Registration Dossier
Registration Dossier
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EC number: 457-320-2 | CAS number: -
Biodegradation in water and sediment: simulation tests
Administrative data
Link to relevant study record(s)
- 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 technically not feasible
- Justification for data waiving:
- the study does not need to be conducted because the substance is highly insoluble in water
- Transformation products:
- not measured
Referenceopen allclose all
Description of key information
In accordance with column 2, section 9.2 and section 9.2.1.4 of REACH Annex IX, further biotic degradation testing is waived. The Chemical Safety Assessment indicates the direct and indirect exposure of sediment is unlikely. ECHA Chapter R.7B and R.7C guidance states that if the PEC/PNEC ratio is below 1, then no risk for the compartment is indicated, that the information available may be sufficient to conclude the assessment, and there is no need to perform further tests. Additionally, ECHA Chapter R.7B guidance states that if the substance is not considered a PBT or vPvB candidate, then it is considered not necessary to conduct further testing on the compartment. Therefore, on the basis of a lack of potential exposure and low risk demonstrated by RCRs of less than 1 based on EUSES modelling, waiving is justified.
In accordance with column 2, section 9.2 and section 9.2.1.2 of REACH Annex IX, the simulation testing on ultimate degradation in surface water is not required if the substance is highly insoluble in water. The water solubility study shows to have a low water solubility as it was determined to be less than the practical quantitation limit of the analytical method employed and is therefore reported at less than 0.31 mg/L. This substance therefore meets the adaption criteria.
Key value for chemical safety assessment
Additional information
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