E.10.3. [10.2] Efficacy data

E.10.3.1. Endpoint study record

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?

E.10.3.1.1. Administrative data

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.

E.10.3.1.2. Background information

Use this field to include any background information, if required, or any relevant introductory remarks on the study summary. Leave field empty if not applicable. Do not include information for which specific fields are provided. For instance, include any relevant information on the test substance in fields on "Test materials".

PURPOSE OF THIS TEMPLATE:

This template can be used for summarising an efficacy study or, if appropriate and in line with relevant legislation guidance, several efficacy studies, conducted to support any proposed label claim.

Note that this template focuses primarily on biocides. If used for other than this purpose additional pieces of information may have to be added in several fields. Consult the programme-specific guidance on the details to be included in a study summary or whether several studies can be summarised in one record.

If this template is used to summarise several efficacy studies, the following should be taken into account:

- Attach summary table(s) in an appropriate rich text area, e.g. field "Any other information on results incl. tables" and/or attach graphs in field "Attached background material".

- Tests summarised in overview table(s) should have some common objectives and conditions as far as possible. For instance, summarise all laboratory studies in one record that are intended to support a specific label claim, while combining all field studies in another record. Likewise you may use other criteria for splitting up into more than one record.

- If possible fill in distinct fields with information that relates to all studies summarised in a given record. For instance, enter fields "Function addressed", "Objective / label claim(s)" addressed".

- Leave those fields or field blocks empty that are intended mainly for reporting an individual study, such as "Reference", "Test guideline", "Principles of method if other than guideline", fields under heading "Test materials". Provide this type of information in the tables.

- It may be useful to indicate that there are studies for which data protection is claimed. If so you can indicate so in the corresponding field and include a note, in the supplementary remarks field, referring to the results table in which the respective study or studies is/are indicated as being data protected.

E.10.3.1.3. Objective / label claim(s) addressed

Briefly describe the objective of the efficacy data summarised in this record. This will normally be a (draft) label or statements concerning the label claim that is addressed or supported. As appropriate, include relevant label information such as function, mode of action, target / pest organism(s), stage of pest targeted, area of use, application methods and rates at which the product is to be applied.

If a label addresses multiple product types, functions, target organisms, materials or organisms to be protected, it may be sensible or required according to legislation-specific guidance to use separate records for each of them, as an alternative option to addressing all label claims by efficacy data in one record. One approach could be to create separate records for the label items taken line by line, or point by point (possibly in another order), and include the corresponding efficacy data intended to support this/these label claim(s). Make sure that every part of each claim and recommendation of the label has been covered.

E.10.3.1.4. Source of information / type of study(ies)

Indicate wether the information entered originates from "public domain evidence" (i.e. suitable information in published papers and books), "summary of preliminary tests" (including early screening studies) or "summary information" (e.g. overview of several tests) or addresses a "laboratory study", "simulated use test / small scale trials", "field study / operational trials" or other ( to be specified). If the information was extrapolated from study(ies) with closely related formulations, select the corresponding indicator from the picklist.

This field is repeatable. As appropriate, copy the field e.g. for indicating "summary information" and "simulated test data".

In the supplementary remarks field, you can add explanations as appropriate.

Note: In field "Study result type", option "experimental result" should also be selected if the efficacy data recorded is extrapolated information from experimental study(ies) with another target or related formulation.

E.10.3.1.5. Reference

Indicate the bibliographic reference of the study report or publication the study summary is based on. Always enter the primary reference in the first block of fields (i.e. Sort no. = 1), if there are more than one reference to be cited. Copy this block of fields for specifying any other references related to this record (e.g. report of a preliminary study or other documentation). If results of a study report have been published, indicate the full citation of that publication(s) in addition to the reference of the original study.

Table E.539. 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.

E.10.3.1.6. Data access

Select appropriate indication for data access. Enter "Not applicable" if the summary consists of information that is commonly accessible such as guidance on safe use.

E.10.3.1.7. Data protection claimed

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")

E.10.3.1.8. Cross-reference to same study

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.

E.10.3.1.9. Test guideline

Indicate according to which test guideline the study was conducted. If no test guideline was explicitly followed, but the methodology used is equivalent or similar to a specific guideline, you can indicate so in the "Qualifier" subfield preceding the field "Guideline".

Copy this block of fields for specifying more than one guideline (e.g. US EPA in addition to OECD guideline).

Table E.540. 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.

E.10.3.1.10. Principles of method if other than guideline

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).

E.10.3.1.11. Compliance with quality standards

Indicate whether the efficiacy data were generated according to GEP (Good Experimental Practice) or by an officially recognised organisation. If neither or is the case, enter "no", "no data" or "not required" as applicable. Refer to programme-specific guidance as to the required adherence to official recognition, GEP or other quality assurance standards.

In the supplementary remarks field, you can add explanations as appropriate, e.g. provide a certificate number. If required, attach any (signed and dated) certificate or quality assurance statement in field "Attached background material".

E.10.3.1.12. Test material equivalent to submission substance identity

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".

E.10.3.1.13. Test material 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.541. 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.

E.10.3.1.14. Formulation type

Indicate the type of formulation used in the study. If not listed, select "other" and specify.

Any remarks can be entered in the supplementary remarks field, for instance any code for the formulation type if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. "VIII.1 (EU BPD)".

E.10.3.1.15. Details on test material

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

E.10.3.1.16. Confidential details on test material

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

E.10.3.1.17. Analytical monitoring

Indicate whether the active substance was monitored during the test.

E.10.3.1.18. Details on sampling and analytical methods

If the amount of test material exposed to the organisms was monitored, provide details on sampling and analytical methods used.

E.10.3.1.19. Test / target organisms

Specify the test / target organism(s) used in the study. Repeat this block of fields for specifying all organisms covered by this record. Due to the great number of possible test organisms this picklist is not exhaustive. If the species name is not listed, choose an appropriate superior term (e.g. "Acaridae:") and specify by entering free text in the related field. If organism is not listed at all, choose "other:" and enter the name or several names in a row in the related text field.

If this template is used to summarise several efficacy studies (e.g. by attaching summary tables as described in the instructions for field "Background information"), this block of fields can be left empty. However, if the number of different species is reasonable, you should also specify them here in addition to the summary tables. This will allow searching.

Table E.542. Field Descriptions

Scientific name of target organism (Scientific name)

Select appropriate scientific name from picklist. If not listed, select "other" and specify. If not given/known, select "no data". See also instructions on this block of fields.

Any remarks can be entered in the supplementary remarks field, for instance any code for target organism if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. "I.1.1.1 (EU BPD)".

Common name of target organism (Common name)

Select appropriate common name from picklist. If not listed, select "other" and specify. If not given/known, select "no data". See also instructions on this block of fields.

Any remarks can be entered in the supplementary remarks field.

Developmental stage of target organism (Developm. stage)

Indicate the developmental stage of the target organism. If not listed, select "other" and specify. If not given/known, select "no data". If not applicable, leave field empty.

Any remarks can be entered in the supplementary remarks field, for instance any code for the developmental stage if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. "I.1.1.1 (EU BPD)".

E.10.3.1.20. Details on test/target organisms

Provide further details on test organisms, particularly on rearing conditions, numbers and sexes used (where appropriate) and any other relevant information. Because of the wide range of efficacy trials identification of all relevant items is not practical. Hence, the optional freetext templates provided are not exhaustive. If you use one of them, delete/add elements and edit text set in [...] as appropriate. Specific studies may require other or additional information to be included. 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. EU BPD (TNsG)) thereof.

If this record summarises several studies with different organisms, it may be appropriate to include the most relevant details in the summary table(s).

E.10.3.1.21. Organisms (to be protected) or treated materials

If applicable, describe and specify the organism(s) or materials(s) / object(s) to be protected as addressed by these efficacy data, e.g. human, pets, farm animals, fur- and wool-bearing animals, drinking water, hard surface material, porous surface.

Note: If studies were conducted on human beings (e.g. testing insect repellents for human skin), it should be indicated whether and what kind of consent was received from the persons studied.

E.10.3.1.22. Total exposure duration (contact time)

Include numeric value or range (if several test runs or trials) and unit of duration in the respective subfields.

Table E.543. Field Descriptions

Exposure duration (Duration)

Enter a numeric value or a range of numeric values according to following conventions:

(i) In the first numeric field, enter a single value (Qualifier subfield left blank) or a value if preceded by ">", ">=" or "ca." (e.g. "20", "ca. 20", ">20").

(ii) In the second numeric field, enter a single value if preceded by "<" or "<=".

(iii) Use both numeric fields and, as required, the lower and upper qualifier field to enter a range of numeric values (e.g. "2 - 8" or ">2 <8").

Unit (no label)

Select from drop-down list.

Remarks

Enter any remarks related to the total exposure duration.

E.10.3.1.23. Mode of efficacy assessment

Describe the parameter(s) measured for assessing efficacy and the intervals of measurements, together with the scoring or assessment system used. Where appropriate, describe the duration of post monitoring of test organisms.

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. EU BPD) thereof.

E.10.3.1.24. Method of application

Indicate the method of application. If not listed, select "other" and specify.

Any remarks can be entered in the supplementary remarks field, for instance any code for the method of application if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. "VII.1 (EU BPD)".

E.10.3.1.25. Details on study design

Provide further details on the study design. Because of the wide range of efficacy trials, identification of all relevant items is not practical. Hence, the optional freetext templates provided are not exhaustive. If you use one of them, delete/add elements and edit items as appropriate. Specific studies may require other or additional information to be included. 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. EU BPD) thereof.

If this record summarises several studies, it may be appropriate to include the most relevant details in the summary table(s).

E.10.3.1.26. Any other information on materials and methods incl. tables

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.

E.10.3.1.27. Efficacy / performance assessment

If possible, indicate the percentage of efficacy in terms of control, reduction, damage of target organisms or reduction of disease caused by pest organisms. Copy this field block for entering more than one efficacy level (e.g. based on other exposure duration, dose or endpoint) if necessary.

Note: It may be appropriate to record, in this block of fields, only the mean level of effect or control. If the effect level relates to several test runs (i.e. test conditions), give ranges.

Table E.544. Field Descriptions

Efficacy parameter

Indicate the efficacy / performance parameter (e.g. % kill/cidal activity) to which the index entered in the next field refers to.

Efficacy (in %)

Enter a numeric value or a range of numeric values according to following conventions:

(i) In the first numeric field, enter a single value (Qualifier subfield left blank) or a value if preceded by ">", ">=" or "ca." (e.g. "20", "ca. 20", ">20").

(ii) In the second numeric field, enter a single value if preceded by "<" or "<=".

(iii) Use both numeric fields and, as required, the lower and upper qualifier field to enter a range of numeric values (e.g. "2 - 8" or ">2 <8").

Time to produce effect

Select from drop-down list.

Treatment

If efficacy results are recorded for different treatment conditions (by repeating this block of fields), briefly indicate the type of treatment/application the results refer to. Specify dose, application rate, duration, etc.

Interfering substances

Indicate if interfering substances were present. If "yes" is selected, briefly specify in the supplementary remarks field.

Remarks

Enter any remarks related to the efficacy / performance assessment recorded in this block of fields.

E.10.3.1.28. Minimum effective dose

If determined, provide the minimum effective dose, i.e. the dose or concentration considered the minimum necessary to achieve sufficient efficacy against the target organism(s) studied under the treatement conditions indicated. Copy this field block for recording values based on different treatment conditions if necessary.

Table E.545. Field Descriptions

Minimum effective dose (Min. effective dose)

Enter numeric value of minimum effective dose.

Unit of minimum effective dose (no label)

Select from drop-down list.

Time to produce effect

Select from drop-down list.

Treatment

If efficacy results are recorded for different treatment conditions (by repeating this block of fields), briefly indicate the type of treatment/application the results refer to. Specify dose, application rate, duration, etc.

Interfering substances

Indicate if interfering substances were present. If "yes" is selected, briefly specify in the supplementary remarks field.

Remarks

Enter any remarks related to the minimum effective dose recorded in this block of fields.

E.10.3.1.29. Details on results

Summarise any relevant results. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report, upload predefined table(s) in the rich text field "Any other information on results incl. tables" or attach graphs in field "Attached background material".

Note: Observed limitations on efficacy in terms of resistance, undesirable or unintended side effects, or other limitations should be described in the corresponding fields below.

E.10.3.1.30. Indication of resistance

Indicate whether any development of resistance was observed or not. In below field "Details on development of resistance", give details or provide any further explanation, e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

E.10.3.1.31. Details on development of resistance

Provide details on the development of resistance as observed in the efficacy study(ies), including any evidence of cross-resistance.

E.10.3.1.32. Undesirable or unintended side effects

Indicate whether any undesirable or unintended side effects were observed or not. In below field "Details on undesirable or unintended side effects", give details or provide any further explanation, e.g. stating that effects were observed, but considered negligible.

Select "not examined" or "no data" as applicable.

E.10.3.1.33. Details on undesirable or unintended side effects

Provide details on undesirable or unintended side effects as observed in the efficacy study(ies).

Where appropriate or required by the relevant legislation, insert subheadings, e.g.:

- Adverse effects on health of host animals

- Adverse effects on site of application (e.g. discoloration, corrosion, etc.)

- Adverse effects on beneficial and other non-target organisms

- Adverse effects on objects to be protected:

E.10.3.1.34. Other limitations observed

Where there is evidence of other possible limitations as derived from the study results, describe the relevant factors that can possibly reduce the efficacy, e.g. certain climatic or edaphic conditions.

E.10.3.1.35. Relevance of study results

For laboratory studies, provide arguments for performing such studies instead of a field test. If a study was conducted in a reduced scale, the dimension should be given as compared to the actual scale of the product (e.g. "Test was reduced to a scale of 1:100").

If the study or studies summarised in this record were conducted with another formulation type or application method, provide a justification for this read-across through either the provision of a reasoned case based on data or through bridging arguments.

Use freetext template and delete/add elements as appropriate.

E.10.3.1.36. Remarks on results including tables and figures

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.

E.10.3.1.37. Overall remarks

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.

E.10.3.1.38. Attached background material

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.546. 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.

E.10.3.1.39. Attached full study report

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.

E.10.3.1.40. Conclusions

Enter any conclusions if applicable.

E.10.3.1.41. Executive summary

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.

E.10.3.1.42. Cross-reference to other study

A Cross-reference to other study or other studies can be included which are considered relevant in the interpretation of the test results, e.g. for supporting the conclusion that an effect observed was not substance-related. Indicate the respective chapter(s) and record ID(s) and enter relevant explanatory text.

Such cross-references may be useful if it is considered relevant to discuss other results at the summary level of a single study. It should be noted that the overall appraisal of results from different studies is normally done in the hazard or risk assessment.

Note that any such cross-reference may become useless if a record is either printed or exchanged on its own.