The <code>EndpointStudyRecord</code> is used for modelling Endpoints in the flexible model such as containers for 'all endpoint study records', 'all endpoints' or even further <code>EndpointStudyRecord</code> entries. Basically everything that is an entry on the 'hierarchical chapter tree' is represented by a <code>EndpointStudyRecord</code>. <p/>The <code>EndpointStudyRecord</code> can be direct parent for <code>Element</code> objects. The latter are already flexible data objects yet provide no addressing capabilities. Modification tracking of this object - any trackable document needs such a record since the queryLastModified() and similar methods require this structure to be present. An optional modification comment. The party performing the modification. The modification date. This structure defines properies on ownership, authentication of the original author, and authorized uses of the current document. If a document originally was filtered during export and thus the data contained within the document is only a subset of the overall, this flag should be set to true. It can be used during import to advise the user if he can safely import the document or should rather take a closer look inside since otherwise data may effectively be lost! Usually no document is sealed and thus can be modified at any time by virtually anybody allowed by the access control. However, there is one big exception: IUCLID5 Agency and management of Dossier documents. Once dossiers have been created, the dossier itself and anything referenced from within is not modifyable anymore - therefore, it can be sealed. Flag that allows or prevents the current document to be copied and pasted. A user-specified name for the endpoint study record. This name is not to be confused with the so called 'default endpoint names' for REACH-IT. It is just a simple name where the user (or later some system automatism) can store text which is displayed in the section tree, the reference tracker, the import/export module, etc. This is the alphanumeric description field which is displayed on screen as indicator where the document reference points to. Usually this field has to be set when the document reference is created and should carry some clear indication where it points to such as the company name, the substance name, etc. This is a free-text field for user convenience to attach additional text to a DocumentReference. Last modification date of the target document. This field is not member of the primary key. Only at dossier creation time, the content of the field is encoded into timeStamp thus virtually creating a snapshot copy of the original object. Type of the target document, required for reference resolving. Unique identifier of the target document Note: primary key composition. Yet this does not belong to the primary key of the current class since there may be any number of DocumentReference objects pointing to the same document effectively. This is the alphanumeric description field which is displayed on screen as indicator where the document reference points to. Usually this field has to be set when the document reference is created and should carry some clear indication where it points to such as the company name, the substance name, etc. This is a free-text field for user convenience to attach additional text to a DocumentReference. The endpoint kind of the endpoint this reference points to. This field is not reliable, it may be null although the referenced document carries an 'endpoint kind' of course. Yet not all code might be changed to properly support this. Also, IUC-468 (sorting) assumes that the 'endpointKind' of the referenced FlexibleEndpoint will never change. Last modification date of the target document. This field is not member of the primary key. Only at dossier creation time, the content of the field is encoded into timeStamp thus virtually creating a snapshot copy of the original object. Type of the target document, required for reference resolving. Unique identifier of the target document Note: primary key composition. Yet this does not belong to the primary key of the current class since there may be any number of DocumentReference objects pointing to the same document effectively. The target type for the referenced flexible element. the level of data protection == confidentiality intended for the associated data / entities A free-text justification on the current confidentiality setting (see member confidentiality) Pick list <b>N78 </b> <p/>The regulatory purpose which applies: <ul> <li>Canada: Existing Substances Program under CEPA</li> <li>Canada: Pest Control Products Act (PCPA)</li> <li>EU: Biocides Programme</li> <li>EU: Existing Chemicals Programme</li> <li>EU: New Chemicals Programme</li> <li>EU: Registration, Evaluation and Authorisation of Chemicals (REACH)</li> <li>Japan: Chemical Substances Control Law</li> <li>OECD: HPV Chemicals Programme</li> <li>US: EPA HPV Chemical Challenge Programme</li> <li>US: Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)</li> <li>US: Toxic Substances Control Act</li> <li>[other]</li> </ul> the purpose flag the data waiving the justification for the data waiving the study result type the study period the reliablility the rational reliablility [Path: EF_EFFECTIVENESS.GENERAL_INFO_HD] [Path: EF_EFFECTIVENESS.BACKGROUND_INFORMATION] Use this field to include any background information, if required, or any relevant introductory remark. Leave field empty if not applicable. Do not include information for which specific fields are provided.PURPOSE OF THIS TEMPLATE:This template can be used for recording general information on the effectiveness of an active substance or a biocidal product, together with its active substances (as required by the relevant legislation).For products,efficacy studies should be reported using the corresponding template "Efficacy data". For active substances, the effectiveness achieved or claimed should be briefly described in this template. If required or sensible such description can be supported by including summary table(s) which give an overview of relevant efficacy studies performed with a product or products.As appropriate, the general information can be provided in one record or in several individual records. For instance, one record may be sensible if several target organisms, but same function and product type are addressed. Separate records may be sensible for addressing different types of target organisms and functions.Note that this template focuses primarily on biocides. If used for other than this purpose additional pieces of information may have to be added in several fields. Consult the programme-specific guidance on the details to be included. [Path: EF_EFFECTIVENESS.BACKGROUND_INFORMATION.TEXT_INT] [Path: EF_EFFECTIVENESS.ORGANISM_HD] [Path: EF_EFFECTIVENESS.TARGETORGANISM] Specify the target organism(s) to be controlled. Repeat this block of fields as necessary. Due to the great number of possible target organisms this picklist is not exhaustive. If the species name is not listed, choose an appropriate superior term (e.g. "Acaridae:") and specify by entering free text in the related field. If organism is not listed at all, choose "other:" and enter the name or several names in a row in the related text field. [Path: EF_EFFECTIVENESS.TARGETORGANISM.SCIENTIFIC_NAME] Select appropriate scientific name from picklist. If not listed, select "other" and specify. If not given/known, select "no data". See also instructions on this block of fields.Any remarks can be entered in the supplementary remarks field, for instance any code for target organism if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. "I.1.1.1 (EU BPD)". [Path: EF_EFFECTIVENESS.TARGETORGANISM.SCIENTIFIC_NAME_TXT] [Path: EF_EFFECTIVENESS.TARGETORGANISM.COMMON_NAME] Select appropriate common name from picklist. If not listed, select "other" and specify. If not given/known, select "no data". See also instructions on this block of fields.Any remarks can be entered in the supplementary remarks field. [Path: EF_EFFECTIVENESS.TARGETORGANISM.COMMON_NAME_TXT] [Path: EF_EFFECTIVENESS.TARGETORGANISM.DEVELSTAGE] Indicate the developmental stage of the target organism. If not listed, select "other" and specify. If not given/known, select "no data". If not applicable, leave field empty.Any remarks can be entered in the supplementary remarks field, for instance any code for the developmental stage if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. "I.1.1.1 (EU BPD)". [Path: EF_EFFECTIVENESS.TARGETORGANISM.DEVELSTAGE_TXT] [Path: EF_EFFECTIVENESS.OBJECTS_PROTECTED_HD] [Path: EF_EFFECTIVENESS.OBJECTS_PROTECTED] Describe and specify the organism(s) or materials(s) / object(s) to be protected, e.g. human, pets, farm animals, fur- and wool-bearing animals, drinking water, hard surface material , porous surface. [Path: EF_EFFECTIVENESS.OBJECTS_PROTECTED.TEXT_INT] [Path: EF_EFFECTIVENESS.INTENDED_USE_HD] [Path: EF_EFFECTIVENESS.FUNCTION] Indicate the function of the substance. You can copy this field for indicating additional functions provided they relate to the same product type indicated in the next field. However, it may be sensible or required according to legislation-specific guidance to use separate records for each function.Any remarks can be entered in the supplementary remarks field, for instance any code for the function if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. "III.1.1 (EU BPD)". [Path: EF_EFFECTIVENESS.FUNCTION.LIST_POP_FIX] [Path: EF_EFFECTIVENESS.FUNCTION.LIST_POP_FIX_TXT] [Path: EF_EFFECTIVENESS.PRODUCT_TYPE] Indicate the product type in which the active substance is intended to be included or which is envisaged for the product. In case of multiple product types use separate records for each of them.Note that only product types related to EU BPD are listed. For other legislations, choose "other:" and specify in the related text field. [Path: EF_EFFECTIVENESS.PRODUCT_TYPE.LIST_SEL] [Path: EF_EFFECTIVENESS.PRODUCT_TYPE.LIST_SEL_TXT] [Path: EF_EFFECTIVENESS.USE_ENVISAGED] In addition to the product type indicated, further information on the envisaged use may be required according to the relevant guidance document (e.g. EU BPD TNsG). This can include a detailed description of the overall use pattern, indication of any relations which give case to exposure, hazard classes, or specific environments in which the product will be used.Note: If the information or part of the information required by the legislation is included in another chapter, it is sufficient to include a cross-reference to that chapter / record. For instance, state "Overall use pattern described in chapter 2.5." [Path: EF_EFFECTIVENESS.USE_ENVISAGED.TEXTAREA_BELOW] [Path: EF_EFFECTIVENESS.APPLICATION_HD] [Path: EF_EFFECTIVENESS.APPLICATION_METHOD] For the product, indicate the method of application. You can copy this field as appropriate for indicating more than one method. If not listed, select "other" and specify.Any remarks can be entered in the supplementary remarks field, for instance any code for the method of application if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. "VII.1 (EU BPD)". [Path: EF_EFFECTIVENESS.APPLICATION_METHOD.LIST_POP_FIX] [Path: EF_EFFECTIVENESS.APPLICATION_METHOD.LIST_POP_FIX_TXT] [Path: EF_EFFECTIVENESS.APPLICATION_DETAILS] For the product, provide further details on the method of application if required so according to the instructions given in the relevant guidance documents (e.g. EU BPD TNsG). Outline the descriptions using the freetext template as appropriate (delete/add elements). You may summarise data on application and geographical or climatic variations in tabular form. Upload predefined table(s) in the rich text field "Overall remarks". Use table numbers in the sequence in which you refer to them in the text (e.g. "... see Table 1").Note: If the information or part of the information required by the legislation is provided in another section, it is sufficient to include a cross-reference to that section / record.Explanations:- DESCRIPTION OF APPLICATION SYSTEM USED: Give name of substances used for dilution including their concentration in the biocidal product. State any other substance(s) added including purpose and concentration in the product. Describe the application technique(s). Particularly if more than one product type or application method is applicable, you may summarize these data in tabular form.- APPLICATION RATE: For each product type and application technique give the recommended dose of the biocidal product and the active substance per object (e.g. per surface area of the material to be protected or as a concentration in a water system). Refer to the instructions given in the relevant guidance documents (e.g. EU BPD TNsG).- LIKELY / FINAL CONCENTRATION AT WHICH ACTIVE SUBSTANCE OR PRODUCT WILL BE USED: self-explanatory- NUMBER AND TIMING OF APPLICATIONS: Indicate the recommeded number and timing, i.e. duration of application and possible reapplications as well as waiting periods considered necessary. Particularly if more than one product type or application method is applicable, you may summarize these data in tabular form.- GEOGRAPHICAL VARIATIONS: Where relevant, describe how the application should be varied in different parts of the Community.- CLIMATIC VARIATIONS: Where relevant, describe how the application should be varied at different climatic conditions.- WAITING PERIODS TO PROTECT MAN AND ANIMALS: Where relevant, specify any waiting periods. [Path: EF_EFFECTIVENESS.APPLICATION_DETAILS.FREETEXT_BELOW] [Path: EF_EFFECTIVENESS.EFFECTIVENESS_HD] [Path: EF_EFFECTIVENESS.EFFECTS_TARGETORGANISMS] The effects on the target organisms required for the claimed efficacy should be described and specified if possible for each use and method of application if these have different effects, including any effect-concentration dependences or the possible existence of a threshold concentration of the active substance. Refer to the instructions given in the relevant guidance documents (e.g. EU BPD TNsG).In case of a submission of an active substance the effectiveness achieved or claimed should be briefly described. If required or sensible such description can be supported by including summary table(s) which give an overview of relevant efficacy studies performed with a product or products. Upload predefined table(s) in the rich text field "Overall remarks". Use table numbers in the sequence in which you refer to them in the text (e.g. "... see Table 1"). To show possible differences, the use, i.e. product type and method of application of the biocidal product(s) envisaged should also be given.For products, efficacy studies should be reported using the corresponding template "Efficacy data". [Path: EF_EFFECTIVENESS.EFFECTS_TARGETORGANISMS.TEXTAREA_BELOW] [Path: EF_EFFECTIVENESS.MODE_ACTION] Indicate the principles of the mode of action for the function indicated in above field, e.g. "acute toxin: contact poison". If not listed, select "other" and specify.Any remarks can be entered in the supplementary remarks field, for instance any code for the mode of action if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. "III.1.2 (EU BPD)". [Path: EF_EFFECTIVENESS.MODE_ACTION.LIST_POP_FIX] [Path: EF_EFFECTIVENESS.MODE_ACTION.LIST_POP_FIX_TXT] [Path: EF_EFFECTIVENESS.MODE_ACTION_DETAILS] For the function indicated in above field, indicate the principles of the mode of action; e.g. "contact poison" or "stomach poison". Briefly describe the biochemical and physiological mechanisms, e.g. "cholinesterase inhibition" and the biochemical pathway and specify any time delay between application and effect. Use the freetext template as appropriate (delete/add elements). For further instructions refer to the relevant guidance documents (e.g. EU BPD TNsG). [Path: EF_EFFECTIVENESS.MODE_ACTION_DETAILS.FREETEXT_BELOW] [Path: EF_EFFECTIVENESS.RESISTANCE_OCCURRENCE] Indicate whether resistance can possibly develop including cross-resistance. As appropriate include an appraisal of the information gained from the efficacy studies. [Path: EF_EFFECTIVENESS.RESISTANCE_OCCURRENCE.TEXTAREA_BELOW] [Path: EF_EFFECTIVENESS.RESISTANCE_STRATEGIES] Describe any appropriate management strategies towards the minimization of the development of resistance. [Path: EF_EFFECTIVENESS.RESISTANCE_STRATEGIES.TEXTAREA_BELOW] [Path: EF_EFFECTIVENESS.OTHER_LIMITATIONS] As applicable describe any other known limitations and relevant management strategies towards them. [Path: EF_EFFECTIVENESS.OTHER_LIMITATIONS.TEXTAREA_BELOW] [Path: EF_EFFECTIVENESS.GEN_OVERALL_HD] [Path: EF_EFFECTIVENESS.REM_ANYOTHER] In this field, you can enter any overall remarks or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry. [Path: EF_EFFECTIVENESS.REM_ANYOTHER.RICHTEXT_BELOW] [Path: EF_EFFECTIVENESS.AD] Attach any background document that cannot be inserted in any rich text editor field, particularly image files (e.g. an image of a structural formula).Copy this block of fields for attaching more than one file. [Path: EF_EFFECTIVENESS.AD.DOC] Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document. [Path: EF_EFFECTIVENESS.AD.REM] As appropriate, include remarks, e.g. a short description of the content of the attached document if the file name is not self-explanatory. [Path: EF_EFFECTIVENESS.AD_STUDYREPORT] If required, an electronic copy of the full study report can be attached as WORD, pdf or other document type, which will not be integrated in any report, but must be handled as separate files.Note: In the export administration you can indicate whether the attached files should be included in the data export or not. [Path: EF_EFFECTIVENESS.AD_STUDYREPORT.ATTACHMENT_BELOW] Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document. [Path: EF_EFFECTIVENESS.PG_ILLUSTRATION] If required, an image can be attached (e.g. jpg, png, gif).Note: Only image formats are supported.It is not possible to include MS Word (doc) or Adobe Portable Documents (pdf). [Path: EF_EFFECTIVENESS.PG_ILLUSTRATION.PIC_BELOW] Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document. [Path: EF_EFFECTIVENESS.GEN_APPL_SUM_HD] [Path: EF_EFFECTIVENESS.APPL_CL] Enter any conclusions if applicable. [Path: EF_EFFECTIVENESS.APPL_CL.TEXTAREA_BELOW] [Path: EF_EFFECTIVENESS.APPL_EXEC_SUM] If required by the respective national/regional programme, briefly summarise the relevant aspects of the study including the conclusions reached. If a specific format is prescribed, upload the respective freetext template if available from the drop-down list or copy it from the corresponding document.Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof. [Path: EF_EFFECTIVENESS.APPL_EXEC_SUM.RICHTEXT_BELOW] [Path: EF_EFFECTIVENESS.CROSSREF_OTHER_STUDY] A Cross-reference to other study or other studies can be included which are considered relevant in the interpretation of the test results, e.g. for supporting the conclusion that an effect observed was not substance-related. Indicate the respective chapter(s) and record ID(s) and enter relevant explanatory text.Such cross-references may be useful if it is considered relevant to discuss other results at the summary level of a single study. It should be noted that the overall appraisal of results from different studies is normally done in the hazard or risk assessment.Note that any such cross-reference may become useless if a record is either printed or exchanged on its own. [Path: EF_EFFECTIVENESS.CROSSREF_OTHER_STUDY.TEXT_BELOW] The version timestamp associates the XSDs with the underlying data format specification version as published by the IUCLID Management Group. See also layout.xml and the version attribute in data documents. The document reference pointing to the current document robust study flag used for classification flag used for MSDS flag