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.

SE05.02.01.0215

DATA SOURCE

[Data source]

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

SE05.02.01.0219

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'

SE05.02.01.0220

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 Select 'Other company data' to characterise any unpublished information from a company other than a study report. Select 'Grey literature' for any other unpublished information or 'other:' and specify.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:TO_BIODEG_WATER_SCREEN>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE05.02.01.0221

Reference type

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE05.02.01.0230

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:TO_BIODEG_WATER_SCREEN>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE05.02.01.0240

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE05.02.01.0250

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).

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE05.02.01.0260

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:TO_BIODEG_WATER_SCREEN>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE05.02.01.0270

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE05.02.01.0280

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE05.02.01.0290

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:TO_BIODEG_WATER_SCREEN>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE05.02.01.0300

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE05.02.01.0310

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE05.02.01.0320

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:TO_BIODEG_WATER_SCREEN>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE05.02.01.0321

Data access

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE05.02.01.0330

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE05.02.01.0331

Data protection claimed

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE05.02.01.0340

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:TO_BIODEG_WATER_SCREEN>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE05.02.01.0345

MATERIALS AND METHODS

[Materials and methods]

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

SE05.02.01.0350

Test type

[Test type]

Picklist Values:

ready biodegradability || inherent biodegradability || other: || no data

Indicate whether the study was a ready biodegradability test or inherent biodegradability test. If 'other:' is selected, specify.

NOTE: Any simulation test should be entered in the respective template.

Indication whether study was a biodegradability test or inherent biodegradability test or other: (to be specifed).

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:TEST_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE05.02.01.0351

Test type

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:TEST_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE05.02.01.0359

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'

SE05.02.01.0360

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' (if so, fill in field 'Principles of method if other than guideline').

- 'no guideline required' (if so, fill in field 'Principles of method if other than guideline').

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:TO_BIODEG_WATER_SCREEN>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE05.02.01.0370

Guideline

[Guideline]

Picklist Values:

OECD Guideline 301 A (old version) (Ready Biodegradability: Modified AFNOR Test) || OECD Guideline 301 A (new version) (Ready Biodegradability: DOC Die Away Test) || OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test) || OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I)) || OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test) || OECD Guideline 301 E (Ready biodegradability: Modified OECD Screening Test) || OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test) || OECD Guideline 302 A (Inherent Biodegradability: Modified SCAS Test) || OECD Guideline 302 B (Inherent biodegradability: Zahn-Wellens/EMPA Test) || OECD Guideline 302 C (Inherent Biodegradability: Modified MITI Test (II)) || OECD Guideline 302 D (Inherent Biodegradability - Concawe Test) || OECD Guideline 310 (Ready Biodegradability - CO2 in Sealed Vessels (Headspace Test) || OECD Guideline 311 (Anaerobic Biodegradability of Organic Compounds in Digested Sludge: Measurement of Gas Production) || EU Method C.4-A (Determination of the 'Ready' Biodegradability - Dissolved Organic Carbon (DOC) Die-Away Test) || EU Method C.4-B (Determination of the 'Ready' Biodegradability - Modified OECD Screening Test) || EU Method C.4-C (Determination of the 'Ready' Biodegradability - Carbon Dioxide Evolution Test) || EU Method C.4-D (Determination of the 'Ready' Biodegradability - Manometric Respirometry Test) || EU Method C.4-E (Determination of the 'Ready' Biodegradability - Closed Bottle Test) || EU Method C.4-F (Determination of the 'Ready' Biodegradability - MITI Test) || EU Method C.5 (Degradation: Biochemical Oxygen Demand) || EU Method C.6 (Degradation: Chemical Oxygen Demand) || EU Method C.9 (Biodegradation: Zahn-Wellens Test) || EU Method C.12 (Biodegradation: Modified SCAS Test) || EPA OPPTS 835.3100 (Aerobic Aquatic Biodegradation) || EPA OPPTS 835.3110 (Ready Biodegradability) || EPA OPPTS 835.3120 (Sealed Vessel Carbon Dioxide Production Test) || EPA OPPTS 835.3170 (Shake Flask Die-away Test) || EPA OPPTS 835.3200 (Zahn-Wellens / EMPA Test) || EPA OPPTS 835.3210 (Inherent Biodegradability: Modified SCAS Test) || EPA OPPTS 835.3400 (Anaerobic Biodegradability of Organic Chemicals) || EPA OPPTS 835.5045 (Modified SCAS Test for Insoluble and Volatile Chemicals) || EPA OTS 795.45 (Inherent Biodegradability: Modified SCAS Test for Chemical Substances that are Water Insoluble or Water Insoluble and Volatile) || EPA OTS 796.3100 (Aerobic Aquatic Biodegradation) || EPA OTS 796.3140 (Anaerobic Biodegradability of Organic Chemicals) || EPA OTS 796.3180 (Ready Biodegradability: Modified AFNOR Test) || EPA OTS 796.3200 (Ready Biodegradability: Closed Bottle Test) || EPA OTS 796.3220 (Ready Biodegradability: Modified MITI Test(I)) || EPA OTS 796.3240 (Ready Biodegradability: Modified OECD Screening Test) || EPA OTS 796.3260 (Ready Biodegradability: Modified Sturm Test) || EPA OTS 796.3340 (Inherent Biodegradability: Modified SCAS Test) || EPA OTS 796.3360 (Inherent Biodegradability: Modified Zahn-Wellens Test) || ECETOC Anaerobic Biodegradation (Technical Report No. 28) || ISO 5815 (Water quality - Determination of Biochemical Oxygen Demand after 5 Days (BOD5) - Dilution and Seeding Method) || ISO DP 6060 (Water Quality - Determination of the Chemical Oxygen Demand)... || ISO DIS 9408 (Ultimate Aerobic Biodegradability - Method by Determining the Oxygen Demand in a Closed Respirometer)...... || 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.

The name of the guideline followed in performing the study or to which the method used can be compared. Also indication if no guideline was used, available or required. In supplementary remarks field indication of guideline version or title if deviating from the picklist value., or of additional test guidelines cited.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE05.02.01.0371

Guideline

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE05.02.01.0380

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:TO_BIODEG_WATER_SCREEN>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE05.02.01.0381

Deviations from guideline

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE05.02.01.0390

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 'Study 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:TO_BIODEG_WATER_SCREEN>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE05.02.01.0400

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:TO_BIODEG_WATER_SCREEN>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE05.02.01.0401

GLP compliance

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE05.02.01.0405

Test materials

[Test materials]

Subheading of section 'Test materials'

SE05.02.01.0410

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

Select 'yes' or 'no' from the drop-down list for indicating that the identity of the test material is the same or is not the same, respectively, as for substance defined in section 1 (General information). In addition, the identity of the test material should be specified in the subsequent block of fields 'Test material identity'.

NOTE: You cannot update this field, if a completed record is copied to another submission substance as reference. Therefore, in case of read-across the indication of 'yes' is not relevant.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE05.02.01.0419

Test material identity

[Test material identity]

Indicate the identity of the test material for one or more appropriate identifiers, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields as appropriate.

NOTE: In order to avoid confusion on the test material identity it is highly recommended to enter at least one substance identifier, regardless of what has been entered in field 'Identity of test material same as for substance defined in section 1 (if not read-across)'.

Heading of field block 'Test material identity'

SE05.02.01.0420

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE05.02.01.0421

Identifier

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE05.02.01.0430

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:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:TESTMAT>

<i5:set>

<i5:ID>

<i5:ID>

SE05.02.01.0435

Physical form

[Test material form]

Picklist Values:

aerosol || compact || crystalline || dispersion || fibre || filaments || flakes || liquified gas || nanomaterial || particulates || paste || pellets || powder || refrigerated liquid || suspension || viscous || other: || no data

Select the test material form from the drop-down list. If the form of the test chemical is not available in the list, select 'other:' and specify in the adjacent field. If the test material form is unknown, select 'no data'.

Form of the substance, i.e. powder, crystalline, compact, viscous, etc.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM>

SE05.02.01.0436

Test material form

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM_TXT>

SE05.02.01.0440

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.02.01.0450

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:TO_BIODEG_WATER_SCREEN>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.02.01.0460

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:

- Henry's law constant (for volatile substances):

- Water solubility (under test conditions):

- Solubility in organic solvents:

- log Pow:

- pKa:

- Base or acid catalysis of test material:

- UV absorption:

- Stability of test material at room temperature:

- pH dependence on stability:

OTHER PROPERTIES (if relevant for this endpoint)

- Adsorption characteristics:

- Toxicity to microorganisms:

- Other:

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 study design' 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, e.g. lower water solubility.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:PROPERTIES_TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.02.01.0465

Study design

[Study design]

Subheading of section 'Study design'

SE05.02.01.0470

Oxygen conditions

[Oxygen conditions]

Picklist Values:

aerobic || anaerobic || other: || no data

Indicate whether test was performed under aerobic or anaerobic conditions. Include any explanations in the supplementary remarks field as appropriate.

Indication whether test was performed under aerobic or anaerobic conditions.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:OXYGEN_CONDITIONS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE05.02.01.0471

Oxygen conditions

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:OXYGEN_CONDITIONS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE05.02.01.0480

Inoculum or test system

[Inoculum or test system]

Picklist Values:

activated sludge (adaptation not specified) || activated sludge, adapted || activated sludge, non-adapted || activated sludge, domestic (adaptation not specified) || activated sludge, domestic, adapted || activated sludge, domestic, non-adapted || activated sludge, industrial (adaptation not specified) || activated sludge, industrial, adapted || activated sludge, industrial, non-adapted || sewage, domestic (adaptation not specified) || sewage, domestic, adapted || sewage, domestic, non-adapted || sewage, industrial (adaptation not specified) || sewage, industrial, adapted || sewage, industrial, non-adapted || sewage, predominantly domestic (adaptation not specified) || sewage, predominantly domestic, adapted || sewage, predominantly domestic, non-adapted || sewage, predominantly industrial (adaptation not specified) || sewage, predominantly industrial, adapted || sewage, predominantly industrial, non-adapted || anaerobic sludge || digested sludge || anaerobic bacteria || anaerobic microorganisms || natural water || natural water / sediment || natural sediment || natural soil || mixture of sewage, soil and natural water || other: || no data

Select the inoculum used. As far as possible, indicate whether any activated sludge or sewage used was adapted or not. If the study report does not give clear information thereof, select '..... (adaptation not specified)', e.g. 'sewage, domestic (adaptation not specified)'. In this case, give further explanation in field 'Details on inoculum', if any. In field 'Rationale for reliability', discuss the impact of this reporting deficiency on the study results.

If no inoculum was added in the strictest sense, but natural water and/or sediment was used, indicate the corresponding test system, e.g. 'natural water / sediment'.

Note that any simulation tests should be recorded using the corresponding template.

Type of inoculum or test system used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:INOCULUM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE05.02.01.0481

Inoculum or test system

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:INOCULUM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE05.02.01.0490

Details on inoculum

[Details on inoculum]

Freetext Templates:

- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure):

- Laboratory culture:

- Method of cultivation:

- Storage conditions:

- Storage length:

- Preparation of inoculum for exposure:

- Pretreatment:

- Concentration of sludge:

- Initial cell/biomass concentration:

- Water filtered: yes/no

- Type and size of filter used, if any:

Give details on inoculum as appropriate. Use freetext template and delete/add elements as appropriate.

Details on inoculum as appropriate.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:INOCULUM_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.02.01.0500

Duration

[Duration of test (contact time)]

Picklist Values:

> || >= || ca.

Enter numeric value(s) (incl. qualifier(s) if any) according to following conventions: (i) Enter single value with no qualifier (left blank) or preceded by '>', '>=' or 'ca.' in first numeric field; (ii) Enter single value preceded by '<' or '<=' in second numeric field; (iii) Enter range in both numeric fields including qualifier(s) if any.

Test (contact time): Lower qualifier field providing a list with following operators: >, >=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE05.02.01.0510

Duration

[no label]

Test (contact time): 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:TO_BIODEG_WATER_SCREEN>

<i5:DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE05.02.01.0520

Duration

[no label]

Picklist Values:

< || <= || ca.

Test (contact time): Upper qualifier field providing a list with following operators: <, <=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE05.02.01.0530

Duration

[no label]

Test (contact time): 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:TO_BIODEG_WATER_SCREEN>

<i5:DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE05.02.01.0540

Unit

[Duration of test (contact time)]

Picklist Values:

min || h || d || wk || mo || yr

Select from drop-down list.

Unit of time.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT>

SE05.02.01.0549

Initial test substance concentration

[Initial test substance concentration]

Specify the initial test concentration applied. If different concentrations were used in different test runs, copy this block of fields accordingly. If a range of concentrations is reported, include the lower and upper values in the numeric range field.

If appropriate copy this block of fields for indicating different parameters the initial concentration is based on (e.g. COD and test substance).

Heading of field block 'Initial test substance concentration'.

SE05.02.01.0550

Initial concentration

[Initial 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').

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:INITIALCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE05.02.01.0560

Initial concentration

[no label]

Initial 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:TO_BIODEG_WATER_SCREEN>

<i5:INITIALCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE05.02.01.0570

Initial concentration

[no label]

Picklist Values:

< || <= || ca.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:INITIALCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE05.02.01.0580

Initial concentration

[no label]

Initial 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:TO_BIODEG_WATER_SCREEN>

<i5:INITIALCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE05.02.01.0590

Unit

[Initial test substance concentration]

Picklist Values:

g/L || mg/L || mmol/L || mol/L || µg/L || µmol/L || other:

Select from drop-down list. Further information can be given in the supplementary remarks field.

Unit of initial test substance concentration.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:INITIALCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT>

SE05.02.01.0591

Unit

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:INITIALCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT_TXT>

SE05.02.01.0600

Based on

[Based on]

Picklist Values:

COD || DOC || ThOD/L || ThIC || test mat. || act. ingr. || formulation || other: || no data

From drop-down list, select the parameter on which the initial concentration is based.

Indication of parameter (e.g. COD, DOC) the initial test substance concentration was related to.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:INITIALCONC>

<i5:set>

<i5:PHRASEOTHER_PARAMETER>

<i5:PARAMETER>

SE05.02.01.0601

Based on

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:INITIALCONC>

<i5:set>

<i5:PHRASEOTHER_PARAMETER>

<i5:PARAMETER_TXT>

SE05.02.01.0609

Parameter followed for biodegradation estimation

[Parameter followed for biodegradation estimation]

Indicate the parameter used to measure biodegradation. Copy field for more than one parameter as appropriate. In supplementary remarks field, give relevant details on the method. For radiochemical measurement or test substance analysis use freetext template in field 'Details on analytical methods'.

Parameter used to measure biodegradation and, in supplementary remarks field, relevant details on the method..

SE05.02.01.0610

Parameter followed for biodegradation estimation

[Parameter followed for biodegradation estimation]

Picklist Values:

CH4 evolution || CO2 evolution || DOC removal || inorg. C analysis || O2 consumption || Radiochem. meas. || Test mat. analysis || TOC removal || other: || no data

Indicate the parameter used to measure biodegradation. Copy field for more than one parameter as appropriate. In supplementary remarks field, give relevant details on the method. For radiochemical measurement or test substance analysis use freetext template in field 'Details on analytical methods'.

Parameter used to measure biodegradation and, in supplementary remarks field, relevant details on the method..

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:PARAMETER_BIODEGRADATION>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE05.02.01.0611

Parameter followed for biodegradation estimation

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:PARAMETER_BIODEGRADATION>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE05.02.01.0620

Details on analytical methods

[Details on analytical methods]

Freetext Templates:

DETAILS ON PRETREATMENT

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

- Extraction (solvent used, method: e.g. liquid-liquid, SPE):

- Total 14C measurement:

- 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 PARENT COMPOUND

- 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):

- Recovery ratio of test material from inoculated vs. blank samples:

- Method of confirmation of identity of measured compound:

IDENTIFICATION AND QUANTIFICATION OF TRANSFORMATION PRODUCTS

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:TO_BIODEG_WATER_SCREEN>

<i5:ANALYT_METHOD_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.02.01.0630

Details on study design

[Details on study design]

Freetext Templates:

TEST CONDITIONS

- Composition of medium:

- Additional substrate:

- Solubilising agent (type and concentration if used):

- Test temperature:

- pH:

- pH adjusted: yes/no

- CEC (meq/100 g):

- Aeration of dilution water:

- Suspended solids concentration:

- Continuous darkness: yes/no

- Other:

TEST SYSTEM

- Culturing apparatus:

- Number of culture flasks/concentration:

- Method used to create aerobic conditions:

- Method used to create anaerobic conditions:

- Measuring equipment:

- Test performed in closed vessels due to significant volatility of test substance:

- Test performed in open system:

- Details of trap for CO2 and volatile organics if used:

- Other:

SAMPLING

- Sampling frequency:

- Sampling method:

- Sterility check if applicable:

- Sample storage before analysis:

- Other:

CONTROL AND BLANK SYSTEM

- Inoculum blank:

- Abiotic sterile control:

- Toxicity control:

- Other:

STATISTICAL METHODS:

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.

Details on study design

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:STUDYDESIGN_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.02.01.0639

Reference substance

[Reference substance]

Indicate identity of reference substance(s) used and give details in the supplementary remarks field as appropriate. Repeat field for each substance.

Indication if a test with a reference substance was performed.

SE05.02.01.0640

Reference substance

[Reference substance]

Picklist Values:

aniline || benzoic acid, sodium salt || acetic acid, sodium salt || ethylene glycol || diethylene glycol || laurylsulfonate || other: || not required || no data

Indicate identity of reference substance(s) used and give details in the supplementary remarks field as appropriate. Repeat field for each substance.

Indication if a test with a reference substance was performed.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:REFERENCE_SUBSTANCE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE05.02.01.0641

Reference substance

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:REFERENCE_SUBSTANCE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE05.02.01.0650

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:TO_BIODEG_WATER_SCREEN>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE05.02.01.0655

RESULTS AND DISCUSSION

[Results and discussions]

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

SE05.02.01.0660

Results of preliminary study

[Preliminary study]

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

Results from preliminary study performed, if any

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:PRELIM_STUDY_RS>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE05.02.01.0670

Test performance

[Test performance]

Report on any unusual observations during test or any other information affecting results. Give reasons for any rejection of the test results if applicable.

Note that any deviations from test procedure should be briefly stated in field 'Deviations from guideline'.

Description of any unusual observations during test, deviations from test procedure or any other information affecting results.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:TEST_PERFORMANCE>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE05.02.01.0679

% Degradation of test substance

[% Degradation of test substance]

Indicate percentage of degradation of test substance including standard deviation at the end of the study period. Indicate the parameter the percentage is based on and the sampling time. Copy this block of fields for recording the percentage values for different parameters.

Note that the degradation at different sampling time points (raw data) should be recorded in below field 'Details on results'.

NOTE: BOD*100/COD results should be entered in the respective fields below.

Heading of field block '% Degradation of test substance'.

SE05.02.01.0680

% degradation

[%Degr.]

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').

Percentage of degradation of test substance: Lower qualifier field providing a list with following operators: >, >=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:DEGRAD>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE05.02.01.0690

% degradation

[no label]

Percentage of degradation of test substance: 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:TO_BIODEG_WATER_SCREEN>

<i5:DEGRAD>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE05.02.01.0700

% degradation

[no label]

Picklist Values:

< || <= || ca.

Percentage of degradation of test substance: Upper qualifier field providing a list with following operators: <, <=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:DEGRAD>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE05.02.01.0710

% degradation

[no label]

Percentage of degradation of test substance: 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:TO_BIODEG_WATER_SCREEN>

<i5:DEGRAD>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE05.02.01.0720

Standard deviation

[St. dev.]

Enter numeric value.

Standard deviation of percentage of degradation of test substance.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:DEGRAD>

<i5:set>

<i5:STDEV>

<i5:STDEV>

SE05.02.01.0730

Parameter

[Parameter]

Picklist Values:

CH4 evolution || CO2 evolution || DOC removal || inorg. C analysis || O2 consumption || Radiochem. meas. || Test mat. analysis || TOC removal || other: || no data

From drop-down list, select the parameter on which the percentage is based. Further information can be given in the supplementary remarks field.

Parameter used to measure biodegradation.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:DEGRAD>

<i5:set>

<i5:PHRASEOTHER_PARAMETER>

<i5:PARAMETER>

SE05.02.01.0731

Parameter

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:DEGRAD>

<i5:set>

<i5:PHRASEOTHER_PARAMETER>

<i5:PARAMETER_TXT>

SE05.02.01.0740

Sampling time

[Sampling time]

Enter numeric value.

Sampling time

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:DEGRAD>

<i5:set>

<i5:VALUEUNIT_TIMEPOINT_VALUE>

<i5:TIMEPOINT_VALUE>

SE05.02.01.0750

Unit sampling time

[% Degradation of test substance]

Picklist Values:

min || h || d || wk || mo || yr

Select from drop-down list.

Unit of time.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:DEGRAD>

<i5:set>

<i5:VALUEUNIT_TIMEPOINT_VALUE>

<i5:TIMEPOINT_UNIT>

SE05.02.01.0760

Remarks

[Remarks]

Enter any remarks related to the recorded values as appropriate.

Remarks

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:DEGRAD>

<i5:set>

<i5:REM>

<i5:REM>

SE05.02.01.0770

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.

Record the degradation / elimination kinetics for the different types of test suspensions, i.e. percentage of degradation at different sampling time points.

For robust study summaries or as requested by the regulatory programme, include table(s) 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').

In field 'Attached background material', attach graph(s) with the full degradation or elimination curves for the test and reference substances, the lag phase, degradation phase, the 10-d window and slope.

For tests for ready biodegradability, in which oxygen consumption is used as analytical method (e.g. MITI method), a BOD curve against time should be attached. If requested by the regulatory programme, also include a table on the material (mass) balance of parent compound and transformation products and a table showing the percentage data for degradability measured as BOD, DOC and by specific chemical analysis (see predefined tables).

Detailed description of degradation / elimination kinetics for the different types of test suspensions, i.e. percentage of degradation at different sampling time points, or reference to results table.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:RESULTS_DETAILS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE05.02.01.0775

BOD5 / COD results

[BOD5 / COD results]

Subheading of section 'BOD5 / COD results'

SE05.02.01.0779

BOD5 / COD

[BOD5 / COD]

For BOD5 tests, copy this block of fields for entering BOD5 and COD values (or ranges if reported so) including the unit, and the ratio BOD5*100/COD (with no unit). If a BOD5/COD ratio is reported, multiply the original value by 100.

Include any raw data in field 'Any other information on results incl. tables'.

Heading of field block 'BOD5 / COD'

SE05.02.01.0780

Parameter

[BOD5 / COD]

Picklist Values:

BOD5 || COD || BOD5*100/COD

Select from drop-down list: BOD5, COD or BOD5*100/COD.

Indication of whether a block of fields refers to BOD5 , COD or the ratio BOD5*100/COD.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:BOD5>

<i5:set>

<i5:PARAMETER>

<i5:PARAMETER>

SE05.02.01.0790

Value

[BOD5 / COD]

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').

BOD5, COD or BOD*100/COD: Lower qualifier field providing a list with following operators: >, >=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:BOD5>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE05.02.01.0800

Value

[no label]

BOD5, COD or BOD*100/COD: 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:TO_BIODEG_WATER_SCREEN>

<i5:BOD5>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE05.02.01.0810

Value

[no label]

Picklist Values:

< || <= || ca.

BOD5, COD or BOD*100/COD: Upper qualifier field providing a list with following operators: <, <=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:BOD5>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE05.02.01.0820

Value

[no label]

BOD5, COD or BOD*100/COD: 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:TO_BIODEG_WATER_SCREEN>

<i5:BOD5>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE05.02.01.0830

Unit

[BOD5 / COD]

Picklist Values:

g O2/g test mat. || mg O2/g test mat. || other:

Select unit from drop-down list or leave empty if 'BOD5*100/COD' was selected as parameter.

Unit of BOD5 or COD. Ratio BOD5/COD with no unit.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:BOD5>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT>

SE05.02.01.0831

Unit

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:BOD5>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT_TXT>

SE05.02.01.0840

Results with reference substance

[Results with reference substance]

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

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:RS_REF_SUBSTANCE>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE05.02.01.0850

Overall remarks

[Any other information on results incl. tables]

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:TO_BIODEG_WATER_SCREEN>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE05.02.01.0855

OVERALL REMARKS, ATTACHMENTS

[Overall remarks, attachments]

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

SE05.02.01.0860

Remarks on results including tables and figures

[Remarks on results including tables and figures]

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:TO_BIODEG_WATER_SCREEN>

<i5:REM_ANYOTHER_2>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE05.02.01.0869

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'.

SE05.02.01.0870

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:TO_BIODEG_WATER_SCREEN>

<i5:AD>

<i5:set>

<i5:DOC>

<i5:DOC>

SE05.02.01.0880

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:TO_BIODEG_WATER_SCREEN>

<i5:AD>

<i5:set>

<i5:REM>

<i5:REM>

SE05.02.01.0889

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

SE05.02.01.0890

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:TO_BIODEG_WATER_SCREEN>

<i5:AD_STUDYREPORT>

<i5:set>

<i5:ATTACHMENT_BELOW>

<i5:ATTACHMENT_BELOW>

SE05.02.01.0892

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:TO_BIODEG_WATER_SCREEN>

<i5:PG_ILLUSTRATION>

<i5:set>

<i5:PIC_BELOW>

<i5:PIC_BELOW>

SE05.02.01.0895

APPLICANT'S SUMMARY AND CONCLUSION

[Applicant's summary and conclusion]

Main heading under which generic 'Applicant's summary and conclusion' fields are subsumed.

SE05.02.01.0900

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.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:VALIDITY_CRIT_SUBM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE05.02.01.0901

Validity criteria fulfilled

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:VALIDITY_CRIT_SUBM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE05.02.01.0910

Interpretation of results

[Interpretation of results]

Picklist Values:

under test conditions no biodegradation observed || readily biodegradable || readily biodegradable, but failing 10-day window || inherently biodegradable || inherently biodegradable, fulfilling specific criteria || inherently biodegradable, not fulfilling specific criteria || not inherently biodegradable || other:

Indicate overall interpretation of test results with respect to the possible biodegradability as given in the study report. For more detailed discussion of test results, use field 'Conclusions'.

Interpretation of test results with respect to the possible biodegradability as given in the study report.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:INTERPRET_RESULTS_SUBM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE05.02.01.0911

Interpretation of results

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:INTERPRET_RESULTS_SUBM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE05.02.01.0920

Conclusions

[Conclusions]

Enter any conclusions if applicable.

Any conclusions either as adapted from the study report / publication or indicated by the submitter.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:APPL_CL>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE05.02.01.0930

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.

Executive summary in which the relevant aspects of the study including the conclusions reached are briefly summarised.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:APPL_EXEC_SUM>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE05.02.01.0940

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.

A cross-reference to another study or other studies including explanatory text on why other results are relevant in the interpretation of the results of a given study, e.g. for supporting any conclusions.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_BIODEG_WATER_SCREEN>

<i5:CROSSREF_OTHER_STUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>