In the following, the online help texts for all data entry fields provided with any Endpoint study record for this IUCLID section are listed. For sections 4 to 10, these guidance notes are completely based on the so-called OECD Harmonised Templates (see Rationale behind IUCLID Endpoint Study Records - OECD harmonised templates in chapter chapter D.4.7.1 What is an Endpoint study record?)
IUCLID per se does not prescribe how detailed the study summaries should be recorded. Refer to the relevant guidance for the respective chemical regulatory programme thereof.
For technical guidance on how to manage Endpoint study records, see chapter D.4.7 How to manage Endpoint study records in sections 4 - 13. For details on data types, see chapter D.4.5 What data types are available for input fields and how are they used?
Under this main heading, fields are subsumed for identifying the purpose of the record (e.g., "key study"), the type of result (e.g., "experimental study"), data waiving indication (if any), reliability indication, and flags for indicating the regulatory purpose envisaged and/or any confidentiality restrictions. This kind of data characterise the relevance of a study summary and are therefore displayed on top of each Endpoint Study Record. For detailed guidance, refer to chapter D.4.7.7.1 Administrative data.
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.
Table E.490. Field Descriptions
| 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 Select "Other company data" to characterise any unpublished information from a company other than a study report. Select "Grey literature" for any other unpublished information or "other:" and specify. |
| Author(s) (or transferred 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. |
| 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". |
| 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). |
| Bibliographic 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: 215-227 Example 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. |
| Testing laboratory | Either manually enter the name of the testing laboratory or select it from the picklist. In either case, editing is possible. |
| 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. |
| Owner company | Either manually enter the identity of the company who owns the data or select it from the picklist. In either case, editing is possible. |
| 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. |
| 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. |
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.
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")
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.
Indicate the appropriate study type. Optionally, include details in the supplementary remarks field.
Definitions:
- Biological effect monitoring: involves the measurement of a biological change that is non-adverse and reversible (in contrast to medical monitoring), e.g. liver toxicity biomarkers (i.e. activity of aminotransferase and other enzymes).
- Biological exposure monitoring: measurement of biomarkers to assess the exposure from dietary, environmental or occupational sources. Biomarkers of exposure include either the measurement of levels of chemical agents and their metabolites in body fluids, tissue, cells or excreta, or the measurement of biological responses such as cytogenetic and reversible physiological changes in the exposed individuals.
- Health record from industry: a review of medical records and occupational exposure.- Health record, other: any other review of medical history and records (e.g. exposed non-occupational).
- Medical monitoring: aims to measure early signs and symptoms of adverse effects for preventive reasons.
- Medical screening: method for detecting disease or body dysfunction before an individual would normally seek medical care. Aim: early diagnosis and treatment.
- Other: any other type of study or information, e.g. self-reported symptoms.
If the study recorded gives useful information on one or several of the classic endpoints, select the endpoint(s) addressed from the picklist. Copy this field as appropriate.
NOTE: The list of endpoints provided is a generic list. Some endpoints may not be applicable for the type of study summarised in this record.
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).
Table E.491. Field Descriptions
| 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"). |
| 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. |
| Deviations from guideline (Deviations) | 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. |
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 "Test result type") state the equation(s) and/or computer software or other methods applied to calculate the value(s).
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.
Indicate if the test material used in the study is equivalent to the submission substance identity. If "yes" is selected, the corresponding identity is automatically entered in the subsequent block of fields "Test material identity".
If "no" is selected, identify the test material in the subsequent block of fields "Test material identity". In this case, also make sure that the information entered in field "Study result type" is consistent, i.e. "read-across from supporting substance (structural analogue or surrogate)".
NOTE: If a completed record is used for another submission, you may have to update both fields "Study result type" and "Test material equivalent to submission substance identity".
If the identity of the test material used for this study is not included in this block of fields automatically, indicate the identity for one or more appropriate identifiers, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields as appropriate.
If another than the submission substance identity was selected erraneously, go back to field "Test material equivalent to submission substance identity" and select "yes". This will prompt automatic entry of the respective identifiers.
Table E.492. Field Descriptions
| 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. |
| Identity | 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. |
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
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
Indicate whether subjects of the general population or from an occupational environment were investigated. If both were included in the same study, duplicate this field and indicate both types. If two independent studies are reported by the same report, use two separate records.
Where ethical approval is required, indicate whether and what kind of consent was received from the persons studied. Include details in the supplementary remarks field. If "not applicable" or "no" is selected, give reasoning as appropriate.
Include detailed information on the design of the health surveillance programme and exposure to the substance in question and to other chemicals. Include or attach tables as appropriate.
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.
Describe the results of the health surveillance study. In addition, include or attach tables and/or an excerpt from the study report.
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.
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.
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.
Table E.493. Field Descriptions
| Attached document | 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. |
| Remarks | As appropriate, include remarks, e.g. a short description of the content of the attached document if the file name is not self-explanatory. |
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.
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.
A Cross-reference to other study or other studys 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 studys 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.
In the following, the online help texts for all data entry fields provided with any Endpoint study record for this IUCLID section are listed. For sections 4 to 10, these guidance notes are completely based on the so-called OECD Harmonised Templates (see Rationale behind IUCLID Endpoint Study Records - OECD harmonised templates in chapter chapter D.4.7.1 What is an Endpoint study record?)
IUCLID per se does not prescribe how detailed the study summaries should be recorded. Refer to the relevant guidance for the respective chemical regulatory programme thereof.
For technical guidance on how to manage Endpoint study records, see chapter D.4.7 How to manage Endpoint study records in sections 4 - 13. For details on data types, see chapter D.4.5 What data types are available for input fields and how are they used?
Under this main heading, fields are subsumed for identifying the purpose of the record (e.g., "key study"), the type of result (e.g., "experimental study"), data waiving indication (if any), reliability indication, and flags for indicating the regulatory purpose envisaged and/or any confidentiality restrictions. This kind of data characterise the relevance of a study summary and are therefore displayed on top of each Endpoint Study Record. For detailed guidance, refer to chapter D.4.7.7.1 Administrative data.
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.
Table E.494. Field Descriptions
| 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. |
| Author(s) (or transferred 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. |
| 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". |
| 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). |
| Bibliographic 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: 215-227 Example 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. |
| Testing laboratory | Either manually enter the name of the testing laboratory or select it from the picklist. In either case, editing is possible. |
| 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. |
| Owner company | Either manually enter the identity of the company who owns the data or select it from the picklist. In either case, editing is possible. |
| 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. |
| 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. |
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.
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")
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.
If the study recorded gives useful information on one or several of the classic endpoints, select the endpoint(s) addressed from the picklist. Copy this field as appropriate.
NOTE: The list of endpoints provided is a generic list. Some endpoints may not be applicable for the type of study summarised in this record.
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).
Table E.495. Field Descriptions
| 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"). |
| 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. |
| Deviations from guideline (Deviations) | 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. |
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 "Test result type") state the equation(s) and/or computer software or other methods applied to calculate the value(s).
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.
Indicate if the test material used in the study is equivalent to the submission substance identity. If "yes" is selected, the corresponding identity is automatically entered in the subsequent block of fields "Test material identity".
If "no" is selected, identify the test material in the subsequent block of fields "Test material identity". In this case, also make sure that the information entered in field "Study result type" is consistent, i.e. "read-across from supporting substance (structural analogue or surrogate)".
NOTE: If a completed record is used for another submission, you may have to update both fields "Study result type" and "Test material equivalent to submission substance identity".
If the identity of the test material used for this study is not included in this block of fields automatically, indicate the identity for one or more appropriate identifiers, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields as appropriate.
If another than the submission substance identity was selected erraneously, go back to field "Test material equivalent to submission substance identity" and select "yes". This will prompt automatic entry of the respective identifiers.
Table E.496. Field Descriptions
| 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. |
| Identity | 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. |
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
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
Indicate whether subjects of the general population or from an occupational environment were investigated. If both were included in the same study, duplicate this field and indicate both types. If two independent studies are reported by the same report, use two separate records.
For ethical reasons indicate whether and what kind of consent was received from the persons studied. Include details in the supplementary remarks field. If "not applicable" or "no" is selected, give reasoning as appropriate.
Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.
Explanations:
- HYPOTHESIS TESTED: If study type is cohort or case control study, state the hypothesis(es) tested in this study.
- STUDY PERIOD: Give dates during which the data were collected (from ... to ...)
- SETTING: Indicate the setting where this study took place, e.g., occupational, residential, hospital-based, clinical practice, environmental (e.g., fenceline of waste sites, air monitoring); its geographic location(s); and any other pertinent information.
- STUDY POPULATION: Include details on the study population using the predefined items and inserting additional ones if required. Alternatively include or a attach a table and refer to respective Table no.
- COMPARISON POPULATION: Indicate one of the predefined types; delete those being not applicable. Provide details, e.g., note the parameters that were "matched" (i.e., smoking, age, sex, etc.).
- HEALTH EFFECTS STUDIED: Describe as appropriate. Note whether the diagnosis of the effects was made blind to exposure status. Alternatively include or a attach a table and refer to respective Table no.
Indicate whether the exposure was measured or estimated.
For robust study summaries or as requested by the regulatory programme, provide further details in the following freetext field.
Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.
Explanations:
- TYPE OF EXPOSURE: Characterise type of exposure including information on manufacturing / processing / use as applicable. If available, describe special exposure situations / workplaces.
- TYPE OF EXPOSURE MEASUREMENT: Indicate relevant predefined type(s); delete those being not applicable.
- EXPOSURE LEVELS: Give exposure level(s) reported (with units) or insert/attach table, for several exposure conditions and levels.
- EXPOSURE PERIOD: Describe when subjects were exposed and duration of exposure, i.e., hours, hours per day, days, days per week, weeks, months, years, person years, other.
- POSTEXPOSURE PERIOD: State period of time elapsed between last exposure/first examination or time study was conducted.
- DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: If several exposure groups (e.g. different concentrations or durations) are analysed, identify the exposure groups or categories, number of subjects within each group, sex, other categorical descriptions, etc.
Describe all statistical methods used and the data to which they were applied (include sample size and power calculations, if available).
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.
Provide exposure data as available. Give numbers of cases for each effect/disease/parameter under consideration, include measures of disease frequency (SMRs, ORs, PMRs, RR, prevalence, incidence, adjusted and/or crude rates), correlations, distributions etc., statistical data (significance, confidence intervals). If appropriate present the data in tabular form. Upload predefined table in the rich text field "Any other information on results incl. tables" 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").
Indicate any (possible) confounding factor(s), e.g. multi chemical exposure or smoking, and discuss their influence on the observed causal association.
Explain findings and discuss any other factors, i.e. bias, validity issues, reliability issues (including the adequacy of the exposure estimation or measurements), representativeness concerns, unique nature of study, influence of past exposures, latency, turnover rates in occupation studies.
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.
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.
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.
Table E.497. Field Descriptions
| Attached document | 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. |
| Remarks | As appropriate, include remarks, e.g. a short description of the content of the attached document if the file name is not self-explanatory. |
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.
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.
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.
In the following, the online help texts for all data entry fields provided with any Endpoint study record for this IUCLID section are listed. For sections 4 to 10, these guidance notes are completely based on the so-called OECD Harmonised Templates (see Rationale behind IUCLID Endpoint Study Records - OECD harmonised templates in chapter chapter D.4.7.1 What is an Endpoint study record?)
IUCLID per se does not prescribe how detailed the study summaries should be recorded. Refer to the relevant guidance for the respective chemical regulatory programme thereof.
For technical guidance on how to manage Endpoint study records, see chapter D.4.7 How to manage Endpoint study records in sections 4 - 13. For details on data types, see chapter D.4.5 What data types are available for input fields and how are they used?
Under this main heading, fields are subsumed for identifying the purpose of the record (e.g., "key study"), the type of result (e.g., "experimental study"), data waiving indication (if any), reliability indication, and flags for indicating the regulatory purpose envisaged and/or any confidentiality restrictions. This kind of data characterise the relevance of a study summary and are therefore displayed on top of each Endpoint Study Record. For detailed guidance, refer to chapter D.4.7.7.1 Administrative data.
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.
Table E.498. Field Descriptions
| 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. |
| Author(s) (or transferred 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. |
| 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". |
| 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). |
| Bibliographic 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: 215-227 Example 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. |
| Testing laboratory | Either manually enter the name of the testing laboratory or select it from the picklist. In either case, editing is possible. |
| 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. |
| Owner company | Either manually enter the identity of the company who owns the data or select it from the picklist. In either case, editing is possible. |
| 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. |
| 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. |
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.
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")
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.
If the study recorded gives useful information on one or several of the classic endpoints, select the endpoint(s) addressed from the picklist. Copy this field as appropriate.
NOTE: The list of endpoints provided is a generic list. Some endpoints may not be applicable for the type of study summarised in this record.
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).
Table E.499. Field Descriptions
| 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"). |
| 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. |
| Deviations from guideline (Deviations) | 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. |
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 "Test result type") state the equation(s) and/or computer software or other methods applied to calculate the value(s).
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.
Indicate if the test material used in the study is equivalent to the submission substance identity. If "yes" is selected, the corresponding identity is automatically entered in the subsequent block of fields "Test material identity".
If "no" is selected, identify the test material in the subsequent block of fields "Test material identity". In this case, also make sure that the information entered in field "Study result type" is consistent, i.e. "read-across from supporting substance (structural analogue or surrogate)".
NOTE: If a completed record is used for another submission, you may have to update both fields "Study result type" and "Test material equivalent to submission substance identity".
If the identity of the test material used for this study is not included in this block of fields automatically, indicate the identity for one or more appropriate identifiers, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields as appropriate.
If another than the submission substance identity was selected erraneously, go back to field "Test material equivalent to submission substance identity" and select "yes". This will prompt automatic entry of the respective identifiers.
Table E.500. Field Descriptions
| 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. |
| Identity | 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. |
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
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
Indicate whether subjects of the general population or from an occupational environment were investigated. If both were included in the same study, duplicate this field and indicate both types. If two independent studies are reported by the same report, use two separate records.
Describe the subject(s) examined based on the freetext template (delete/add elements as appropriate). As an option you may include an excerpt from the study report.
In the case of a study with volunteers indicate whether and what kind of consent was received from the persons studied. Include details in the supplementary remarks field. If "not applicable" or "no" is selected, give reasoning as appropriate.
Indicate whether the exposure was measured or estimated.
For robust study summaries or as requested by the regulatory programme, provide further details in the following freetext field.
Describe type and incidence of exposure including quantitative data if available, i.e. state if single or multiple exposure, duration, exposure concentrations (if inhalation), amount of substance ingested, dermal contact etc. Include methods of analysis if data available.
If exposure was estimated, describe how this was done, if available.
Indicate type of examinations performed and at what time after start of exposure. Use freetext template (delete/add elements as appropriate). As an option you may include an excerpt from the study report.
Indicate if and what medical treatment exposed / intoxicated persons received.
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.
Describe the results of examinations based on freetext template (delete/add elements as appropriate). As an option you may include an excerpt from the study report.
Indicate whether and during what time intoxicated persons responded to medical treatment.
Describe the clinical manifestation of signs and symptoms, partial or total recovery after what time etc. If reported, give data on any follow-up examinations.
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.
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.
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.
Table E.501. Field Descriptions
| Attached document | 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. |
| Remarks | As appropriate, include remarks, e.g. a short description of the content of the attached document if the file name is not self-explanatory. |
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.
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.
A Cross-reference to other study or other studys 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 studys 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.
In the following, the online help texts for all data entry fields provided with any Endpoint study record for this IUCLID section are listed. For sections 4 to 10, these guidance notes are completely based on the so-called OECD Harmonised Templates (see Rationale behind IUCLID Endpoint Study Records - OECD harmonised templates in chapter chapter D.4.7.1 What is an Endpoint study record?)
IUCLID per se does not prescribe how detailed the study summaries should be recorded. Refer to the relevant guidance for the respective chemical regulatory programme thereof.
For technical guidance on how to manage Endpoint study records, see chapter D.4.7 How to manage Endpoint study records in sections 4 - 13. For details on data types, see chapter D.4.5 What data types are available for input fields and how are they used?
Under this main heading, fields are subsumed for identifying the purpose of the record (e.g., "key study"), the type of result (e.g., "experimental study"), data waiving indication (if any), reliability indication, and flags for indicating the regulatory purpose envisaged and/or any confidentiality restrictions. This kind of data characterise the relevance of a study summary and are therefore displayed on top of each Endpoint Study Record. For detailed guidance, refer to chapter D.4.7.7.1 Administrative data.
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.
Table E.502. Field Descriptions
| 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. |
| Author(s) (or transferred 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. |
| 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". |
| 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). |
| Bibliographic 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: 215-227 Example 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. |
| Testing laboratory | Either manually enter the name of the testing laboratory or select it from the picklist. In either case, editing is possible. |
| 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. |
| Owner company | Either manually enter the identity of the company who owns the data or select it from the picklist. In either case, editing is possible. |
| 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. |
| 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. |
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.
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")
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.
Indicate whether respiratory or skin sensitisation was studied. If both, duplicate this field.
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).
Table E.503. Field Descriptions
| 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"). |
| 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. |
| Deviations from guideline (Deviations) | 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. |
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 "Test result type") state the equation(s) and/or computer software or other methods applied to calculate the value(s).
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.
Indicate if the test material used in the study is equivalent to the submission substance identity. If "yes" is selected, the corresponding identity is automatically entered in the subsequent block of fields "Test material identity".
If "no" is selected, identify the test material in the subsequent block of fields "Test material identity". In this case, also make sure that the information entered in field "Study result type" is consistent, i.e. "read-across from supporting substance (structural analogue or surrogate)".
NOTE: If a completed record is used for another submission, you may have to update both fields "Study result type" and "Test material equivalent to submission substance identity".
If the identity of the test material used for this study is not included in this block of fields automatically, indicate the identity for one or more appropriate identifiers, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields as appropriate.
If another than the submission substance identity was selected erraneously, go back to field "Test material equivalent to submission substance identity" and select "yes". This will prompt automatic entry of the respective identifiers.
Table E.504. Field Descriptions
| 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. |
| Identity | 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. |
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
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
Indicate whether subjects of the general population or from an occupational environment were investigated. If both were included in the same study, duplicate this field and indicate both types. If two independent studies are reported by the same report, use two separate records.
In the case of a study with volunteers indicate whether and what kind of consent was received from the persons studied. Include details in the supplementary remarks field. If "not applicable" or "no" is selected, give reasoning as appropriate.
Describe the subject(s) examined based on the freetext template (delete/add elements as appropriate). As an option you may include an excerpt from the study report.
Note: The description of the race of individuals should be in accordance with ethical and legal standards. Above all, race should be self-described by the individuals.
Describe the clinical history of the subject(s) examined based on the freetext template (delete/add elements as appropriate). As an option you may include an excerpt from the study report.
Indicate control or reference group or other comparison group and application of control/reference substances.
Describe the test design, i.e. type of test(s) used, method of application and the examinations performed.
Select freetext template for the respective type of sensitisation investigated and delete/add elements as appropriate. As an option you may include an excerpt from the study report.
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.
Describe the results of examinations based on freetext template (delete/add elements as appropriate). As an option you may include an excerpt from the study report.
Give number of persons with positive / negative / equivocal reactions vs. number of study population or volunteers. Include corresponding data for control groups if any. As appropriate, include or attach table(s) of results.
For case reports, briefly describe the results including the grading (e.g.: +/-, +, ++, +++) after different reading times.
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.
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.
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.
Table E.505. Field Descriptions
| Attached document | 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. |
| Remarks | As appropriate, include remarks, e.g. a short description of the content of the attached document if the file name is not self-explanatory. |
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.
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.
A Cross-reference to other study or other studys 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 studys 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.
In the following, the online help texts for all data entry fields provided with any Endpoint study record for this IUCLID section are listed. For sections 4 to 10, these guidance notes are completely based on the so-called OECD Harmonised Templates (see Rationale behind IUCLID Endpoint Study Records - OECD harmonised templates in chapter chapter D.4.7.1 What is an Endpoint study record?)
IUCLID per se does not prescribe how detailed the study summaries should be recorded. Refer to the relevant guidance for the respective chemical regulatory programme thereof.
For technical guidance on how to manage Endpoint study records, see chapter D.4.7 How to manage Endpoint study records in sections 4 - 13. For details on data types, see chapter D.4.5 What data types are available for input fields and how are they used?
Under this main heading, fields are subsumed for identifying the purpose of the record (e.g., "key study"), the type of result (e.g., "experimental study"), data waiving indication (if any), reliability indication, and flags for indicating the regulatory purpose envisaged and/or any confidentiality restrictions. This kind of data characterise the relevance of a study summary and are therefore displayed on top of each Endpoint Study Record. For detailed guidance, refer to chapter D.4.7.7.1 Administrative data.
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.
Table E.506. Field Descriptions
| 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. |
| Author(s) (or transferred 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. |
| 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". |
| 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). |
| Bibliographic 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: 215-227 Example 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. |
| Testing laboratory | Either manually enter the name of the testing laboratory or select it from the picklist. In either case, editing is possible. |
| 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. |
| Owner company | Either manually enter the identity of the company who owns the data or select it from the picklist. In either case, editing is possible. |
| 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. |
| 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. |
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.
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")
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.
Briefly indicate the type of information (which does not fit into any of the specific chapter.)
If the study recorded gives useful information on one or several of the classic endpoints, select the endpoint(s) addressed from the picklist. Copy this field as appropriate.
NOTE: The list of endpoints provided is a generic list. Some endpoints may not be applicable for the type of study summarised in this record.
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).
Table E.507. Field Descriptions
| 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"). |
| 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. |
| Deviations from guideline (Deviations) | 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. |
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 "Test result type") state the equation(s) and/or computer software or other methods applied to calculate the value(s).
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.
Indicate if the test material used in the study is equivalent to the submission substance identity. If "yes" is selected, the corresponding identity is automatically entered in the subsequent block of fields "Test material identity".
If "no" is selected, identify the test material in the subsequent block of fields "Test material identity". In this case, also make sure that the information entered in field "Study result type" is consistent, i.e. "read-across from supporting substance (structural analogue or surrogate)".
NOTE: If a completed record is used for another submission, you may have to update both fields "Study result type" and "Test material equivalent to submission substance identity".
If the identity of the test material used for this study is not included in this block of fields automatically, indicate the identity for one or more appropriate identifiers, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields as appropriate.
If another than the submission substance identity was selected erraneously, go back to field "Test material equivalent to submission substance identity" and select "yes". This will prompt automatic entry of the respective identifiers.
Table E.508. Field Descriptions
| 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. |
| Identity | 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. |
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
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
Where ethical approval is required, indicate whether and what kind of consent was received from the persons studied. Include details in the supplementary remarks field. If "not applicable" or "no" is selected, give reasoning as appropriate.
Describe the study design including any relevant information from a study report, publication or other source. Include or attach tables or excerpts from stufy report as appropriate.
Indicate whether the exposure was measured or estimated.
For robust study summaries or as requested by the regulatory programme, provide further details in the following freetext field.
Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.
Explanations:
- TYPE OF EXPOSURE: Characterise type of exposure including information on manufacturing / processing / use as applicable. If available, describe special exposure situations / workplaces.
- TYPE OF EXPOSURE MEASUREMENT: Indicate relevant predefined type(s); delete those being not applicable.
- EXPOSURE LEVELS: Give exposure level(s) reported (with units) or insert/attach table, for several exposure conditions and levels.
- EXPOSURE PERIOD: Describe when subjects were exposed and duration of exposure, i.e., hours, hours per day, days, days per week, weeks, months, years, person years, other.
- POSTEXPOSURE PERIOD: State period of time elapsed between last exposure/first examination or time study was conducted.
- DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: If several exposure groups (e.g. different concentrations or durations) are analysed, identify the exposure groups or categories, number of subjects within each group, sex, other categorical descriptions, etc.
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.
Provide exposure data as available and describe any relevant outcome of the study. If appropriate present the data in tabular form and/or attach excerpt(s) from the study report.
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.
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.
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.
Table E.509. Field Descriptions
| Attached document | 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. |
| Remarks | As appropriate, include remarks, e.g. a short description of the content of the attached document if the file name is not self-explanatory. |
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.
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.
A Cross-reference to other study or other studys 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 studys 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.