Dear Forum members,
I am using the Toolbox for filling pre-identified data gaps during preparation of REACH Registration Dossiers. As a first step I use the Toolbox to fill these data gaps, and then I export relevant data to IUCLID 5.3. I then manually fill some parts here as described in the following guidance documents (Practical Guide 5: How to report (Q)SARs and Guidance on information requirements... Chapter R.6:QSAR and grouping of chemicals). Afterwards, when I run the Technical Completeness Check (TCC) at IUCLID for the endpoint, there are still several TCC failures, as understandably the TCC is designed for the robust study summaries prepared from the actual test reports and requires all these fields to be filled. My understanding is that ECHA in fact advocates the usage of QSAR and particularly the Toolbox and this seems like a dilemma to me. I was wondering if you have any experience, suggestion on how to deal with these TCC failures when using the Toolbox.
I have recently contacted the ECHA Helpdesk but did not hear yet on this issue.
Thank you in advance for your time.
Dear Hülya, The QSAR Toolbox can help you in filling data gaps, however, for registration purposes certain information has to be provided by the registrant, such as the reliability score or if the generated information was used as supporting study, weight of evidence, etc (purpose flag). In the export wizard of the QSAR Toolbox, you can access an interface which allows you to fill in such information. At stage 2, there is a button called “Review export data…”. The fields that are to be filled as a minimum to pass the technical completeness check for registration purposes are indicated with “mandatory for evaluators”. The same principle applies for the report generated by the Toolbox. Certain information is pre-filled in order to assist the user in compiling relevant information. Other information has to be provided by the user, for example conclusions on the adequacy of the prediction. The fields where the user can modify pre-filled text or add own information are indicated as “manually editable field”. Let me know in case you still experience problems with passing the TCC. regards, Doris
Thank you so much for taking time to reply. Following the import to IUCLID from the Toolbox, I have been manually filling the parts you are referring in IUCLID as this is mentioned in the guidances I have refererred in my original post.
Despite this there are still TCC failures, especially on materials and methods and experimental details. I have faced this in the case of skin irritation end-point. I will look at this more in case I am missing something, but if you have further suggestions I would be very happy to hear.
Dear Hülya, You have been contacted by the ECHA Helpdesk to submit the TCC results table in order for us to better understand where the problem comes from. As soon as we have received further details, we will try to help you. I am providing support to the ECHA Helspdesk in this case. kind regards, Doris
I would like to inform you that I have managed to overcome the TCC failures, and are able to use to the Toolbox with the IUCLID in paralell effectively for the REACH registration dossiers for several endpoints.
Thank you so much for the support.
Hülya Genc-Fuhrman, PhD
Environment and Toxicology
Agern Alle 5
This is very good to hear. Thank you for letting us know.
kind regards, Doris