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 "Test performance". 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.

If the photodegradation was estimated, e.g. the photochemical reaction with OH radicals, include details on the computational method used. Use freetext template as appropriate. As an alternative option, attach a document e.g. excerpt from the study report.

Record the estimated half-life under "Dissipation half-life of parent compound" in the Results section.

Guidance on freetext template:

- Concentration of OH radicals: e.g. "50000 molecules/cm³"

- Degradation rate constant: e.g. "18.3 x 10E-12 cm³/(molecule*sec)"

- Temperature for which rate constant was calculated: e.g. "25 °C"

- Computer programme: e.g. "EPIWIN, part AOPWIN v.1.90. (2000)" or "AOP based on SAR methods developed by Atkinson"

Select light source used.

Include wavelength (in nm) range of the indicated light source. Not applicable if light source is sunlight.

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

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

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

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

Include the relative intensity of light based on sunlight or its range as appropriate.

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

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

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

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

Enter any relevant details on the light source. Use either of the two freetext templates as appropriate. As an alternative option, attach a document e.g. excerpt from the study report.

Briefly describe the experimental set-up and procedure used.

Indicate the test duration, temperature and initial test substance concentration at which test was conducted. If test runs with different conditions and durations were performed, copy this block of fields as appropriate.

Indicate if test(s) with a substance with known photolysis was performed. If yes, report the identity of the substance 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.

Describe results from preliminary study performed, if any (e.g., adsorption of test material to the walls of the test container).

Report on any unusual observations during test, deviations from test procedure or any other information affecting results.

Select spectral parameter from picklist and enter value in the subsequent subfield. Any notes can be included in subfield "Remarks". Repeat field for each parameter cited in the study report.

If the substance absorbs light at wavelengths >295 nm, give the wavelength (lambda value) of maximum absorption at wavelengths >295 nm and the maximum molar absorption (extinction) coefficient (epsilon value). If there is no absorption maximum at >295 nm, give the molar extinction coefficient at 295 nm. An alternative to the above is to attach a file that depicts graphically or in tabular form the complete UV/VIS absorption spectrum (include reference to respective Figure or Table No. in subfield "Remarks").

Specify percentage of degradation or range and sampling time. Copy this block of fields for recording results at different test conditions.

Give the reaction quantum yield of the test substance (values between 0 and 1).

Provide the half-life / DT50 or range as appropriate. Copy this block of fields for recording results at different test conditions.

Indicate whether transformation products occurred. If yes, provide the identified transformation products in following block of fields. Any further details can be entered in field "Any other information on results incl. tables".

Indicate the identity of the transformation products using an appropriate identifier, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields for each relevant substance.

Any further details on transformation products can be provided in field "Any other information on materials and methods incl. tables".

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

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

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

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

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.

Indicate if labelled or non-labelled test material was used. Details on labelled material to be described in field "Details on test material".

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

Note that any information that can be claimed confidential should be included in the subsequent field "Confidential details on test material".

Explanations:

- Name of test material (as cited in study report): only if different from any other identifiers provided in the preceding fields.

- Molecular formula (if other than submission substance): specify

- Molecular weight (if other than submission substance): specify

- Smiles notation (if other than submission substance): provide if available

- InChl (if other than submission substance): provide if available

- Structural formula attached as image file (if other than submission substance): see Fig.: only if different from submission substance. Indicate Fig. no. if a file is attached in field "Attached document", e.g. state "see Fig. 1".

- Substance type: indicate whether pure active substance, technical product, formulation or other.

- Physical state: indicate "gas", "solid" or "liquid" only if different from submission substance or if substance can occur in different physical states.

- Analytical purity: specify in %

- Impurities (identity and concentrations): specify

- Composition of the test material, percentage of components: specify if applicable

- Isomers composition: specify if applicable

- Purity test date: provide if available

- Lot/batch No.: provide if available

- Expiration date of the lot/batch: provide if available

- Radiochemical purity (if radiolabelling): specify if applicable

- Specific activity (if radiolabelling): specify if applicable

- Locations of the label (if radiolabelling): specify if applicable

- Expiration date of radiochemical substance (if radiolabelling): specify if applicable

- Storage condition of test substance: specify if applicable

- Stability under test conditions: indicate if available

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 "Test performance". 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.

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.

Enter details on sampling regime and method. Use freetext template as appropriate.

If the amount of test material in the test solutions was monitored, enter any details on the analytical methods used. Use freetext template and delete/add elements as appropriate. Copy any subheading(s) under IDENTIFICATION AND QUANTIFICATION OF PARENT COMPOUND to include the respective information for transformation products.

Give details on the buffer(s) used for each nominal pH tested; copy any subheading(s) as appropriate for indicating buffers at different pH values. Use freetext template and delete/add elements as appropriate.

If an estimation method was used, describe relevant details and input parameters and/or indicate the computer programme used.

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.

If an estimation method was used, describe relevant details and input parameters and/or the computer programme used in field "Principles of method if other than guideline".

Indicate the test duration, pH and temperature condition and initial test substance concentration at which test was conducted. Copy this block of fields for different test conditions as appropriate.

Indicate the number of replicates tested. If different at the different test runs, specify for each pH and temperature.

Indicate if a positive control (test with a substance with known hydrolysis) was performed. If yes, report the identity of the substance in the supplementary remarks field.

Indicate if a negative control (test with a stable substance) was performed. If yes, report the identity of the substance in the supplementary remarks field.

Enter details on statistical methods used to interprete the results.

In this field, you can enter any information on materials and methods, for which no distinct field is available, or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.

Describe results from preliminary study performed, if any (e.g., adsorption of test material to the walls of the test container).

Report on any unusual observations during test, deviations from test procedure or any other information affecting results.

Indicate whether transformation products occurred. If yes, provide the identified transformation products in following block of fields. Any further details can be entered in field "Any other information on results incl. tables".

Indicate the identity of the transformation products using an appropriate identifier, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields for each relevant substance.

Any further details on transformation products can be provided in field "Any other information on materials and methods incl. tables".

Indicate the hydrolysis of the test material and appearance of transformation products, expressed as percentage of the parent substance or applied radioactivity. Use freetext template and delete/add items as appropriate.

Particularly with comprehensive data include a table 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").

If useful attach a figure in field "Attached background material".

For each pH and temperature condition, indicate the total recovery in % of initial concentration (with standard deviation) or range if reported so. Copy this block of fields as necessary.

Indicate the half-lives measured at different pH values and temperature as well as the extrapolated results for 25 degrees Celsius where applicable. Copy this block of fields for each test condition as appropriate.

For robust study summaries or as requested by the regulatory programme, fill in also subfields "Regression equation and r²" and "DT90" (with unit) if available.

Describe any other kinetic paramaters, if relevant.

Indicate any further relevant details of test results. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.

TEST CONDITIONS: If the test conditions were not maintained, describe any anomalies or problems encountered.

MAJOR / MINOR TRANSFORMATION PRODUCTS: Indicate concentration ranges of the transformation products specified in the defined field "Identity of transformation products" or specify if no major transformation products were detected. Tabulate comprehensive data and refer to respective table no. (use predefined table if any) or other appropriate table. Distinguish between dark and irradiated samples; compare the transformation products formed in the dark and irradiated samples, and identify and quantify the products that are formed by phototransformation only.

As appropriate attach Figure showing the pathway of phototransformation of the test substance.

SUPPLEMENTARY EXPERIMENT: Briefly describe the results of the supplementary experiment, if any.

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

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

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

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 whether direct or indirect photolysis was studied. Note: Any model calculation should be indicated in field "Test result 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.

Indicate if labelled or non-labelled test material was used. Details on labelled material to be described in field "Details on test material".

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

Note that any information that can be claimed confidential should be included in the subsequent field "Confidential details on test material".

Explanations:

- Name of test material (as cited in study report): only if different from any other identifiers provided in the preceding fields.

- Molecular formula (if other than submission substance): specify

- Molecular weight (if other than submission substance): specify

- Smiles notation (if other than submission substance): provide if available

- InChl (if other than submission substance): provide if available

- Structural formula attached as image file (if other than submission substance): see Fig.: only if different from submission substance. Indicate Fig. no. if a file is attached in field "Attached document", e.g. state "see Fig. 1".

- Substance type: indicate whether pure active substance, technical product, formulation or other.

- Physical state: indicate "gas", "solid" or "liquid" only if different from submission substance or if substance can occur in different physical states.

- Analytical purity: specify in %

- Impurities (identity and concentrations): specify

- Composition of the test material, percentage of components: specify if applicable

- Isomers composition: specify if applicable

- Purity test date: provide if available

- Lot/batch No.: provide if available

- Expiration date of the lot/batch: provide if available

- Radiochemical purity (if radiolabelling): specify if applicable

- Specific activity (if radiolabelling): specify if applicable

- Locations of the label (if radiolabelling): specify if applicable

- Expiration date of radiochemical substance (if radiolabelling): specify if applicable

- Storage condition of test substance: specify if applicable

- Stability under test conditions: indicate if available

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 "Test performance". 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.

Indicate which method was used. Copy field for more than one method. If not available from picklist, select "other" and specify.

Enter details on sampling regime and method. Use freetext template as appropriate.

If the amount of test material in the test solutions was monitored, enter any details on the analytical methods used. Use freetext template and delete/add elements as appropriate. Copy any subheading(s) under IDENTIFICATION AND QUANTIFICATION OF PARENT COMPOUND to include the respective information for transformation products.

Using freetext template give details on the buffer(s) used for each nominal pH tested; copy any subheading(s) as appropriate for indicating buffers at different pH values.

Select light source used.

Include wavelength (in nm) range of the indicated light source. Not applicable if light source is sunlight.

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

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

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

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

Include the relative intensity of light based on sunlight or its range as appropriate.

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

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

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

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

Enter any relevant details on the light source. Use either of the two freetext templates as appropriate. As an alternative option, attach a document e.g. excerpt from the study report.

Only in the case of an indirect photolysis study indicate what sensitiser was used. For (simulated) natural water or other, give details e.g. on source, pH, dissolved substances e.g. humic acids etc. in subfield "Details on sensitiser". Include concentration (range).

Copy this block of fields as appropriate.

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 test duration, temperature and initial test substance concentration at which test was conducted. If test runs with different conditions and durations were performed, copy this block of fields as appropriate.

Indicate if test(s) with a substance with known photolysis was performed. If yes, report the identity of the substance in the supplementary remarks field.

Indicate if dark, i.e. negative controls were used in parallel studies. Remarks can be included in the supplementary remarks field.

Enter details on computational methods used to calculate relevant parameters. Use freetext template as appropriate. As an alternative option, attach a document e.g. excerpt from the study report.

In this field, you can enter any information on materials and methods, for which no distinct field is available, or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.

Describe results from preliminary study performed, if any (e.g., adsorption of test material to the walls of the test container).

Report on any unusual observations during test, deviations from test procedure or any other information affecting results.

Select spectral parameter from picklist and enter value in the subsequent subfield. Any notes can be included in subfield "Remarks". Copy block of fields for each parameter cited in the study report.

If the substance absorbs light at wavelengths >295 nm, give the wavelength (lambda value) of maximum absorption at wavelengths >295 nm and the maximum molar absorption (extinction) coefficient (epsilon value). If there is no absorption maximum at >295 nm, give the molar extinction coefficient at 295 nm. An alternative to the above is to attach a file that depicts graphically or in tabular form the complete UV/VIS absorption spectrum (include reference to respective Figure or Table No. in subfield "Remarks").

Specify percentage of degradation or range and sampling time. Copy this block of fields for recording results at different test conditions.

For direct photolysis only, give the reaction quantum yield of the test substance (values between 0 and 1).

For indirect photolysis only, give photolysis rate constant or range.

Provide the half-life / DT50 for phototransformation (difference between the irradiated and dark samples) or range as appropriate. Copy this block of fields for recording results at different test conditions.

Include the predicted environmental photolytic half-life derived from the measured half-life in a sterile buffer solution, if provided. State for which latitude, time of day, season, location etc. the estimation was made.

Indicate whether transformation products occurred. If yes, provide the identified transformation products in following block of fields. Any further details can be entered in field "Any other information on results incl. tables".

Indicate the identity of the transformation products using an appropriate identifier, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields for each relevant substance.

Any further details on transformation products can be provided in field "Any other information on materials and methods incl. tables".

Indicate any further relevant details of test results. Use freetext template and delete/add elements as appropriate. As appropriate or requested by the regulatory programme 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").

Explanations on freetext prompts:

TEST CONDITIONS: If the test conditions were not maintained, describe any anomalies or problems encountered.

HALF-LIFE: Include a table with detailed results for dark and irradiated samples including Regression equation, r²" and DT90 if available.

MAJOR / MINOR TRANSFORMATION PRODUCTS: Indicate concentration ranges of the transformation products specified in the defined field "Identity of transformation products" or specify if no major transformation products were detected. Tabulate comprehensive data and refer to respective table no. (use predefined table if any) or other appropriate table. Distinguish between dark and irradiated samples; compare the transformation products formed in the dark and irradiated samples, and identify and quantify the products that are formed by phototransformation only.

As appropriate attach Figure showing the pathway of phototransformation of the test substance.

SUPPLEMENTARY EXPERIMENT: Briefly describe the results of the supplementary experiment, if any.

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

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

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

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

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.

Indicate if labelled or non-labelled test material was used. Details on labelled material should be described in field "Details on test material".

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

Note that any information that can be claimed confidential should be included in the subsequent field "Confidential details on test material".

Explanations:

- Name of test material (as cited in study report): only if different from any other identifiers provided in the preceding fields.

- Molecular formula (if other than submission substance): specify

- Molecular weight (if other than submission substance): specify

- Smiles notation (if other than submission substance): provide if available

- InChl (if other than submission substance): provide if available

- Structural formula attached as image file (if other than submission substance): see Fig.: only if different from submission substance. Indicate Fig. no. if a file is attached in field "Attached document", e.g. state "see Fig. 1".

- Substance type: indicate whether pure active substance, technical product, formulation or other.

- Physical state: indicate "gas", "solid" or "liquid" only if different from submission substance or if substance can occur in different physical states.

- Analytical purity: specify in %

- Impurities (identity and concentrations): specify

- Composition of the test material, percentage of components: specify if applicable

- Isomers composition: specify if applicable

- Purity test date: provide if available

- Lot/batch No.: provide if available

- Expiration date of the lot/batch: provide if available

- Radiochemical purity (if radiolabelling): specify if applicable

- Specific activity (if radiolabelling): specify if applicable

- Locations of the label (if radiolabelling): specify if applicable

- Expiration date of radiochemical substance (if radiolabelling): specify if applicable

- Storage condition of test substance: specify if applicable

- Stability under test conditions: indicate if available

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 "Test performance". 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.

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.

Indicate which method was used. Copy field for more than one method. If not available from picklist, select "other" and specify.

Enter details on sampling regime and method. Use freetext template as appropriate.

If the amount of test material in the test solutions was monitored, enter any details on the analytical methods used. Use freetext template and delete/add elements as appropriate. Copy any subheading(s) under IDENTIFICATION AND QUANTIFICATION OF PARENT COMPOUND to include the respective information for transformation products.

Using freetext template give details on the soil used. As an alternative option, attach a document e.g. excerpt from the study report.

Note: If applicable, indicate the title and year of the soil classification system used after the respective prompt, i.e. Canadian System of Soil Classification / DIN 19863 (Deutsche Industrie-Norm) / NF X31-107 (Norme francaise) / USDA (US Department of Agriculture) / WRB (World Reference Base for Soil Resources) / or other (to be specified).

Select light source used.

Include wavelength (in nm) range of the indicated light source. Not applicable if light source is sunlight.

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

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

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

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

Include the relative intensity of light based on sunlight or its range as appropriate.

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

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

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

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

Enter any relevant details on the light source. Use either of the two freetext templates as appropriate. As an alternative option, attach a document e.g. excerpt from the study report.

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 test duration and % moisture, temperature and initial test substance concentration at which test was conducted. If test runs with different conditions and durations were performed, copy this block of fields as appropriate.

Indicate if test(s) with a substance with known photolysis was performed. If yes, report the identity of the substance in the supplementary remarks field.

Indicate if dark, i.e. negative controls were used in parallel studies. Remarks can be included in the supplementary remarks field.

Enter details on computational methods used to calculate relevant parameters.

In this field, you can enter any information on materials and methods, for which no distinct field is available, or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.

Describe results from preliminary study performed, if any (e.g., adsorption of test material to the walls of the test container).

Report on any unusual observations during test, deviations from test procedure or any other information affecting results.

Select spectral parameter from picklist and enter value in the subsequent subfield. Any notes can be included in subfield "Remarks". Copy block of fields for each parameter cited in the study report.

If the substance absorbs light at wavelengths >295 nm, give the wavelength (lambda value) of maximum absorption at wavelengths >295 nm and the maximum molar absorption (extinction) coefficient (epsilon value). If there is no absorption maximum at >295 nm, give the molar extinction coefficient at 295 nm. An alternative to the above is to attach a file that depicts graphically or in tabular form the complete UV/VIS absorption spectrum (include reference to respective Figure or Table No. in subfield "Remarks").

Specify percentage of degradation or range and sampling time. Copy this block of fields for recording results at different test conditions.

Give the reaction quantum yield of the test substance (values between 0 and 1).

Provide the half-life / DT50 or range as appropriate. Copy this block of fields for recording results at different test conditions.

Indicate whether transformation products occurred. If yes, provide the identified transformation products in following block of fields. Any further details can be entered in field "Any other information on results incl. tables".

Indicate the identity of the transformation products using an appropriate identifier, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields for each relevant substance.

Any further details on transformation products can be provided in field "Any other information on materials and methods incl. tables".

Indicate any further relevant details of test results. Use freetext template and delete/add elements as appropriate. As appropriate or requested by the regulatory programme 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").

Explanations on freetext prompts:

TEST CONDITIONS: If the test conditions were not maintained, describe any anomalies or problems encountered.

HALF-LIFE: Include a table with detailed results for dark and irradiated samples including Regression equation, r²" and DT90 if available.

MAJOR / MINOR TRANSFORMATION PRODUCTS: Indicate concentration ranges of the transformation products specified in the defined field "Identity of transformation products" or specify if no major transformation products were detected. Tabulate comprehensive data and refer to respective table no. (use predefined table if any) or other appropriate table. Distinguish between dark and irradiated samples; compare the transformation products formed in the dark and irradiated samples, and identify and quantify the products that are formed by phototransformation only.

As appropriate attach Figure showing the pathway of phototransformation of the test substance.

SUPPLEMENTARY EXPERIMENT: Briefly describe the results of the supplementary experiment, if any.

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

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

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

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