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

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”
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