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3738 Views 5 Replies Latest reply: May 2, 2012 8:03 AM by Doris HIRMANN RSS
New User 2 posts since
Feb 27, 2012
Currently Being Moderated

Feb 27, 2012 1:27 PM

TCC failures for data imported to IUCLID from the Toolbox

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.

Kind regards,

Hülya

  • Doris HIRMANN New User 16 posts since
    Jan 26, 2010

    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

  • Hülya Genc-Fuhrman New User 3 posts since
    Oct 4, 2011

    Dear 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.

     

    Kind regards,

     

    Hülya Genc-Fuhrman, PhD

    Senior Consultant

    Environment and Toxicology

    DHI

    Agern Alle 5

    2970 Denmark

    hgf@dhigroup.com

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