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Biodegradation in water and sediment: simulation tests

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biodegradation in water: sediment simulation testing
Data waiving:
other justification
Justification for data waiving:
Justification for type of information:
According to column 2, section 9.2 ANNEX IX of the REACH regulation additional data on biodegradation are only required if the chemical safety assessment according to ANNEX I indicates the need to investigate further the degradation of the substance and its degradation products.
However, based on the existing data from the available degradation studies according to OECD 301 and OECD 310, a conclusion on the chemical safety assessment (i.e., PBT/vPvB) can be made. In fact, the results from this study confirms that the substance is persistent (P) and very persistent (vP) according to the ECHA Guidance on Information requirements and Chemical Safety Assessment, chapter R11, version 3.0, June 2017. Therefore, any additional simulation degradation test will not bring any added value to the chemical safety (e.g., PBT/vPvB-) assessment.

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Materials and methods

Results and discussion

Applicant's summary and conclusion