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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:
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 specified
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:
the study does not need to be conducted because the substance is highly insoluble in water
Transformation products:
not specified

Description of key information

No data on the biodegradation in simulation tests are available.

In accordance with Regulation (EC) No 1907/2006, Annex IX, Section
9.2.1.2 Column 2 the simulation test on ultimate degradation in surface
water does not need to be conducted if the substance is highly insoluble in
water. This has been demonstrated by the Key study (Ciba Specialty
Chemicals Corporation, USA, REPORT ON WATER SOLUBILITY,
Report no. GLP97010, 1997) according to EU MEthod A.6 (Water Solubility),
EEC Directive 92/69, A.1 (section 4.8). The water solubility of test
substance was determined to be < 40 µg/L at 20°C and therefore meets the
waiving criteria.

Furthermore, in accordance with Regulation (EC) No 1907/2006,
Annex IX, Section 9.2.1.4 Column 2, the sediment simulation testing
does not need to be conducted if direct and indirect exposure of sediment
is unlikey. No hazard regarding the envirionment has been identified.

Key value for chemical safety assessment

Additional information