5 Replies Latest reply on Jan 21, 2011 9:38 AM by 415881

    Propriety Databases - Acceptance of data

    New User

      Hi,

       

      As certain industries (i.e. Fragrance Companies) will have structures which may be out of domain during analysis due to lack of comparable structures within the current selection of databases, the use of propriety databases will increasingly become more important.

       

      When reporting an analysis result, will the supplying company be required to also supply their propriety database, or only the structures used in the analysis?

      How will ECHA check this information is correct?

       

      Thanks,

      Geoff…

        • Re: Propriety Databases - Acceptance of data
          83059 Expert

          Hi Geoff,

           

          Your question is really linked to the procedures for complying with a specific regulation. I recommend that you contact ECHA directly on this subject.

           

          I can give you a generic response though.

           

          Experience with using the chemical category approach in the OECD HPV Chemicals Programme has shown that one of the biggest strength of this approach is it's complete transparency. Especially regarding the data that is used as the basis for the read-across.

           

          Any reviewer should be able to judge the reliability of the experimental result that is used as the basis for the read-across. This means that robust study summaries need to be available for the experimental results that you are using for the read-across and have to be part of your documentation for filling the data gap.

           

          Of course you can always discuss how many chemicals you need in your category for making a case and whether you always need to provide the robust study summaries for all studies and all the chemicals in your category. Maybe showing the overall trend for all the chemicals in your category and providing the robust study summaries for only the nearest neighbors is sufficient. But that is for the respective authorities to decide.

           

          Hope this helps.

           

          Cheers

           

          Bob

            • Re: Propriety Databases - Acceptance of data
              New User

              Hi Bob,

               

              Many thanks for the response.

               

              I guess this was one of the options I'd been thinking about and was really wondering just how much information the respective authorities would require. The inclusion of a robust study summary (RSS) would appear to be a good starting point. I think only including the nearest neighbours would be a good compromise when thinking about the amount of data required and time spent creating each individual RSS.

               

              Cheers,

              Geoff...

            • Re: Propriety Databases - Acceptance of data
              415881 New User

              In order for ECHA to be able to assess the information in the dossier, information for each member of the category has to be provided in the Registration dossier to support the category approach itself and/or read-across for data gap filling.  This means that all category members and all related endpoints to support the category itself and the read-across have to be provided. Under Article 119 of REACH a registrant can claim certain parts of a registration dossier confidential. This restricts the public access to information for other companies while giving the possibility to ECHA to evaluate the provided (non-test) information.

               

              If a large database of fragrances exists for a given endpoint but only a subset of substances is used for the category approach, the registrant shall provide information on the members of the category used to fill the data gap. Information on endpoint data should be given at least at the level of a robust study summary. In general the smaller the category is, the more information will need to be given for the substances used for data gap filling in order to demonstrate that the non-test information is adequate for risk assessment and/or classification and labelling purposes. For bigger categories, careful analysis for trends and outliers should be carried out.

               

              For more information on the practical aspects of read-across and category submission in registration dossier under REACH, please consult the practical guide “how to report read-across and categories” available on ECHA website: http://echa.europa.eu/doc/publications/practical_guides/pg_report_readacross_categ.pdf

               

              For more information on the practical aspects of the dissemination of information and confidentiality claims under REACH, please consult Data Submission Manuals 15, 16 and 17 available on ECHA website: http://echa.europa.eu/help/help_docs_en.asp?view=dissemination.

               

              The fragrance industry is invited to consider as well the possibility to donate proprietary data in order to improve the representation of fragrance structures in the QSAR Toolbox for the benefit of all users.

               

              If you would like to make an official enquiry to ECHA, please use the web form available at: http://apps.echa.europa.eu/forms/helpdesk_form.aspx.