Registration Dossier
Registration Dossier
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EC number: 947-519-7 | CAS number: -
Sediment toxicity
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
Toxicity to sediment organisms:
In accordance with column 2 of REACH Annex X long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment indicates the need to investigate further the effects of the substance and/or relevant degradation products on sediment organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment. No information concerning sediment toxicity is available for the substance, but REACH allows the omission of certain studies based on the exposure scenarios developed for the substance. In detail, according to Annex XI, 3, exposure based adaptation is possible for tests in section 8.6 and 8.7 of Annex VIII and tests in section 9.3 and 9.4 in Annex IX and X. In order to qualify for exposure based adaptation, the registrant needs to develop exposure scenarios for the substance. In addition, the registrant needs to provide adequate justification and documentation for the adaptation, which shall be based on thorough and rigorous exposure assessment. So, in accordance with column 2 of REACH Annex X and refering to the environmental and human Exposure Assessment presented in the CSR, the study on sediment organisms does not need to be conducted as direct and indirect exposure of the sediment compartment is unlikely, which was demonstrated in the Exposure Assessment. Moreover, in accordance with ECHA REACH Guidance R.10, the Predicted No Effect Concentration (PNEC) for sediment was derived from the PNEC for freshwater using the equilibrium partitioning method.
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.
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