Registration Dossier

Ecotoxicological information

Sediment toxicity

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
sediment toxicity: long-term
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
In Annex X of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity testing on sediment organisms shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the toxicity of chemical substances on this compartment. According to Figure R7.8-9 "Integrated testing strategy (ITS) for toxicity to sediment organisms" (p.157) from Guidance on information requirements and chemical safety assessment, chapter R7b (v4.0 ; June 2017), sediment risk assessment is necessary when log kow of the substance is higher than 3, which is the case of BPA (1-4.5 PO). In accordance with this ITS, the EPM method was applied for risk assessment of the sediment compartment. Risk assessment demonstrated that there is no risk for sediment organisms using the PNEC derived through equilibrium partitioning method. Therefore, the chemical safety assessment indicates no need for toxicity testing on sediment organisms. Thus, no testing is proposed, in compliance with Annex X of Regulation (EC) No 1907/2006.

Description of key information

No toxicity test on sediment organisms is available. Therefore, the equilibrium partitioning method has been applied to derive the PNEC for sediment and to assess the hazard to sediment organisms. All risk characterization ratios are under 1.0. In accordance with REACH Annex X, Column 2  there is no need to further investigate the effects on sediment organisms and no further long-term testing on sediment is proposed.

Key value for chemical safety assessment

Additional information