Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 915-790-0 | CAS number: -
Sediment toxicity
Administrative data
Link to relevant study record(s)
Description of key information
The EPM strategy that we applied to sediment follows the rules set out in the integrated testing strategy (ITS) detailed in R.7.8.14, Chapter R.7b of the ECHA Guidance on information requirements and chemical safety assessment (v3.0, Feb. 2016, pp.157 -158). No adequate toxicity datum is available for toxicity of the substance to sediment organisms. Therefore, both freshwater and marine sediment PNECs were derived from their respective aquatic PNECs, using the EPM method. The subsequent calculated RCRs are all inferior to 1 for both compartments and no further testing is therefore required to cover the risk for both sediment compartments. This information is presented in the CSA. It has to be noted that both octanol-water partition (log Kow) and adsorption (log Koc) coefficients are inferior to 3. Consequently, a chemical safety assessment for the sediment compartment was not mandatory, as stated in R.7.8.7, Chapter R.7b of the ECHA Guidance on information requirements and chemical safety assessment (v3.0, Feb. 2016, p.159): “ The main property of a substance that triggers the assessment for the sediment compartment is the potential to adsorb or bind onto sediment. [...] A log Kow of 3 should be used as trigger value for a sediment assessment.”. However, a chemical safety assessment is yet provided. It indicates an acceptable risk (all RCRs < 1) for both sediment compartments (both freshwater and marine).
Key value for chemical safety assessment
Additional information
An unreliable toxicity study for sediment-dwelling organisms relating to the test substance is available and included in the dossier.
Torp (1997) conducted a (Klimisch 3) GLP compliant study following methods based on OSPAR 1995Protocols on Methods for the Testing of Chemicals Used in the Offshore Oil Industry, Part A: A sediment bioassay using a amphipod, Corophium sp. Adult Corophium volutator were exposed to sediment spiked with the test substance at nominal concentrations of 20, 54, 163, 514, 1592, 4996 (mg/kg dry sediment weight) for 10 days. At the end of the test, control mortality was 3%. The 10 day LC50 was 1260 mg/kg dry weight. Although this study is considered not reliable, it is included for comparison. PNECsediment is calculated based on koc and equilibrium partitioning coefficient method.
In accordance with REACH Regulation 1907/2006, Annex X, Column 2, studies of the effects on sediment organisms need not be conducted if exposure assessment indicates no concern for exposure to environmental compartments. The substance is not expected to adsorb to sediment or soil as the log kow is low (2.51). Additionally, reliable model results indicate that the adsorption coefficient is low (Log Koc of <3), indicating low adsorption potential. No significant exposure of the sediment compartment is therefore expected and additional information on the effects of the substance and its degradation products on soil micro-organisms are therefore not required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
