mineralization in the environment is already assumed for substances that are extensively or readily biodegradable (>60% in 28 days or longer). Hence, the study substance, being biodegradable to >60% in freshwater, is expected to be rapidly and extensively biodegraded in the environment including under simulated conditions (i.e., wastewater treatment) (ECHA 2008b).
Since the study substance has been shown to be extensively and rapidly biodegraded (>60%) in the OECD 301 tests, it is also expected to be rapidly biodegraded in the environment including sediment. Therefore, this available information should be sufficient to assess the biodegradability potential in sediment as well. As pointed out in the REACH guidance document, Chapter R7b, pg. 161-163, the simulation testing in sediment will provide little additional information since rapid mineralization in the environment is assumed for materials that are biodegraded to >60%.
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