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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 608-209-4 | CAS number: 284461-73-0
Endpoint summary
Administrative data
Description of key information
Additional information
Within a study on the bioconcentration according to OECD 305 sorafenib tosylate (as analogue of the test substance) was tested in a flow-through fish test. The BCF was determined to be 5300 at a concentration of 0.32 µg/L after 22 d and >7300 at a concentration of 0.04 µg/L after 26 d (but no steady state was reached). These values are greater than the threshold for the vB criterion that is 5000 and show that the test substance has a high bioaccumulation potential.
In addition, a QSAR derived bioaccumulation factor was calculated based on the logKow=3.3 of the test substance. The bioaccumulation factor of the test substance was calculated to be 69.9 L/kg (ww) using the BCFBAF model included in the EPI-Suite Program. According to this value the test substance has a low potential to bioaccumulate in biota. The findings from the OECD 305 study are rather surprising as these deviate significantly from the behavior expected from QSAR that is based on physico-chemical properties.
QSAR applications reflect established relationships between molecular structures, physico-chemical properties, and biological activities of the test substance. However, bioconcentration of a substance is the result of lipid-water partitioning (Know) and other processes, e.g., metabolism and interactions with specific tissues. The QSAR can be adapted to include such processes to a certain degree. Nevertheless, BCF estimates from QSAR applications can differ from real BCF values when the test substance, e.g., accumulates in specific target tissues or body fluids, such as blood. Therefore, BCF values derived from the bioconcentration study (OECD 305) are used to assess the bioaccumulation potential and the test substance is assigned to be very bioaccumulative (vB).
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.
