Enter a full short description of the most relevant endpoint data. This includes in principle the summary information that is compiled e.g. in the OECD Full SIDS Summary format or other endpoint summary formats. Provide only the most relevant details, which could be, depending on the cases, the test guideline used, test organism and exposure duration. Normally no reliability score needs to be indicated as it can be assumed that the studies identified are valid (reliability score 1 or 2). If this is not the case (for instance if the reliability of a published study cannot be assigned or if several less valid studies are used for a weight of evidence analysis), the reliability indicators should be specified.

Also several key studies can be referenced as applicable. However, the characterisation of the endpoint data should be kept as concise as possible. Examples of what could be entered here are as follows:

- Melting point: 54.6-55.8 °C at 1,013 hPa

- Water solubility: completely miscible

- pH: 6.9 (80 mg/l water) at 20°C (OECD TG105)

- Oxidation reduction potential: no data available

- Phototransformation in air: T1/2 = 9.32 x 10-2 yr (sensitizer: OH radical) (AOP Win v 1.86)

- Biodegradation in water: screening tests: Not readily biodegradable: 0 - 8% (BOD) in 28 days, 0 - 1% (HPLC) in 28 days (OECD TG 301C)

- Short-term toxicity to fish:

LC50 (96h) < 100 mg/l for Pimephales promelas (OECD TG 203)

LC50 (48h) = 3.2 mg/l for Oryzias latipes (OECD TG 203)

- Acute toxicity:

Dermal: LD50: > 2,000 mg/kg for rat (limit test)

- Genetic toxicity:

In vitro:

Gene mutation (Bacterial reverse mutation assay / Ames test): S. typhimurium TA 100: positive with and without metabolic activation; TA 1535: positive without metabolic activation (equivalent to OECD TG 471)

The field(s) under this heading (if provided) can be optionally completed in order to specify the key parameter(s) that may subsequently be used in the chemical safety assessment, classification and labelling or other. In order to enable the use of any specific software, only a minimum number of structured and hence, searchable fields are provided, in many cases only one.

Key parameters are intended to condense the data summarised in field "Full short description of relevant endpoint data" to one single numeric value or concluding remark (e.g. negative / positive) chosen from a drop-down list. Where a numeric field is provided, only a clear value can be entered, that is, no range and no less than or greater than qualifiers. Conversion to a predefined unit as indicated in the field label (e.g. mg/L) may be required.

If the key value is no clear number, but a range or preceded by <, <=, >, or >=, you may either leave this field empty or make up a value you consider most appropriate for the intended subsequent purpose. The rationale for any user-derived values should be described in field "Discussion" for the sake of transparency. Some non-exhaustive examples of user-derived parameters are as follows:

- Aquatic short-term L(E)C50 >100 mg/L (e.g. because only tested up to water solubility of the substance): it may be appropriate to assume 100 mg/L as worst case value.

- Aquatic long-term LOEC 1 mg/L (>10 and <20% effect): calculate NOEC as LOEC/2 and enter 0.5 mg/L in the field for NOEC.

- Acute oral LD50 >2000 mg/kg b.w. (because no LD50 was achieved in a limit test): enter 2000 mg/kg b.w.

In this rich text field, describe the assessment you have made for the given endpoint. Provide the rationale for the choice of the key study(ies) and the choice of the key parameter that, according to your judgement, characterise the endpoint. This includes a discussion of the key information identified and in some instances of studies which are considered to be unreliable, but give critical results. A discussion as to why they were discarded in favour of other studies should then be included. Vice versa, a weight of evidence analysis based on less reliable data or use of published data, the reliability of which cannot be judged because of limited reporting, should be justified.

If several studies were identified to be relevant for the assessment, discuss possible reasons for differing results if any, e.g. differences in purity / impurities of the test substance used, differences in the methods and test conditions, etc.

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.

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 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).

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.

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

ONLY if another substance, i.e. analogue or surrogate (e.g. degradation/transformation product) was used as test material, enter any relevant details on the properties of this substance that may possibly affect the test performance, particularly physico-chemical properties.

Use freetext template and delete/add elements as appropriate.

Note that the physico-chemical properties of the substance for which the submission is made should be recorded in the corresponding templates and therefore need not be repeated here. Nevertheless, the possible influence of any physico-chemical properties should be indicated / discussed in appropriate fields, particularly in fields "Details on test conditions" and "Details on results". This holds also true if any property of the substance is different in the test medium as compared to the data recorded in the section on physico-chemical properties, e.g. lower water solubility.

Indicate whether test substance was monitored in the test solutions.

For robust study summaries or as requested by the regulatory programme, provide further details on sampling and analytical methods in the corresponding freetext fields.

If the amount of test material exposed to the organisms was monitored, enter details on sampling. Use freetext template as appropriate and delete/add elements as appropriate.

Note: Indicate which concentrations were measured if not all. As applicable, provide information for soil, stock and/or spray solution.

If the amount of test material exposed to the organisms was monitored, enter any details on the analytical methods used. Use freetext template and delete/add elements as appropriate.

Indicate whether vehicle was used to emulsify or mix the experimental test material to enhance its solubility. If yes, specify in field "Details on preparation and application of test substrate".

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.

Select species from picklist. If not available, select "other" and enter name of organism (species).

Indicate the animal group, e.g. "annelids" for a test with a worm species. Helpful for searching purposes.

Enter any details that could be relevant for evaluating this study summary. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.

Indicate the study type, i.e. laboratory study, extended laboratory study (e.g. with a more natural substrate), semi-field study (mimicing a near-natural environment with ambient climatic conditions) or field study (using natural populations).

Indicate test duration type, i.e. either short-term or long-term. If a test was designed to determine both short and long term effects, create two different records for each test duration type.

Select type of substrate.

Indicate if the experiment was a limit test.

Include numeric value and unit of duration in the respective subfields. Any range reported because several test runs were summarised or any relevant remark should be entered in subfield "Remarks".

Indicate the post-observation period (with unit) if appropriate, e.g. in the case of a reproduction test.

Indicate test temperature values measured in the treatment and control vessels during test. Include range, mean, standard deviation and unit. As appropriate state the location and type of measurement (e.g. continuous monitoring). Alternatively refer to table (e.g. "see table no. 2") if the test conditions are presented in tabular form in the rich text editor field.

Indicate the pH of the soil and water at the start and end of the test. Alternatively refer to table (e.g. "see table no. 2") if the test conditions are presented in tabular form in the rich text editor field.

Indicate the water content of the soil at the start and end of the test. Alternatively refer to table (e.g. "see table no. 2") if the test conditions are presented in tabular form in the rich text editor field.

List nominal and, if available, measured test concentrations (with unit). As appropriate tabulate nominal vs. measured concentrations in the rich text field "Any other information on results incl. tables". Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the Remarks text (e.g. "... see Table 1").

Note: Specific tables may be required. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

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.

Indicate if a positive control was tested, i.e. a reference substance with known toxicity. If yes, include the identity of the substance(s) and the concentrations in the supplementary remarks field.

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.

Report the LC50 (for acute tests) or EC50, NOEC, LOEC or other effect levels. Copy this field block for entering more than one effect level if necessary.

Briefly summarise relevant observations and any dose response relationship. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.

Include table(s) with raw data in the rich text field "Any other information on results incl. tables". Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the text (e.g. "... see Table 1").

Note: Specific tables may be required. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

If reference substance(s) was/were tested, indicate whether the results with it/them are valid and provide relevant effect levels and other relevant information.

Use freetext template and delete/add elements as appropriate.

Indicate the parameters analysed, the statistical method used and the statistical test performed. If probit analysis was used, indicate the intercept and probit slope. As appropriate state any relevant error estimates associated with the determination of concentration-response relationship.

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.

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.

Indicate whether validity criteria given by test guideline have been fulfilled or not. Use supplementary remarks field for indicating the criteria and entering remarks. Clearly indicate if the criteria used are not consistent with those given by the test guideline. If so, give justification in field "Rationale for reliability incl. deficiences" as to why this study summary is considered reliable.

Enter any conclusions if applicable.

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.

Enter a full short description of the most relevant endpoint data. This includes in principle the summary information that is compiled e.g. in the OECD Full SIDS Summary format or other endpoint summary formats. Provide only the most relevant details, which could be, depending on the cases, the test guideline used, test organism and exposure duration. Normally no reliability score needs to be indicated as it can be assumed that the studies identified are valid (reliability score 1 or 2). If this is not the case (for instance if the reliability of a published study cannot be assigned or if several less valid studies are used for a weight of evidence analysis), the reliability indicators should be specified.

Also several key studies can be referenced as applicable. However, the characterisation of the endpoint data should be kept as concise as possible. Examples of what could be entered here are as follows:

- Melting point: 54.6-55.8 °C at 1,013 hPa

- Water solubility: completely miscible

- pH: 6.9 (80 mg/l water) at 20°C (OECD TG105)

- Oxidation reduction potential: no data available

- Phototransformation in air: T1/2 = 9.32 x 10-2 yr (sensitizer: OH radical) (AOP Win v 1.86)

- Biodegradation in water: screening tests: Not readily biodegradable: 0 - 8% (BOD) in 28 days, 0 - 1% (HPLC) in 28 days (OECD TG 301C)

- Short-term toxicity to fish:

LC50 (96h) < 100 mg/l for Pimephales promelas (OECD TG 203)

LC50 (48h) = 3.2 mg/l for Oryzias latipes (OECD TG 203)

- Acute toxicity:

Dermal: LD50: > 2,000 mg/kg for rat (limit test)

- Genetic toxicity:

In vitro:

Gene mutation (Bacterial reverse mutation assay / Ames test): S. typhimurium TA 100: positive with and without metabolic activation; TA 1535: positive without metabolic activation (equivalent to OECD TG 471)

The field(s) under this heading (if provided) can be optionally completed in order to specify the key parameter(s) that may subsequently be used in the chemical safety assessment, classification and labelling or other. In order to enable the use of any specific software, only a minimum number of structured and hence, searchable fields are provided, in many cases only one.

Key parameters are intended to condense the data summarised in field "Full short description of relevant endpoint data" to one single numeric value or concluding remark (e.g. negative / positive) chosen from a drop-down list. Where a numeric field is provided, only a clear value can be entered, that is, no range and no less than or greater than qualifiers. Conversion to a predefined unit as indicated in the field label (e.g. mg/L) may be required.

If the key value is no clear number, but a range or preceded by <, <=, >, or >=, you may either leave this field empty or make up a value you consider most appropriate for the intended subsequent purpose. The rationale for any user-derived values should be described in field "Discussion" for the sake of transparency. Some non-exhaustive examples of user-derived parameters are as follows:

- Aquatic short-term L(E)C50 >100 mg/L (e.g. because only tested up to water solubility of the substance): it may be appropriate to assume 100 mg/L as worst case value.

- Aquatic long-term LOEC 1 mg/L (>10 and <20% effect): calculate NOEC as LOEC/2 and enter 0.5 mg/L in the field for NOEC.

- Acute oral LD50 >2000 mg/kg b.w. (because no LD50 was achieved in a limit test): enter 2000 mg/kg b.w.

In this rich text field, describe the assessment you have made for the given endpoint. Provide the rationale for the choice of the key study(ies) and the choice of the key parameter that, according to your judgement, characterise the endpoint. This includes a discussion of the key information identified and in some instances of studies which are considered to be unreliable, but give critical results. A discussion as to why they were discarded in favour of other studies should then be included. Vice versa, a weight of evidence analysis based on less reliable data or use of published data, the reliability of which cannot be judged because of limited reporting, should be justified.

If several studies were identified to be relevant for the assessment, discuss possible reasons for differing results if any, e.g. differences in purity / impurities of the test substance used, differences in the methods and test conditions, etc.

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.

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.

Select as method of application as appropriate. If not available from picklist, select "other" and specify.

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).

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.

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

ONLY if another substance, i.e. analogue or surrogate (e.g. degradation/transformation product) was used as test material, enter any relevant details on the properties of this substance that may possibly affect the test performance, particularly physico-chemical properties.

Use freetext template and delete/add elements as appropriate.

Note that the physico-chemical properties of the substance for which the submission is made should be recorded in the corresponding templates and therefore need not be repeated here. Nevertheless, the possible influence of any physico-chemical properties should be indicated / discussed in appropriate fields, particularly in fields "Details on test conditions" and "Details on results". This holds also true if any property of the substance is different in the test medium as compared to the data recorded in the section on physico-chemical properties, e.g. lower water solubility.

Indicate whether test substance was monitored in the test solutions.

For robust study summaries or as requested by the regulatory programme, provide further details on sampling and analytical methods in the corresponding freetext fields.

If the amount of test material exposed to the organisms was monitored, enter details on sampling. Use freetext template as appropriate and delete/add elements as appropriate.

Note: Indicate which concentrations were measured if not all. As applicable, provide information for soil, stock and/or spray solution.

If the amount of test material exposed to the organisms was monitored, enter any details on the analytical methods used. Use freetext template and delete/add elements as appropriate.

Indicate whether vehicle was used to emulsify or mix the experimental test material to enhance its solubility. If yes, specify in field "Details on preparation and application of test substrate".

Depending on the type of study, select appropriate freetext template (e.g. Honeybees: contact study) 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.

Select species from picklist. If not available, select "other" and enter name of organism (species).

Indicate the animal group, e.g. "Hymenoptera (honeybees)" for honeybees or "Collembola (soil-dwelling springtail)" for a test with Folsomia candida. Helpful for searching purposes.

Enter any details that could be relevant for evaluating this study summary. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.

Indicate the study type, i.e. laboratory study, extended laboratory study (e.g. with a more natural substrate), semi-field study (mimicing a near-natural environment with ambient climatic conditions) or field study (using natural populations).

Where applicable, indicate test duration type, i.e. either short-term or long-term. If a test was designed to determine both short and long term effects, create two different records for each test duration type.

Indicate if the experiment was a limit test.

Include numeric value and unit of duration in the respective subfields. Any range reported because several test runs were summarised or any relevant remark should be entered in subfield "Remarks".

Indicate the post-observation period (with unit) if appropriate, e.g. in the case of a reproduction test.

Indicate test temperature values measured in the treatment and control vessels during test. Include range, mean, standard deviation and unit. As appropriate state the location and type of measurement (e.g. continuous monitoring). As applicable indicate the life-stage in parentheses if different temperatures were used e.g. in case of predator and parasite studies. Example: 20+/-1°C (adults), 25+/-1.5°C (larval exposure), 18+/-1°C (pupal development), 25+/-1°C (fecundity).

Alternatively refer to table (e.g. "see table no. 2") if the test conditions are presented in tabular form in the rich text editor field.

If study with soil-dwellling arthropods, indicate the pH of the soil and water at the start and end of the test. Alternatively refer to table (e.g. "see table no. 2") if the test conditions are presented in tabular form in the rich text editor field.

If study with soil-dwellling arthropods, indicate the water content of the soil at the start and end of the test.

If study with above-ground arthropods, indicate the relative humidity of the experimental room during the test measured in the treatment and control vessels. Include range, mean, standard deviation and unit. As applicable indicate the life-stage in parentheses if different humidities were used e.g. in case of predator and parasite studies.

Alternatively refer to table (e.g. "see table no. 2") if the test conditions are presented in tabular form in the rich text editor field.

If study with above-ground arthropods, indicate the photoperiod and lighting intensity in the experimental room during the test measured in the treatment and control vessels. Include range, mean, standard deviation and unit. As applicable indicate the life-stage in parentheses if different lighting conditions were used e.g. in case of predator and parasite studies.

Alternatively refer to table (e.g. "see table no. 2") if the test conditions are presented in tabular form in the rich text editor field.

List nominal and, if available, measured test concentrations (with unit) or, if contact or oral study with honeybees, the nominal and measured doses applied. As appropriate tabulate nominal vs. measured concentrations in the rich text field "Any other information on results incl. tables". Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the Remarks text (e.g. "... see Table 1").

Note: Specific tables may be required. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Depending on the type of study, select appropriate freetext template (i.e. soil or above-ground arthropods) 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.

Indicate if a positive control was tested, i.e. a reference substance with known toxicity. If yes, include the identity of the substance(s) and the concentrations in the supplementary remarks field.

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.

Report the LC50 (for acute tests) or EC50, NOEC, LOEC or other effect levels. Copy this field block for entering more than one effect level if necessary.

Briefly summarise relevant observations and any dose response relationship. Depending on the type of study, select appropriate freetext template (i.e. soil or above-ground arthropods or honeybees) and delete/add elements as appropriate.

Include table(s) with raw data in the rich text field "Any other information on results incl. tables". Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the text (e.g. "... see Table 1").

Note: Specific tables may be required. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

If reference substance(s) was/were tested, indicate whether the results with it/them are valid and provide relevant effect levels and other relevant information.

Use freetext template and delete/add elements as appropriate.

Indicate the parameters analysed, the statistical method used and the statistical test performed. If probit analysis was used, indicate the intercept and probit slope. As appropriate state any relevant error estimates associated with the determination of concentration-response relationship.

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.

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.

Indicate whether validity criteria given by test guideline have been fulfilled or not. Use supplementary remarks field for indicating the criteria and entering remarks. Clearly indicate if the criteria used are not consistent with those given by the test guideline. If so, give justification in field "Rationale for reliability incl. deficiences" as to why this study summary is considered reliable.

Enter any conclusions if applicable.

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.

Enter a full short description of the most relevant endpoint data. This includes in principle the summary information that is compiled e.g. in the OECD Full SIDS Summary format or other endpoint summary formats. Provide only the most relevant details, which could be, depending on the cases, the test guideline used, test organism and exposure duration. Normally no reliability score needs to be indicated as it can be assumed that the studies identified are valid (reliability score 1 or 2). If this is not the case (for instance if the reliability of a published study cannot be assigned or if several less valid studies are used for a weight of evidence analysis), the reliability indicators should be specified.

Also several key studies can be referenced as applicable. However, the characterisation of the endpoint data should be kept as concise as possible. Examples of what could be entered here are as follows:

- Melting point: 54.6-55.8 °C at 1,013 hPa

- Water solubility: completely miscible

- pH: 6.9 (80 mg/l water) at 20°C (OECD TG105)

- Oxidation reduction potential: no data available

- Phototransformation in air: T1/2 = 9.32 x 10-2 yr (sensitizer: OH radical) (AOP Win v 1.86)

- Biodegradation in water: screening tests: Not readily biodegradable: 0 - 8% (BOD) in 28 days, 0 - 1% (HPLC) in 28 days (OECD TG 301C)

- Short-term toxicity to fish:

LC50 (96h) < 100 mg/l for Pimephales promelas (OECD TG 203)

LC50 (48h) = 3.2 mg/l for Oryzias latipes (OECD TG 203)

- Acute toxicity:

Dermal: LD50: > 2,000 mg/kg for rat (limit test)

- Genetic toxicity:

In vitro:

Gene mutation (Bacterial reverse mutation assay / Ames test): S. typhimurium TA 100: positive with and without metabolic activation; TA 1535: positive without metabolic activation (equivalent to OECD TG 471)

The field(s) under this heading (if provided) can be optionally completed in order to specify the key parameter(s) that may subsequently be used in the chemical safety assessment, classification and labelling or other. In order to enable the use of any specific software, only a minimum number of structured and hence, searchable fields are provided, in many cases only one.

Key parameters are intended to condense the data summarised in field "Full short description of relevant endpoint data" to one single numeric value or concluding remark (e.g. negative / positive) chosen from a drop-down list. Where a numeric field is provided, only a clear value can be entered, that is, no range and no less than or greater than qualifiers. Conversion to a predefined unit as indicated in the field label (e.g. mg/L) may be required.

If the key value is no clear number, but a range or preceded by <, <=, >, or >=, you may either leave this field empty or make up a value you consider most appropriate for the intended subsequent purpose. The rationale for any user-derived values should be described in field "Discussion" for the sake of transparency. Some non-exhaustive examples of user-derived parameters are as follows:

- Aquatic short-term L(E)C50 >100 mg/L (e.g. because only tested up to water solubility of the substance): it may be appropriate to assume 100 mg/L as worst case value.

- Aquatic long-term LOEC 1 mg/L (>10 and <20% effect): calculate NOEC as LOEC/2 and enter 0.5 mg/L in the field for NOEC.

- Acute oral LD50 >2000 mg/kg b.w. (because no LD50 was achieved in a limit test): enter 2000 mg/kg b.w.

In this rich text field, describe the assessment you have made for the given endpoint. Provide the rationale for the choice of the key study(ies) and the choice of the key parameter that, according to your judgement, characterise the endpoint. This includes a discussion of the key information identified and in some instances of studies which are considered to be unreliable, but give critical results. A discussion as to why they were discarded in favour of other studies should then be included. Vice versa, a weight of evidence analysis based on less reliable data or use of published data, the reliability of which cannot be judged because of limited reporting, should be justified.

If several studies were identified to be relevant for the assessment, discuss possible reasons for differing results if any, e.g. differences in purity / impurities of the test substance used, differences in the methods and test conditions, etc.

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.

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 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).

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.

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

ONLY if another substance, i.e. analogue or surrogate (e.g. degradation/transformation product) was used as test material, enter any relevant details on the properties of this substance that may possibly affect the test performance, particularly physico-chemical properties.

Use freetext template and delete/add elements as appropriate.

Note that the physico-chemical properties of the substance for which the submission is made should be recorded in the corresponding templates and therefore need not be repeated here. Nevertheless, the possible influence of any physico-chemical properties should be indicated / discussed in appropriate fields, particularly in fields "Details on test conditions" and "Details on results". This holds also true if any property of the substance is different in the test medium as compared to the data recorded in the section on physico-chemical properties, e.g. lower water solubility.

Indicate whether test substance was monitored in the test solutions.

For robust study summaries or as requested by the regulatory programme, provide further details on sampling and analytical methods in the corresponding freetext fields.

If the amount of test material exposed to the organisms was monitored, enter details on sampling. Use freetext template as appropriate and delete/add elements as appropriate.

Note: Indicate which concentrations were measured if not all. As applicable, provide information for soil, stock and/or spray solution.

If the amount of test material exposed to the organisms was monitored, enter any details on the analytical methods used. Use freetext template and delete/add elements as appropriate.

Note: Indicate whether the analytical method is for analysis of soil, stock and/or spray solution as applicable.

Indicate whether vehicle was used to emulsify or mix the experimental test material to enhance its solubility. If yes, specify in field "Details on preparation and application of test substrate".

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.

Indicate the species and corresponding plant group.

As appropriate you can prepare a study summary for each species used in a given study or cover all species tested in one record. In the latter case, copy this field block and enter the information required for each species.

Indicate the study type, i.e. laboratory study, extended laboratory study (e.g. with a more natural substrate), semi-field study (mimicing a near-natural environment with ambient climatic conditions) or field study (using natural populations).

Indicate test duration type, i.e. either short-term or long-term. If a test was designed to determine both short and long term effects, create two different records for each test duration type.

Select appropriate test type.

Select type of substrate.

Indicate if the experiment was a limit test.

Include numeric value and unit of duration in the respective subfields. Any range reported because several test runs were summarised or any relevant remark should be entered in subfield "Remarks".

For life cycle studies, also indicate the duration of exposure of parental fish (F0) and subsequent generation(s), i.e. F1, F2.

Indicate the post-observation period (with unit) if appropriate.

Indicate test temperature values measured in the treatment and control vessels during test. Include range, mean, standard deviation and unit. As appropriate state the location and type of measurement (e.g. continuous monitoring). Alternatively refer to table (e.g. "see table no. 2") if the test conditions are presented in tabular form in the rich text editor field.

Indicate the pH of the soil at the start and end of the test. Alternatively refer to table (e.g. "see table no. 2") if the test conditions are presented in tabular form in the rich text editor field.

Indicate the water content of the soil at the start and end of the test. Alternatively refer to table (e.g. "see table no. 2") if the test conditions are presented in tabular form in the rich text editor field.

List nominal and, if available, measured test concentrations (with unit). Indicate which concentration was measured, e.g. highest test concentration.

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: If any information is specific to a given species (in case several species are recorded in one record), add the species name in parentheses, e.g. "- No. of seeds per container: 50 (Sorghum vulgare); 100 (Oryza sativa)"

Indicate if a positive control was tested, i.e. a reference substance with known toxicity. If yes, include the identity of the substance(s) and the concentrations in the supplementary remarks field.

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.

Report the NOEC, ECx or ERx (x% effect concentration or effect (field application) rate) or other effect levels with 95% conf. limits if available. Copy this field block for entering more than one effect level if necessary.

Briefly summarise relevant observations and any dose response relationship. Use freetext template and delete/add elements as appropriate, e.g. copy headings for including data on different species. As an option you may include an excerpt from the study report.

Include table(s) with raw data in the rich text field "Any other information on results incl. tables". Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the text (e.g. "... see Table 1").

Note: Specific tables may be required. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

If reference substance(s) was/were tested, indicate whether the results with it/them are valid and provide relevant effect levels and other relevant information.

Use freetext template and delete/add elements as appropriate.

Indicate the parameters analysed, the statistical method used and the statistical test performed. If probit analysis was used, indicate the intercept and probit slope. As appropriate state any relevant error estimates associated with the determination of concentration-response relationship.

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.

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.

Indicate whether validity criteria given by test guideline have been fulfilled or not. Use supplementary remarks field for indicating the criteria and entering remarks. Clearly indicate if the criteria used are not consistent with those given by the test guideline. If so, give justification in field "Rationale for reliability incl. deficiences" as to why this study summary is considered reliable.

Enter any conclusions if applicable.

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.

Enter a full short description of the most relevant endpoint data. This includes in principle the summary information that is compiled e.g. in the OECD Full SIDS Summary format or other endpoint summary formats. Provide only the most relevant details, which could be, depending on the cases, the test guideline used, test organism and exposure duration. Normally no reliability score needs to be indicated as it can be assumed that the studies identified are valid (reliability score 1 or 2). If this is not the case (for instance if the reliability of a published study cannot be assigned or if several less valid studies are used for a weight of evidence analysis), the reliability indicators should be specified.

Also several key studies can be referenced as applicable. However, the characterisation of the endpoint data should be kept as concise as possible. Examples of what could be entered here are as follows:

- Melting point: 54.6-55.8 °C at 1,013 hPa

- Water solubility: completely miscible

- pH: 6.9 (80 mg/l water) at 20°C (OECD TG105)

- Oxidation reduction potential: no data available

- Phototransformation in air: T1/2 = 9.32 x 10-2 yr (sensitizer: OH radical) (AOP Win v 1.86)

- Biodegradation in water: screening tests: Not readily biodegradable: 0 - 8% (BOD) in 28 days, 0 - 1% (HPLC) in 28 days (OECD TG 301C)

- Short-term toxicity to fish:

LC50 (96h) < 100 mg/l for Pimephales promelas (OECD TG 203)

LC50 (48h) = 3.2 mg/l for Oryzias latipes (OECD TG 203)

- Acute toxicity:

Dermal: LD50: > 2,000 mg/kg for rat (limit test)

- Genetic toxicity:

In vitro:

Gene mutation (Bacterial reverse mutation assay / Ames test): S. typhimurium TA 100: positive with and without metabolic activation; TA 1535: positive without metabolic activation (equivalent to OECD TG 471)

The field(s) under this heading (if provided) can be optionally completed in order to specify the key parameter(s) that may subsequently be used in the chemical safety assessment, classification and labelling or other. In order to enable the use of any specific software, only a minimum number of structured and hence, searchable fields are provided, in many cases only one.

Key parameters are intended to condense the data summarised in field "Full short description of relevant endpoint data" to one single numeric value or concluding remark (e.g. negative / positive) chosen from a drop-down list. Where a numeric field is provided, only a clear value can be entered, that is, no range and no less than or greater than qualifiers. Conversion to a predefined unit as indicated in the field label (e.g. mg/L) may be required.

If the key value is no clear number, but a range or preceded by <, <=, >, or >=, you may either leave this field empty or make up a value you consider most appropriate for the intended subsequent purpose. The rationale for any user-derived values should be described in field "Discussion" for the sake of transparency. Some non-exhaustive examples of user-derived parameters are as follows:

- Aquatic short-term L(E)C50 >100 mg/L (e.g. because only tested up to water solubility of the substance): it may be appropriate to assume 100 mg/L as worst case value.

- Aquatic long-term LOEC 1 mg/L (>10 and <20% effect): calculate NOEC as LOEC/2 and enter 0.5 mg/L in the field for NOEC.

- Acute oral LD50 >2000 mg/kg b.w. (because no LD50 was achieved in a limit test): enter 2000 mg/kg b.w.

In this rich text field, describe the assessment you have made for the given endpoint. Provide the rationale for the choice of the key study(ies) and the choice of the key parameter that, according to your judgement, characterise the endpoint. This includes a discussion of the key information identified and in some instances of studies which are considered to be unreliable, but give critical results. A discussion as to why they were discarded in favour of other studies should then be included. Vice versa, a weight of evidence analysis based on less reliable data or use of published data, the reliability of which cannot be judged because of limited reporting, should be justified.

If several studies were identified to be relevant for the assessment, discuss possible reasons for differing results if any, e.g. differences in purity / impurities of the test substance used, differences in the methods and test conditions, etc.

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.

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 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).

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.

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

ONLY if another substance, i.e. analogue or surrogate (e.g. degradation/transformation product) was used as test material, enter any relevant details on the properties of this substance that may possibly affect the test performance, particularly physico-chemical properties.

Use freetext template and delete/add elements as appropriate.

Note that the physico-chemical properties of the substance for which the submission is made should be recorded in the corresponding templates and therefore need not be repeated here. Nevertheless, the possible influence of any physico-chemical properties should be indicated / discussed in appropriate fields, particularly in fields "Details on test conditions" and "Details on results". This holds also true if any property of the substance is different in the test medium as compared to the data recorded in the section on physico-chemical properties, e.g. lower water solubility.

Indicate whether test substance was monitored in the test solutions.

For robust study summaries or as requested by the regulatory programme, provide further details on sampling and analytical methods in the corresponding freetext fields.

If the amount of test material exposed to the organisms was monitored, enter details on sampling. Use freetext template as appropriate and delete/add elements as appropriate.

If the amount of test material exposed to the organisms was monitored, enter any details on the analytical methods used. Use freetext template and delete/add elements as appropriate.

Indicate whether vehicle was used to emulsify or mix the experimental test material to enhance its solubility. If yes, specify in field "Details on preparation and application of test substrate".

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.

Select "soil" if soil samples were used as inoculum. Otherwise select "other" and specify.

Include numeric value and unit of duration in the respective subfields. Any range reported because several test runs were summarised or any relevant remark should be entered in subfield "Remarks".

Indicate test temperature values measured in the treatment and control vessels during test. Include range, mean, standard deviation and unit. As appropriate state the location and type of measurement (e.g. continuous monitoring). Alternatively refer to table (e.g. "see table no. 2") if the test conditions are presented in tabular form in the rich text editor field.

Indicate the water content of the soil at the start and end of the test. Alternatively refer to table (e.g. "see table no. 2") if the test conditions are presented in tabular form in the rich text editor field.

Indicate the organic matter or organic carbon content of the soil sample in % dry weight.

Indicate the nitrogen content of the soil sample in % dry weight.

Indicate the test concentrations with unit and note whether they are nominal or measured. Normally the concentrations of the test substance added to soil are calculated, e.g. assuming uniform incorporation to a depth of 5 cm and a soil bulk density of 1.5.

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.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.

Indicate if a positive control was tested, i.e. a reference substance with known toxicity. If yes, include the identity of the substance(s) and the concentrations in the supplementary remarks field.

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.

Report the EC50 or other effect levels. Copy this field block for entering more than one effect level if necessary.

Report any other relevant results using freetext template as appropriate. As appropriate include table with raw data (use predefined table if any or adapt similar table from study report) and/or attach graph of the dose-repsonse curve.

Indicate whether the results with the reference substance(s) are valid.

Indicate the parameters analysed, the statistical method used and the statistical test performed. If probit analysis was used, indicate the intercept and probit slope. As appropriate state any relevant error estimates associated with the determination of concentration-response relationship.

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.

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.

Indicate whether validity criteria given by test guideline have been fulfilled or not. Use supplementary remarks field for indicating the criteria and entering remarks. Clearly indicate if the criteria used are not consistent with those given by the test guideline. If so, give justification in field "Rationale for reliability incl. deficiences" as to why this study summary is considered reliable.

Enter any conclusions if applicable.

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.

Enter a full short description of the most relevant endpoint data. This includes in principle the summary information that is compiled e.g. in the OECD Full SIDS Summary format or other endpoint summary formats. Provide only the most relevant details, which could be, depending on the cases, the test guideline used, test organism and exposure duration. Normally no reliability score needs to be indicated as it can be assumed that the studies identified are valid (reliability score 1 or 2). If this is not the case (for instance if the reliability of a published study cannot be assigned or if several less valid studies are used for a weight of evidence analysis), the reliability indicators should be specified.

Also several key studies can be referenced as applicable. However, the characterisation of the endpoint data should be kept as concise as possible. Examples of what could be entered here are as follows:

- Melting point: 54.6-55.8 °C at 1,013 hPa

- Water solubility: completely miscible

- pH: 6.9 (80 mg/l water) at 20°C (OECD TG105)

- Oxidation reduction potential: no data available

- Phototransformation in air: T1/2 = 9.32 x 10-2 yr (sensitizer: OH radical) (AOP Win v 1.86)

- Biodegradation in water: screening tests: Not readily biodegradable: 0 - 8% (BOD) in 28 days, 0 - 1% (HPLC) in 28 days (OECD TG 301C)

- Short-term toxicity to fish:

LC50 (96h) < 100 mg/l for Pimephales promelas (OECD TG 203)

LC50 (48h) = 3.2 mg/l for Oryzias latipes (OECD TG 203)

- Acute toxicity:

Dermal: LD50: > 2,000 mg/kg for rat (limit test)

- Genetic toxicity:

In vitro:

Gene mutation (Bacterial reverse mutation assay / Ames test): S. typhimurium TA 100: positive with and without metabolic activation; TA 1535: positive without metabolic activation (equivalent to OECD TG 471)

The field(s) under this heading (if provided) can be optionally completed in order to specify the key parameter(s) that may subsequently be used in the chemical safety assessment, classification and labelling or other. In order to enable the use of any specific software, only a minimum number of structured and hence, searchable fields are provided, in many cases only one.

Key parameters are intended to condense the data summarised in field "Full short description of relevant endpoint data" to one single numeric value or concluding remark (e.g. negative / positive) chosen from a drop-down list. Where a numeric field is provided, only a clear value can be entered, that is, no range and no less than or greater than qualifiers. Conversion to a predefined unit as indicated in the field label (e.g. mg/L) may be required.

If the key value is no clear number, but a range or preceded by <, <=, >, or >=, you may either leave this field empty or make up a value you consider most appropriate for the intended subsequent purpose. The rationale for any user-derived values should be described in field "Discussion" for the sake of transparency. Some non-exhaustive examples of user-derived parameters are as follows:

- Aquatic short-term L(E)C50 >100 mg/L (e.g. because only tested up to water solubility of the substance): it may be appropriate to assume 100 mg/L as worst case value.

- Aquatic long-term LOEC 1 mg/L (>10 and <20% effect): calculate NOEC as LOEC/2 and enter 0.5 mg/L in the field for NOEC.

- Acute oral LD50 >2000 mg/kg b.w. (because no LD50 was achieved in a limit test): enter 2000 mg/kg b.w.

In this rich text field, describe the assessment you have made for the given endpoint. Provide the rationale for the choice of the key study(ies) and the choice of the key parameter that, according to your judgement, characterise the endpoint. This includes a discussion of the key information identified and in some instances of studies which are considered to be unreliable, but give critical results. A discussion as to why they were discarded in favour of other studies should then be included. Vice versa, a weight of evidence analysis based on less reliable data or use of published data, the reliability of which cannot be judged because of limited reporting, should be justified.

If several studies were identified to be relevant for the assessment, discuss possible reasons for differing results if any, e.g. differences in purity / impurities of the test substance used, differences in the methods and test conditions, etc.

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.

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 test type.

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).

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.

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

ONLY if another substance, i.e. analogue or surrogate (e.g. degradation/transformation product) was used as test material, enter any relevant details on the properties of this substance that may possibly affect the test performance, particularly physico-chemical properties.

Use freetext template and delete/add elements as appropriate.

Note that the physico-chemical properties of the substance for which the submission is made should be recorded in the corresponding templates and therefore need not be repeated here. Nevertheless, the possible influence of any physico-chemical properties should be indicated / discussed in appropriate fields, particularly in fields "Details on test conditions" and "Details on results". This holds also true if any property of the substance is different in the test medium as compared to the data recorded in the section on physico-chemical properties, e.g. lower water solubility.

Select as appropriate. If not available from picklist, select "other" and specify.

Indicate whether test substance was monitored in the test medium. If yes, specify in field "Details on preparation and monitoring of diet".

Indicate whether vehicle was used, e.g. to facilitate mixing with feed.

Indicate details about diet preparation and homogeneity analysis of test material. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.

In the case of OECD or similarly acknowledged guideline only items may be covered where deviations apply or where parameters are left open in the guideline, provided the respective regulatory programme allows so.

Select species from picklist. If not available, select "other" and enter name of organism (species).

Enter any details that could be relevant for evaluating this study summary. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.

Indicate if the experiment was a limit test.

Include numeric value and unit of duration in the respective subfields. Any range reported because several test runs were summarised or any relevant remark should be entered in subfield "Remarks".

Indicate the post-observation period (with unit) during which "clean" feed was administered.

Indicate number of animals used per dose group. State if different numbers were used and reason why.

Indicate whether and what type of concurrent control groups were used. If not available from picklist, select "other" and specify. Copy field if more than one type of control was used.

List nominal and, if available, measured dose levels or test concentrations (with unit). Indicate if nominal in diet, nominal in water, actual ingested, actual in diet, measured concentration in diet, etc. Provide range, median, mean, SD as applicable. As appropriate tabulate nominal vs. measured concentrations and refer to Table no..

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.

Indicate the time schedule and further details for the examinations and observations performed (use separate freetext field for reproductive parameters, if applicable). Also indicate the dose groups that were examined if not all. When tabulating parameters examined, refer to respective table no.

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

For avian reproduction toxicity test, indicate the reproductive parameters examined.

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.

Indicate if a positive control was tested, i.e. a reference substance with known toxicity. If yes, include the identity of the substance(s) and the concentrations in the supplementary remarks field.

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.

Report the LC50, LD50, NOEC or LOEC for all health (and reproductive) parameters depending on the study type. Copy this field block for entering more than one effect level if necessary.

If repellency was investigated, describe the repellency results including all repellency factors (RF) given in the study report, i.e. either for each bird (choice test) or for per test group (no-choice test). As appropriate include or attach a table.

Briefly summarise relevant observations and any dose response relationship. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.

Include table(s) with raw data in the rich text field "Any other information on results incl. tables". Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the text (e.g. "... see Table 1").

Note: Specific tables may be required. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

For avian reproduction toxicity test, include data on reproduction during pre-treatment and treatment periods depending on the requirements of the test guideline used. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.

Include table(s) with raw data in the rich text field "Any other information on results incl. tables". Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the text (e.g. "... see Table 1").

Note: Specific tables may be required. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

If reference substance(s) was/were tested, indicate whether the results with it/them are valid and provide relevant effect levels and other relevant information.

Use freetext template and delete/add elements as appropriate.

Report any other relevant results. Compare the results for the test substance with that for the reference substance.

Indicate the parameters analysed, the statistical method used and the statistical test performed.

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.

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.

Indicate whether validity criteria given by test guideline have been fulfilled or not. Use supplementary remarks field for indicating the criteria and entering remarks. Clearly indicate if the criteria used are not consistent with those given by the test guideline. If so, give justification in field "Rationale for reliability incl. deficiences" as to why this study summary is considered reliable.

Enter any conclusions if applicable.

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.

Enter a full short description of the most relevant endpoint data. This includes in principle the summary information that is compiled e.g. in the OECD Full SIDS Summary format or other endpoint summary formats. Provide only the most relevant details, which could be, depending on the cases, the test guideline used, test organism and exposure duration. Normally no reliability score needs to be indicated as it can be assumed that the studies identified are valid (reliability score 1 or 2). If this is not the case (for instance if the reliability of a published study cannot be assigned or if several less valid studies are used for a weight of evidence analysis), the reliability indicators should be specified.

Also several key studies can be referenced as applicable. However, the characterisation of the endpoint data should be kept as concise as possible. Examples of what could be entered here are as follows:

- Melting point: 54.6-55.8 °C at 1,013 hPa

- Water solubility: completely miscible

- pH: 6.9 (80 mg/l water) at 20°C (OECD TG105)

- Oxidation reduction potential: no data available

- Phototransformation in air: T1/2 = 9.32 x 10-2 yr (sensitizer: OH radical) (AOP Win v 1.86)

- Biodegradation in water: screening tests: Not readily biodegradable: 0 - 8% (BOD) in 28 days, 0 - 1% (HPLC) in 28 days (OECD TG 301C)

- Short-term toxicity to fish:

LC50 (96h) < 100 mg/l for Pimephales promelas (OECD TG 203)

LC50 (48h) = 3.2 mg/l for Oryzias latipes (OECD TG 203)

- Acute toxicity:

Dermal: LD50: > 2,000 mg/kg for rat (limit test)

- Genetic toxicity:

In vitro:

Gene mutation (Bacterial reverse mutation assay / Ames test): S. typhimurium TA 100: positive with and without metabolic activation; TA 1535: positive without metabolic activation (equivalent to OECD TG 471)

The field(s) under this heading (if provided) can be optionally completed in order to specify the key parameter(s) that may subsequently be used in the chemical safety assessment, classification and labelling or other. In order to enable the use of any specific software, only a minimum number of structured and hence, searchable fields are provided, in many cases only one.

Key parameters are intended to condense the data summarised in field "Full short description of relevant endpoint data" to one single numeric value or concluding remark (e.g. negative / positive) chosen from a drop-down list. Where a numeric field is provided, only a clear value can be entered, that is, no range and no less than or greater than qualifiers. Conversion to a predefined unit as indicated in the field label (e.g. mg/L) may be required.

If the key value is no clear number, but a range or preceded by <, <=, >, or >=, you may either leave this field empty or make up a value you consider most appropriate for the intended subsequent purpose. The rationale for any user-derived values should be described in field "Discussion" for the sake of transparency. Some non-exhaustive examples of user-derived parameters are as follows:

- Aquatic short-term L(E)C50 >100 mg/L (e.g. because only tested up to water solubility of the substance): it may be appropriate to assume 100 mg/L as worst case value.

- Aquatic long-term LOEC 1 mg/L (>10 and <20% effect): calculate NOEC as LOEC/2 and enter 0.5 mg/L in the field for NOEC.

- Acute oral LD50 >2000 mg/kg b.w. (because no LD50 was achieved in a limit test): enter 2000 mg/kg b.w.

In this rich text field, describe the assessment you have made for the given endpoint. Provide the rationale for the choice of the key study(ies) and the choice of the key parameter that, according to your judgement, characterise the endpoint. This includes a discussion of the key information identified and in some instances of studies which are considered to be unreliable, but give critical results. A discussion as to why they were discarded in favour of other studies should then be included. Vice versa, a weight of evidence analysis based on less reliable data or use of published data, the reliability of which cannot be judged because of limited reporting, should be justified.

If several studies were identified to be relevant for the assessment, discuss possible reasons for differing results if any, e.g. differences in purity / impurities of the test substance used, differences in the methods and test conditions, etc.

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.

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 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).

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.

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

ONLY if another substance, i.e. analogue or surrogate (e.g. degradation/transformation product) was used as test material, enter any relevant details on the properties of this substance that may possibly affect the test performance, particularly physico-chemical properties.

Use freetext template and delete/add elements as appropriate.

Note that the physico-chemical properties of the substance for which the submission is made should be recorded in the corresponding templates and therefore need not be repeated here. Nevertheless, the possible influence of any physico-chemical properties should be indicated / discussed in appropriate fields, particularly in fields "Details on test conditions" and "Details on results". This holds also true if any property of the substance is different in the test medium as compared to the data recorded in the section on physico-chemical properties, e.g. lower water solubility.

Indicate whether test substance was monitored in the test solutions.

For robust study summaries or as requested by the regulatory programme, provide further details on sampling and analytical methods in the corresponding freetext fields.

If the amount of test material exposed to the organisms was monitored, enter details on sampling. Use freetext template as appropriate and delete/add elements as appropriate.

Enter any details that could be relevant for evaluating this study summary. Use freetext template as appropriate.

Indicate whether vehicle was used to emulsify or mix the experimental test material to enhance its solubility.

Enter any details that could be relevant for evaluating this study summary. For tests with honeybees use freetext template and delete/add elements as appropriate. For other tests briefly describe the method of preparation and application of the test material indicating the most relevant details.

Select species from picklist. If not available, select "other" and enter name of organism (species).

Note that studies with terrestrial arthropods should be recorded using the template "Toxicity to terrestrial arthropods".

Enter any details that could be relevant for evaluating this study summary. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.

Indicate the study type, i.e. laboratory study, extended laboratory study (e.g. with a more natural substrate), semi-field study (mimicing a near-natural environment with ambient climatic conditions) or field study (using natural populations).

Indicate if the experiment was a limit test.

Include numeric value and unit of duration in the respective subfields. Any range reported because several test runs were summarised or any relevant remark should be entered in subfield "Remarks".

Indicate the post-observation period (with unit) if appropriate, e.g. in the case of a reproduction test.

Indicate test temperature values measured in the treatment and control vessels during test. Include range, mean, standard deviation and unit. As applicable indicate the life-stage in parentheses if different temperatures were used e.g. in case of predator and parasite studies. Example: 20+/-1°C (adults), 25+/-1.5°C (larval exposure), 18+/-1°C (pupal development), 25+/-1°C (fecundity).

Alternatively refer to table (e.g. "see table no. 2") if the test conditions are presented in tabular form in the rich text editor field.

Indicate the relative humidity of the experimental room during the test measured in the treatment and control vessels. Include range, mean, standard deviation and unit. As applicable indicate the life-stage in parentheses if different humidities were used e.g. in case of predator and parasite studies.

Alternatively refer to table (e.g. "see table no. 2") if the test conditions are presented in tabular form in the rich text editor field.

Indicate the photoperiod and lighting intensity in the experimental room during the test measured in the treatment and control vessels. Include range, mean, standard deviation and unit. As applicable indicate the life-stage in parentheses if different lighting conditions were used e.g. in case of predator and parasite studies.

Alternatively refer to table (e.g. "see table no. 2") if the test conditions are presented in tabular form in the rich text editor field.

List nominal and, if available, measured test concentrations (with unit). As appropriate tabulate nominal vs. measured concentrations and refer to Table No. (use predefined table if any).

Provide any other relevant details on test conditions.

Indicate if a positive control was tested, i.e. a reference substance with known toxicity. If yes, include the identity of the substance(s) and the concentrations in the supplementary remarks field.

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.

Report the EC50, NOEC or other effect levels. Copy this field block for entering more than one effect level if necessary.

Briefly summarize relevant observations and any dose response relationship. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.

For acute oral tests with honeybees, provide information about palatability of the treated diet, rate of consumption of diet in treated and untreated groups.

Include table(s) with raw data in the rich text field "Any other information on results incl. tables". Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the text (e.g. "... see Table 1").

Note: Specific tables may be required. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

If reference substance(s) was/were tested, indicate whether the results with it/them are valid and provide relevant effect levels and other relevant information.

Use freetext template and delete/add elements as appropriate.

Indicate the parameters analysed, the statistical method used and the statistical test performed. If probit analysis was used, indicate the intercept and probit slope. As appropriate state any relevant error estimates associated with the determination of concentration-response relationship.

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.

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.

Indicate whether validity criteria given by test guideline have been fulfilled or not. Use supplementary remarks field for indicating the criteria and entering remarks. Clearly indicate if the criteria used are not consistent with those given by the test guideline. If so, give justification in field "Rationale for reliability incl. deficiences" as to why this study summary is considered reliable.

Enter any conclusions if applicable.

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.