Registration Dossier
Registration Dossier
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EC number: 629-679-7 | CAS number: 42482-06-4
Biodegradation in water and sediment: simulation tests
Administrative data
Link to relevant study record(s)
- 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 readily biodegradable
Reference
Description of key information
Further biodegradation testing, including biodegradation simulation testing in surface water and sediment, is waived, in accordance with Regulation (EC) No.1907/2006, Annexes VIII and IX, Column 2.
Key value for chemical safety assessment
Additional information
According to Regulation (EC) No.1907/2006, Annexes VIII and IX, Column 2, further biodegradation testing, including testing for ultimate biodegradation in surface water or sediment, shall be proposed if the chemical safety assessment according to Annex 1 indicates the need to investigate further the degradation of the substance or its degradation products; additional testing need not be proposed if the substance is readily biodegradable, or if direct and indirect exposure to the relevant environmental compartment is unlikely. The substance was shown to be readily biodegradable. The chemical safety assessment did not indicate the need to investigate the degradation of the substance; the risk characterisation ratios for surface water are below one. Therefore, in accordance with Annex I, the risks are considered to be controlled. Therefore, simulation testing in surface water is not indicated.
According to Regulation (EC) No.1907/2006, Annexes VIII and IX, Column 2, further biodegradation testing, including testing for ultimate biodegradation in sediment, need not be conducted if the substance is readily biodegradable, or if direct and indirect exposure to sediments is unlikely. The substance was shown to be readily biodegradable. The experimentally-determined Kocfor tetrapropenyl succinic anhydride is 825, from read-across based on a grouping of substances (category approach); this value falls within the range of Kocvalues of 500-1000, below which substances are unlikely to adsorb to sediment. The chemical safety assessment did not indicate the need to investigate the degradation of the substance; the risk characterisation ratios for sediment are below one. Therefore, in accordance with Annex I, the risks are considered to be controlled. Therefore, simulation testing in sediment is not indicated.
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