Registration Dossier

Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

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Administrative data

Endpoint:
biodegradation in water: sediment simulation testing
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
Simulation testing on sediment is part of degradation studies according to Annex IX REACH. Column 2 of Annex IX states that “Further biotic degradation testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance and its degradation products. The choice of the appropriate test(s) depends on the results of the chemical safety assessment and may include simulation testing in appropriate media (e.g. water, sediment or soil).”

JUSTIFICATION FOR DATA WAIVING
Relevant physico-chemical properties of substance were tested with following results.
• Adsorption/Desorption study shows low adsorption rate to soil and sludge: log Koc (soil) < 1.3 (pH = 6.1, 25°C), log Koc (sludge) < 1.5 (pH = 6.1, 25°C)
• From results of hydrolysis study, the substance is found hydrolytically stable after preliminary test and the half-time of degradation is estimated to be more than 1 year. Therefore, no degradation products of parental substance are expected in water.

With regard to available information which show no degradation products are expected in the environment and the substance has low potential for adsorption, there is no need to investigate degradation of substance in sediment.

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Transformation products:
not specified

Applicant's summary and conclusion