Data Submission Manual part 14 – How to Prepare ... - ECHA - Europa

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48 Data Submission Manual Version: 2.0 Figure 60: Adding a new endpoint study report A “New endpoint study record” section appears. Re-name the new endpoint record to “SDS of Substance X” or “Commercial interest justification”, as appropriate and click the button (Figure 61). Figure 61: Naming of added information In the next screenshot, shown below, from the pick-list under “Type of report” select “Safety data sheet” for attaching the SDS of the substance or “other” for attaching the commercial interest justification. In the “document” field click the button and the button that appears. You may be requested to save at this stage, which you should do. You can then attach the relevant document (Figure 62). Use the “Remarks” field to specify further the nature of the document. Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
Part 14 - How to Prepare and Submit a Request for Use of an Alternative Chemical Name for a Substance in a Mixture using IUCLID 5 Release date: July 2012 49 Figure 62: Attach a document All alternative name requests must contain at least the following endpoint study records in IUCLID 5 section 13: - the Safety Data Sheet (SDS) of the substance for which an alternative chemical name is requested; - demonstration that the request submitter has a commercial interest worthy of protection for non-disclosure of the actual substance name. 5.9. Information to be provided in IUCLID 5 section 14.2 – Alternative name request (mandatory) In this section the request submitter needs to provide the SDS of the mixture(s) that contains the substance for which an alternative chemical name is requested. Open the section 14.2 of the IUCLID 5 Substance dataset by double-clicking on “14.2 Alternative name request”. The “information on mixtures” block is repeatable so that you can indicate several mixtures in case the substance for which an alternative chemical name is requested is contained in more than one mixture. To do so, click the button (Figure 65). Indicate in the field “Mixture name” the name of the mixture. In the “Trade names and safety data sheets of the mixture” table, select “Add” to create a row and indicate the required mixture information. A pop-up window entitled “Trade name and safety data sheet information” appears on the screen (Figure 63). To identify the mixture in which the substance is contained, complete the fields in the pop-up window as follows (Figure 63): o indicate the “Trade name” of the mixture in the country that this mixture is marketed; o choose from the drop-down list the country in which this mixture is marketed; o remarks (if any); Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
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Data Submission Manual part 14 – How to Prepare ... - ECHA - Europa

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