Registration Dossier

Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

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Description of key information

Waived:  Simulation tests are not justified based on exposure considerations

Key value for chemical safety assessment

Additional information

As per Annex IX and X, item 9.2 Column 2, degradation simulation testing in water and /or sediment does not need to be conducted, as the chemical safety assessment indicates no need to investigate further the degradation of the substances and its degradation products.

Despite the fact that no further simulation tests are needed, Dow Benelux B.V., the registrant of this dossier, has conducted a simulation test using activated sludge from the registrant’s waste water treatment plant. A degradation rate of min 7% was achieved. This data has been incorporated in the site specific risk assessment of the manufacturing scenario of the registrant.

Microbial degradation metabolites have been predicted by a QSAR study. These metabolites have Log KOWvalues similar or less than their corresponding parent compounds. Since the ecotoxicity and bioaccumulation potential of these polyols and their metabolites correlate well with their Log KOW, the metabolites are not expected to be more toxic or more bioaccumulative than their parent compounds.

Additional tests are not required for ecological risk assessment, or PBT assessment, of the UVCB substance and its associated components and degradation products.