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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 947-519-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Additional information
No data on terrestrial organisms are available or considered to be required, as 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.
A reliable Koc value is available for this substance, the PNECsoil was estimated using the equilibrium partitioning method (EPM) described in ECHA REACH Guidance R.10. It is considered that the information available is sufficient and further testing is not required, for the following reasons: 1) direct and indirect exposure of the soil compartment is unlikely, 2) the substance is not significantly bioavailable because of the high Koc and the low water solubility; 3) the substance is not a PBT or vPvB candidate; and 4) the chemical safety assessment did not indicate the need to investigate further its effects on terrestrial organisms. The CSA clearly suggests that the PEC/PNEC screen ratio will be irrelevantly low. Therefore, based on the compositional description and structural formula, and the lack of functional groups of concern and in accordance with column 2 of REACH Annex X and refering to the environmental and human Exposure Assessment presented in the CSR, no relevant exposure of soil macroorganisms to the submission item is expected (as is has been shown in the chemical safety assessment) and testing for effects is deemed not necessary. If necessary, data available from aquatic toxicity testing can be used as a worst case scenario if further characterization of the terrestrial compartment is desired.
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.
