ADMINISTRATIVE DATA

REMARKS:

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 may therefore be displayed on top of each template. For detailed guidance, refer to Administrative data.

SE06.02.00.0215

DATA SOURCE

[DATA SOURCE]

Main heading under which generic 'Data source' fields are subsumed.

SE06.02.00.0219

Reference

[Reference]

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

Heading of field block 'Reference'

SE06.02.00.0220

Reference type

[Reference type]

Picklist Values:

study report || other company data || publication || review article or handbook || secondary source || grey literature || other:

Indicate the type of reference, e.g. 'Study report' or 'Publication'. Select 'Other company data' to characterise any unpublished information from a company other than a study report. Select 'Grey literature' for any other unpublished information or 'other:' and specify.

Indicator specifying the type of reference, e.g. 'Study report' or 'Publication'.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE06.02.00.0221

Reference type

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE06.02.00.0230

Author(s) (or transferred reference)

[Author]

For ease of sorting and searchability use following convention: Surname, Initial (Example 1: White D, Ruehl KJ, Borman SA & Little J. Example 2: Hartley M & Murray W (avoid unnecessary full-stops, commas)). If no individuals are cited as authors, enter name of company or organisation or 'Anon.' as appropriate.

Note that the complete bibliographic reference may appear in this field after migration of unstructured data from existing databases.

Name(s) of author(s) of the study report or publication.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE06.02.00.0240

Year

[Year]

Enter year of study report or publication. For a study report this field should be completed to include it in any searches, regardless of whether the complete date is given in field 'Report date'.

Year of the study report or publication.

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<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE06.02.00.0250

Title

[Title]

Include the title of the report. For publications, include the title of the article of a journal or article/chapter of a book (e.g. handbook).

Title of a study report or title of published article of journal or book (e.g. handbook).

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<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE06.02.00.0260

Bibliographic source

[Bibliographic source]

Not relevant for any study report. For publications or any other literature source (grey literature) specify the following type of information: (i) Title of scientific journal or book (e.g. if handbook); (ii) Volume of journal; (iii) Editor, publisher, place of publication for books or articles in books; (iv) Pagination.

Example 1 (journal): J. Agric. Food Chem. 38: 215-227

Example 2 (handbook): In: Lyman WJ (ed.) Handbook of chemical property estimation methods. Environmental behavior of organic compounds. McGraw-Hill Book Company 15.1-15.34, New York.

Bibliographic source of the study report or publication.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE06.02.00.0270

Testing laboratory

[Testing laboratory]

Either manually enter the name of the testing laboratory or select it from the picklist. In either case, editing is possible.

Name of the testing laboratory.

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<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE06.02.00.0280

Report no.

[Report no.]

Specify the report number allocated by the testing laboratory. Note that any company-specific study number should be included in the respective field.

Report number allocated by the testing laboratory.

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<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE06.02.00.0290

Owner company

[Owner company]

Either manually enter the identity of the company who owns the data or select it from the picklist. In either case, editing is possible.

Identity of the sponsor company who owns the study report.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE06.02.00.0300

Company study no.

[Company study no.]

Specify any company study no. if there is such a number and if it is different from the report no. of the testing laboratory. Otherwise leave field empty.

Company-specific study number.

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<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE06.02.00.0310

Report date

[Report date]

Specify the complete date of the study report, e.g. '2005-05-12' for 12 May 2005. Note that subfield 'Year' should be completed in any case for sorting and searching purposes.

Complete date of the study report.

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<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE06.02.00.0320

Data access

[Data access]

Picklist Values:

data submitter is data owner || data submitter has Letter of Access || data no longer protected || data published || not applicable || other:

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.

Indication for data access.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE06.02.00.0321

Data access

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE06.02.00.0330

Data protection claimed

[Data protection claimed]

Picklist Values:

yes || yes, but willing to share || yes, but not willing to share

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')

Indication if data protection is claimed by the submitter who has to be data owner or have letter of access.

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<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE06.02.00.0331

Data protection claimed

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE06.02.00.0340

Cross-reference to same study

[Cross-reference to same study]

A cross-reference can be included to indicate that the same study is recorded in another record. Indicate the respective chapter and record ID and enter relevant explanatory text. This may be useful if specific endpoints of a given study are described in another chapter (e.g. results on reproduction toxicity in case of a combined repeated dose / reproduction toxicity study) or if more than one experiment is described by the same study report, but included in separate records.

Check with the relevant guidance document whether all the methodology details must be repeated or whether a cross-reference to the same study in another chapter may suffice.

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

Indication that the same study is described in another study summary / chapter of the data set.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.02.00.0345

MATERIALS AND METHODS

[Materials and methods]

Main heading under which generic 'Materials and methods' fields are subsumed.

SE06.02.00.0349

Test guideline

[Test guideline]

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

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

Heading of field block 'Guideline'

SE06.02.00.0350

Qualifier

[Qualifier]

Picklist Values:

according to || equivalent or similar to || no guideline followed || no guideline available || no guideline required

Select appropriate qualifier, i.e.

- 'according to' (if a given test guideline was followed);

- 'equivalent or similar to' (if no test guideline was explicitly followed, but the methodology is equivalent or similar to a specific guideline);

- 'no guideline followed' (if none of above qualifiers apply. If so, fill in field 'Principles of method if other than guideline');

- 'no guideline available/required' (if applicable; fill in field 'Principles of method if other than guideline').

An indicator signifying how strict the guideline given in the subsequent field 'Guideline' was followed or whether no guideline was used or available/required.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE06.02.00.0360

Guideline

[Guideline]

Picklist Values:

OECD Guideline 218 (Sediment-Water Chironomid Toxicity Test Using Spiked Sediment) || OECD Guideline 219 (Sediment-Water Chironomid Toxicity Test Using Spiked Water) || OECD Guideline 225 (Sediment-Water Lumbriculus Toxicity Test Using Spiked Sediment) || EPA OPPTS 850.1735 (Whole Sediment Acute Toxicity of Invertebrates, freshwater) || EPA OPPTS 850.1740 (Whole Sediment Acute Toxicity of Invertebrates, marine) || EPA OPPTS 850.1790 (Chironomid Sediment Toxicity Test) || EPA OPPTS 850.1800 (Tadpole/Sediment Subchronic Toxicity Test) || EPA OTS 795.1350 (Chironomid Sediment Toxicity Test) || EPA OTS 797.1995 (Tadpole/Sediment Subchronic Toxicity Test) || ASTM E1367-92 (10-day Static Sediment Toxicity Test (Media: Sediment-marine)) || ASTM E1367-92 (10-day Static Sediment Toxicity Test (Media: Sediment-estuarine)) || ASTM E1383-94 (Sediment Toxicity Test (Media: Sediment-freshwater)) || ASTM E1525-94a (Sediment Toxicity Test) || ASTM E1611-94 (Sediment Toxicity Test (Media: Sediment-marine)) || ASTM E1611-94 (Sediment Toxicity Test (Media: Sediment-estuarine)) || ASTM E1688-96 (Sediment Toxicity Test (Media: Sediment-freshwater)) || ASTM E1688-96 (Sediment Toxicity Test (Media: Sediment-marine)) || ASTM E1706-95b (Sediment Toxicity Test (Media: Sediment-freshwater)) || ASTM E1706-04 (Test Method for Measuring the Toxicity of Sediment-Associated Contaminants with Freshwater Invertebrates) || other guideline:

Select the applicable test guideline, e.g. 'OECD Guideline xxx'. If the test guideline used is not listed, choose 'other guideline:' and specify the test guideline in the related text field.

In this text field, you can also enter any remarks as applicable, particularly:

- To include any other title of the test guideline draft used, a subtitle, another version or update number and the year of update (For instance, different titles and/or numbers may exist for a given EU test guideline.);

- To indicate if a the study was performed prior to the adoption of the test guideline specified;

- To indicate if the methodology used was based on an extension of the test guideline specified.

An indicator signifying how strict the guideline given in the subsequent field 'Guideline' was followed or whether no guideline was used or available/required.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE06.02.00.0361

Guideline

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE06.02.00.0370

Deviations from guideline

[Deviations]

Picklist Values:

yes || no || no data || not applicable

For robust study summaries or as requested by the regulatory programme, indicate if there are any deviations from the test guideline specified. If 'yes' is selected, only briefly state relevant deviations in the supplementary remarks field (e.g. 'other species used'); details should be described in the respective fields of the section MATERIALS AND METHODS.

Indication that a study contains deviations from the standard test protocol.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE06.02.00.0371

Deviations from guideline

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE06.02.00.0380

Principles of method if other than guideline

[Principles of method if other than guideline]

If no guideline was followed, include a description of the principles of the test protocol or estimated method used in the study. Details should be entered in appropriate distinct fields of section MATERIALS AND METHODS if available. Also provide a justification for using this method if appropriate.

If an estimation method was used (to be indicated in field 'Test result type') state the equation(s) and/or computer software or other methods applied to calculate the value(s).

Description of the test protocol or estimated method used in the study, if other than a guideline, and justification for using this method if appropriate.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE06.02.00.0390

GLP compliance

[GLP compliance]

Picklist Values:

yes (incl. certificate) || yes || no || no data

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.

Indication whether a GLP certificate or compliance statement is available.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE06.02.00.0391

GLP compliance

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE06.02.00.0395

Test materials

[Test materials]

Subheading of section 'Test materials'

SE06.02.00.0400

Test material equivalent to submission substance identity

[Identity of test material same as for substance defined in section 1 (if not read across)]

Picklist Values:

yes || no

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'.

Indicator showing whether the test material used is equivalent to the submission substance identity.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE06.02.00.0409

Test material identity

[Test material identity]

If the identity of the test material used for this study is not included in this block of fields automatically, indicate the identity for one or more appropriate identifiers, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields as appropriate.

If another than the submission substance identity was selected erroneously, go back to field 'Test material equivalent to submission substance identity' and select 'yes'. This will prompt automatic entry of the respective identifiers.

Heading of field block 'Test material identity'

SE06.02.00.0410

Identifier

[Identifier]

Picklist Values:

CAS name || CAS number || Common name || EC name || EC number || IUPAC name || TSCA name || other:

Select an appropriate identifier from drop-down list, e.g. 'CAS number'. Use 'Other:' and specify, if identity according to a standard identifier is not known or if an additional chemical name or number is provided.

Indicator specifying the type of chemical identifier, e.g. CAS name.

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<i5:EC_SEDIMENTDWELLINGTOX>

<i5:TESTMAT>

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<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE06.02.00.0411

Identifier

[no label]

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<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE06.02.00.0420

Identity

[Identity]

Select the corresponding substance identity from drop-down list or enter manually if the identity is not available from the list or if no list is provided for the type of identifier selected.

Identity of the chemical substance used in the study or referred to in the record.

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<i5:EC_SEDIMENTDWELLINGTOX>

<i5:TESTMAT>

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<i5:ID>

<i5:ID>

SE06.02.00.0430

Details on test material

[Details on test material]

Freetext Templates:

- Name of test material (as cited in study report):

- Molecular formula (if other than submission substance):

- Molecular weight (if other than submission substance):

- Smiles notation (if other than submission substance):

- InChl (if other than submission substance):

- Structural formula attached as image file (if other than submission substance): see Fig.

- Substance type:

- Physical state:

- Analytical purity:

- Impurities (identity and concentrations):

- Composition of test material, percentage of components:

- Isomers composition:

- Purity test date:

- Lot/batch No.:

- Expiration date of the lot/batch:

- Radiochemical purity (if radiolabelling):

- Specific activity (if radiolabelling):

- Locations of the label (if radiolabelling):

- Expiration date of radiochemical substance (if radiolabelling):

- Stability under test conditions:

- Storage condition of test material:

- Other:

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

Details on description and specification of the actual test material.

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<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.02.00.0440

Confidential details on test material

[Confidential details on test material]

Freetext Templates:

- Analytical purity:

- Impurities (identity and concentrations):

- Composition of test material, percentage of components:

- Purity test date:

- Lot/batch No.:

- Expiration date of the lot/batch:

- Isomers composition:

- Other:

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

Confidential details on the actual test material.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.02.00.0450

Details on properties of test surrogate or analogue material

[Details on properties of test surrogate or analogue material]

Freetext Templates:

PHYSICO-CHEMICAL PROPERTIES

- Melting point:

- Boiling point:

- Vapour pressure:

- Water solubility (under test conditions):

- Henry's law constant:

- log Pow:

- pKa:

- Stability in water:

- Stability in sediment:

- Kd/Koc (if available):

- Stability in light:

- pH dependence on stability:

OTHER PROPERTIES (if relevant for this endpoint)

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.||CHR(10)||Use freetext template and delete/add elements as appropriate.||CHR(10)||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.

Details on properties of test material, particularly physico-chemical properties. Relevant if an analogue or surrogate was used.

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<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:PROPERTIES_TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.02.00.0460

Analytical monitoring

[Analytical monitoring]

Picklist Values:

yes || no || no data || not required

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.

Indicator that instrumental analyses were applied to detect the precise amount of chemical exposed to the organisms throughout the experiment.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:ANALYT_MONIT>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE06.02.00.0470

Details on sampling

[Details on sampling]

Freetext Templates:

SEDIMENT

- Concentrations:

- Sampling interval:

- Sample storage before analysis:

PORE WATER

- Concentrations:

- Sampling interval:

- Sample storage before analysis:

OVERLYING WATER

- Concentrations:

- Sampling interval:

- Sample storage before analysis:

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.

Details on sampling.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:SAMPLING_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.02.00.0480

Details on analytical methods

[Details on analytical methods]

Freetext Templates:

DETAILS ON PRETREATMENT

- Centrifugation:

- Filtration:

- Digestion (acid used, method: e.g. micro-oven):

- Extraction (solvent used, method: e.g. liquid-liquid, SPE; solid/liquid by soxhlet or ASE):

- Clean up method: e.g. chemical used for chemistry method (Cu, Hg, ...) or phase and solvent used for SPE method:

- Derivatisation method if used:

- Concentration (method):

IDENTIFICATION AND QUANTIFICATION OF TEST SUBSTANCE/PRODUCT

- Separation method (e.g. HPLC, GC):

- Conditions (column, mobile phase, etc.):

- Detection method (e.g. ECD, UV, MS, ICP-AES, ICP-MS):

- Detection limits (LOD, LOQ) (indicate method of determination/calculation):

- Reproducibility in % (indicate method of evaluation; should be given for stated concentration levels):

- Linearity range:

- Internal or external calibration:

- Extraction recovery (indicate if results are corrected or not for recoveries):

- Method of confirmation of identity of measured compound:

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.

Details on the analytical method used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:ANALYT_METHOD_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.02.00.0490

Vehicle

[Vehicle]

Picklist Values:

yes || no || no data

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

Indicator that a chemical was used to emulsify or mix the experimental test material to enhance its solubility.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:VEHICLE>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE06.02.00.0500

Details on sediment and application

[Details on sediment and application]

Freetext Templates:

PREPARATION OF SPIKED SEDIMENT

- Pooling or mixing of different substrates:

- Method of mixing:

- Details of spiking:

- Equilibration time:

- Equilibration conditions:

- Controls:

- Chemical name of vehicle (organic solvent, emulsifier or dispersant):

- Concentration of vehicle in test medium (stock solution and final test solution):

- Evaporation of vehicle before use:

PREPARATION OF SPIKED WATER

- Details of spiking:

- Controls:

- Chemical name of vehicle (organic solvent, emulsifier or dispersant):

- Concentration of vehicle in final test 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.

Additional details on sediment and application.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:SEDIMENT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.02.00.0505

Test organisms

[Test organisms]

Subheading of section 'Test organisms'

SE06.02.00.0510

Test organisms (species)

[Test organisms (species)]

Picklist Values:

Ampelisca abdita || Arenicola marina || Branchiura sowerbyi || Caenorhabditis elegans || Chironomus riparius || Chironomus sp. || Chironomus tentans || Chironomus yoshimatsui || Corophium arenarium || Corophium sp. || Corophium volutator || Echinocardium cordatum || Diporeia sp. || Eohaustorius estuarius || Gammarus sp || Hexagenia sp. || Hyalella azteca || Hyalella sp. || Leptocheirus plumulosus || Lumbriculus variegatus || Neanthes arenaceodentata || Neanthes sp. || nematodes || Nereis sp. || Rana catesbaeana (frog tadpole) || Rhepoxynius abronius || Tubifex tubifex || other:

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

The test species or organism in an experimental study.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE06.02.00.0511

Test organisms (species)

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE06.02.00.0520

Details on test organisms

[Details on test organisms]

Freetext Templates:

TEST ORGANISM

- Common name:

- Strain/clone:

- Justification for species other than prescribed by test guideline:

- Source:

- Details on collection:

- Age of parental stock (mean and range, SD):

- Breeding conditions:

- Handling of egg masses and larvae:

- Age of animals at beginning of exposure:

- Synchronisation of worms prior to testing:

- Feeding during test

- Food type:

- Amount:

- Frequency:

ACCLIMATION

- Acclimation period:

- Acclimation conditions (same as test or not):

- Type and amount of food:

- Feeding frequency:

- Health during acclimation (any mortality observed):

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.

Details on test organisms and acclimation.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:ORGANISM_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.02.00.0525

Study design

[Study design]

Subheading of section 'Study design'

SE06.02.00.0530

Study type

[Study type]

Picklist Values:

laboratory study || extended laboratory study || semi-field study || field study || other:

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

Indicator specifying the type of study, e.g. laboratory or semi-field study

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:STUDYTYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE06.02.00.0531

Study type

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:STUDYTYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE06.02.00.0540

Test duration type

[Test duration type]

Picklist Values:

short-term toxicity || long-term toxicity

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.

Indicator specifying test duration type, i.e. either short-term or long-term.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:TEST_DURATION_TYPE>

<i5:set>

<i5:LIST_BELOW_POP>

<i5:LIST_BELOW_POP>

SE06.02.00.0550

Test type

[Test type]

Picklist Values:

static || semi-static || flow-through || other: || no data

Select appropriate test type.

Indicator showing whether medium was supplied in a static, semi-static or flow-through way.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:TESTTYPE_AQUATOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE06.02.00.0551

Test type

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:TESTTYPE_AQUATOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE06.02.00.0560

Water media type

[Water media type]

Picklist Values:

freshwater || saltwater || brackish water || no data

Indicate whether organisms were tested in fresh-/salt- or brackish/estuarine water.

Indicator specifying whether organisms were tested in fresh-/salt- or brackish/estuarine water.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:WATERTYPE>

<i5:set>

<i5:LIST_RIGHT_POP>

<i5:LIST_RIGHT_POP>

SE06.02.00.0570

Type of sediment

[Type of sediment]

Picklist Values:

natural sediment || artificial sediment || no data

Indicate whether natural or formulated sediment was used as substrate

Indicator specifying the type of substrate for exposure

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:SEDIMENT_TYPE>

<i5:set>

<i5:LIST_BELOW_POP>

<i5:LIST_BELOW_POP>

SE06.02.00.0580

Limit test

[Limit test]

Picklist Values:

yes || no

Indicate if the experiment was a limit test.

An indicator that the experiment was a limit test.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:LIMIT_TEST>

<i5:set>

<i5:LIST_RIGHT_SEL>

<i5:LIST_RIGHT_SEL>

SE06.02.00.0590

Duration

[Total exposure duration]

Enter numeric value.

Numeric value of exposure duration.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EXP_DURATION>

<i5:set>

<i5:VALUEUNIT_VALUE>

<i5:VALUE>

SE06.02.00.0600

Unit

[Total exposure duration]

Picklist Values:

min || h || d || wk

Select from drop-down list.

Unit of exposure duration

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EXP_DURATION>

<i5:set>

<i5:VALUEUNIT_VALUE>

<i5:UNIT>

SE06.02.00.0610

Remarks

[Remarks]

Enter any remarks related to the total exposure duration.

Remarks on exposure duration.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EXP_DURATION>

<i5:set>

<i5:REM>

<i5:REM>

SE06.02.00.0620

Post exposure observation period

[Post exposure observation period]

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

Observation period after last exposure to the test chemical.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:POSTEXP_PERIOD>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.02.00.0625

Test conditions

[Test conditions]

Subheading of section 'Test conditions'

SE06.02.00.0630

Hardness

[Hardness]

For freshwater tests, indicate water hardness as mg/L calcium carbonate equivalent values measured in the treatment and control solutions during test. Include range, mean, standard deviation and unit. 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.

The concentration of calcium and magnesium ions in water, measured as mg/L calcium carbonate equivalent.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:HARDNESS>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.02.00.0640

Test temperature

[Test temperature]

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 (e.g. water bath, test chambers) 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.

The temperature used in the experimental determination of the test value.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:TEST_TEMP>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.02.00.0650

pH

[pH]

Indicate pH values measured in the treatment and control vessels during test. Include range, mean, standard deviation and unit. 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.

The pH value applicable to the measured test value or mean or range.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:PH>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.02.00.0660

Dissolved oxygen

[Dissolved oxygen]

Indicate dissolved oxygen values measured in the treatment and control solutions during test. Include range, mean, standard deviation and unit. 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.

The amount of soluble oxygen in water including mean or range.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:DISS_OXYGEN>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.02.00.0670

Salinity

[Salinity]

For marine studies, indicate salinity values measured in the treatment and control solutions during test. Include range, mean, standard deviation and unit. 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.

The salinity used in the experimental determination of the test value.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:SALINITY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.02.00.0680

Ammonia

[Ammonia]

Indicate the ammonia concentration measured in the treatment and control solutions during test. Include range, mean, standard deviation and unit. 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.

The amount of ammonia in water including mean or range.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:AMMONIA>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.02.00.0690

Nominal and measured concentrations

[Nominal and measured concentrations]

REMARKS:

Available predefined table(s) are displayed below, after this template. See also List of Predefined Tables in Annex 2.

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.

Nominal and, if available, measured test concentrations (with unit) and/or reference to table.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:NOM_MEAS_CONC>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.02.00.0700

Details on test conditions

[Details on test conditions]

Freetext Templates:

TEST SYSTEM

- Test container (material, size):

- Sediment volume:

- Weight of wet sediment with and without pore water:

- Overlying water volume:

- Depth of sediment and overlying water:

- Aeration: yes/no

- Aeration frequency and intensity:

- Replacement of evaporated test water, if any:

EXPOSURE REGIME

- No. of organisms per container (treatment):

- No. of replicates per treatment group:

- No. of replicates per control / vehicle control:

- Feeding regime:

- Type and preparation of food:

- Amount of food:

RENEWAL OF OVERLYING WATER

- Details on volume additions:

- Flow-rate:

OVERLYING WATER CHARACTERISTCS

- Type of water (e.g. deionized, ground water, sea water, Elendt medium acc. to OECD 219, reconst. water acc. to OECD 203):

- Source of water (if non-standard medium)

- Location:

- Description of sampling site:

- Filtration:

- Alkalinity:

- Salinity:

- Conductivity:

- Particulate matter:

- Total organic carbon:

- Chemical oxygen demand:

- Unionized/total ammonia:

- Residual chlorine:

- Total organic chlorine compounds and PCBs:

- Total organophosphorous compounds:

- Total organic chlorine:

SOURCE OF NATURAL SEDIMENT

- Location and description of sampling site:

- Contamination history of site:

HANDLING OF NATURAL SEDIMENT

- Time of collection:

- Core depth:

- Water depth:

- Storage conditions:

- Storage duration (prior to test):

CHARACTERIZATION OF (ARTIFICIAL; delete if not applicable) SEDIMENT

- % dry weight of sphagnum moss peat:

- Particle size distribution

- % sand:

- % silt:

- % clay:

- % water content:

- Composition (if artificial substrate):

- Method of preparation (if artificial substrate):

- Maturation of artificial substrate (if any): yes/no

- Colour/texture:

- Moisture:

- Presence of macrophytes/animals:

- Food source incorporated into sediment:

- Further constituents

- Metals:

- Sulfides:

- Organic compounds:

- Total volatile solids:

- Acid volatile sulfides:

- Oil and grease:

- Petroleum hydrocarbons:

- Other:

- Eh:

- Sediment sieved: yes/no

- pH pore water:

- pH dry matter and/or whole sediment:

- Ammonia content of pore water:

- Total organic carbon (%):

- Total inorganic carbon (%):

- BOD:

- COD:

- CEC:

- Proof of absence of chemical contaminants:

OTHER TEST CONDITIONS

- Light quality:

- Photoperiod:

- Light intensity:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

VEHICLE CONTROL PERFORMED: yes/no

TEST CONCENTRATIONS

- Spacing factor for test concentrations:

- Justification for using less concentrations than requested by guideline:

- Range finding study

- Test concentrations:

- Results used to determine the conditions for the definitive study:

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.

Further details on test conditions.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:TESTCONDIT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.02.00.0710

Reference substance (positive control)

[Reference substance (positive control)]

Picklist Values:

yes || no || no data

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.

Indicator specifying whether reference substance(s) was/were tested and identity and concentrations in supplementary remarks field.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:REFERENCE_SUBSTANCE>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE06.02.00.0711

Reference substance (positive control)

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:REFERENCE_SUBSTANCE>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE06.02.00.0720

Any other information on materials and methods incl. tables

[Any other information on materials and methods incl. tables]

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

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

Rich text editor field for creating formatted text and tables or inserting and editing any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE06.02.00.0725

RESULTS AND DISCUSSION

[Results and discussions]

Main heading under which generic 'Results and discussion' fields are subsumed.

SE06.02.00.0729

Effect concentrations

[Effect concentrations]

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

Heading of field block 'Effect concentrations'

SE06.02.00.0730

Exposure duration

[Duration]

Enter numeric value.

Numeric value of exposure duration to which the effect concentration refers.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EFFCONC>

<i5:set>

<i5:VALUEUNIT_EXP_DURATION_VALUE>

<i5:EXP_DURATION_VALUE>

SE06.02.00.0740

Unit

[Effect concentrations]

Picklist Values:

min || h || d || wk

Select from drop-down list.

Unit of exposure duration

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EFFCONC>

<i5:set>

<i5:VALUEUNIT_EXP_DURATION_VALUE>

<i5:EXP_DURATION_UNIT>

SE06.02.00.0750

Endpoint

[Endpoint]

Picklist Values:

LC0 || LC10 || LC50 || LC100 || EC0 || EC10 || EC50 || EC100 || LD0 || LD10 || LD50 || LD100 || LR0 || LR10 || LR50 || LR100 || NOEC || LOEC || other:

Select from drop-down list.

Endpoint type, e.g. LC50, to which the effect concentration refers.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EFFCONC>

<i5:set>

<i5:PHRASEOTHER_ENDPOINT>

<i5:ENDPOINT>

SE06.02.00.0751

Endpoint

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EFFCONC>

<i5:set>

<i5:PHRASEOTHER_ENDPOINT>

<i5:ENDPOINT_TXT>

SE06.02.00.0760

Effect concentration

[Effect conc.]

Picklist Values:

> || >= || ca.

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').

Effect concentration: Lower qualifier field providing a list with following operators: >, >=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE06.02.00.0770

Effect concentration

[no label]

Effect concentration: Lower numeric field for entering a numeric value preceded either by no operator, '>', '>=' or 'ca.' (e.g. '20', '>20', '>=20', '20')

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE06.02.00.0780

Effect concentration

[no label]

Picklist Values:

< || <= || ca.

Effect concentration: Upper qualifier field providing a list with following operators: <, <=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE06.02.00.0790

Effect concentration

[no label]

Effect concentration: Upper numeric field for entering a numeric value only if either a lower value is already entered to specify a numeric range or if the numeric value is preceded by either operator '<' or '<='.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE06.02.00.0800

Unit of effect concentrations

[Effect concentrations]

Picklist Values:

ng/kg sediment dw || µg/kg sediment dw || mg/kg sediment dw || ng/L || µg/L || mg/L || other:

Select from drop-down list.

Unit of effect concentrations

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT>

SE06.02.00.0801

Unit of effect concentrations

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT_TXT>

SE06.02.00.0810

Basis for concentration

[Nominal/Measured]

Picklist Values:

nominal || meas. (initial) || meas. (geom. mean) || meas. (arithm. mean) || meas. (TWA) || meas. (not specified) || acid equivalent || estimated || no data

Indicate whether the effect concentration is based on nominal, measured (initial / geometric mean / arithmetic mean), measured (time weighted average = TWA), measured (not specified), acid equivalent or estimated. Select 'no data' if not known.

Indication of whether the effect concentration is based on (mean/initial) measured, nominal or estimated concentrations.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EFFCONC>

<i5:set>

<i5:BASIS_CONC>

<i5:BASIS_CONC>

SE06.02.00.0820

Effect concentration type

[Conc. based on]

Picklist Values:

test mat. || act. ingr. || element || dissolved || labile/free || other: || no data

Indicate whether the concentration is based on the test material (test matl), active ingredient (act. ingr.), element, dissolved (if inorganic non-metal), labile/free (if metal) or other (specify). Further information can be given in the supplementary remarks field.

Select 'no data' if effect concentration type is not known.

Indication of whether the concentration is based on the test material, active ingredient, free metal etc.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EFFCONC>

<i5:set>

<i5:PHRASEOTHER_EFF_CONC_TYPE>

<i5:EFF_CONC_TYPE>

SE06.02.00.0821

Effect concentration type

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EFFCONC>

<i5:set>

<i5:PHRASEOTHER_EFF_CONC_TYPE>

<i5:EFF_CONC_TYPE_TXT>

SE06.02.00.0830

Basis for effect

[Basis for effect]

Picklist Values:

emergence rate || development rate || growth rate || mortality || total number of worms || reproduction || morphology || behaviour || biomass || other:

Select effect parameter such as development, which the effect concentration relates to. As appropriate include further details in the supplementary remarks field, e.g. 'mean development rate, male and female midges pooled'.

Effect parameter such as mortality or behaviour, which the effect concentration relates to.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EFFCONC>

<i5:set>

<i5:PHRASEOTHER_BASIS_EFFECT>

<i5:BASIS_EFFECT>

SE06.02.00.0831

Basis for effect

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EFFCONC>

<i5:set>

<i5:PHRASEOTHER_BASIS_EFFECT>

<i5:BASIS_EFFECT_TXT>

SE06.02.00.0840

Remarks (e.g. 95% CL)

[Remarks (e.g. 95% CL)]

For robust study summaries or as requested by the regulatory programme, provide the 95% confidence limits and/or any relevant short remarks.

Remarks on effect concentration.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:EFFCONC>

<i5:set>

<i5:REM>

<i5:REM>

SE06.02.00.0850

Details on results

[Details on results]

REMARKS:

Available predefined table(s) are displayed below, after this template. See also List of Predefined Tables in Annex 2.

Freetext Templates:

- Mortality of test animals at end of exposure period:

- Total mass of test animals at beginning of test:

- Changes in body weigthH58 of live adults (% of initial weight) at end of exposure period:

- No. of offspring produced:

- No. of emerged male and female midges (per vessel and per day):

- No. of pupae failing to emerge (per vessel and per day):

- Percent emergence per replicate and test concentration:

- Mean development rate of fully emerged midges (per replicate and treatment rate; male and female midges pooled):

- Mean individual dry weight of larvae (per larvae and per instar):

- Number of living worms per replicate:

- Number of dead worms per replicate:

- Total biomass per replicate:

- Morphological abnormalities:

- Behavioural abnormalities:

- Other biological observations:

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.

Additional information on results

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:RESULTS_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.02.00.0860

Results with reference substance (positive control)

[Results with reference substance (positive control)]

Freetext Templates:

- Results with reference substance valid?

- Relevant effect levels:

- Other:

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.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:RS_REF_SUBSTANCE>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.02.00.0870

Reported statistics and error estimates

[Reported statistics and error estimates]

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.

Indication of statistical data and error estimates associated with the determination of the concentration-response relationship.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:STATISTICS>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE06.02.00.0880

Any other information on results incl. tables

[Any other information on results incl. tables]

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.

Rich text editor field for creating formatted text and tables or inserting and editing any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:REM_RS>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE06.02.00.0885

OVERALL REMARKS, ATTACHMENTS

[Overall remarks, attachments]

Main heading under which 'Overall remarks, attachments' fields are subsumed.

SE06.02.00.0890

Overall remarks

[Overall remarks]

In this field, you can enter any overall remarks or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

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

Rich text editor field for creating formatted text and tables or inserting and editing any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE06.02.00.0899

Attached background material

[Attached background material]

Attach any background document that cannot be inserted in any rich text editor field, particularly image files (e.g. an image of a structural formula).

Copy this block of fields for attaching more than one file.

Heading of field block 'Attached document'.

SE06.02.00.0900

Attached document

[Attached document]

Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document.

File name of document uploaded, i.e. attached. No restriction as to file type.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:AD>

<i5:set>

<i5:DOC>

<i5:DOC>

SE06.02.00.0910

Remarks

[Remarks]

As appropriate, include remarks, e.g. a short description of the content of the attached document if the file name is not self-explanatory.

Remarks on attached document.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:AD>

<i5:set>

<i5:REM>

<i5:REM>

SE06.02.00.0919

Attached full study report

[Attached full study report]

If required, an electronic copy of the full study report can be attached as WORD, pdf or other document type, which will not be integrated in any report, but must be handled as separate files.

Note: In the export administration you can indicate whether the attached files should be included in the data export or not.

Attached full study report

SE06.02.00.0920

Attached full study report

[Attached full study report]

Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document.

Attached full study report

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:AD_STUDYREPORT>

<i5:set>

<i5:ATTACHMENT_BELOW>

<i5:ATTACHMENT_BELOW>

SE06.02.00.0922

Illustration (picture/graph)

[Illustration (picture/graph)]

Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document.

Illustration (picture/graph)

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:PG_ILLUSTRATION>

<i5:set>

<i5:PIC_BELOW>

<i5:PIC_BELOW>

SE06.02.00.0925

Applicant's summary and conclusion

[Applicant's summary and conclusion]

SE06.02.00.0930

Validity criteria fulfilled

[Validity criteria fulfilled]

Picklist Values:

yes || no || no data || not applicable

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. deficiencies' as to why this study summary is considered reliable.

Indication of validity criteria and whether they have been fulfilled or not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:VALIDITY_CRIT_SUBM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE06.02.00.0931

Validity criteria fulfilled

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:VALIDITY_CRIT_SUBM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE06.02.00.0940

Conclusions

[Conclusions]

Enter any conclusions if applicable.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:APPL_CL>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE06.02.00.0950

Executive summary

[Executive summary]

If required by the respective national/regional programme, briefly summarise the relevant aspects of the study including the conclusions reached. If a specific format is prescribed, upload the respective freetext template if available from the drop-down list or copy it from the corresponding document.

Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:APPL_EXEC_SUM>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE06.02.00.0960

Cross-reference to other study

[Cross-reference to other study]

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

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

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_SEDIMENTDWELLINGTOX>

<i5:CROSSREF_OTHER_STUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>