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: TO_NEUROTOX.GEN_DATA_SOURCE_HD] [Path: TO_NEUROTOX.REFERENCE] Indicate the bibliographic reference of the study report or publication the study summary is based on. Always enter the primary reference in the first block of fields (i.e. Sort no. = 1), if there are more than one reference to be cited. Copy this block of fields for specifying any other references related to this record (e.g. report of a preliminary study or other documentation). If results of a study report have been published, indicate the full citation of that publication(s) in addition to the reference of the original study. [Path: TO_NEUROTOX.REFERENCE.REFERENCE_TYPE] Indicate the type of reference, e.g. "Study report" or "Publication". Select "Other company data" to characterise any unpublished information from a company other than a study report. Select "Grey literature" for any other unpublished information or "other:" and specify. [Path: TO_NEUROTOX.REFERENCE.REFERENCE_TYPE_TXT] [Path: TO_NEUROTOX.REFERENCE.REFERENCE_AUTHOR] For ease of sorting and searchability use following convention: Surname, Initial (Example 1: White D, Ruehl KJ, Borman SA & Little J. Example 2: Hartley M & Murray W (avoid unnecessary full-stops, commas)). If no individuals are cited as authors, enter name of company or organisation or "Anon." as appropriate.Note that the complete bibliographic reference may appear in this field after migration of unstructured data from existing databases. [Path: TO_NEUROTOX.REFERENCE.REFERENCE_YEAR] Enter year of study report or publication. For a study report this field should be completed to include it in any searches, regardless of whether the complete date is given in field "Report date". [Path: TO_NEUROTOX.REFERENCE.REFERENCE_TITLE] Include the title of the report. For publications, include the title of the article of a journal or article/chapter of a book (e.g. handbook). [Path: TO_NEUROTOX.REFERENCE.REFERENCE_SOURCE] Not relevant for any study report. For publications or any other literature source (grey literature) specify the following type of information: (i) Title of scientific journal or book (e.g. if handbook); (ii) Volume of journal; (iii) Editor, publisher, place of publication for books or articles in books; (iv) Pagination.Example 1 (journal): J. Agric. Food Chem. 38: 215-227Example 2 (handbook): In: Lyman WJ (ed.) Handbook of chemical property estimation methods. Environmental behavior of organic compounds. McGraw-Hill Book Company 15.1-15.34, New York. [Path: TO_NEUROTOX.REFERENCE.REFERENCE_TESTLAB] Either manually enter the name of the testing laboratory or select it from the picklist. In either case, editing is possible. [Path: TO_NEUROTOX.REFERENCE.REFERENCE_REPORT_NO] Specify the report number allocated by the testing laboratory. Note that any company-specific study number should be included in the respective field. [Path: TO_NEUROTOX.REFERENCE.REFERENCE_COMPANY_ID] Either manually enter the identity of the company who owns the data or select it from the picklist. In either case, editing is possible. [Path: TO_NEUROTOX.REFERENCE.REFERENCE_COMPANY_STUDY_NO] Specify any company study no. if there is such a number and if it is different from the report no. of the testing laboratory. Otherwise leave field empty. [Path: TO_NEUROTOX.REFERENCE.REFERENCE_REPORT_DATE] Specify the complete date of the study report, e.g. "2005-05-12" for 12 May 2005. Note that subfield "Year" should be completed in any case for sorting and searching purposes. [Path: TO_NEUROTOX.DATA_ACCESS] Select appropriate indication for data access. Enter "Not applicable" if the summary consists of information that is commonly accessible such as guidance on safe use. [Path: TO_NEUROTOX.DATA_ACCESS.LIST_POP] [Path: TO_NEUROTOX.DATA_ACCESS.LIST_POP_TXT] [Path: TO_NEUROTOX.DATA_PROT_CLAIM] Indicate as appropriate. Note: "yes" should be selected only if "Data submitter is data owner" or "Data submitter has Letter of Access". Options "yes, but willing to share" or "yes, but not willing to share" may be relevant for specific regulatory programmes where the submitter is requested to indicate whether he is willing to share studies (e.g. with vertebrates).In the supplementary remarks field, include an explanation as appropriate, i.e. justification for denial of sharing the corresponding study or refer to a document attached that provides justification (e.g. "for justification see attached document X") [Path: TO_NEUROTOX.DATA_PROT_CLAIM.LIST_POP_FIX] [Path: TO_NEUROTOX.DATA_PROT_CLAIM.LIST_POP_FIX_TXT] [Path: TO_NEUROTOX.CROSSREF_SAMESTUDY] A cross-reference can be included to indicate that the same study is recorded in another record. Indicate the respective chapter and record ID and enter relevant explanatory text. This may be useful if specific endpoints of a given study are described in another chapter (e.g. results on reproduction toxicity in case of a combined repeated dose / reproduction toxicity study) or if more than one experiment is described by the same study report, but included in separate records.Check with the relevant guidance document whether all the methodology details must be repeated or whether a cross-reference to the same study in another chapter may suffice.Note that any such cross-reference may become useless if a record is either printed or exchanged on its own. [Path: TO_NEUROTOX.CROSSREF_SAMESTUDY.TEXT_BELOW] [Path: TO_NEUROTOX.GEN_MAT_ME_HD] [Path: TO_NEUROTOX.TESTTYPE_TOX] Select appropriate test type. Note: This field may be redundant with the information given in field "Guideline", but is considered useful for searching reasons. [Path: TO_NEUROTOX.TESTTYPE_TOX.LIST_POP] [Path: TO_NEUROTOX.TESTTYPE_TOX.LIST_POP_TXT] [Path: TO_NEUROTOX.LIMIT_TEST] Indicate if the experiment was a limit test. [Path: TO_NEUROTOX.LIMIT_TEST.LIST_BELOW_SEL] [Path: TO_NEUROTOX.GUIDELINE] Indicate according to which test guideline the study was conducted. If no test guideline was explicitly followed, but the methodology used is equivalent or similar to a specific guideline, you can indicate so in the "Qualifier" subfield preceding the field "Guideline".Copy this block of fields for specifying more than one guideline (e.g. US EPA in addition to OECD guideline). [Path: TO_NEUROTOX.GUIDELINE.QUALIFIER] Select appropriate qualifier, i.e.- "according to" (if a given test guideline was followed);- "equivalent or similar to" (if no test guideline was explicitly followed, but the methodology is equivalent or similar to a specific guideline);- "no guideline followed" (if none of above qualifiers apply. If so, fill in field "Principles of method if other than guideline");- "no guideline available" (if so, fill in field "Principles of method if other than guideline").- "no guideline required" (if so, fill in field "Principles of method if other than guideline"). [Path: TO_NEUROTOX.GUIDELINE.GUIDELINE] Select the applicable test guideline, e.g. "OECD Guideline xxx". If the test guideline used is not listed, choose "other guideline:" and specify the test guideline in the related text field.In this text field, you can also enter any remarks as applicable, particularly:- To include any other title of the test guideline draft used, a subtitle, another version or update number and the year of update (For instance, different titles and/or numbers may exist for a given EU test guideline.);- To indicate if a the study was performed prior to the adoption of the test guideline specified;- To indicate if the methodology used was based on an extension of the test guideline specified. [Path: TO_NEUROTOX.GUIDELINE.GUIDELINE_TXT] [Path: TO_NEUROTOX.GUIDELINE.DEVIATION] For robust study summaries or as requested by the regulatory programme, indicate if there are any deviations from the test guideline specified. If "yes" is selected, only briefly state relevant deviations in the supplementary remarks field (e.g. "other species used"); details should be described in the respective fields of the section MATERIALS AND METHODS. [Path: TO_NEUROTOX.GUIDELINE.DEVIATION_TXT] [Path: TO_NEUROTOX.METHOD_NOGUIDELINE] If no guideline was followed, include a description of the principles of the test protocol or estimated method used in the study. Details should be entered in appropriate distinct fields of section MATERIALS AND METHODS if available. Also provide a justification for using this method if appropriate.If an estimation method was used (to be indicated in field "Study result type") state the equation(s) and/or computer software or other methods applied to calculate the value(s). [Path: TO_NEUROTOX.METHOD_NOGUIDELINE.TEXTAREA_BELOW] [Path: TO_NEUROTOX.GLP_COMPLIANCE_STATEMENT] Indicate whether the study was conducted following Good Laboratory Practice or not. Select "yes (incl. certificate)" if a GLP certificate of a test facility is available. Select "yes" if a GLP compliance statement is available, but no information on a GLP certificate. You can give an explanation in the supplementary remarks field, e.g. for explaining why GLP was not complied with or for specifying which (national) GLP was followed. [Path: TO_NEUROTOX.GLP_COMPLIANCE_STATEMENT.LIST_SEL_FIX] [Path: TO_NEUROTOX.GLP_COMPLIANCE_STATEMENT.LIST_SEL_FIX_TXT] [Path: TO_NEUROTOX.TESTMAT_HD] [Path: TO_NEUROTOX.TESTMAT_INDICATOR] Select "yes" or "no" from the drop-down list for indicating that the identity of the test material is the same or is not the same, respectively, as for substance defined in section 1 (General information). In addition, the identity of the test material should be specified in the subsequent block of fields "Test material identity".NOTE: You cannot update this field, if a completed record is copied to another submission substance as reference. Therefore, in case of read-across the indication of "yes" is not relevant. [Path: TO_NEUROTOX.TESTMAT_INDICATOR.LIST_BELOW_SEL] [Path: TO_NEUROTOX.TESTMAT] Indicate the identity of the test material for one or more appropriate identifiers, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields as appropriate.NOTE: In order to avoid confusion on the test material identity it is highly recommended to enter at least one substance identifier, regardless of what has been enterd in field "Identity of test material same as for substance defined in section 1 (if not read-across)". [Path: TO_NEUROTOX.TESTMAT.IDENTIFIER] Select an appropriate identifier from drop-down list, e.g. "CAS number". Use "Other:" and specify, if identity according to a standard identifier is not known or if an additional chemical name or number is provided. [Path: TO_NEUROTOX.TESTMAT.IDENTIFIER_TXT] [Path: TO_NEUROTOX.TESTMAT.ID] Select the corresponding substance identity from drop-down list or enter manually if the identity is not available from the list or if no list is provided for the type of identifier selected. [Path: TO_NEUROTOX.TESTMAT_FORM] Select the test material form from the drop-down list. If the form of the test chemical is not available in the list, select 'other:' and specify in the adjacent field. If the test material form is unknown, select 'no data'. [Path: TO_NEUROTOX.TESTMAT_FORM.TESTMAT_FORM] [Path: TO_NEUROTOX.TESTMAT_FORM.TESTMAT_FORM_TXT] [Path: TO_NEUROTOX.TESTMAT_DETAILS] Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.Note that any information that can be claimed confidential should be included in the subsequent field "Confidential details on test material".Explanations:- Name of test material (as cited in study report): only if different from any other identifiers provided in the preceding fields.- Molecular formula (if other than submission substance): specify- Molecular weight (if other than submission substance): specify- Smiles notation (if other than submission substance): provide if available- InChl (if other than submission substance): provide if available- Structural formula attached as image file (if other than submission substance): see Fig.: only if different from submission substance. Indicate Fig. no. if a file is attached in field "Attached document", e.g. state "see Fig. 1".- Substance type: indicate whether pure active substance, technical product, formulation or other.- Physical state: indicate "gas", "solid" or "liquid" only if different from submission substance or if substance can occur in different physical states.- Analytical purity: specify in %- Impurities (identity and concentrations): specify- Composition of the test material, percentage of components: specify if applicable- Isomers composition: specify if applicable- Purity test date: provide if available- Lot/batch No.: provide if available- Expiration date of the lot/batch: provide if available- Radiochemical purity (if radiolabelling): specify if applicable- Specific activity (if radiolabelling): specify if applicable- Locations of the label (if radiolabelling): specify if applicable- Expiration date of radiochemical substance (if radiolabelling): specify if applicable- Storage condition of test substance: specify if applicable- Stability under test conditions: indicate if available [Path: TO_NEUROTOX.TESTMAT_DETAILS.FREETEXT_BELOW] [Path: TO_NEUROTOX.TESTMAT_CONFIDENTIAL_DETAILS] Enter any confidential information on the test material in this separate field. Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.Explanations:- Analytical purity: specify in %- Impurities (identity and concentrations): specify- Composition of the test material, percentage of components: specify if applicable- Purity test date: provide if available- Lot/batch No.: : provide if available- Expiration date of the lot/batch: : provide if available- Isomers composition: specify if applicable [Path: TO_NEUROTOX.TESTMAT_CONFIDENTIAL_DETAILS.FREETEXT_BELOW] [Path: TO_NEUROTOX.ORGANISM_HD] [Path: TO_NEUROTOX.ORGANISM] Select name of species. If not available from picklist, select "other" and specify. [Path: TO_NEUROTOX.ORGANISM.LIST_POP] [Path: TO_NEUROTOX.ORGANISM.LIST_POP_TXT] [Path: TO_NEUROTOX.STRAIN] Select strain as appropriate. If not available from picklist, select "other" and specify. [Path: TO_NEUROTOX.STRAIN.LIST_POP] [Path: TO_NEUROTOX.STRAIN.LIST_POP_TXT] [Path: TO_NEUROTOX.SEX] Select as appropriate. [Path: TO_NEUROTOX.SEX.LIST_BELOW_POP] [Path: TO_NEUROTOX.ORGANISM_DETAILS] Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.Explanations:- Housing: describe housing conditions. Indicate whether individual metabolism cages were used.- Diet: Describe type of diet (e.g. conventional laboratory diet / caloric restriction) and whether it was provided ad libitum.- Water: Describe type (e.g. drinking water) and whether it was provided ad libitum.- IN-LIFE DATES: If required, specify the in-life dates (i.e. the phase of a study following treatment in which the test system is alive/growing). [Path: TO_NEUROTOX.ORGANISM_DETAILS.FREETEXT_BELOW] [Path: TO_NEUROTOX.ADMIN_EXP_HD] [Path: TO_NEUROTOX.ROUTE] Select as appropriate. If not available from picklist, select "other" and specify. [Path: TO_NEUROTOX.ROUTE.LIST_POP] [Path: TO_NEUROTOX.ROUTE.LIST_POP_TXT] [Path: TO_NEUROTOX.VEHICLE_TOX] Select "unchanged (no vehicle)" if none was used or select vehicle used if any. If not available from picklist, select "other" and specify. Further information can be given in the supplementary remarks field.Note that some of the vehicles provided in this list are used for specific routes of administration only. [Path: TO_NEUROTOX.VEHICLE_TOX.LIST_POP_FIX] [Path: TO_NEUROTOX.VEHICLE_TOX.LIST_POP_FIX_TXT] [Path: TO_NEUROTOX.EXP_DETAILS] Select freetext template for the respective route of administration and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof. [Path: TO_NEUROTOX.EXP_DETAILS.FREETEXT_BELOW] [Path: TO_NEUROTOX.ANALYT_VERIF_DOSE_CONC] Indicate whether the doses or concentrations were analytically verified. [Path: TO_NEUROTOX.ANALYT_VERIF_DOSE_CONC.LIST_BELOW_SEL] [Path: TO_NEUROTOX.ANALYT_VERIF_DETAILS] For robust study summaries or as requested by the regulatory programme, include a short description on the method of analysis in the supplementary remarks field. If any problems occurred in any of these procedures, then they should be reported in more detail. If this could have affected the veracity or conclusions of the study, discuss this in field "Rationale for reliability incl. deficiences".Further route-dependent information to be included:- For oral studies: State whether the analytical data indicated that the variance between nominal and actual dosage (if diet is route of administration) or concentrations (for drinking water study) was acceptable.If diet is the route of administration, briefly record when and at what dose levels the dosage analyses were made and include the results (range of values) of (i) Homogeneity analysis, (ii) Stability analysis and (iii) Concentration analysis.It may be appropriate to include a cross-reference to another study in which stability analysis was performed and reported. If so, a justification should also be included briefly explaining the rationale of referring to another study.- For inhalation studies: State whether the analytical data indicated that the variance between nominal and actual concentrations was acceptable.- For dermal studies: State whether the analytical data indicated that the variance between nominal and actual concentrations of the test substance in the vehicle was acceptable. [Path: TO_NEUROTOX.ANALYT_VERIF_DETAILS.TEXTAREA_BELOW] [Path: TO_NEUROTOX.MATING_PROCEDURES_DETAILS] Briefly describe the mating procedure.Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof. [Path: TO_NEUROTOX.MATING_PROCEDURES_DETAILS.FREETEXT_BELOW] [Path: TO_NEUROTOX.EXP_PERIOD] Indicate duration in days, weeks or months, e.g. "28 days" or "18 months". [Path: TO_NEUROTOX.EXP_PERIOD.TEXT_BELOW] [Path: TO_NEUROTOX.FREQUENCY] Indicate the frequency of the administration of doses to the test animals (e.g., "daily, 7 days each week"). Use of non-standard dosing regime (e.g. a five-day per week regime) should be justified. [Path: TO_NEUROTOX.FREQUENCY.TEXT_BELOW] [Path: TO_NEUROTOX.DOSES] Indicate the dose or concentration levels applied and the basis of quantity used. Copy this block of fields if the dose/concentration levels were determined on more than one basis of quantity as appropriate. [Path: TO_NEUROTOX.DOSES.CONCENTRATIONS] Indicate the doses or concentrations including unit applied to the test animals, e.g. "0, 112, 220, 523 mg/kg bw/day (m/f)" or "0, 112, 220, 523 mg/kg bw/day (m); 0, 87, 198, 477 mg/kg bw/day (f)". You may enter explanatory text. [Path: TO_NEUROTOX.DOSES.BASIS] Indicate whether doses/concentrations are based on nominal or actually ingested or analytically measured values. In the supplementary remarks field provide further details as appropriate. [Path: TO_NEUROTOX.DOSES.BASIS_TXT] [Path: TO_NEUROTOX.NUMBER_ANIMALS] Enter value or specify according to dose if different number of animals per dose or test, e.g. "10 in each dose group of FOB".For robust study summaries or as requested by the regulatory programme, also include a detailed table on the animal assignment in the rich text field "Any other information on results incl. tables". Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the Remarks text (e.g. "... see Table 1").For a developmental neurotoxicity study it should be noted: The method of animal assignment should have minimized potential problems related to litter effects, i.e., by using one pup/sex/litter (or one measure/litter, e.g., mean body weight for each litter).When allocating animals to FOB and motor activity testing, the same individual animals should have been evaluated at all scheduled time points.For the selection of animals and testing paradigms for cognitive (learning and memory) assessment, it is important to ensure that tasks were selected and/or animals allocated so that comparable assessments of learning were made at both times, i.e., shortly after PND 21 and around PND 60. Indicate whether the same or different animals were used for assessments at the weanling and adult ages. In general, the use of separate animals at the two time points is preferred, because for many tasks, initial learning (PND 21) may confound later (PND 60) assessment of learning. If the same animals were used at both times, different tasks would likely have been necessary. The selection of the test for assessing learning should have been adequately justified regardless of whether the same or a different task was used. [Path: TO_NEUROTOX.NUMBER_ANIMALS.TEXT_BELOW] [Path: TO_NEUROTOX.CONTROL_GROUP] Indicate whether and what type of concurrent control groups were used. If not available from picklist, select "other" and specify. Copy field if more than one type of control was used. [Path: TO_NEUROTOX.CONTROL_GROUP.LIST_POP] [Path: TO_NEUROTOX.CONTROL_GROUP.LIST_POP_TXT] [Path: TO_NEUROTOX.STUDY_DESIGN_DETAILS] Include any details on the study design including a brief description of the rationale for dose selection, animal assignment and selection of satellite groups including the duration of the post-exposure recovery period. As appropriate state study type(s) and briefly describe the results from range-finding or other studies used as basis for dose selection. More comprehensive details may be attached.Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.For a developmental neurotoxicity study it should be noted: Dose selection rationale should be discussed, including information from the prenatal developmental or two-generation reproduction studies, if applicable. Any pilot study data (including biomarker data, such as cholinesterase activity) or pharmacokinetic data (e.g., milk or blood levels of test substance, or data that established time of peak effect) should be described in detail. If these data were submitted in a separate study report, the methods and results (including detailed tables of analytical results) should be presented in a separate record (include a reference in field "Cross-reference to same study" or "Cross-reference to other study" as applicable); alternatively, they could be appended to this record. [Path: TO_NEUROTOX.STUDY_DESIGN_DETAILS.FREETEXT_BELOW] [Path: TO_NEUROTOX.EXAM_HD] [Path: TO_NEUROTOX.CLIN_EXAM_PERFORMED] Indicate if and which examinations were performed and the time schedule for those examinations. Also indicate the dose groups that were examined if not all. When tabulating parameters examined, refer to respective table no.If other observations (e.g. haematology) are reported in another study summary (e.g. repeated dose toxicity), include a note in field "Cross-reference to same study" and refer to that summary.Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof. [Path: TO_NEUROTOX.CLIN_EXAM_PERFORMED.FREETEXT_BELOW] [Path: TO_NEUROTOX.EXAM_BIOCHEMISTRY] If specific biochemical determinations were made, provide details on the sampling, the tissues tested (e.g. plasma, whole blood, RBCs, brain (whole brain or regions)) and methodology. When tabulating parameters examined, refer to respective table no.Use freetext template and delete/add elements as appropriate (e.g. delete items on NTE activity if not applicable). Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof. [Path: TO_NEUROTOX.EXAM_BIOCHEMISTRY.FREETEXT_BELOW] [Path: TO_NEUROTOX.EXAM_NEUROBEHAVIOUR] Provide details on the neurobehavioural examinations performed and frequency. Use freetext template and delete/add elements as appropriate (e.g. delete items on NTE activity if not applicable). Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.Particularly with comprehensive data, include a table in the rich text field "Any other information on results incl. tables" and refer to respective table no., e.g. "see Table 1" (use predefined table if any). Narrative accompanying such tabular data should address the toxicological significance of the results and not repeat what is presented in the table(s). [Path: TO_NEUROTOX.EXAM_NEUROBEHAVIOUR.FREETEXT_BELOW] [Path: TO_NEUROTOX.EXAM_PATHOLOGY] Indicate details on gross pathological and histopathological examinations. Also indicate those dose groups which were examined.Use freetext template and delete/add elements as appropriate (e.g. delete items on NTE activity if not applicable). Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.Particularly with comprehensive data, include a table in the rich text field "Any other information on results incl. tables" and refer to respective table no., e.g. "see Table 1" (use predefined table if any). Narrative accompanying such tabular data should address the toxicological significance of the results and not repeat what is presented in the table(s).Specific guidance for acute or subchronic neurotoxicity:Indicate when and how were animals sacrificed, how many were perfused, what parameters were measured (e.g. brain weight, length and width), what were the procedures for perfusion, what tissues were evaluated, what type of staining was used, how were sections prepared (thickness, embedding media, number of sections). How many animals from each sex and treatment group were evaluated?Specific guidance for developmental neurotoxicity studies: see freetext template.Tables are optional, particuarly for postmortem examinations of the offspring and the specific morphometric measures taken. [Path: TO_NEUROTOX.EXAM_PATHOLOGY.FREETEXT_BELOW] [Path: TO_NEUROTOX.EXAM_LITTER] For developmental neurotoxicity studies, indicate the relevant developmental landmarks and details on postweaning and litter observations. Use freetext template and delete/add elements as appropriate (e.g. delete items on NTE activity if not applicable). Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.Specific guidance on DEVELOPMENTAL LANDMARKS: If other developmental landmarks than those specified in the guideline are included in the study report, a detailed description of any developmental landmarks evaluated is MANDATORY, e.g. , e.g., eye opening, pinna unfolding, incisor eruption, etc. [Path: TO_NEUROTOX.EXAM_LITTER.FREETEXT_BELOW] [Path: TO_NEUROTOX.PHARMACOKINETIC_DATA] For developmental neurotoxicity studies, provide pharmacokinetic data. If applicable] Measures of [list parameters examined, e.g., test substance and metabolites in milk or in maternal, fetal, or pup blood] were determined in [Provide study identification, source of the animals (e.g., were they part of a range-finding or companion study?). Describe how many animals of each age group at each time point, how often, at what age for offspring. Indicate specifics of sample collection and processing; describe analytical methods used. [Path: TO_NEUROTOX.PHARMACOKINETIC_DATA.TEXTAREA_BELOW] [Path: TO_NEUROTOX.OTHER_EXAM] Describe any other examinations. [Path: TO_NEUROTOX.OTHER_EXAM.TEXTAREA_BELOW] [Path: TO_NEUROTOX.POS_CONTROL] Briefly describe the positive control data cited, and its acceptability for use with the current study.For positive control data to be acceptable, it must demonstrate the sensitivity of the test method to detect changes in the measured parameters. These data do not have to be from studies using prenatal exposures. However, the laboratory must demonstrate competence in evaluation of effects in neonatal animals perinatally exposed to chemicals and establish test norms for the appropriate age group. For observational measures, the data should demonstrate the ability to detect major neurotoxic endpoints, including limb weakness, paralysis, tremor, and autonomic signs; motor activity positive control data should demonstrate the ability to detect both increases and decreases in motor activity; pathology positive control data should demonstrate the ability to detect central and peripheral nervous system pathology (separate groups may be used to demonstrate each type of pathology, for example, acrylamide for peripheral nervous system pathology and trimethyl tin for central nervous system pathology).The methods should be completely described, and must be the same as those used in the study being evaluated (for example, the same equipment should be used, motor activity sessions should be of the same duration, the observation arena should be the same, the same sections should be evaluated for neuropathology, using the same types of stains, etc.), and preferably the same personnel should have conducted the testing. The data presentation should be complete enough to evaluate the sensitivity of the method, including individual data and measures of variability. Statistical evaluations used to demonstrate sensitivity should also be the same as those used in the study being evaluated. The number of animals per test group should not be greater than that used in the study under evaluation. Positive control data should also demonstrate inter-observer reliability for the FOB (i.e., the same results should be seen regardless of who is doing the observations). The positive control data should have been collected within a reasonable time frame before the current study, e.g., the last few years. New data should also be collected when observational personnel or other critical laboratory elements change. [Path: TO_NEUROTOX.POS_CONTROL.TEXT_INT] [Path: TO_NEUROTOX.STATISTICS] List parameters that were analysed and the statistical methods used; include a statement that the Reviewer considers the analyses used to be appropriate. If inappropriate, provide alternative/rationale. [Path: TO_NEUROTOX.STATISTICS.TEXT_INT] [Path: TO_NEUROTOX.REM_ME_TC] In this field, you can enter any information on materials and methods, for which no distinct field is available, 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: TO_NEUROTOX.REM_ME_TC.RICHTEXT_BELOW] [Path: TO_NEUROTOX.GEN_RESULTS_HD] [Path: TO_NEUROTOX.EFFLEVEL] Record effect levels, based on different endpoints and/or separated for each generation (if applicable) and/or sex. Copy this block of fields as appropriate. [Path: TO_NEUROTOX.EFFLEVEL.ENDPOINT] Select type of endpoint, normally NOAEC or LOAEC. If adverse effects were observed at the highest dose tested, select "no NOAEC identified". If a benchmark dose / concentration was calculated, select appropriate BMC indicator (e.g. "BMC05" or "BMC:" and specify in the related text field). If the critical effects at a specific dose or concentration level are reported only, select "dose. level:" or "conc. level:" and specify. [Path: TO_NEUROTOX.EFFLEVEL.ENDPOINT_TXT] [Path: TO_NEUROTOX.EFFLEVEL.GENERATION] For developmental neurotoxicity study, select the generation (i.e. "maternal" or "offspring"). If not applicable, leave this subfield empty. [Path: TO_NEUROTOX.EFFLEVEL.GENERATION_TXT] [Path: TO_NEUROTOX.EFFLEVEL.SEX] Select from drop-down list. [Path: TO_NEUROTOX.EFFLEVEL.LOQUALIFIER] Enter a numeric value or a range of numeric values according to following conventions:(i) In the first numeric field, enter a single value (Qualifier subfield left blank) or a value if preceded by ">", ">=" or "ca." (e.g. "20", "ca. 20", ">20").(ii) In the second numeric field, enter a single value if preceded by "<" or "<=".(iii) Use both numeric fields and, as required, the lower and upper qualifier field to enter a range of numeric values (e.g. "2 - 8" or ">2 <8"). [Path: TO_NEUROTOX.EFFLEVEL.LOVALUE] [Path: TO_NEUROTOX.EFFLEVEL.UPQUALIFIER] [Path: TO_NEUROTOX.EFFLEVEL.UPVALUE] [Path: TO_NEUROTOX.EFFLEVEL.UNIT] Select unit of dose or concentration as appropriate. [Path: TO_NEUROTOX.EFFLEVEL.UNIT_TXT] [Path: TO_NEUROTOX.EFFLEVEL.EFF_CONC_TYPE] Indicate whether the dose/concentration is based on the test material (test mat.), active ingredient (act. ingr.), element, dissolved (if inorganic non-metal), labile/free (if metal) or other (specify). Further information can be given in the supplementary remarks field.Leave blank or select "no data" if type is not known. [Path: TO_NEUROTOX.EFFLEVEL.EFF_CONC_TYPE_TXT] [Path: TO_NEUROTOX.EFFLEVEL.BASIS] Indicate the parameter(s) used to establish the given effect level. If necessary, give further details. Delete any elements in the predefined freetext that do not apply.This subfield can also be used to enter any other explanations, e.g. for indicating that the effect level provided was derived by the notifier or for indicating "NOAEL = highest dose tested" if applicable. [Path: TO_NEUROTOX.OBSERV_HD] [Path: TO_NEUROTOX.OBSERV_CLIN_SIGNS] Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible. Select "not examined" or "no data" as applicable. [Path: TO_NEUROTOX.OBSERV_CLIN_SIGNS.LIST_SEL_FIX] [Path: TO_NEUROTOX.OBSERV_CLIN_SIGNS.LIST_SEL_FIX_TXT] [Path: TO_NEUROTOX.OBSERV_BODYWEIGHT] Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible. Select "not examined" or "no data" as applicable. [Path: TO_NEUROTOX.OBSERV_BODYWEIGHT.LIST_SEL_FIX] [Path: TO_NEUROTOX.OBSERV_BODYWEIGHT.LIST_SEL_FIX_TXT] [Path: TO_NEUROTOX.OBSERV_FOOD_CONSUM] Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible. Select "not examined" or "no data" as applicable. [Path: TO_NEUROTOX.OBSERV_FOOD_CONSUM.LIST_SEL_FIX] [Path: TO_NEUROTOX.OBSERV_FOOD_CONSUM.LIST_SEL_FIX_TXT] [Path: TO_NEUROTOX.OBSERV_FOOD_EFFICIENCY] Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible. Select "not examined" or "no data" as applicable. [Path: TO_NEUROTOX.OBSERV_FOOD_EFFICIENCY.LIST_SEL_FIX] [Path: TO_NEUROTOX.OBSERV_FOOD_EFFICIENCY.LIST_SEL_FIX_TXT] [Path: TO_NEUROTOX.OBSERV_WATER_CONSUM] Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible. Select "not examined" or "no data" as applicable. [Path: TO_NEUROTOX.OBSERV_WATER_CONSUM.LIST_SEL_FIX] [Path: TO_NEUROTOX.OBSERV_WATER_CONSUM.LIST_SEL_FIX_TXT] [Path: TO_NEUROTOX.OBSERV_OPHTHALM] Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible. Select "not examined" or "no data" as applicable. [Path: TO_NEUROTOX.OBSERV_OPHTHALM.LIST_SEL_FIX] [Path: TO_NEUROTOX.OBSERV_OPHTHALM.LIST_SEL_FIX_TXT] [Path: TO_NEUROTOX.OBSERV_BIOCHEMISTRY] Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.Select "not examined" or "no data" as applicable. [Path: TO_NEUROTOX.OBSERV_BIOCHEMISTRY.LIST_SEL_FIX] [Path: TO_NEUROTOX.OBSERV_BIOCHEMISTRY.LIST_SEL_FIX_TXT] [Path: TO_NEUROTOX.OBSERV_NEUROBEHAVIOUR] Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible. Select "not examined" or "no data" as applicable. [Path: TO_NEUROTOX.OBSERV_NEUROBEHAVIOUR.LIST_SEL_FIX] [Path: TO_NEUROTOX.OBSERV_NEUROBEHAVIOUR.LIST_SEL_FIX_TXT] [Path: TO_NEUROTOX.OBSERV_GRPATHOL] Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible. Select "not examined" or "no data" as applicable. [Path: TO_NEUROTOX.OBSERV_GRPATHOL.LIST_SEL_FIX] [Path: TO_NEUROTOX.OBSERV_GRPATHOL.LIST_SEL_FIX_TXT] [Path: TO_NEUROTOX.OBSERV_NEUROPATHOL] Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.Select "not examined" or "no data" as applicable. [Path: TO_NEUROTOX.OBSERV_NEUROPATHOL.LIST_SEL_FIX] [Path: TO_NEUROTOX.OBSERV_NEUROPATHOL.LIST_SEL_FIX_TXT] [Path: TO_NEUROTOX.RESULTS_DETAILS] Describe the effects by dose level for each of the previous fields answered "yes". If answered "no effects", you may provide any further explanations, e.g. stating that effects were observed, but considered negligible and not of biological or statistical significance (to be explained why).Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.Relate treatment-related findings to any histological findings where appropriate.Particularly with comprehensive data, include a table in the rich text field "Any other information on results incl. tables" and refer to respective table no., e.g. "see Table 1" (use predefined table if any). Narrative accompanying such tabular data should address the toxicological significance of the results and not repeat what is presented in the table(s).NOTE: Depending on the regulatory programme some form of a table(s) may be mandatory.Explanations:- CLINICAL SIGNS AND MORTALITY: Clinical signs include gross observations for behaviour and appearance ("cage-side observations"). Note when signs were first observed and if they were reversible. For mortalities the cause of death should be indicated.- WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Water consumption may not be specifically requested under the respective test guideline, unless the substance was administered in the drinking water.- BIOCHEMISTRY: Provide separate tables for blood and brain cholinesterase activity and, if determined, for other enzyme activities (i.e. NTE for delayed neurotoxicity of organophosphorus substances). Include all data for whole brain (if brain regions were evaluated, also include all data from cortex and hippocampus; for other regions include data from all time points if statistically significant changes were found for a particular region or if changes from baseline of 20% or greater were seen).- NEUROBEHAVIOUR: Provide separate tables for functional observation battery results, motor activity, auditory startle field and learning and memory testing results as appropriate. Data should be included for all statistically significant findings, and for any findings that could be toxicologically relevant (even if not statistically significant). If significant effects are found, data from all groups, time points, and both sexes should be included for that parameter. Include severity information if there are changes in severity. Duplicate the tables as necessary to include different types of findings (e.g. activity levels, landing foot splay, etc.).- GROSS PATHOLOGY: Give absolute AND relative brain weights as appropriate.- NEUROPATHOLOGY: Describe what types of lesions were found. If neuropathological alterations were observed in the high dose group, were lower dose groups sequentially examined? If evidence of neuropathological alterations was seen, was a subjective diagnosis (dose-blind coded re-reading) conducted? If treatment-related lesions were found, include information in a table, including information regarding lesion severity; if no treatment-related lesions were found, include some information in text regarding reported incidence of lesions unrelated to treatment and in control groups.- OTHER FINDINGS: Describe the results of any other examinations or include a cross-reference in field "Cross-reference to same study" to indicate that specific results of the same study are described in another chapter. [Path: TO_NEUROTOX.RESULTS_DETAILS.FREETEXT_BELOW] [Path: TO_NEUROTOX.OBSERV_DNT_HD] [Path: TO_NEUROTOX.RS_REPRO_PERFORM_PARENT] Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.Select "not examined" or "no data" as applicable. [Path: TO_NEUROTOX.RS_REPRO_PERFORM_PARENT.LIST_SEL_FIX] [Path: TO_NEUROTOX.RS_REPRO_PERFORM_PARENT.LIST_SEL_FIX_TXT] [Path: TO_NEUROTOX.RS_VIABILITY_OFFSPRING] Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.Select "not examined" or "no data" as applicable. [Path: TO_NEUROTOX.RS_VIABILITY_OFFSPRING.LIST_SEL_FIX] [Path: TO_NEUROTOX.RS_VIABILITY_OFFSPRING.LIST_SEL_FIX_TXT] [Path: TO_NEUROTOX.RS_MATURATION_OFFSPRING] Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.Select "not examined" or "no data" as applicable. [Path: TO_NEUROTOX.RS_MATURATION_OFFSPRING.LIST_SEL_FIX] [Path: TO_NEUROTOX.RS_MATURATION_OFFSPRING.LIST_SEL_FIX_TXT] [Path: TO_NEUROTOX.RS_DEVELOPM_OFFSPRING] Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.Select "not examined" or "no data" as applicable. [Path: TO_NEUROTOX.RS_DEVELOPM_OFFSPRING.LIST_SEL_FIX] [Path: TO_NEUROTOX.RS_DEVELOPM_OFFSPRING.LIST_SEL_FIX_TXT] [Path: TO_NEUROTOX.RESULTS_DETAILS_DEV_NEUROTOX] Describe the effects by dose level for each of the previous fields answered "yes". If answered "no effects", you may provide any further explanations, e.g. stating that effects were observed, but considered negligible.Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.Particularly with comprehensive data, include a table in the rich text field "Any other information on results incl. tables" and refer to respective table no., e.g. "see Table 1" (use predefined table if any). Narrative accompanying such tabular data should address the toxicological significance of the results and not repeat what is presented in the table(s).NOTE: Depending on the regulatory programme some form of a table(s) may be mandatory.Explanations:- REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS): Describe the effects by dose level as stated above. Summarise any biologically relevant effects on reproductive performance. Any table included should be based on report content and include any calculated reproductive indices.- VIABILITY (OFFSPRING): Describe, for each generation and sex, the effects at the different doses, i.e. mean litter size and viability (survival) results from pups during lactation. Also describe anogenital distance results, if measured.- SEXUAL MATURATION (OFFSPRING): Describe the effects by dose level as stated above. Summarize any biologically relevant effects on vaginal opening and balanopreputial separation. Describe findings on sexual maturation.- DEVELOPMENTAL LANDMARKS (OFFSPRING): For developmental neurotoxicity studies, describe the effects at the different doses in the supplementary remarks field.- OTHER FINDINGS: Describe the results of any other examinations. [Path: TO_NEUROTOX.RESULTS_DETAILS_DEV_NEUROTOX.FREETEXT_BELOW] [Path: TO_NEUROTOX.REM_RS] In this field, you can enter any other remarks on results. 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: Both the "Materials and methods" section and "Results" section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry. [Path: TO_NEUROTOX.REM_RS.RICHTEXT_BELOW] [Path: TO_NEUROTOX.GEN_OVERALL_HD] [Path: TO_NEUROTOX.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: TO_NEUROTOX.REM_ANYOTHER.RICHTEXT_BELOW] [Path: TO_NEUROTOX.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: TO_NEUROTOX.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: TO_NEUROTOX.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: TO_NEUROTOX.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: TO_NEUROTOX.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: TO_NEUROTOX.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: TO_NEUROTOX.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: TO_NEUROTOX.GEN_APPL_SUM_HD] [Path: TO_NEUROTOX.APPL_CL] Enter any conclusions if applicable. [Path: TO_NEUROTOX.APPL_CL.TEXTAREA_BELOW] [Path: TO_NEUROTOX.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: TO_NEUROTOX.APPL_EXEC_SUM.RICHTEXT_BELOW] [Path: TO_NEUROTOX.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: TO_NEUROTOX.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