Registration Dossier

Administrative data

Endpoint:
sediment toxicity: long-term
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
The substances low log octanol/water partition coefficient (Log Pow -045) indicates that the substance will predominately stay in the aquatic environment if released. The low adsorption coefficient of log Koc <1.25 indicates the substance has low potential for adsorption to organic content in sediments and is therefore not likely to partition into the sediment compartment and accumulate in the sediment compartment. Exposure to sediment organisms will therefore be very limited. The hydrolysis product pf the parent substance is also expected to have low potential for adsorption to sediments based on predicted log Kow and log Koc values (predicted log Pow -3.95 and log Koc <1).

ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7b (v 4.0, June 2017) includes an integrates testing strategy (ITS) for toxicity to sedmient. The initial assessment in the ITS is that for the substances with that do not have log Kow >3 or high adsoprtion, no sediment testing is necessary.

In the absence of toxicity data for sediment organisms, the Equilibrium Partitioning Method may be applied to assess the hazard to sediment organisms. However, as no hazard was identified in acute toxicity studies in fish, Daphnia and algae, the equilibrium partitioning method is not considered likely to provide further useful additional information.

The chemical safety assessment does not indicate the need to investigate further the effects of the substance and/or degradation productions on sediment organisms. No risk to the sediment compartment was identified and a PNECsediment considered unnecessary.

Based on the above, a long-term toxicity to sediment organsims test is not considered to be necessary.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion