Practical Guide 5: How to report (Q)SARs - ECHA - Europa

More documents

Recommendations

Info

Block “Results and discussion” • In a standard case you are requested to provide results in the foreseen result fields (repeatable block). It will allow you to transfer information automatically in these result fields to the CSR when the IUCLID 5 CSR plug-in is used. The list of fields to be filled in the “Results and discussion” block will vary depending on the endpoint. Therefore we recommend consulting the Data Submission Manual 5 “How to complete a technical dossier for registrations and PPORD notifications” available in the ECHA website at http://echa.europa.eu/help/help_docs_en.asp, for instructions on how to fill in the results. • The field “Details on results” or the field “Any other information on results incl. tables” is used to include the description of the applicability domain, reference to the type of model used, description and results of any possible structural analogues of the substance to assess the reliability of the prediction, uncertainty of the prediction and the mechanistic domain (for toxicity and ecotoxicity endpoints, if possible). It is advisable to create additionally, an endpoint study summary when more than one endpoint study record is available and provide the justification on read-across/ category in the “Discussion” field of the endpoint study summary together with the overall assessment on the particular endpoint. This will enable the automatic transfer of this information in the CSR when the IUCLID 5 CSR plug-in is used. In case there is only one endpoint study record provided on read-across, you may still copy-paste the justification from the endpoint study record to the “Discussion” field in the endpoint study summary for the above stated reasons. Block “Overall remarks, attachments” and/or “Applicant’s summary and conclusions” 9
− the result of the adequacy assessment for a regulatory purpose (risk assessment, classification & labelling, PBT analysis) should be reported in “Overall remarks”, “Conclusion” and/or “Executive summary”. Additionally, the (Q)SAR Prediction Reporting Format (QPRF) and (Q)SAR Model Reporting Format (QMRF) can be attached as a stand alone document. Please note that the endpoint summary record shall contain sufficient information on the prediction and the (Q)SAR model applied in order to allow an independent assessment of the adequacy of the predicted property. Summary information in the endpoint study record can be complemented with more detailed information in attached files (QMRF and QPRF). NOTE: In order to evaluate the validity of a specific model, a filled QMRF might be needed. The completed QMRF can be attached to the endpoint study record in the IUCLID dossier. If necessary, use the Endpoint summary to conclude on the prediction for the substance which you want to register (the substance as reported in Section 1.1 of IUCLUD 5). 10
Page 1 and 2: Practical guide 5: How to report (Q
Page 3 and 4: TABLE OF CONTENTS 1. INTRODUCTION .
Page 5 and 6: 2. HOW TO GET STARTED WITH (Q)SARS
Page 7 and 8: 3. QUESTIONS ON HOW TO APPLY AND RE
Page 9 and 10: classification and labelling and/or
Page 11: − the field “Principles of meth
Page 15: European Chemicals Agency P.O. Box

Practical Guide 5: How to report (Q)SARs - ECHA - Europa

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?